Difference between revisions of "Head and neck cancer - historical"

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The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. 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]. Is there a regimen missing from this list? See the [[Head_and_neck_cancer|main head and neck cancer page]] for current regimens.
 
The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. 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]. Is there a regimen missing from this list? See the [[Head_and_neck_cancer|main head and neck cancer page]] for current regimens.
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<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>
 
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=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}}==
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<div class="toccolours" style="background-color:#eeeeee">
 
===Regimen {{#subobject:7d2178|Variant=1}}===
 
===Regimen {{#subobject:7d2178|Variant=1}}===
 
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|-
 
|-
 
|}
 
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<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Bleomycin (Blenoxane)]]
 
*[[Bleomycin (Blenoxane)]]
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====Radiotherapy====
 
====Radiotherapy====
 
*[[External_beam_radiotherapy|RT]]
 
*[[External_beam_radiotherapy|RT]]
−
 
+
</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] [https://pubmed.ncbi.nlm.nih.gov/2451713 PubMed]
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+
==Cetuximab & RT {{#subobject:5eb410|Regimen=1}}==
 +
Cetuximab & RT: Cetuximab & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:6e9a4f|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|Years 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/10.1056/NEJMoa053422 Bonner et al. 2006 (IMCL-9815)]
 +
|1999-2002
 +
|style="background-color:#1a9851"|Phase 3 (E-RT-esc)
 +
|[[Head_and_neck_cancer#Radiation_therapy_2|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)
 +
|-
 +
|[https://doi.org/10.1200/jco.2012.42.3988 Lefebvre et al. 2013 (TREMPLIN)]
 +
|2006-2008
 +
|style="background-color:#1a9851"|Randomized Phase 2 (E-switch-ooc)
 +
|[[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]]
 +
|style="background-color:#ffffbf"|Did not meet primary endpoint of LP at 3 months
 +
|-
 +
|[https://doi.org/10.1093/annonc/mdx299 Ghi et al. 2017 (GSTTC H&N07)]
 +
|2008-2012
 +
| style="background-color:#91cf61" |Non-randomized portion of phase 2/3 RCT
 +
| style="background-color:#d3d3d3" |
 +
| style="background-color:#d3d3d3" |
 +
|-
 +
|[https://doi.org/10.1016/j.oraloncology.2022.106087 Hitt et al. 2013 (TTCC-2007-01)]
 +
|2008-2013
 +
|style="background-color:#1a9851"|Phase 3 (E-switch-ooc)
 +
|[[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)
 +
|-
 +
|[https://doi.org/10.1200/JCO.2017.76.2518 Tao et al. 2018 (GORTEC 2007-01)]
 +
|2008-2014
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[Head_and_neck_cancer#Carboplatin.2C_Fluorouracil.2C_Cetuximab.2C_RT|Carboplatin, 5-FU, Cetuximab, RT]]
 +
| style="background-color:#d73027" |Inferior PFS
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7771720/ Gebre-Medhin et al. 2020 (ARTSCAN III)]
 +
|2013-2018
 +
|style="background-color:#1a9851"|Phase 3 (E-switch-ooc)
 +
|[[Head_and_neck_cancer#Cisplatin_.26_RT|Cisplatin & RT]]
 +
|style="background-color:#ffffbf"|Did not meet primary endpoint of OS<br>OS36: 78% vs 88%<br>(HR 1.63, 95% CI 0.93-2.86)
 +
|-
 +
|}
 +
''Note: all patients in TREMPLIN received conventional RT.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 +
====Preceding treatment====
 +
*TREMPLIN: [[Head_and_neck_cancer#DCF|TPF]] x 3
 +
*GSTTC H&N07: [[Head_and_neck_cancer_-_null_regimens#No_induction|No induction]] versus [[#DCF|TPF]] x 3
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Targeted 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
 +
**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 (Erbitux)]]
 +
====Radiotherapy====
 +
*Concurrent [[External_beam_radiotherapy|radiation therapy]] with one of the following regimens:
 +
**"Coventional" regimen: 2 Gy fractions x 35 fractions (total dose: 70 Gy), once per day 5 times per week over 7 weeks
 +
**"Twice per day" regimen: 1.2 Gy fractions x 60 to 64 fractions (total dose: 72 to 76.8 Gy), given twice per day for a total of 10 times per week over 6 to 6.5 weeks
 +
**"Concomitant boost" regimen: 1.8 Gy fractions x 18 fractions (total dose: 32.4 Gy), once per day 5 times per week for 3.6 weeks; and twice per day fractions:
 +
***Morning dose: 1.8 Gy fractions x 12 fractions (total dose: 21.6 Gy), given 5 days per week over 2.4 weeks
 +
***Afternoon dose: 1.5 Gy fractions x 12 fractions (total dose: 18 Gy), given 5 days per week over 2.4 weeks
 +
***Total dose for concomitant boost regimen: 72 Gy
 +
**ARTSCAN III: Concurrent [[External_beam_radiotherapy|radiation therapy]], 2 Gy fractions to primary tumor and lymph node metastases (total dose: 68.0 Gy) and 1.6 Gy fractions to elective neck volumes (total dose: 54.4 Gy), given 5 times per week
 +
'''One course'''
 +
</div></div>
 +
===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
 +
## '''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]
 +
<!-- 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
 +
# '''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
 +
# '''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
 +
# '''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] 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] NCT00716391
 +
# '''GORTEC 2017-01:''' NCT02999087
 
=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:#eeeeee">
 
===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;"  
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|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Cisplatin (Platinol)]]
 
*[[Cisplatin (Platinol)]]
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*[[Bleomycin (Blenoxane)]]
 
*[[Bleomycin (Blenoxane)]]
 
*[[Vincristine (Oncovin)]]
 
*[[Vincristine (Oncovin)]]
 +
</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:#eeeeee">
−
 
 
 
===Regimen {{#subobject:c40d1f|Variant=1}}===
 
===Regimen {{#subobject:c40d1f|Variant=1}}===
 
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
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''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.''
 
''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.''
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
 
*[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV once on day 1
 
*[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV once on day 1
Line 91: Line 173:
 
**Cycle 1: 400 mg/m<sup>2</sup> IV over 2 hours once on day 1, then 250 mg/m<sup>2</sup> IV over 60 minutes once per day on days 8, 15, 22
 
**Cycle 1: 400 mg/m<sup>2</sup> IV over 2 hours once on day 1, then 250 mg/m<sup>2</sup> IV over 60 minutes once per day on days 8, 15, 22
 
**Cycle 2 onwards: 250 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15, 22
 
**Cycle 2 onwards: 250 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15, 22
−
 
 
'''28-day cycles (see note)'''  
 
'''28-day cycles (see note)'''  
−
 
+
</div></div>
 
===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] NCT00003809
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[[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]]

Revision as of 20:51, 20 October 2022

The purpose of this page is to provide references to regimens that are obsolete, outdated, or of historical interest only. 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 NCCN Guidelines. 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 Years 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

Radiotherapy

References

  1. 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 PubMed

Cetuximab & RT

Cetuximab & RT: Cetuximab & Radiation Therapy

Regimen

Study Years 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
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 portion of phase 2/3 RCT
Hitt et al. 2013 (TTCC-2007-01) 2008-2013 Phase 3 (E-switch-ooc) Cisplatin & RT Inconclusive whether non-inferior OS
Median OS: 42.9 vs 63.6 mo
(HR 1.11, 90% CI 0.89-1.38)
Tao et al. 2018 (GORTEC 2007-01) 2008-2014 Phase 3 (C) Carboplatin, 5-FU, Cetuximab, RT Inferior PFS
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)

Note: all patients in TREMPLIN received conventional RT.

Preceding treatment

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

Radiotherapy

  • Concurrent radiation therapy with one of the following regimens:
    • "Coventional" regimen: 2 Gy fractions x 35 fractions (total dose: 70 Gy), once per day 5 times per week over 7 weeks
    • "Twice per day" regimen: 1.2 Gy fractions x 60 to 64 fractions (total dose: 72 to 76.8 Gy), given twice per day for a total of 10 times per week over 6 to 6.5 weeks
    • "Concomitant boost" regimen: 1.8 Gy fractions x 18 fractions (total dose: 32.4 Gy), once per day 5 times per week for 3.6 weeks; and twice per day fractions:
      • Morning dose: 1.8 Gy fractions x 12 fractions (total dose: 21.6 Gy), given 5 days per week over 2.4 weeks
      • Afternoon dose: 1.5 Gy fractions x 12 fractions (total dose: 18 Gy), given 5 days per week over 2.4 weeks
      • Total dose for concomitant boost regimen: 72 Gy
    • ARTSCAN III: Concurrent radiation therapy, 2 Gy fractions to primary tumor and lymph node metastases (total dose: 68.0 Gy) and 1.6 Gy fractions to elective neck volumes (total dose: 54.4 Gy), given 5 times per week

One course

References

  1. 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
    1. 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
    2. 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
    3. 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
  2. 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
  3. 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
  4. 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
  5. 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
  6. 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
  7. GORTEC 2017-01: NCT02999087

Recurrent or metastatic disease, first-line therapy

CABO

CABO: Cisplatin, Amithopterin (Methotrexate), Bleomycin, Oncovin (Vincristine)

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Clavel et al. 1994 1984-1987 Phase 3 (C) 1. CF Seems to have superior ORR
2. Cisplatin Superior ORR

Chemotherapy

References

  1. 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 Years 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

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

  1. 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
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