Difference between revisions of "Head and neck cancer - historical"
Warner-admin (talk | contribs) m (Text replacement - "8 PubMed" to "8/ PubMed") |
Warner-admin (talk | contribs) m (Text replacement - "As a general rule, this includes the inferior arm(s) of a randomized study, unless said regimens continue to be recommended by trustworthy sources such as the [http://www.nccn.org/professionals/physician_gls/f_guidelines.asp NCCN Guidelines]. " to "") |
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− | The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only | + | <span id="BackToTop"></span> |
+ | <div class="noprint" style="background-color:LightGray; position:fixed; bottom:2%; right:0.25%; padding-left:5px; padding-right:5px; margin: 15px; opacity:0.8; border-style: solid; border-color:DarkGray; border-width: 1px"> | ||
+ | [[#top|Back to Top]] | ||
+ | </div> | ||
+ | The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the [[Head_and_neck_cancer|main head and neck cancer page]] for current regimens. | ||
{| class="wikitable" style="float:right; margin-right: 5px;" | {| class="wikitable" style="float:right; margin-right: 5px;" | ||
|- | |- | ||
− | |<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] | + | |<div style="background-color: #fee0d1; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}" align="right"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Regimen |limit=10000|format=sum}} [[Tutorial#Regimens|regimens]] on this page</b></font></div> |
− | <div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] | + | <div style="background-color: #deebf6; border: 1px solid #808000; padding: 5px; {{border-radius|16px}}"><font size="4"><b>{{#ask: [[-Has subobject::{{FULLPAGENAME}}]] |?Variant |limit=10000|format=sum}} [[Tutorial#Variants|variants]] on this page</b></font></div> |
|} | |} | ||
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
=Locally advanced disease, definitive therapy= | =Locally advanced disease, definitive therapy= | ||
==Bleomycin, Methotrexate, Vinblastine/RT {{#subobject:b1cea5|Regimen=1}}== | ==Bleomycin, Methotrexate, Vinblastine/RT {{#subobject:b1cea5|Regimen=1}}== | ||
− | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen {{#subobject:7d2178|Variant=1}}=== | ===Regimen {{#subobject:7d2178|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 20: | Line 24: | ||
|1983-1986 | |1983-1986 | ||
|style="background-color:#1a9851"|Phase 3 (E-switch-ic) | |style="background-color:#1a9851"|Phase 3 (E-switch-ic) | ||
− | |[[#Bleomycin.2C_Methotrexate. | + | |[[#Bleomycin.2C_Methotrexate.2C_Vinblastine_888|Bleomycin, MTX, Vinblastine]], then [[#Radiation_therapy_888|RT]] |
| style="background-color:#91cf60" |Seems to have superior PFS | | style="background-color:#91cf60" |Seems to have superior PFS | ||
|- | |- | ||
Line 26: | Line 30: | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Bleomycin (Blenoxane)]] | + | *[[Bleomycin (Blenoxane)]] as follows: |
− | *[[Methotrexate (MTX)]] | + | **Cycles 1, 2, 4, 6: 30 units IV once on day 1, '''given second, six hours later''' |
− | *[[Vinblastine (Velban)]] | + | *[[Methotrexate (MTX)]] as follows: |
+ | **Cycles 1, 2, 4, 6: 200 mg IV once on day 2 | ||
+ | *[[Vinblastine (Velban)]] as follows: | ||
+ | **Cycles 1, 2, 4, 6: 6 mg/m<sup>2</sup> IV once on day 1, '''given first''' | ||
+ | ====Supportive therapy==== | ||
+ | *[[Leucovorin (Folinic acid)]] as follows: | ||
+ | **Cycles 1, 2, 4, 6: 45 mg (route not specified) once on day 3 | ||
====Radiotherapy==== | ====Radiotherapy==== | ||
− | *[[External_beam_radiotherapy|RT]] | + | *[[External_beam_radiotherapy|RT]] as follows: |
+ | **Cycles 3, 5, 7: 200 cGy per fraction x 10 fractions | ||
+ | '''14-day cycle for 7 cycles''' | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # Merlano M, Rosso R, Sertoli MR, Bonelli L, Margarino G, Grimaldi A, Benasso M, Gardin G, Corvó R, Scarpati D, Barbieri A, Pallestrini E, Castiglia G, Santelli A, Scasso F, Bottero G, Ciurlo E, Fracchia P, Moratti M, Santi L. Sequential versus alternating chemotherapy and radiotherapy in stage III-IV squamous cell carcinoma of the head and neck: a phase III study. J Clin Oncol. 1988 Apr;6(4):627-32. [https://doi.org/10.1200/JCO.1988.6.4.627 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2451713/ PubMed] | + | # Merlano M, Rosso R, Sertoli MR, Bonelli L, Margarino G, Grimaldi A, Benasso M, Gardin G, Corvó R, Scarpati D, Barbieri A, Pallestrini E, Castiglia G, Santelli A, Scasso F, Bottero G, Ciurlo E, Fracchia P, Moratti M, Santi L. Sequential versus alternating chemotherapy and radiotherapy in stage III-IV squamous cell carcinoma of the head and neck: a phase III study. J Clin Oncol. 1988 Apr;6(4):627-32. [https://doi.org/10.1200/JCO.1988.6.4.627 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/2451713/ PubMed] |
+ | |||
==Cetuximab & RT {{#subobject:5eb410|Regimen=1}}== | ==Cetuximab & RT {{#subobject:5eb410|Regimen=1}}== | ||
Cetuximab & RT: Cetuximab & '''<u>R</u>'''adiation '''<u>T</u>'''herapy | Cetuximab & RT: Cetuximab & '''<u>R</u>'''adiation '''<u>T</u>'''herapy | ||
− | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
− | ===Regimen variant #1, conventional RT ( | + | ===Regimen variant #1, conventional RT (6800 cGy) {{#subobject:6e9a4f|Variant=1}}=== |
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
Line 56: | Line 69: | ||
*[[Cetuximab (Erbitux)]] 400 mg/m<sup>2</sup> IV over 2 hours once 1 week before radiation therapy begins; then 250 mg/m<sup>2</sup> IV over 60 minutes once per week during course of radiation therapy | *[[Cetuximab (Erbitux)]] 400 mg/m<sup>2</sup> IV over 2 hours once 1 week before radiation therapy begins; then 250 mg/m<sup>2</sup> IV over 60 minutes once per week during course of radiation therapy | ||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | *[[Diphenhydramine (Benadryl)]] (or equivalent) 50 mg (route not specified) once per week, prior to | + | *[[Diphenhydramine (Benadryl)]] (or equivalent) 50 mg (route not specified) once per week, prior to cetuximab |
====Radiotherapy==== | ====Radiotherapy==== | ||
− | *Concurrent [[External_beam_radiotherapy|radiation therapy]] to primary tumor and lymph node metastases: | + | *Concurrent [[External_beam_radiotherapy|radiation therapy]] to primary tumor and lymph node metastases: 200 cGy fractions x 34 fractions, once per day, 5 days per week (total dose: 6800 cGy) |
− | *Concurrent [[External_beam_radiotherapy|radiation therapy]] to elective neck volumes: | + | *Concurrent [[External_beam_radiotherapy|radiation therapy]] to elective neck volumes: 160 cGy fractions x 34 fractions, once per day, 5 days per week (total dose: 5440 cGy) |
'''7-week course''' | '''7-week course''' | ||
</div></div><br> | </div></div><br> | ||
− | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
− | ===Regimen variant #2, conventional RT ( | + | ===Regimen variant #2, conventional RT (7000 cGy) {{#subobject:6e9a4f|Variant=1}}=== |
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
!style="width: 20%"|Study | !style="width: 20%"|Study | ||
Line 74: | Line 87: | ||
|1999-2002 | |1999-2002 | ||
|style="background-color:#1a9851"|Phase 3 (E-RT-esc) | |style="background-color:#1a9851"|Phase 3 (E-RT-esc) | ||
− | |[[ | + | |[[#Radiation_therapy|Radiation therapy]] |
− | |style="background-color:#91cf60"|Seems to have superior OS<br>Median OS: 49 vs 29.3 mo<br>(HR 0.74, 95% CI 0.57-0.97) | + | |style="background-color:#91cf60"|Seems to have superior OS (secondary endpoint)<br>Median OS: 49 vs 29.3 mo<br>(HR 0.74, 95% CI 0.57-0.97) |
|- | |- | ||
|[https://doi.org/10.1200/jco.2012.42.3988 Lefebvre et al. 2013 (TREMPLIN)] | |[https://doi.org/10.1200/jco.2012.42.3988 Lefebvre et al. 2013 (TREMPLIN)] | ||
Line 85: | Line 98: | ||
|[https://doi.org/10.1093/annonc/mdx299 Ghi et al. 2017 (GSTTC H&N07)] | |[https://doi.org/10.1093/annonc/mdx299 Ghi et al. 2017 (GSTTC H&N07)] | ||
|2008-2012 | |2008-2012 | ||
− | | style="background-color:#91cf61" |Non-randomized | + | | style="background-color:#91cf61" |Non-randomized part of phase 2/3 RCT |
| style="background-color:#d3d3d3" | | | style="background-color:#d3d3d3" | | ||
| style="background-color:#d3d3d3" | | | style="background-color:#d3d3d3" | | ||
Line 99: | Line 112: | ||
|style="background-color:#1a9851"|Phase 3 (E-switch-ooc) | |style="background-color:#1a9851"|Phase 3 (E-switch-ooc) | ||
|[[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]] | |[[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]] | ||
− | |style="background-color:#ffffbf"|Inconclusive whether non-inferior OS<br>Median OS: 42.9 vs 63.6 mo<br>(HR 1.11, 90% CI 0.89-1.38) | + | |style="background-color:#ffffbf"|Inconclusive whether non-inferior OS (primary endpoint)<br>Median OS: 42.9 vs 63.6 mo<br>(HR 1.11, 90% CI 0.89-1.38) |
|- | |- | ||
|} | |} | ||
<div class="toccolours" style="background-color:#cbd5e8"> | <div class="toccolours" style="background-color:#cbd5e8"> | ||
====Preceding treatment==== | ====Preceding treatment==== | ||
− | *TREMPLIN: [[Head_and_neck_cancer#DCF|TPF]] x 3 | + | *TREMPLIN: [[Head_and_neck_cancer#DCF|TPF]] induction x 3 |
− | *GSTTC H&N07: [[ | + | *GSTTC H&N07: [[#DCF|TPF]] x 3 versus [[Head_and_neck_cancer_-_null_regimens#No_induction|No]] induction |
</div> | </div> | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
Line 112: | Line 125: | ||
**IMCL-9815: A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose | **IMCL-9815: A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose | ||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | *[[Diphenhydramine (Benadryl)]] (or equivalent) 50 mg (route not specified) once per week, prior to | + | *[[Diphenhydramine (Benadryl)]] (or equivalent) 50 mg (route not specified) once per week, prior to cetuximab |
====Radiotherapy==== | ====Radiotherapy==== | ||
− | *Concurrent [[External_beam_radiotherapy|radiation therapy]], | + | *Concurrent [[External_beam_radiotherapy|radiation therapy]], 200 cGy fractions x 35 fractions, once per day, 5 days per week (total dose: 7000 cGy) |
'''7-week course''' | '''7-week course''' | ||
</div></div><br> | </div></div><br> | ||
− | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen variant #3, twice-daily RT {{#subobject:6e9a4f|Variant=1}}=== | ===Regimen variant #3, twice-daily RT {{#subobject:6e9a4f|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 129: | Line 142: | ||
|1999-2002 | |1999-2002 | ||
|style="background-color:#1a9851"|Phase 3 (E-RT-esc) | |style="background-color:#1a9851"|Phase 3 (E-RT-esc) | ||
− | |[[ | + | |[[#Radiation_therapy|Radiation therapy]] |
− | |style="background-color:#91cf60"|Seems to have superior OS<br>Median OS: 49 vs 29.3 mo<br>(HR 0.74, 95% CI 0.57-0.97) | + | |style="background-color:#91cf60"|Seems to have superior OS (secondary endpoint)<br>Median OS: 49 vs 29.3 mo<br>(HR 0.74, 95% CI 0.57-0.97)<br><br>Superior LRC (primary endpoint) |
|- | |- | ||
|} | |} | ||
Line 138: | Line 151: | ||
**A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose | **A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose | ||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | *[[Diphenhydramine (Benadryl)]] (or equivalent) 50 mg (route not specified) once per week, prior to | + | *[[Diphenhydramine (Benadryl)]] (or equivalent) 50 mg (route not specified) once per week, prior to cetuximab |
====Radiotherapy==== | ====Radiotherapy==== | ||
− | *Concurrent [[External_beam_radiotherapy|radiation therapy]], | + | *Concurrent [[External_beam_radiotherapy|radiation therapy]], 120 cGy fractions x 60 to 64 fractions, twice per day, 5 days per week (total dose: 72 to 7680 cGy) |
'''6- to 6.5-week course''' | '''6- to 6.5-week course''' | ||
</div></div><br> | </div></div><br> | ||
− | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
+ | |||
===Regimen variant #4, concomitant boost {{#subobject:6e9a4f|Variant=1}}=== | ===Regimen variant #4, concomitant boost {{#subobject:6e9a4f|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 155: | Line 169: | ||
|1999-2002 | |1999-2002 | ||
|style="background-color:#1a9851"|Phase 3 (E-RT-esc) | |style="background-color:#1a9851"|Phase 3 (E-RT-esc) | ||
− | |[[ | + | |[[#Radiation_therapy|Radiation therapy]] |
− | |style="background-color:#91cf60"|Seems to have superior OS<br>Median OS: 49 vs 29.3 mo<br>(HR 0.74, 95% CI 0.57-0.97) | + | |style="background-color:#91cf60"|Seems to have superior OS (secondary endpoint)<br>Median OS: 49 vs 29.3 mo<br>(HR 0.74, 95% CI 0.57-0.97) |
|- | |- | ||
|} | |} | ||
Line 164: | Line 178: | ||
**A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose | **A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose | ||
====Supportive therapy==== | ====Supportive therapy==== | ||
− | *[[Diphenhydramine (Benadryl)]] (or equivalent) 50 mg (route not specified) once per week, prior to | + | *[[Diphenhydramine (Benadryl)]] (or equivalent) 50 mg (route not specified) once per week, prior to cetuximab |
====Radiotherapy==== | ====Radiotherapy==== | ||
− | *Concurrent [[External_beam_radiotherapy|radiation therapy]] | + | *Concurrent [[External_beam_radiotherapy|radiation therapy]] as follows: |
− | ** | + | **First 3.6 weeks: 180 cGy fractions x 18 fractions (total dose: 3240 cGy), once per day, 5 days per week for 3.6 weeks |
− | ** | + | **Last 2.4 weeks, morning dose: 180 cGy fractions x 12 fractions (total dose: 2160 cGy), given 5 days per week over 2.4 weeks |
− | **Total dose for concomitant boost regimen: | + | **Last 2.4 weeks, afternoon dose: 150 cGy fractions x 12 fractions (total dose: 1800 cGy), given 5 days per week over 2.4 weeks |
+ | **Total dose for concomitant boost regimen: 7200 cGy | ||
'''6-week course''' | '''6-week course''' | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
− | # '''IMCL-9815:''' Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. [https://doi.org/10.1056/NEJMoa053422 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16467544/ PubMed] NCT00004227 | + | # '''IMCL-9815:''' Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. [https://doi.org/10.1056/NEJMoa053422 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16467544/ PubMed] [https://clinicaltrials.gov/study/NCT00004227 NCT00004227] |
## '''HRQoL analysis:''' Curran D, Giralt J, Harari PM, Ang KK, Cohen RB, Kies MS, Jassem J, Baselga J, Rowinsky EK, Amellal N, Comte S, Bonner JA. Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab. J Clin Oncol. 2007 Jun 1;25(16):2191-7. [https://doi.org/10.1200/jco.2006.08.8005 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/17538164/ PubMed] | ## '''HRQoL analysis:''' Curran D, Giralt J, Harari PM, Ang KK, Cohen RB, Kies MS, Jassem J, Baselga J, Rowinsky EK, Amellal N, Comte S, Bonner JA. Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab. J Clin Oncol. 2007 Jun 1;25(16):2191-7. [https://doi.org/10.1200/jco.2006.08.8005 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/17538164/ PubMed] | ||
## '''Update:''' Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. Epub 2009 Nov 10. [https://doi.org/10.1016/S1470-2045(09)70311-0 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/19897418/ PubMed] | ## '''Update:''' Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. Epub 2009 Nov 10. [https://doi.org/10.1016/S1470-2045(09)70311-0 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/19897418/ PubMed] | ||
## '''Subgroup analysis:''' Rosenthal DI, Harari PM, Giralt J, Bell D, Raben D, Liu J, Schulten J, Ang KK, Bonner JA. Association of Human Papillomavirus and p16 Status With Outcomes in the IMCL-9815 Phase III Registration Trial for Patients With Locoregionally Advanced Oropharyngeal Squamous Cell Carcinoma of the Head and Neck Treated With Radiotherapy With or Without Cetuximab. J Clin Oncol. 2016 Apr 20;34(12):1300-8. Epub 2015 Dec 28. [https://doi.org/10.1200/jco.2015.62.5970 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070577/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26712222/ PubMed] | ## '''Subgroup analysis:''' Rosenthal DI, Harari PM, Giralt J, Bell D, Raben D, Liu J, Schulten J, Ang KK, Bonner JA. Association of Human Papillomavirus and p16 Status With Outcomes in the IMCL-9815 Phase III Registration Trial for Patients With Locoregionally Advanced Oropharyngeal Squamous Cell Carcinoma of the Head and Neck Treated With Radiotherapy With or Without Cetuximab. J Clin Oncol. 2016 Apr 20;34(12):1300-8. Epub 2015 Dec 28. [https://doi.org/10.1200/jco.2015.62.5970 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070577/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26712222/ PubMed] | ||
<!-- Presented as oral presentations at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), Orlando, FL, May 29-June 2, 2009, and at the 47th Annual Meeting of ASCO, Chicago, IL, June 3-7, 2011. --> | <!-- Presented as oral presentations at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), Orlando, FL, May 29-June 2, 2009, and at the 47th Annual Meeting of ASCO, Chicago, IL, June 3-7, 2011. --> | ||
− | # '''TREMPLIN:''' Lefebvre JL, Pointreau Y, Rolland F, Alfonsi M, Baudoux A, Sire C, de Raucourt D, Malard O, Degardin M, Tuchais C, Blot E, Rives M, Reyt E, Tourani JM, Geoffrois L, Peyrade F, Guichard F, Chevalier D, Babin E, Lang P, Janot F, Calais G, Garaud P, Bardet E. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study. J Clin Oncol. 2013 Mar 1;31(7):853-9. Epub 2013 Jan 22. [https://doi.org/10.1200/jco.2012.42.3988 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23341517/ PubMed] NCT00169247 | + | # '''TREMPLIN:''' Lefebvre JL, Pointreau Y, Rolland F, Alfonsi M, Baudoux A, Sire C, de Raucourt D, Malard O, Degardin M, Tuchais C, Blot E, Rives M, Reyt E, Tourani JM, Geoffrois L, Peyrade F, Guichard F, Chevalier D, Babin E, Lang P, Janot F, Calais G, Garaud P, Bardet E. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study. J Clin Oncol. 2013 Mar 1;31(7):853-9. Epub 2013 Jan 22. [https://doi.org/10.1200/jco.2012.42.3988 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/23341517/ PubMed] [https://clinicaltrials.gov/study/NCT00169247 NCT00169247] |
− | # '''GSTTC H&N07:''' Ghi MG, Paccagnella A, Ferrari D, Foa P, Alterio D, Codecà C, Nolè F, Verri E, Orecchia R, Morelli F, Parisi S, Mastromauro C, Mione CA, Rossetto C, Polsinelli M, Koussis H, Loreggian L, Bonetti A, Campostrini F, Azzarello G, D'Ambrosio C, Bertoni F, Casanova C, Emiliani E, Guaraldi M, Bunkheila F, Bidoli P, Niespolo RM, Gava A, Massa E, Frattegiani A, Valduga F, Pieri G, Cipani T, Da Corte D, Chiappa F, Rulli E; GSTTC. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer: a phase II-III trial. Ann Oncol. 2017 Sep 1;28(9):2206-2212. [https://doi.org/10.1093/annonc/mdx299 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28911070/ PubMed] NCT01086826 | + | # '''GSTTC H&N07:''' Ghi MG, Paccagnella A, Ferrari D, Foa P, Alterio D, Codecà C, Nolè F, Verri E, Orecchia R, Morelli F, Parisi S, Mastromauro C, Mione CA, Rossetto C, Polsinelli M, Koussis H, Loreggian L, Bonetti A, Campostrini F, Azzarello G, D'Ambrosio C, Bertoni F, Casanova C, Emiliani E, Guaraldi M, Bunkheila F, Bidoli P, Niespolo RM, Gava A, Massa E, Frattegiani A, Valduga F, Pieri G, Cipani T, Da Corte D, Chiappa F, Rulli E; GSTTC. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer: a phase II-III trial. Ann Oncol. 2017 Sep 1;28(9):2206-2212. [https://doi.org/10.1093/annonc/mdx299 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28911070/ PubMed] [https://clinicaltrials.gov/study/NCT01086826 NCT01086826] |
− | # '''GORTEC 2007-01:''' Tao Y, Auperin A, Sire C, Martin L, Khoury C, Maingon P, Bardet E, Kaminsky MC, Lapeyre M, Chatellier T, Alfonsi M, Pointreau Y, Jadaud E, Géry B, Zawadi A, Tourani JM, Laguerre B, Coutte A, Racadot S, Hasbini A, Malaurie E, Borel C, Meert N, Cornely A, Ollivier N, Casiraghi O, Sun XS, Bourhis J. Improved outcome by adding concurrent chemotherapy to cetuximab and radiotherapy for locally advanced head and neck carcinomas: results of the GORTEC 2007-01 phase III randomized trial. J Clin Oncol. 2018 Nov 1;36(31):3084-90. Epub 2018 Jun 7. [https://doi.org/10.1200/JCO.2017.76.2518 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29878867/ PubMed] NCT00609284 | + | # '''GORTEC 2007-01:''' Tao Y, Auperin A, Sire C, Martin L, Khoury C, Maingon P, Bardet E, Kaminsky MC, Lapeyre M, Chatellier T, Alfonsi M, Pointreau Y, Jadaud E, Géry B, Zawadi A, Tourani JM, Laguerre B, Coutte A, Racadot S, Hasbini A, Malaurie E, Borel C, Meert N, Cornely A, Ollivier N, Casiraghi O, Sun XS, Bourhis J. Improved outcome by adding concurrent chemotherapy to cetuximab and radiotherapy for locally advanced head and neck carcinomas: results of the GORTEC 2007-01 phase III randomized trial. J Clin Oncol. 2018 Nov 1;36(31):3084-90. Epub 2018 Jun 7. [https://doi.org/10.1200/JCO.2017.76.2518 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/29878867/ PubMed] [https://clinicaltrials.gov/study/NCT00609284 NCT00609284] |
− | # '''ARTSCAN III:''' Gebre-Medhin M, Brun E, Engström P, Haugen Cange H, Hammarstedt-Nordenvall L, Reizenstein J, Nyman J, Abel E, Friesland S, Sjödin H, Carlsson H, Söderkvist K, Thomasson M, Zackrisson B, Nilsson P. ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer. J Clin Oncol. 2021 Jan 1;39(1):38-47. Epub 2020 Oct 14. [https://doi.org/10.1200/jco.20.02072 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7771720/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33052757/ PubMed] | + | # '''ARTSCAN III:''' Gebre-Medhin M, Brun E, Engström P, Haugen Cange H, Hammarstedt-Nordenvall L, Reizenstein J, Nyman J, Abel E, Friesland S, Sjödin H, Carlsson H, Söderkvist K, Thomasson M, Zackrisson B, Nilsson P. ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer. J Clin Oncol. 2021 Jan 1;39(1):38-47. Epub 2020 Oct 14. [https://doi.org/10.1200/jco.20.02072 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7771720/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/33052757/ PubMed] [https://clinicaltrials.gov/study/NCT01969877 NCT01969877] |
− | + | # '''TTCC-2007-01:''' Hitt R, Mesía R, Lozano A, Iglesias Docampo L, Grau JJ, Taberna M, Rubió-Casadevall J, Martínez-Trufero J, Morillo EDB, García Girón C, Vázquez Estévez S, Cirauqui B, Cruz-Hernández JJ. Randomized phase 3 noninferiority trial of radiotherapy and cisplatin vs radiotherapy and cetuximab after docetaxel-cisplatin-fluorouracil induction chemotherapy in patients with locally advanced unresectable head and neck cancer. Oral Oncol. 2022 Nov;134:106087. Epub 2022 Sep 18. [https://doi.org/10.1016/j.oraloncology.2022.106087 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36126605/ PubMed] [https://clinicaltrials.gov/study/NCT00716391 NCT00716391] | |
− | # '''GORTEC 2017-01:''' NCT02999087 | + | # '''GORTEC 2017-01:''' [https://clinicaltrials.gov/study/NCT02999087 NCT02999087] |
+ | |||
+ | ==Radiation therapy {{#subobject:5ac377|Regimen=1}}== | ||
+ | <div class="toccolours" style="background-color:#ee6b6e"> | ||
+ | ===Regimen {{#subobject:ce3d2d|Variant=1}}=== | ||
+ | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
+ | !style="width: 20%"|Study | ||
+ | !style="width: 20%"|Dates of enrollment | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
+ | !style="width: 20%"|Comparator | ||
+ | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
+ | |- | ||
+ | |[https://doi.org/10.2214/ajr.114.1.83 Gollin et al. 1972] | ||
+ | |1961-NR | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Fluorouracil_.26_RT|5-FU & RT]] | ||
+ | |style="background-color:#fc8d59"|Seems to have inferior OS<sup>1</sup> | ||
+ | |- | ||
+ | |rowspan=2|[https://doi.org/10.1016/0360-3016(90)90342-h Sanchíz et al. 1990] | ||
+ | |rowspan=2|1978-1988 | ||
+ | |rowspan=2 style="background-color:#1a9851"|Phase 3 (E-de-esc) | ||
+ | |1. [[Head_and_neck_cancer#Fluorouracil_.26_RT|5-FU & RT]] | ||
+ | | style="background-color:#d73027" |Inferior OS | ||
+ | |- | ||
+ | |2. [[#Radiation_therapy|RT]]; twice-daily | ||
+ | | style="background-color:#d73027" |Inferior OS | ||
+ | |- | ||
+ | |[https://doi.org/10.1056/NEJM199106133242402 Wolf et al. 1991] | ||
+ | |1985-NR | ||
+ | |style="background-color:#91cf61"|Non-randomized part of phase 3 RCT | ||
+ | |style="background-color:#d3d3d3"| | ||
+ | |style="background-color:#d3d3d3"| | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/jco.1994.12.2.385 Taylor et al. 1994a] | ||
+ | |1986-1991 | ||
+ | |style="background-color:#91cf61"|Non-randomized part of phase 3 RCT | ||
+ | |style="background-color:#d3d3d3"| | ||
+ | |style="background-color:#d3d3d3"| | ||
+ | |- | ||
+ | |[https://doi.org/10.1056/NEJM199210153271602 Merlano et al. 1992] | ||
+ | |1987-1990 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] | ||
+ | | style="background-color:#d73027" |Inferior OS<sup>2</sup> | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/JCO.1994.12.12.2648 Browman et al. 1994] | ||
+ | |1987-1991 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Fluorouracil_.26_RT|5-FU & RT]] | ||
+ | |style="background-color:#fee08b"|Might have inferior OS | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/JCO.1998.16.4.1318 Wendt et al. 1998] | ||
+ | |1989-1993 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Cisplatin.2C_Fluorouracil.2C_Folinic_acid.2C_RT_888|Cisplatin, 5-FU, LV, RT]] | ||
+ | | style="background-color:#d73027" |Inferior OS | ||
+ | |- | ||
+ | |[https://doi.org/10.1056/NEJM199806183382503 Brizel et al. 1998] | ||
+ | |1990-1995 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] | ||
+ | | style="background-color:#fee08b" |Might have inferior OS | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/JCO.2000.18.7.1458 Jeremic et al. 2000] | ||
+ | |1991-1993 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]] | ||
+ | | style="background-color:#d73027" |Inferior OS | ||
+ | |- | ||
+ | |rowspan=2|[https://doi.org/10.1200/jco.2003.01.008 Adelstein et al. 2003 (Head and Neck Intergroup)] | ||
+ | |rowspan=2|1992-1999 | ||
+ | |rowspan=2 style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |1. [[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] | ||
+ | |style="background-color:#ffffbf"|Did not meet primary endpoint of OS | ||
+ | |- | ||
+ | |2. [[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]] | ||
+ | |style="background-color:#fc8d59"|Seems to have inferior OS | ||
+ | |- | ||
+ | |[https://journals.sagepub.com/doi/abs/10.1177/030089161009600210 Ruo Redda et al. 2010] | ||
+ | |1992-1995 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Carboplatin_.26_RT|Carboplatin & RT]] | ||
+ | |style="background-color:#ffffbf"|Did not meet primary endpoint of LRC | ||
+ | |- | ||
+ | |[https://doi.org/10.1056/NEJMoa031317 Forastiere et al. 2003 (RTOG 91-11)] | ||
+ | |1992-2000 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Complex_multipart_regimens#RTOG_91-11|See link]] | ||
+ | |style="background-color:#fc8d59"|[[Complex_multipart_regimens#RTOG_91-11|See link]] | ||
+ | |- | ||
+ | |[https://academic.oup.com/jnci/article/91/24/2081/2964959 Calais et al. 1999 (GORTEC 94-01)] | ||
+ | |1994-1997 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Carboplatin.2C_Fluorouracil.2C_RT|Carboplatin, 5-FU, RT]] | ||
+ | |style="background-color:#fc8d59"|Seems to have inferior OS | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/JCO.2004.12.193 Huguenin et al. 2004 (SAKK 10/94)] | ||
+ | |1994-2000 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]] | ||
+ | |style="background-color:#ffffbf"|Did not meet primary endpoint of TTF | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/JCO.2005.07.010 Budach et al. 2005 (ARO 95-06)] | ||
+ | |1995-1999 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Fluorouracil.2C_Mitomycin.2C_RT|5-FU, Mitomycin, RT]] | ||
+ | |style="background-color:#fc8d59"|Seems to have inferior OS | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/s0167-8140(03)00020-3 Grau et al. 2003] | ||
+ | |1996-1999 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Mitomycin_.26_RT_999|Mitomycin & RT]] | ||
+ | |style="background-color:#ffffbf"|Did not meet primary endpoint of LRC | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/j.radonc.2011.07.006 Bourhis et al. 2011] | ||
+ | |1996-2000 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] | ||
+ | |style="background-color:#ffffbf"|Did not meet primary endpoint of EFS | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2724854/ Lefebvre et al. 2009 (EORTC 24954)] | ||
+ | |1996-2004 | ||
+ | |style="background-color:#1a9851"|Phase 3 (E-switch-ic) | ||
+ | |[[Complex_multipart_regimens#EORTC_24954|See link]] | ||
+ | |style="background-color:#ffffbf"|[[Complex_multipart_regimens#EORTC_24954|See link]] | ||
+ | |- | ||
+ | |[https://doi.org/10.1016/j.ijrobp.2005.09.041 Bensadoun et al. 2006 (FNCLCC 96003)] | ||
+ | |1997-2002 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_.26_RT|CF & RT]] | ||
+ | |style="background-color:#fc8d59"|Seems to have inferior OS | ||
+ | |- | ||
+ | |[https://doi.org/10.1056/NEJMoa053422 Bonner et al. 2006 (IMCL-9815)] | ||
+ | |1999-2002 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[#Cetuximab_.26_RT|Cetuximab & RT]] | ||
+ | |style="background-color:#fc8d59"|Seems to have inferior OS | ||
+ | |- | ||
+ | |[https://doi.org/10.1056/NEJMoa071028 Vermorken et al. 2007 (TAX 323)] | ||
+ | |1999-2002 | ||
+ | |style="background-color:#91cf61"|Non-randomized part of phase 3 RCT | ||
+ | |style="background-color:#d3d3d3"| | ||
+ | |style="background-color:#d3d3d3"| | ||
+ | |- | ||
+ | |[http://jnci.oxfordjournals.org/content/101/7/498.long Pointreau et al. 2009 (GORTEC 2000-01)] | ||
+ | |2000-2005 | ||
+ | |style="background-color:#91cf61"|Non-randomized part of phase 3 RCT | ||
+ | |style="background-color:#d3d3d3"| | ||
+ | |style="background-color:#d3d3d3"| | ||
+ | |- | ||
+ | |rowspan=2|[https://doi.org/10.1016/S1470-2045(11)70346-1 Bourhis et al. 2012 (GORTEC 99-02)] | ||
+ | |rowspan=2|2000-2007 | ||
+ | |rowspan=2 style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |1. [[Head_and_neck_cancer#Carboplatin.2C_Fluorouracil.2C_RT|Carboplatin, 5-FU, RT]] | ||
+ | |style="background-color:#fc8d59"|Seems to have inferior PFS | ||
+ | |- | ||
+ | |2. [[Head_and_neck_cancer#Carboplatin.2C_Fluorouracil.2C_RT|Carboplatin, 5-FU, RT]]; accelerated concurrent RT | ||
+ | |style="background-color:#fee08b"|Might have inferior PFS | ||
+ | |- | ||
+ | |rowspan=2|[https://doi.org/10.1002/hed.23865 Ghosh-Laskar et al. 2014] | ||
+ | |rowspan=2|2000-2007 | ||
+ | |rowspan=2 style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |1. [[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]] | ||
+ | | style="background-color:#fc8d59" |Seems to have inferior LRC | ||
+ | |- | ||
+ | |2. [[#Radiation_therapy|RT]]; accelerated | ||
+ | |style="background-color:#d3d3d3"|Not reported | ||
+ | |- | ||
+ | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5546524/ Yi et al. 2017] | ||
+ | |2002-2012 | ||
+ | |style="background-color:#1a9851"|Phase 3 (C) | ||
+ | |[[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]] | ||
+ | |style="background-color:#ffffbf"|Did not meet primary endpoint of OS | ||
+ | |- | ||
+ | |[https://doi.org/10.1200/jco.22.00980 Patil et al. 2023a] | ||
+ | |2017-07 to 2021-05 | ||
+ | |style="background-color:#1a9851"|Phase 2/3 (C) | ||
+ | |[[Head_and_neck_cancer#Docetaxel_.26_RT|Docetaxel & RT]] | ||
+ | | style="background-color:#d73027" |Inferior DFS24 | ||
+ | |- | ||
+ | |} | ||
+ | ''<sup>1</sup>Reported efficacy for Gollin et al. 1972 is based on the 1976 update, for oral lesions only.''<br> | ||
+ | ''<sup>2</sup>Reported efficacy in Merlano et al. 1992 is based on the 1995 update.''<br> | ||
+ | ''This is included for historical context and is unlikely to be further completed.'' | ||
+ | <div class="toccolours" style="background-color:#cbd5e8"> | ||
+ | ====Preceding treatment==== | ||
+ | *RTOG 91-11: [[#Cisplatin_.26_Fluorouracil_.28CF.29|CF]] x 3 versus [[Head_and_neck_cancer_-_null_regimens#No_induction|no]] induction | ||
+ | *Taylor et al. 1994a: [[#Cisplatin_.26_Fluorouracil_.28CF.29|CF]] induction x 7 | ||
+ | *GORTEC 2000-01: [[#Cisplatin_.26_Fluorouracil_.28CF.29|CF]] x 3 versus [[#DCF|TPF]] induction x 3 | ||
+ | *Wolf et al. 1991: [[#Cisplatin_.26_Fluorouracil_.28CF.29|CF]] induction x 3 | ||
+ | *TAX 323: [[#Cisplatin_.26_Fluorouracil_.28CF.29|CF]] x 4 versus [[#DCF|TPF]] induction x 4 | ||
+ | *EORTC 24954: [[#Cisplatin_.26_Fluorouracil_.28CF.29|CF]] induction x 4 | ||
+ | </div> | ||
+ | <div class="toccolours" style="background-color:#b3e2cd"> | ||
+ | ====Radiotherapy==== | ||
+ | *[[External beam radiotherapy]], varying regimens | ||
+ | </div></div> | ||
+ | |||
+ | ===References=== | ||
+ | # Gollin FF, Ansfield FJ, Brandenburg JH, Ramirez G, Vermund H. Combined therapy in advanced head and neck cancer: a randomized study. Am J Roentgenol Radium Ther Nucl Med. 1972 Jan;114(1):83-8. [https://doi.org/10.2214/ajr.114.1.83 link to original article] [https://pubmed.ncbi.nlm.nih.gov/4550551/ PubMed] | ||
+ | ## '''Update:''' Lo TC, Wiley AL Jr, Ansfield FJ, Brandenburg JH, Davis HL Jr, Gollin FF, Johnson RO, Ramirez G, Vermund H. Combined radiation therapy and 5-fluorouracil for advanced squamous cell carcinoma of the oral cavity and oropharynx: a randomized study. AJR Am J Roentgenol. 1976 Feb;126(2):229-35. [https://doi.org/10.2214/ajr.126.2.229 link to original article] [https://pubmed.ncbi.nlm.nih.gov/175693/ PubMed] | ||
+ | # Vermund H, Kaalhus O, Winther F, Trausjø J, Thorud E, Harang R. Bleomycin and radiation therapy in squamous cell carcinoma of the upper aero-digestive tract: a phase III clinical trial. Int J Radiat Oncol Biol Phys. 1985 Nov;11(11):1877-86. [https://doi.org/10.1016/0360-3016(85)90267-6 link to original article] [https://pubmed.ncbi.nlm.nih.gov/2414253/ PubMed] | ||
+ | # Sanchíz F, Millá A, Torner J, Bonet F, Artola N, Carreño L, Moya LM, Riera D, Ripol S, Cirera L. Single fraction per day versus two fractions per day versus radiochemotherapy in the treatment of head and neck cancer. Int J Radiat Oncol Biol Phys. 1990 Dec;19(6):1347-50. [https://doi.org/10.1016/0360-3016(90)90342-h link to original article] [https://pubmed.ncbi.nlm.nih.gov/2262356/ PubMed] | ||
+ | # Wolf GT, Fisher SG, Hong WK, Hillman R, Spaulding M, Laramore GE, Endicott JW, McClatchey K, Henderson WG; Department of Veterans Affairs Laryngeal Cancer Study Group. Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N Engl J Med. 1991 Jun 13;324(24):1685-90. [https://doi.org/10.1056/NEJM199106133242402 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/2034244/ PubMed] | ||
+ | # Merlano M, Vitale V, Rosso R, Benasso M, Corvò R, Cavallari M, Sanguineti G, Bacigalupo A, Badellino F, Margarino G, Brema F, Pastorino G, Marziano C, Grimaldi A, Scasso F, Sperati G, Pallestrini E, Garaventa G, Accomando E, Cordone G, Comella G, Daponte A, Rubagotti A, Bruzzi P, Santi L. Treatment of advanced squamous-cell carcinoma of the head and neck with alternating chemotherapy and radiotherapy. N Engl J Med. 1992 Oct 15;327(16):1115-21. [https://doi.org/10.1056/NEJM199210153271602 link to original article] [https://pubmed.ncbi.nlm.nih.gov/1302472/ PubMed] | ||
+ | ## '''Update:''' Merlano M, Benasso M, Corvò R, Rosso R, Vitale V, Blengio F, Numico G, Margarino G, Bonelli L, Santi L. Five-year update of a randomized trial of alternating radiotherapy and chemotherapy compared with radiotherapy alone in treatment of unresectable squamous cell carcinoma of the head and neck. J Natl Cancer Inst. 1996 May 1;88(9):583-9. [https://doi.org/10.1093/jnci/88.9.583 link to original article] [https://pubmed.ncbi.nlm.nih.gov/8609658/ PubMed] | ||
+ | # Taylor SG 4th, Murthy AK, Vannetzel JM, Colin P, Dray M, Caldarelli DD, Shott S, Vokes E, Showel JL, Hutchinson JC, Witt TR, Griem KL, Hartsell WF, Kies MS, Mittal B, Rebischung JL, Coupez DJ, Desphieux JL, Bobin S, LePajolec C. Randomized comparison of neoadjuvant cisplatin and fluorouracil infusion followed by radiation versus concomitant treatment in advanced head and neck cancer. J Clin Oncol. 1994 Feb;12(2):385-95. [https://doi.org/10.1200/jco.1994.12.2.385 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/8113846/ PubMed] | ||
+ | # Browman GP, Cripps C, Hodson DI, Eapen L, Sathya J, Levine MN. Placebo-controlled randomized trial of infusional fluorouracil during standard radiotherapy in locally advanced head and neck cancer. J Clin Oncol. 1994 Dec;12(12):2648-53. [https://doi.org/10.1200/JCO.1994.12.12.2648 link to original article] [https://pubmed.ncbi.nlm.nih.gov/7989940/ PubMed] | ||
+ | # Wendt TG, Grabenbauer GG, Rödel CM, Thiel HJ, Aydin H, Rohloff R, Wustrow TP, Iro H, Popella C, Schalhorn A. Simultaneous radiochemotherapy versus radiotherapy alone in advanced head and neck cancer: a randomized multicenter study. J Clin Oncol. 1998 Apr;16(4):1318-24. [https://doi.org/10.1200/JCO.1998.16.4.1318 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9552032/ PubMed] | ||
+ | # Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. [https://doi.org/10.1056/NEJM199806183382503 link to original article] [https://pubmed.ncbi.nlm.nih.gov/9632446/ PubMed] | ||
+ | # '''GORTEC 94-01:''' Calais G, Alfonsi M, Bardet E, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Oudinot P, Bertrand P. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999 Dec 15;91(24):2081-6. [https://academic.oup.com/jnci/article/91/24/2081/2964959 link to original article] [https://pubmed.ncbi.nlm.nih.gov/10601378/ PubMed] | ||
+ | ## '''Update:''' Denis F, Garaud P, Bardet E, Alfonsi M, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Calais G. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004 Jan 1;22(1):69-76. Epub 2003 Dec 2. [https://doi.org/10.1200/jco.2004.08.021 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14657228/ PubMed] | ||
+ | # Jeremic B, Shibamoto Y, Milicic B, Nikolic N, Dagovic A, Aleksandrovic J, Vaskovic Z, Tadic L. Hyperfractionated radiation therapy with or without concurrent low-dose daily cisplatin in locally advanced squamous cell carcinoma of the head and neck: a prospective randomized trial. J Clin Oncol. 2000 Apr;18(7):1458-64. [https://doi.org/10.1200/JCO.2000.18.7.1458 link to original article] [https://pubmed.ncbi.nlm.nih.gov/10735893/ PubMed] | ||
+ | # '''Head and Neck Intergroup:''' Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. [https://doi.org/10.1200/jco.2003.01.008 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/12506176/ PubMed] | ||
+ | # Grau C, Prakash Agarwal J, Jabeen K, Rab Khan A, Abeyakoon S, Hadjieva T, Wahid I, Turkan S, Tatsuzaki H, Dinshaw KA, Overgaard J. Radiotherapy with or without mitomycin c in the treatment of locally advanced head and neck cancer: results of the IAEA multicentre randomised trial. Radiother Oncol. 2003 Apr;67(1):17-26. [https://doi.org/10.1016/s0167-8140(03)00020-3 link to original article] [https://pubmed.ncbi.nlm.nih.gov/12758236/ PubMed] | ||
+ | # '''RTOG 91-11:''' Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, Glisson B, Trotti A, Ridge JA, Chao C, Peters G, Lee DJ, Leaf A, Ensley J, Cooper J. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003 Nov 27;349(22):2091-8. [https://doi.org/10.1056/NEJMoa031317 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/14645636/ PubMed] [https://clinicaltrials.gov/study/NCT00002496 NCT00002496] | ||
+ | ## '''Update:''' Forastiere AA, Zhang Q, Weber RS, Maor MH, Goepfert H, Pajak TF, Morrison W, Glisson B, Trotti A, Ridge JA, Thorstad W, Wagner H, Ensley JF, Cooper JS. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 2013 Mar 1;31(7):845-52. Epub 2012 Nov 26. [https://doi.org/10.1200/jco.2012.43.6097 link to original article] '''contains partial protocol''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3577950/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/23182993/ PubMed] | ||
+ | # '''SAKK 10/94:''' Huguenin P, Beer KT, Allal A, Rufibach K, Friedli C, Davis JB, Pestalozzi B, Schmid S, Thöni A, Ozsahin M, Bernier J, Töpfer M, Kann R, Meier UR, Thum P, Bieri S, Notter M, Lombriser N, Glanzmann C. Concomitant cisplatin significantly improves locoregional control in advanced head and neck cancers treated with hyperfractionated radiotherapy. J Clin Oncol. 2004 Dec 1;22(23):4665-73. Epub 2004 Nov 8. Erratum in: J Clin Oncol. 2005 Jan 1;23(1):248. [https://doi.org/10.1200/JCO.2004.12.193 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15534360/ PubMed] [https://clinicaltrials.gov/study/NCT00002654 NCT00002654] | ||
+ | ## '''Update:''' Ghadjar P, Simcock M, Studer G, Allal AS, Ozsahin M, Bernier J, Töpfer M, Zimmermann F, Betz M, Glanzmann C, Aebersold DM; Swiss Group for Clinical Cancer Research. Concomitant cisplatin and hyperfractionated radiotherapy in locally advanced head and neck cancer: 10-year follow-up of a randomized phase III trial (SAKK 10/94). Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):524-31. Epub 2011 Feb 16. [https://doi.org/10.1016/j.ijrobp.2010.11.067 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21300466/ PubMed] | ||
+ | # '''ARO 95-06:''' Budach V, Stuschke M, Budach W, Baumann M, Geismar D, Grabenbauer G, Lammert I, Jahnke K, Stueben G, Herrmann T, Bamberg M, Wust P, Hinkelbein W, Wernecke KD. Hyperfractionated accelerated chemoradiation with concurrent fluorouracil-mitomycin is more effective than dose-escalated hyperfractionated accelerated radiation therapy alone in locally advanced head and neck cancer: final results of the radiotherapy cooperative clinical trials group of the German Cancer Society 95-06 prospective randomized trial. J Clin Oncol. 2005 Feb 20;23(6):1125-35. [https://doi.org/10.1200/JCO.2005.07.010 link to original article] [https://pubmed.ncbi.nlm.nih.gov/15718308/ PubMed] | ||
+ | ## '''Update:''' Budach V, Stromberger C, Poettgen C, Baumann M, Budach W, Grabenbauer G, Marnitz S, Olze H, Wernecke KD, Ghadjar P. Hyperfractionated accelerated radiation therapy (HART) of 7060 cGy with concurrent 5-FU/Mitomycin C is superior to HART of 7760 cGy alone in locally advanced head and neck cancer: long-term results of the ARO 95-06 randomized phase III trial. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):916-24. Epub 2015 Feb 7. [https://doi.org/10.1016/j.ijrobp.2014.12.034 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25670541/ PubMed] | ||
+ | # '''FNCLCC 96003:''' Bensadoun RJ, Bénézery K, Dassonville O, Magné N, Poissonnet G, Ramaïoli A, Lemanski C, Bourdin S, Tortochaux J, Peyrade F, Marcy PY, Chamorey E, Vallicioni J, Seng H, Alzieu C, Géry B, Chauvel P, Schneider M, Santini J, Demard F, Calais G. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: Results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):983-94. Epub 2006 Jan 10. [https://doi.org/10.1016/j.ijrobp.2005.09.041 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16376489/ PubMed] [https://clinicaltrials.gov/study/NCT00003627 NCT00003627] | ||
+ | # '''IMCL-9815:''' Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. [https://doi.org/10.1056/NEJMoa053422 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16467544/ PubMed] [https://clinicaltrials.gov/study/NCT00004227 NCT00004227] | ||
+ | ## '''HRQoL analysis:''' Curran D, Giralt J, Harari PM, Ang KK, Cohen RB, Kies MS, Jassem J, Baselga J, Rowinsky EK, Amellal N, Comte S, Bonner JA. Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab. J Clin Oncol. 2007 Jun 1;25(16):2191-7. [https://doi.org/10.1200/jco.2006.08.8005 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/17538164/ PubMed] | ||
+ | ## '''Update:''' Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. Epub 2009 Nov 10. [https://doi.org/10.1016/S1470-2045(09)70311-0 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/19897418/ PubMed] | ||
+ | ## '''Subgroup analysis:''' Rosenthal DI, Harari PM, Giralt J, Bell D, Raben D, Liu J, Schulten J, Ang KK, Bonner JA. Association of Human Papillomavirus and p16 Status With Outcomes in the IMCL-9815 Phase III Registration Trial for Patients With Locoregionally Advanced Oropharyngeal Squamous Cell Carcinoma of the Head and Neck Treated With Radiotherapy With or Without Cetuximab. J Clin Oncol. 2016 Apr 20;34(12):1300-8. Epub 2015 Dec 28. [https://doi.org/10.1200/jco.2015.62.5970 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5070577/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/26712222/ PubMed] | ||
+ | # '''TAX 323:''' Vermorken JB, Remenar E, van Herpen C, Gorlia T, Mesia R, Degardin M, Stewart JS, Jelic S, Betka J, Preiss JH, van den Weyngaert D, Awada A, Cupissol D, Kienzer HR, Rey A, Desaunois I, Bernier J, Lefebvre JL; [[Study_Groups#EORTC|EORTC]]; TAX 323 Study Group. Cisplatin, fluorouracil, and docetaxel in unresectable head and neck cancer. N Engl J Med. 2007 Oct 25;357(17):1695-704. [https://doi.org/10.1056/NEJMoa071028 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17960012/ PubMed] [https://clinicaltrials.gov/study/NCT00003888 NCT00003888] | ||
+ | ## '''HRQoL analysis:''' van Herpen CM, Mauer ME, Mesia R, Degardin M, Jelic S, Coens C, Betka J, Bernier J, Remenar E, Stewart JS, Preiss JH, van den Weyngaert D, Bottomley A, Vermorken JB; [[Study_Groups#EORTC|EORTC]] Head and Neck Group. Short-term health-related quality of life and symptom control with docetaxel, cisplatin, 5-fluorouracil and cisplatin (TPF), 5-fluorouracil (PF) for induction in unresectable locoregionally advanced head and neck cancer patients (EORTC 24971/TAX 323). Br J Cancer. 2010 Oct 12;103(8):1173-81. Epub 2010 Sep 14. [https://doi.org/10.1038/sj.bjc.6605860 link to original article] '''contains dosing details in manuscript''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2967049/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/20842129/ PubMed] | ||
+ | # '''EORTC 24954:''' Lefebvre JL, Rolland F, Tesselaar M, Bardet E, Leemans CR, Geoffrois L, Hupperets P, Barzan L, de Raucourt D, Chevalier D, Licitra L, Lunghi F, Stupp R, Lacombe D, Bogaerts J, Horiot JC, Bernier J, Vermorken JB; [[Study_Groups#EORTC|EORTC]] Head and Neck Cancer Cooperative Group; [[Study_Groups#EORTC|EORTC]] Radiation Oncology Group. Phase 3 randomized trial on larynx preservation comparing sequential vs alternating chemotherapy and radiotherapy. J Natl Cancer Inst. 2009 Feb 4;101(3):142-52. Epub 2009 Jan 27. [https://academic.oup.com/jnci/article/101/3/142/947754 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2724854/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/19176454/ PubMed] [https://clinicaltrials.gov/study/NCT00002839 NCT00002839] | ||
+ | ## '''Update:''' Henriques De Figueiredo B, Fortpied C, Menis J, Lefebvre JL, Barzan L, de Raucourt D, Geoffrois L, Giurgea L, Hupperets P, Leemans CR, Licitra L, Rolland F, Tesselaar M, Vermorken JB, Grégoire V; [[Study_Groups#EORTC|EORTC]] Head and Neck Cancer Group; [[Study_Groups#EORTC|EORTC]] Radiation Oncology Group. Long-term update of the 24954 EORTC phase III trial on larynx preservation. Eur J Cancer. 2016 Sep;65:109-12. Epub 2016 Aug 2. [https://doi.org/10.1016/j.ejca.2016.06.024 link to original article] [https://pubmed.ncbi.nlm.nih.gov/27494036/ PubMed] | ||
+ | # '''GORTEC 2000-01:''' Pointreau Y, Garaud P, Chapet S, Sire C, Tuchais C, Tortochaux J, Faivre S, Guerrif S, Alfonsi M, Calais G. Randomized trial of induction chemotherapy with cisplatin and 5-fluorouracil with or without docetaxel for larynx preservation. J Natl Cancer Inst. 2009 Apr 1;101(7):498-506. Epub 2009 Mar 24. [http://jnci.oxfordjournals.org/content/101/7/498.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/19318632/ PubMed] [https://clinicaltrials.gov/study/NCT00169182 NCT00169182] | ||
+ | ## '''Update:''' Janoray G, Pointreau Y, Garaud P, Chapet S, Alfonsi M, Sire C, Jadaud E, Calais G. Long-term results of a multicenter randomized phase III trial of induction chemotherapy with cisplatin, 5-fluorouracil, ± docetaxel for larynx preservation. J Natl Cancer Inst. 2015 Dec 16;108(4). [https://academic.oup.com/jnci/article/108/4/djv368/2412557 link to original article] [https://pubmed.ncbi.nlm.nih.gov/26681800/ PubMed] | ||
+ | # Ruo Redda MG, Ragona R, Ricardi U, Beltramo G, Rampino M, Gabriele P, Allis S, La Porta MR, Moro G, Melano A, Gabriele AM, Tessa M, Fossati P, Orecchia R. Radiotherapy alone or with concomitant daily low-dose carboplatin in locally advanced, unresectable head and neck cancer: definitive results of a phase III study with a follow-up period of up to ten years. Tumori. 2010 Mar-Apr;96(2):246-53. [https://journals.sagepub.com/doi/abs/10.1177/030089161009600210 link to original article] [https://pubmed.ncbi.nlm.nih.gov/20572581/ PubMed] | ||
+ | # Bourhis J, Lapeyre M, Tortochaux J, Lusinchi A, Etessami A, Ducourtieux M, Geoffrois L, Domenge C, Verrelle P, Wibault P, Janot F, Temam S, Blanchard P, Tao YG, Auperin A; GORTEC. Accelerated radiotherapy and concomitant high dose chemotherapy in non resectable stage IV locally advanced HNSCC: results of a GORTEC randomized trial. Radiother Oncol. 2011 Jul;100(1):56-61. Epub 2011 Aug 8. [https://doi.org/10.1016/j.radonc.2011.07.006 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21831465/ PubMed] | ||
+ | # '''GORTEC 99-02:''' Bourhis J, Sire C, Graff P, Grégoire V, Maingon P, Calais G, Gery B, Martin L, Alfonsi M, Desprez P, Pignon T, Bardet E, Rives M, Geoffrois L, Daly-Schveitzer N, Sen S, Tuchais C, Dupuis O, Guerif S, Lapeyre M, Favrel V, Hamoir M, Lusinchi A, Temam S, Pinna A, Tao YG, Blanchard P, Aupérin A. Concomitant chemoradiotherapy versus acceleration of radiotherapy with or without concomitant chemotherapy in locally advanced head and neck carcinoma (GORTEC 99-02): an open-label phase 3 randomised trial. Lancet Oncol. 2012 Feb;13(2):145-53. Epub 2012 Jan 18. [https://doi.org/10.1016/S1470-2045(11)70346-1 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/22261362/ PubMed] [https://clinicaltrials.gov/study/NCT00158652 NCT00158652] | ||
+ | # Ghosh-Laskar S, Kalyani N, Gupta T, Budrukkar A, Murthy V, Sengar M, Chaukar D, Pai P, Chaturvedi P, D'Cruz A, Agarwal J. Conventional radiotherapy versus concurrent chemoradiotherapy versus accelerated radiotherapy in locoregionally advanced carcinoma of head and neck: results of a prospective randomized trial. Head Neck. 2016 Feb;38(2):202-7. Epub 2014 Sep 15. [https://doi.org/10.1002/hed.23865 link to original article] [https://pubmed.ncbi.nlm.nih.gov/25224814/ PubMed] | ||
+ | # Yi J, Huang X, Xu Z, Liu S, Wang X, He X, Luo D, Luo J, Xiao J, Zhang S, Wang K, Qu Y, Tang Y, Liu W, Xu G, Gao L, Wang D. Phase III randomized trial of preoperative concurrent chemoradiotherapy versus preoperative radiotherapy for patients with locally advanced head and neck squamous cell carcinoma. Oncotarget. 2017 Jul 4;8(27):44842-44850. [https://doi.org/10.18632/oncotarget.15107 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5546524/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/28179586/ PubMed] | ||
+ | # Patil VM, Noronha V, Menon N, Singh A, Ghosh-Laskar S, Budrukkar A, Bhattacharjee A, Swain M, Mathrudev V, Nawale K, Balaji A, Peelay Z, Alone M, Pathak S, Mahajan A, Kumar S, Purandare N, Agarwal A, Puranik A, Pendse S, Reddy Yallala M, Sahu H, Kapu V, Dey S, Choudhary J, Krishna MR, Shetty A, Karuvandan N, Ravind R, Rai R, Jobanputra K, Chaturvedi P, Pai PS, Chaukar D, Nair S, Thiagarajan S, Prabhash K. Results of Phase III Randomized Trial for Use of Docetaxel as a Radiosensitizer in Patients With Head and Neck Cancer, Unsuitable for Cisplatin-Based Chemoradiation. J Clin Oncol. 2023 May 1;41(13):2350-2361. Epub 2023 Jan 27. [https://doi.org/10.1200/jco.22.00980 link to original article] [https://pubmed.ncbi.nlm.nih.gov/36706347/ PubMed] CTRI/2017/05/008700 | ||
=Recurrent or metastatic disease, first-line therapy= | =Recurrent or metastatic disease, first-line therapy= | ||
==CABO {{#subobject:b42ea5|Regimen=1}}== | ==CABO {{#subobject:b42ea5|Regimen=1}}== | ||
CABO: '''<u>C</u>'''isplatin, '''<u>A</u>'''mithopterin (Methotrexate), '''<u>B</u>'''leomycin, '''<u>O</u>'''ncovin (Vincristine) | CABO: '''<u>C</u>'''isplatin, '''<u>A</u>'''mithopterin (Methotrexate), '''<u>B</u>'''leomycin, '''<u>O</u>'''ncovin (Vincristine) | ||
− | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen {{#subobject:8e0178|Variant=1}}=== | ===Regimen {{#subobject:8e0178|Variant=1}}=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
Line 199: | Line 451: | ||
|rowspan=2|[https://doi.org/10.1093/oxfordjournals.annonc.a058906 Clavel et al. 1994] | |rowspan=2|[https://doi.org/10.1093/oxfordjournals.annonc.a058906 Clavel et al. 1994] | ||
|rowspan=2|1984-1987 | |rowspan=2|1984-1987 | ||
− | |rowspan=2 style="background-color:#1a9851"|Phase 3 ( | + | |rowspan=2 style="background-color:#1a9851"|Phase 3 (E-esc) |
|1. [[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_2|CF]] | |1. [[Head_and_neck_cancer#Cisplatin_.26_Fluorouracil_.28CF.29_2|CF]] | ||
| style="background-color:#91cf60" |Seems to have superior ORR | | style="background-color:#91cf60" |Seems to have superior ORR | ||
Line 209: | Line 461: | ||
<div class="toccolours" style="background-color:#b3e2cd"> | <div class="toccolours" style="background-color:#b3e2cd"> | ||
====Chemotherapy==== | ====Chemotherapy==== | ||
− | *[[Cisplatin (Platinol)]] | + | *[[Cisplatin (Platinol)]] 50 mg/m<sup>2</sup> IV once on day 4 |
− | *[[Methotrexate (MTX)]] | + | *[[Methotrexate (MTX)]] 40 mg/m<sup>2</sup> IV once per day on days 1 & 15 |
− | *[[Bleomycin (Blenoxane)]] | + | *[[Bleomycin (Blenoxane)]] 10 mg IV once per day on days 1, 8, 15 |
− | *[[Vincristine (Oncovin)]] | + | *[[Vincristine (Oncovin)]] 2 mg IV once per day on days 1, 8, 15 |
+ | '''21-day cycles''' | ||
</div></div> | </div></div> | ||
===References=== | ===References=== | ||
# Clavel M, Vermorken JB, Cognetti F, Cappelaere P, de Mulder PH, Schornagel JH, Tueni EA, Verweij J, Wildiers J, Clerico M, Dalesio O, Kirkpatrick A, Snow GB; EORTC Head and Neck Cancer Cooperative Group. Randomized comparison of cisplatin, methotrexate, bleomycin and vincristine (CABO) versus cisplatin and 5-fluorouracil (CF) versus cisplatin (C) in recurrent or metastatic squamous cell carcinoma of the head and neck: a phase III study of the EORTC Head and Neck Cancer Cooperative Group. Ann Oncol. 1994 Jul;5(6):521-6. [https://doi.org/10.1093/oxfordjournals.annonc.a058906 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/7522527/ PubMed] | # Clavel M, Vermorken JB, Cognetti F, Cappelaere P, de Mulder PH, Schornagel JH, Tueni EA, Verweij J, Wildiers J, Clerico M, Dalesio O, Kirkpatrick A, Snow GB; EORTC Head and Neck Cancer Cooperative Group. Randomized comparison of cisplatin, methotrexate, bleomycin and vincristine (CABO) versus cisplatin and 5-fluorouracil (CF) versus cisplatin (C) in recurrent or metastatic squamous cell carcinoma of the head and neck: a phase III study of the EORTC Head and Neck Cancer Cooperative Group. Ann Oncol. 1994 Jul;5(6):521-6. [https://doi.org/10.1093/oxfordjournals.annonc.a058906 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/7522527/ PubMed] | ||
+ | |||
==Cisplatin & Cetuximab {{#subobject:58744c|Regimen=1}}== | ==Cisplatin & Cetuximab {{#subobject:58744c|Regimen=1}}== | ||
− | <div class="toccolours" style="background-color:# | + | <div class="toccolours" style="background-color:#ee6b6e"> |
===Regimen {{#subobject:c40d1f|Variant=1}}=== | ===Regimen {{#subobject:c40d1f|Variant=1}}=== | ||
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===References=== | ===References=== | ||
<!-- Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, May 18-21, Orlando, FL, and the American Association for Cancer Research/National Cancer Institute/European Organisation for Research and Treatment of Cancer International Conference on Molecular Targets in Cancer Therapy, November 17-21, 2003, Boston, MA. --> | <!-- Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, May 18-21, Orlando, FL, and the American Association for Cancer Research/National Cancer Institute/European Organisation for Research and Treatment of Cancer International Conference on Molecular Targets in Cancer Therapy, November 17-21, 2003, Boston, MA. --> | ||
− | # '''ECOG E5397:''' Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; [[Study_Groups#ECOG|ECOG]]. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. [https://doi.org/10.1200/jco.2005.02.4646 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16314626/ PubMed] NCT00003809 | + | # '''ECOG E5397:''' Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; [[Study_Groups#ECOG|ECOG]]. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. [https://doi.org/10.1200/jco.2005.02.4646 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16314626/ PubMed] [https://clinicaltrials.gov/study/NCT00003809 NCT00003809] |
[[Category:Head and neck cancer regimens]] | [[Category:Head and neck cancer regimens]] | ||
[[Category:Historical regimens]] | [[Category:Historical regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Head and neck cancers]] | [[Category:Head and neck cancers]] |
Latest revision as of 11:33, 13 May 2024
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. Is there a regimen missing from this list? See the main head and neck cancer page for current regimens.
5 regimens on this page
5 variants on this page
|
Locally advanced disease, definitive therapy
Bleomycin, Methotrexate, Vinblastine/RT
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Merlano et al. 1988 | 1983-1986 | Phase 3 (E-switch-ic) | Bleomycin, MTX, Vinblastine, then RT | Seems to have superior PFS |
Chemotherapy
- Bleomycin (Blenoxane) as follows:
- Cycles 1, 2, 4, 6: 30 units IV once on day 1, given second, six hours later
- Methotrexate (MTX) as follows:
- Cycles 1, 2, 4, 6: 200 mg IV once on day 2
- Vinblastine (Velban) as follows:
- Cycles 1, 2, 4, 6: 6 mg/m2 IV once on day 1, given first
Supportive therapy
- Leucovorin (Folinic acid) as follows:
- Cycles 1, 2, 4, 6: 45 mg (route not specified) once on day 3
Radiotherapy
- RT as follows:
- Cycles 3, 5, 7: 200 cGy per fraction x 10 fractions
14-day cycle for 7 cycles
References
- Merlano M, Rosso R, Sertoli MR, Bonelli L, Margarino G, Grimaldi A, Benasso M, Gardin G, Corvó R, Scarpati D, Barbieri A, Pallestrini E, Castiglia G, Santelli A, Scasso F, Bottero G, Ciurlo E, Fracchia P, Moratti M, Santi L. Sequential versus alternating chemotherapy and radiotherapy in stage III-IV squamous cell carcinoma of the head and neck: a phase III study. J Clin Oncol. 1988 Apr;6(4):627-32. link to original article contains dosing details in manuscript PubMed
Cetuximab & RT
Cetuximab & RT: Cetuximab & Radiation Therapy
Regimen variant #1, conventional RT (6800 cGy)
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gebre-Medhin et al. 2020 (ARTSCAN III) | 2013-2018 | Phase 3 (E-switch-ooc) | Cisplatin & RT | Did not meet primary endpoint of OS OS36: 78% vs 88% (HR 1.63, 95% CI 0.93-2.86) |
Targeted therapy
- Cetuximab (Erbitux) 400 mg/m2 IV over 2 hours once 1 week before radiation therapy begins; then 250 mg/m2 IV over 60 minutes once per week during course of radiation therapy
Supportive therapy
- Diphenhydramine (Benadryl) (or equivalent) 50 mg (route not specified) once per week, prior to cetuximab
Radiotherapy
- Concurrent radiation therapy to primary tumor and lymph node metastases: 200 cGy fractions x 34 fractions, once per day, 5 days per week (total dose: 6800 cGy)
- Concurrent radiation therapy to elective neck volumes: 160 cGy fractions x 34 fractions, once per day, 5 days per week (total dose: 5440 cGy)
7-week course
Regimen variant #2, conventional RT (7000 cGy)
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Bonner et al. 2006 (IMCL-9815) | 1999-2002 | Phase 3 (E-RT-esc) | Radiation therapy | Seems to have superior OS (secondary endpoint) Median OS: 49 vs 29.3 mo (HR 0.74, 95% CI 0.57-0.97) |
Lefebvre et al. 2013 (TREMPLIN) | 2006-2008 | Randomized Phase 2 (E-switch-ooc) | Cisplatin & RT | Did not meet primary endpoint of LP at 3 months |
Ghi et al. 2017 (GSTTC H&N07) | 2008-2012 | Non-randomized part of phase 2/3 RCT | ||
Tao et al. 2018 (GORTEC 2007-01) | 2008-01 to 2014-03 | Phase 3 (C) | Carboplatin, 5-FU, Cetuximab, RT | Inferior PFS |
Hitt et al. 2013 (TTCC-2007-01) | 2008-07-15 to 2013-07-05 | Phase 3 (E-switch-ooc) | Cisplatin & RT | Inconclusive whether non-inferior OS (primary endpoint) Median OS: 42.9 vs 63.6 mo (HR 1.11, 90% CI 0.89-1.38) |
Targeted therapy
- Cetuximab (Erbitux) 400 mg/m2 IV over 2 hours once 1 week before radiation therapy begins, then 250 mg/m2 IV over 60 minutes once per week during course of radiation therapy
- IMCL-9815: A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose
Supportive therapy
- Diphenhydramine (Benadryl) (or equivalent) 50 mg (route not specified) once per week, prior to cetuximab
Radiotherapy
- Concurrent radiation therapy, 200 cGy fractions x 35 fractions, once per day, 5 days per week (total dose: 7000 cGy)
7-week course
Regimen variant #3, twice-daily RT
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Bonner et al. 2006 (IMCL-9815) | 1999-2002 | Phase 3 (E-RT-esc) | Radiation therapy | Seems to have superior OS (secondary endpoint) Median OS: 49 vs 29.3 mo (HR 0.74, 95% CI 0.57-0.97) Superior LRC (primary endpoint) |
Targeted therapy
- Cetuximab (Erbitux) 400 mg/m2 IV over 2 hours once 1 week before radiation therapy begins, then 250 mg/m2 IV over 60 minutes once per week during course of radiation therapy
- A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose
Supportive therapy
- Diphenhydramine (Benadryl) (or equivalent) 50 mg (route not specified) once per week, prior to cetuximab
Radiotherapy
- Concurrent radiation therapy, 120 cGy fractions x 60 to 64 fractions, twice per day, 5 days per week (total dose: 72 to 7680 cGy)
6- to 6.5-week course
Regimen variant #4, concomitant boost
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Bonner et al. 2006 (IMCL-9815) | 1999-2002 | Phase 3 (E-RT-esc) | Radiation therapy | Seems to have superior OS (secondary endpoint) Median OS: 49 vs 29.3 mo (HR 0.74, 95% CI 0.57-0.97) |
Targeted therapy
- Cetuximab (Erbitux) 400 mg/m2 IV over 2 hours once 1 week before radiation therapy begins, then 250 mg/m2 IV over 60 minutes once per week during course of radiation therapy
- A test dose of 20 mg IV over 10 minutes, followed by 30 minutes of observation, was given prior to the first full dose
Supportive therapy
- Diphenhydramine (Benadryl) (or equivalent) 50 mg (route not specified) once per week, prior to cetuximab
Radiotherapy
- Concurrent radiation therapy as follows:
- First 3.6 weeks: 180 cGy fractions x 18 fractions (total dose: 3240 cGy), once per day, 5 days per week for 3.6 weeks
- Last 2.4 weeks, morning dose: 180 cGy fractions x 12 fractions (total dose: 2160 cGy), given 5 days per week over 2.4 weeks
- Last 2.4 weeks, afternoon dose: 150 cGy fractions x 12 fractions (total dose: 1800 cGy), given 5 days per week over 2.4 weeks
- Total dose for concomitant boost regimen: 7200 cGy
6-week course
References
- IMCL-9815: Bonner JA, Harari PM, Giralt J, Azarnia N, Shin DM, Cohen RB, Jones CU, Sur R, Raben D, Jassem J, Ove R, Kies MS, Baselga J, Youssoufian H, Amellal N, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for squamous-cell carcinoma of the head and neck. N Engl J Med. 2006 Feb 9;354(6):567-78. link to original article contains dosing details in manuscript PubMed NCT00004227
- HRQoL analysis: Curran D, Giralt J, Harari PM, Ang KK, Cohen RB, Kies MS, Jassem J, Baselga J, Rowinsky EK, Amellal N, Comte S, Bonner JA. Quality of life in head and neck cancer patients after treatment with high-dose radiotherapy alone or in combination with cetuximab. J Clin Oncol. 2007 Jun 1;25(16):2191-7. link to original article contains partial protocol PubMed
- Update: Bonner JA, Harari PM, Giralt J, Cohen RB, Jones CU, Sur RK, Raben D, Baselga J, Spencer SA, Zhu J, Youssoufian H, Rowinsky EK, Ang KK. Radiotherapy plus cetuximab for locoregionally advanced head and neck cancer: 5-year survival data from a phase 3 randomised trial, and relation between cetuximab-induced rash and survival. Lancet Oncol. 2010 Jan;11(1):21-8. Epub 2009 Nov 10. link to original article contains partial protocol PubMed
- Subgroup analysis: Rosenthal DI, Harari PM, Giralt J, Bell D, Raben D, Liu J, Schulten J, Ang KK, Bonner JA. Association of Human Papillomavirus and p16 Status With Outcomes in the IMCL-9815 Phase III Registration Trial for Patients With Locoregionally Advanced Oropharyngeal Squamous Cell Carcinoma of the Head and Neck Treated With Radiotherapy With or Without Cetuximab. J Clin Oncol. 2016 Apr 20;34(12):1300-8. Epub 2015 Dec 28. link to original article link to PMC article PubMed
- TREMPLIN: Lefebvre JL, Pointreau Y, Rolland F, Alfonsi M, Baudoux A, Sire C, de Raucourt D, Malard O, Degardin M, Tuchais C, Blot E, Rives M, Reyt E, Tourani JM, Geoffrois L, Peyrade F, Guichard F, Chevalier D, Babin E, Lang P, Janot F, Calais G, Garaud P, Bardet E. Induction chemotherapy followed by either chemoradiotherapy or bioradiotherapy for larynx preservation: the TREMPLIN randomized phase II study. J Clin Oncol. 2013 Mar 1;31(7):853-9. Epub 2013 Jan 22. link to original article contains dosing details in manuscript PubMed NCT00169247
- GSTTC H&N07: Ghi MG, Paccagnella A, Ferrari D, Foa P, Alterio D, Codecà C, Nolè F, Verri E, Orecchia R, Morelli F, Parisi S, Mastromauro C, Mione CA, Rossetto C, Polsinelli M, Koussis H, Loreggian L, Bonetti A, Campostrini F, Azzarello G, D'Ambrosio C, Bertoni F, Casanova C, Emiliani E, Guaraldi M, Bunkheila F, Bidoli P, Niespolo RM, Gava A, Massa E, Frattegiani A, Valduga F, Pieri G, Cipani T, Da Corte D, Chiappa F, Rulli E; GSTTC. Induction TPF followed by concomitant treatment versus concomitant treatment alone in locally advanced head and neck cancer: a phase II-III trial. Ann Oncol. 2017 Sep 1;28(9):2206-2212. link to original article contains dosing details in manuscript PubMed NCT01086826
- GORTEC 2007-01: Tao Y, Auperin A, Sire C, Martin L, Khoury C, Maingon P, Bardet E, Kaminsky MC, Lapeyre M, Chatellier T, Alfonsi M, Pointreau Y, Jadaud E, Géry B, Zawadi A, Tourani JM, Laguerre B, Coutte A, Racadot S, Hasbini A, Malaurie E, Borel C, Meert N, Cornely A, Ollivier N, Casiraghi O, Sun XS, Bourhis J. Improved outcome by adding concurrent chemotherapy to cetuximab and radiotherapy for locally advanced head and neck carcinomas: results of the GORTEC 2007-01 phase III randomized trial. J Clin Oncol. 2018 Nov 1;36(31):3084-90. Epub 2018 Jun 7. link to original article contains dosing details in manuscript PubMed NCT00609284
- ARTSCAN III: Gebre-Medhin M, Brun E, Engström P, Haugen Cange H, Hammarstedt-Nordenvall L, Reizenstein J, Nyman J, Abel E, Friesland S, Sjödin H, Carlsson H, Söderkvist K, Thomasson M, Zackrisson B, Nilsson P. ARTSCAN III: A Randomized Phase III Study Comparing Chemoradiotherapy With Cisplatin Versus Cetuximab in Patients With Locoregionally Advanced Head and Neck Squamous Cell Cancer. J Clin Oncol. 2021 Jan 1;39(1):38-47. Epub 2020 Oct 14. link to original article contains dosing details in manuscript link to PMC article PubMed NCT01969877
- TTCC-2007-01: Hitt R, Mesía R, Lozano A, Iglesias Docampo L, Grau JJ, Taberna M, Rubió-Casadevall J, Martínez-Trufero J, Morillo EDB, García Girón C, Vázquez Estévez S, Cirauqui B, Cruz-Hernández JJ. Randomized phase 3 noninferiority trial of radiotherapy and cisplatin vs radiotherapy and cetuximab after docetaxel-cisplatin-fluorouracil induction chemotherapy in patients with locally advanced unresectable head and neck cancer. Oral Oncol. 2022 Nov;134:106087. Epub 2022 Sep 18. link to original article PubMed NCT00716391
- GORTEC 2017-01: NCT02999087
Radiation therapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Gollin et al. 1972 | 1961-NR | Phase 3 (C) | 5-FU & RT | Seems to have inferior OS1 |
Sanchíz et al. 1990 | 1978-1988 | Phase 3 (E-de-esc) | 1. 5-FU & RT | Inferior OS |
2. RT; twice-daily | Inferior OS | |||
Wolf et al. 1991 | 1985-NR | Non-randomized part of phase 3 RCT | ||
Taylor et al. 1994a | 1986-1991 | Non-randomized part of phase 3 RCT | ||
Merlano et al. 1992 | 1987-1990 | Phase 3 (C) | CF & RT | Inferior OS2 |
Browman et al. 1994 | 1987-1991 | Phase 3 (C) | 5-FU & RT | Might have inferior OS |
Wendt et al. 1998 | 1989-1993 | Phase 3 (C) | Cisplatin, 5-FU, LV, RT | Inferior OS |
Brizel et al. 1998 | 1990-1995 | Phase 3 (C) | CF & RT | Might have inferior OS |
Jeremic et al. 2000 | 1991-1993 | Phase 3 (C) | Cisplatin & RT | Inferior OS |
Adelstein et al. 2003 (Head and Neck Intergroup) | 1992-1999 | Phase 3 (C) | 1. CF & RT | Did not meet primary endpoint of OS |
2. Cisplatin & RT | Seems to have inferior OS | |||
Ruo Redda et al. 2010 | 1992-1995 | Phase 3 (C) | Carboplatin & RT | Did not meet primary endpoint of LRC |
Forastiere et al. 2003 (RTOG 91-11) | 1992-2000 | Phase 3 (C) | See link | See link |
Calais et al. 1999 (GORTEC 94-01) | 1994-1997 | Phase 3 (C) | Carboplatin, 5-FU, RT | Seems to have inferior OS |
Huguenin et al. 2004 (SAKK 10/94) | 1994-2000 | Phase 3 (C) | Cisplatin & RT | Did not meet primary endpoint of TTF |
Budach et al. 2005 (ARO 95-06) | 1995-1999 | Phase 3 (C) | 5-FU, Mitomycin, RT | Seems to have inferior OS |
Grau et al. 2003 | 1996-1999 | Phase 3 (C) | Mitomycin & RT | Did not meet primary endpoint of LRC |
Bourhis et al. 2011 | 1996-2000 | Phase 3 (C) | CF & RT | Did not meet primary endpoint of EFS |
Lefebvre et al. 2009 (EORTC 24954) | 1996-2004 | Phase 3 (E-switch-ic) | See link | See link |
Bensadoun et al. 2006 (FNCLCC 96003) | 1997-2002 | Phase 3 (C) | CF & RT | Seems to have inferior OS |
Bonner et al. 2006 (IMCL-9815) | 1999-2002 | Phase 3 (C) | Cetuximab & RT | Seems to have inferior OS |
Vermorken et al. 2007 (TAX 323) | 1999-2002 | Non-randomized part of phase 3 RCT | ||
Pointreau et al. 2009 (GORTEC 2000-01) | 2000-2005 | Non-randomized part of phase 3 RCT | ||
Bourhis et al. 2012 (GORTEC 99-02) | 2000-2007 | Phase 3 (C) | 1. Carboplatin, 5-FU, RT | Seems to have inferior PFS |
2. Carboplatin, 5-FU, RT; accelerated concurrent RT | Might have inferior PFS | |||
Ghosh-Laskar et al. 2014 | 2000-2007 | Phase 3 (C) | 1. Cisplatin & RT | Seems to have inferior LRC |
2. RT; accelerated | Not reported | |||
Yi et al. 2017 | 2002-2012 | Phase 3 (C) | Cisplatin & RT | Did not meet primary endpoint of OS |
Patil et al. 2023a | 2017-07 to 2021-05 | Phase 2/3 (C) | Docetaxel & RT | Inferior DFS24 |
1Reported efficacy for Gollin et al. 1972 is based on the 1976 update, for oral lesions only.
2Reported efficacy in Merlano et al. 1992 is based on the 1995 update.
This is included for historical context and is unlikely to be further completed.
Preceding treatment
Radiotherapy
- External beam radiotherapy, varying regimens
References
- Gollin FF, Ansfield FJ, Brandenburg JH, Ramirez G, Vermund H. Combined therapy in advanced head and neck cancer: a randomized study. Am J Roentgenol Radium Ther Nucl Med. 1972 Jan;114(1):83-8. link to original article PubMed
- Update: Lo TC, Wiley AL Jr, Ansfield FJ, Brandenburg JH, Davis HL Jr, Gollin FF, Johnson RO, Ramirez G, Vermund H. Combined radiation therapy and 5-fluorouracil for advanced squamous cell carcinoma of the oral cavity and oropharynx: a randomized study. AJR Am J Roentgenol. 1976 Feb;126(2):229-35. link to original article PubMed
- Vermund H, Kaalhus O, Winther F, Trausjø J, Thorud E, Harang R. Bleomycin and radiation therapy in squamous cell carcinoma of the upper aero-digestive tract: a phase III clinical trial. Int J Radiat Oncol Biol Phys. 1985 Nov;11(11):1877-86. link to original article PubMed
- Sanchíz F, Millá A, Torner J, Bonet F, Artola N, Carreño L, Moya LM, Riera D, Ripol S, Cirera L. Single fraction per day versus two fractions per day versus radiochemotherapy in the treatment of head and neck cancer. Int J Radiat Oncol Biol Phys. 1990 Dec;19(6):1347-50. link to original article PubMed
- Wolf GT, Fisher SG, Hong WK, Hillman R, Spaulding M, Laramore GE, Endicott JW, McClatchey K, Henderson WG; Department of Veterans Affairs Laryngeal Cancer Study Group. Induction chemotherapy plus radiation compared with surgery plus radiation in patients with advanced laryngeal cancer. N Engl J Med. 1991 Jun 13;324(24):1685-90. link to original article contains dosing details in abstract PubMed
- Merlano M, Vitale V, Rosso R, Benasso M, Corvò R, Cavallari M, Sanguineti G, Bacigalupo A, Badellino F, Margarino G, Brema F, Pastorino G, Marziano C, Grimaldi A, Scasso F, Sperati G, Pallestrini E, Garaventa G, Accomando E, Cordone G, Comella G, Daponte A, Rubagotti A, Bruzzi P, Santi L. Treatment of advanced squamous-cell carcinoma of the head and neck with alternating chemotherapy and radiotherapy. N Engl J Med. 1992 Oct 15;327(16):1115-21. link to original article PubMed
- Update: Merlano M, Benasso M, Corvò R, Rosso R, Vitale V, Blengio F, Numico G, Margarino G, Bonelli L, Santi L. Five-year update of a randomized trial of alternating radiotherapy and chemotherapy compared with radiotherapy alone in treatment of unresectable squamous cell carcinoma of the head and neck. J Natl Cancer Inst. 1996 May 1;88(9):583-9. link to original article PubMed
- Taylor SG 4th, Murthy AK, Vannetzel JM, Colin P, Dray M, Caldarelli DD, Shott S, Vokes E, Showel JL, Hutchinson JC, Witt TR, Griem KL, Hartsell WF, Kies MS, Mittal B, Rebischung JL, Coupez DJ, Desphieux JL, Bobin S, LePajolec C. Randomized comparison of neoadjuvant cisplatin and fluorouracil infusion followed by radiation versus concomitant treatment in advanced head and neck cancer. J Clin Oncol. 1994 Feb;12(2):385-95. link to original article contains dosing details in manuscript PubMed
- Browman GP, Cripps C, Hodson DI, Eapen L, Sathya J, Levine MN. Placebo-controlled randomized trial of infusional fluorouracil during standard radiotherapy in locally advanced head and neck cancer. J Clin Oncol. 1994 Dec;12(12):2648-53. link to original article PubMed
- Wendt TG, Grabenbauer GG, Rödel CM, Thiel HJ, Aydin H, Rohloff R, Wustrow TP, Iro H, Popella C, Schalhorn A. Simultaneous radiochemotherapy versus radiotherapy alone in advanced head and neck cancer: a randomized multicenter study. J Clin Oncol. 1998 Apr;16(4):1318-24. link to original article PubMed
- Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. link to original article PubMed
- GORTEC 94-01: Calais G, Alfonsi M, Bardet E, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Oudinot P, Bertrand P. Randomized trial of radiation therapy versus concomitant chemotherapy and radiation therapy for advanced-stage oropharynx carcinoma. J Natl Cancer Inst. 1999 Dec 15;91(24):2081-6. link to original article PubMed
- Update: Denis F, Garaud P, Bardet E, Alfonsi M, Sire C, Germain T, Bergerot P, Rhein B, Tortochaux J, Calais G. Final results of the 94-01 French Head and Neck Oncology and Radiotherapy Group randomized trial comparing radiotherapy alone with concomitant radiochemotherapy in advanced-stage oropharynx carcinoma. J Clin Oncol. 2004 Jan 1;22(1):69-76. Epub 2003 Dec 2. link to original article contains dosing details in manuscript PubMed
- Jeremic B, Shibamoto Y, Milicic B, Nikolic N, Dagovic A, Aleksandrovic J, Vaskovic Z, Tadic L. Hyperfractionated radiation therapy with or without concurrent low-dose daily cisplatin in locally advanced squamous cell carcinoma of the head and neck: a prospective randomized trial. J Clin Oncol. 2000 Apr;18(7):1458-64. link to original article PubMed
- Head and Neck Intergroup: Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. link to original article contains dosing details in manuscript PubMed
- Grau C, Prakash Agarwal J, Jabeen K, Rab Khan A, Abeyakoon S, Hadjieva T, Wahid I, Turkan S, Tatsuzaki H, Dinshaw KA, Overgaard J. Radiotherapy with or without mitomycin c in the treatment of locally advanced head and neck cancer: results of the IAEA multicentre randomised trial. Radiother Oncol. 2003 Apr;67(1):17-26. link to original article PubMed
- RTOG 91-11: Forastiere AA, Goepfert H, Maor M, Pajak TF, Weber R, Morrison W, Glisson B, Trotti A, Ridge JA, Chao C, Peters G, Lee DJ, Leaf A, Ensley J, Cooper J. Concurrent chemotherapy and radiotherapy for organ preservation in advanced laryngeal cancer. N Engl J Med. 2003 Nov 27;349(22):2091-8. link to original article contains dosing details in manuscript PubMed NCT00002496
- Update: Forastiere AA, Zhang Q, Weber RS, Maor MH, Goepfert H, Pajak TF, Morrison W, Glisson B, Trotti A, Ridge JA, Thorstad W, Wagner H, Ensley JF, Cooper JS. Long-term results of RTOG 91-11: a comparison of three nonsurgical treatment strategies to preserve the larynx in patients with locally advanced larynx cancer. J Clin Oncol. 2013 Mar 1;31(7):845-52. Epub 2012 Nov 26. link to original article contains partial protocol link to PMC article PubMed
- SAKK 10/94: Huguenin P, Beer KT, Allal A, Rufibach K, Friedli C, Davis JB, Pestalozzi B, Schmid S, Thöni A, Ozsahin M, Bernier J, Töpfer M, Kann R, Meier UR, Thum P, Bieri S, Notter M, Lombriser N, Glanzmann C. Concomitant cisplatin significantly improves locoregional control in advanced head and neck cancers treated with hyperfractionated radiotherapy. J Clin Oncol. 2004 Dec 1;22(23):4665-73. Epub 2004 Nov 8. Erratum in: J Clin Oncol. 2005 Jan 1;23(1):248. link to original article PubMed NCT00002654
- Update: Ghadjar P, Simcock M, Studer G, Allal AS, Ozsahin M, Bernier J, Töpfer M, Zimmermann F, Betz M, Glanzmann C, Aebersold DM; Swiss Group for Clinical Cancer Research. Concomitant cisplatin and hyperfractionated radiotherapy in locally advanced head and neck cancer: 10-year follow-up of a randomized phase III trial (SAKK 10/94). Int J Radiat Oncol Biol Phys. 2012 Feb 1;82(2):524-31. Epub 2011 Feb 16. link to original article PubMed
- ARO 95-06: Budach V, Stuschke M, Budach W, Baumann M, Geismar D, Grabenbauer G, Lammert I, Jahnke K, Stueben G, Herrmann T, Bamberg M, Wust P, Hinkelbein W, Wernecke KD. Hyperfractionated accelerated chemoradiation with concurrent fluorouracil-mitomycin is more effective than dose-escalated hyperfractionated accelerated radiation therapy alone in locally advanced head and neck cancer: final results of the radiotherapy cooperative clinical trials group of the German Cancer Society 95-06 prospective randomized trial. J Clin Oncol. 2005 Feb 20;23(6):1125-35. link to original article PubMed
- Update: Budach V, Stromberger C, Poettgen C, Baumann M, Budach W, Grabenbauer G, Marnitz S, Olze H, Wernecke KD, Ghadjar P. Hyperfractionated accelerated radiation therapy (HART) of 7060 cGy with concurrent 5-FU/Mitomycin C is superior to HART of 7760 cGy alone in locally advanced head and neck cancer: long-term results of the ARO 95-06 randomized phase III trial. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):916-24. Epub 2015 Feb 7. link to original article PubMed
- FNCLCC 96003: Bensadoun RJ, Bénézery K, Dassonville O, Magné N, Poissonnet G, Ramaïoli A, Lemanski C, Bourdin S, Tortochaux J, Peyrade F, Marcy PY, Chamorey E, Vallicioni J, Seng H, Alzieu C, Géry B, Chauvel P, Schneider M, Santini J, Demard F, Calais G. French multicenter phase III randomized study testing concurrent twice-a-day radiotherapy and cisplatin/5-fluorouracil chemotherapy (BiRCF) in unresectable pharyngeal carcinoma: Results at 2 years (FNCLCC-GORTEC). Int J Radiat Oncol Biol Phys. 2006 Mar 15;64(4):983-94. Epub 2006 Jan 10. link to original article PubMed NCT00003627
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Recurrent or metastatic disease, first-line therapy
CABO
CABO: Cisplatin, Amithopterin (Methotrexate), Bleomycin, Oncovin (Vincristine)
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Clavel et al. 1994 | 1984-1987 | Phase 3 (E-esc) | 1. CF | Seems to have superior ORR |
2. Cisplatin | Superior ORR |
Chemotherapy
- Cisplatin (Platinol) 50 mg/m2 IV once on day 4
- Methotrexate (MTX) 40 mg/m2 IV once per day on days 1 & 15
- Bleomycin (Blenoxane) 10 mg IV once per day on days 1, 8, 15
- Vincristine (Oncovin) 2 mg IV once per day on days 1, 8, 15
21-day cycles
References
- Clavel M, Vermorken JB, Cognetti F, Cappelaere P, de Mulder PH, Schornagel JH, Tueni EA, Verweij J, Wildiers J, Clerico M, Dalesio O, Kirkpatrick A, Snow GB; EORTC Head and Neck Cancer Cooperative Group. Randomized comparison of cisplatin, methotrexate, bleomycin and vincristine (CABO) versus cisplatin and 5-fluorouracil (CF) versus cisplatin (C) in recurrent or metastatic squamous cell carcinoma of the head and neck: a phase III study of the EORTC Head and Neck Cancer Cooperative Group. Ann Oncol. 1994 Jul;5(6):521-6. link to original article contains dosing details in abstract PubMed
Cisplatin & Cetuximab
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Burtness et al. 2005 (ECOG E5397) | 1999-2001 | Phase 3 (E-esc) | Cisplatin | Did not meet primary endpoint of PFS |
Note: Per physician discretion, patients with complete response (CR) could have treatment discontinued 2 cycles past the point at which CR was attained. Patients with partial response (PR) continued on treatment until there was evidence of CR or progression disease. Patients with stable disease (SD) could discontinue treatment after 6 cycles. Patients with progressive disease discontinued therapy.
Chemotherapy
- Cisplatin (Platinol) 100 mg/m2 IV once on day 1
Targeted therapy
- Cetuximab (Erbitux) as follows:
- Cycle 1: 400 mg/m2 IV over 2 hours once on day 1, then 250 mg/m2 IV over 60 minutes once per day on days 8, 15, 22
- Cycle 2 onwards: 250 mg/m2 IV over 60 minutes once per day on days 1, 8, 15, 22
28-day cycles (see note)
References
- ECOG E5397: Burtness B, Goldwasser MA, Flood W, Mattar B, Forastiere AA; ECOG. Phase III randomized trial of cisplatin plus placebo compared with cisplatin plus cetuximab in metastatic/recurrent head and neck cancer: an Eastern Cooperative Oncology Group study. J Clin Oncol. 2005 Dec 1;23(34):8646-54. link to original article contains dosing details in manuscript PubMed NCT00003809