Difference between revisions of "Editing test page"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m
 
(120 intermediate revisions by 3 users not shown)
Line 1: Line 1:
{{TOC limit|limit=3}}
+
=Locally advanced disease, definitive chemoradiotherapy=
==CF & Trastuzumab -- original {{#subobject:ca9cd1|Regimen=1}}==
+
==Carboplatin & RT {{#subobject:56c4ee|Regimen=1}}==
{| class="wikitable" style="float:right; margin-left: 5px;"
+
Carboplatin & RT: Carboplatin & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:3794ff|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/10.1016/j.ejca.2007.03.022 Chitapanarux et al. 2007]
 +
|1999-2004
 +
|style="background-color:#1a9851"|Phase 3 (E-switch-ic)
 +
|[[#Cisplatin_.26_RT|Cisplatin & RT]], then [[#Cisplatin_.26_Fluorouracil_.28CF.29_2|CF]]
 +
|style="background-color:#eeee01"|Seems to have non-inferior OS36
 
|-
 
|-
|[[#top|back to top]]
 
 
|}
 
|}
CF & Trastuzumab: '''<u>C</u>'''isplatin, '''<u>F</u>'''luorouracil, Trastuzumab
+
<div class="toccolours" style="background-color:#b3e2cd">
 
+
====Chemotherapy====
===Regimen {{#subobject:b2731|Variant=1}}===
+
*[[Carboplatin (Paraplatin)]] 100 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15, 22, 29, 36
{| class="wikitable" style="width: 100%; text-align:center;"  
+
====Radiotherapy====
! style="width: 25%" |Study
+
*Concurrent [[External_beam_radiotherapy|radiation therapy]] to the primary tumor:
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
! style="width: 25%" |Comparator
+
!style="width: 25%"|RT dose per fraction
! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
+
!style="width: 25%"|Number of fractions
 +
!style="width: 25%"|Total RT dose
 +
!style="width: 25%"|Schedule
 
|-
 
|-
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961121-X/fulltext Bang et al. 2010 (ToGA)]
+
|200 cGy
| style="background-color:#1a9851" |Phase III (E)
+
|35
|[[#Cisplatin_.26_Fluorouracil_4|CF]]
+
|7000 cGy
| style="background-color:#1a9850" |Superior OS
+
|5 days per week
 
|-
 
|-
 
|}
 
|}
''Patients had overexpression of HER2 protein by immunohistochemistry or gene amplification by fluorescence in-situ hybridisation.''
+
'''7-week course'''
==CF & Trastuzumab -- modified {{#subobject:ca9cd1|Regimen=1}}==
+
</div>
{| class="wikitable" style="float:right; margin-left: 5px;"
+
<div class="toccolours" style="background-color:#cbd5e7">
 +
====Subsequent treatment====
 +
*[[#Carboplatin_.26_Fluorouracil|Carboplatin & fluorouracil]] consolidation, after 4 weeks
 +
</div></div>
 +
===References===
 +
# Chitapanarux I, Lorvidhaya V, Kamnerdsupaphon P, Sumitsawan Y, Tharavichitkul E, Sukthomya V, Ford J. Chemoradiotherapy comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: randomised, non-inferiority, open trial. Eur J Cancer. 2007 Jun;43(9):1399-406. Epub 2007 Apr 27. [https://doi.org/10.1016/j.ejca.2007.03.022 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17467265/ PubMed]
 +
==Cisplatin & RT {{#subobject:c7061f|Regimen=1}}==
 +
Cisplatin & RT: Cisplatin & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #1, 30 mg/m<sup>2</sup> weekly dosing {{#subobject:c0e2e2|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://academic.oup.com/jnci/article/103/23/1761/2516849 Chen et al. 2011]
 +
|2003-2007
 +
|style="background-color:#1a9851"|Phase 3 (E-esc)
 +
|[[#Radiation_therapy|Radiation therapy]]
 +
| style="background-color:#1a9850" |Superior OS (primary endpoint)<br>OS60: 94.5% vs 85.8%<br>(HR 0.30, 95% CI 0.12-0.76)
 
|-
 
|-
|[[#top|back to top]]
 
 
|}
 
|}
CF & Trastuzumab: '''<u>C</u>'''isplatin, '''<u>F</u>'''luorouracil, Trastuzumab
+
<div class="toccolours" style="background-color:#b3e2cd">
 
+
====Chemotherapy====
===Regimen {{#subobject:b2731|Variant=1}}===
+
*[[Cisplatin (Platinol)]] 30 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22, 29, 36, 43
{| class="wikitable" style="width: 100%; text-align:center;"  
+
====Radiotherapy====
! style="width: 25%" |Study
+
*Concurrent [[External_beam_radiotherapy|radiation therapy]]:
! style="width: 25%" |[[Levels_of_Evidence#Evidence|Evidence]]
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
! style="width: 25%" |Comparator
+
!style="width: 25%"|RT dose per fraction
! style="width: 25%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
+
!style="width: 25%"|Number of fractions
 +
!style="width: 25%"|Total RT dose
 +
!style="width: 25%"|Schedule
 
|-
 
|-
|[https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961121-X/fulltext Bang et al. 2010 (ToGA)]
+
|200 cGy
| style="background-color:#1a9851" |Phase III (E)
+
|34 to 35
|[[#Cisplatin_.26_Fluorouracil_4|CF]]
+
|6800 to 7000 cGy
| style="background-color:#1a9850" |Superior OS
+
|5 days per week
 
|-
 
|-
 
|}
 
|}
====Biomarker eligiblity criteria====
+
'''7-week course'''
*Gene: HER2
+
</div></div><br>
*Alteration: amplification
+
<div class="toccolours" style="background-color:#eeeeee">
*Acceptable methods of measurement: IHC or FISH
 
  
====Chemotherapy====
+
===Regimen variant #2, 40 mg/m<sup>2</sup> weekly dosing {{#subobject:b41045|Variant=1}}===
*[[Cisplatin (Platinol)]] 80 mg/m<sup>2</sup> IV once on day 1
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
*[[Fluorouracil (5-FU)]] 800 mg/m<sup>2</sup>/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 4000 mg/m<sup>2</sup>)
+
!style="width: 20%"|Study
*[[Trastuzumab (Herceptin)]] as follows:
+
!style="width: 20%"|Dates of enrollment
**Cycle 1: 8 mg/kg IV once on day 1
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
**Subsequent cycles: 6 mg/kg IV once on day 1
+
!style="width: 20%"|Comparator
 
+
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
'''21-day cycles'''
 
 
 
===References===
 
# Bang YJ, Van Cutsem E, Feyereislova A, Chung HC, Shen L, Sawaki A, Lordick F, Ohtsu A, Omuro Y, Satoh T, Aprile G, Kulikov E, Hill J, Lehle M, Rüschoff J, Kang YK; ToGA Trial Investigators. Trastuzumab in combination with chemotherapy versus chemotherapy alone for treatment of HER2-positive advanced gastric or gastro-oesophageal junction cancer (ToGA): a phase 3, open-label, randomised controlled trial. Lancet. 2010 Aug 28;376(9742):687-97. Epub 2010 Aug 19. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736%2810%2961121-X/fulltext link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/20728210 PubMed]
 
 
 
==Abemaciclib & Anastrozole -- original {{#subobject:213a4e|Regimen=1}}==
 
{| class="wikitable" style="float:right; margin-left: 5px;"
 
 
|-
 
|-
|[[#top|back to top]]
+
|[https://doi.org/10.1200/JCO.2002.08.149 Chan et al. 2002]
|}
+
|1994-1999
===Regimen {{#subobject:c0e636|Variant=1}}===
+
|style="background-color:#1a9851"|Phase 3 (E-esc)
{| class="wikitable" style="color:white; background-color:#404040"
+
|[[#Radiation_therapy|Radiation therapy]]
|<small>'''FDA-recommended dose'''</small>
+
|style="background-color:#d9ef8b"|Might have superior OS<sup>1</sup>
 
|-
 
|-
|}
+
|[https://doi.org/10.1016/j.ijrobp.2015.01.002 Tan et al. 2015]
{| class="wikitable" style="width: 100%; text-align:center;"
+
|2004-2012
!style="width: 25%"|Study
+
|style="background-color:#91cf61"|Non-randomized part of phase 2/3 RCT
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
|style="background-color:#d3d3d3"|
!style="width: 25%"|Comparator
+
|style="background-color:#d3d3d3"|
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
 
|-
 
|-
|[https://ascopubs.org/doi/full/10.1200/JCO.2017.75.6155 Goetz et al. 2017 (MONARCH 3)]
+
|[https://doi.org/10.1016/S1470-2045(11)70320-5 Chen et al. 2011 (YP2008004)]
| style="background-color:#1a9851" |Phase III (E)
+
|2006-2010
|[[#Anastrozole_monotherapy_3|Anastrozole]]
+
|style="background-color:#91cf61"|Non-randomized part of phase 3 RCT
| style="background-color:#1a9850" |Superior PFS
+
|style="background-color:#d3d3d3"|
 +
|style="background-color:#d3d3d3"|
 
|-
 
|-
 
|}
 
|}
 +
''<sup>1</sup>Reported efficacy for Chan et al. 2002 is based on the 2005 update.''<br>
 +
''Note: See Chan et al. 2005 for additional information about boost doses.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 +
====Preceding treatment====
 +
*Tan et al. 2015: [[#GCP_999|GCP]] induction x 3 versus [[Nasopharyngeal_carcinoma_-_null_regimens#No_induction|no induction therapy]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
*[[Abemaciclib (Verzenio)]] 150 mg PO twice per day
+
*[[Cisplatin (Platinol)]] 40 mg/m<sup>2</sup> IV over 2 hours once per day on days 1, 8, 15, 22, 29, 36, 43
 
+
====Radiotherapy====
====Hormonotherapy====
+
*Concurrent [[External_beam_radiotherapy|radiation therapy]]:
*[[Anastrozole (Arimidex)]] 1 mg PO once per day
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
+
!style="width: 25%"|RT dose per fraction
'''28-day cycles'''
+
!style="width: 25%"|Number of fractions
 
+
!style="width: 25%"|Total RT dose
===References===
+
!style="width: 25%"|Schedule
# '''MONARCH 3:''' Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. Epub 2017 Oct 2. [https://ascopubs.org/doi/full/10.1200/JCO.2017.75.6155 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/28968163 PubMed]
+
|-
 
+
|200 cGy
==Abemaciclib & Anastrozole -- modified {{#subobject:213a4e|Regimen=1}}==
+
|33
{| class="wikitable" style="float:right; margin-left: 5px;"
+
|6600 cGy
 +
|5 days per week
 
|-
 
|-
|[[#top|back to top]]
 
 
|}
 
|}
===Regimen {{#subobject:c0e636|Variant=1}}===
+
'''6.5-week course'''
{| class="wikitable" style="color:white; background-color:#404040"
+
</div>
|<small>'''FDA-recommended dose'''</small>
+
<div class="toccolours" style="background-color:#cbd5e7">
 +
====Subsequent treatment====
 +
*YP2008004: [[#Cisplatin_.26_Fluorouracil_.28CF.29_2|CF]] consolidation versus [[Nasopharyngeal_carcinoma_-_null_regimens#Observation|no further treatment]]
 +
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #3, 40 mg/m<sup>2</sup> weekly dosing x 6 {{#subobject:b4ugh2|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://www.ncbi.nlm.nih.gov/pmc/articles/PMC8974421/ Xia et al. 2021]
 +
|2011-2016
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Cisplatin_.26_RT|Cisplatin & RT]]; q3wk x 2
 +
|style="background-color:#eeee01"|Non-inferior FFS
 
|-
 
|-
 
|}
 
|}
{| class="wikitable" style="width: 100%; text-align:center;"  
+
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Cisplatin (Platinol)]] 40 mg/m<sup>2</sup> IV over 2 hours once per day on days 1, 8, 15, 22, 29, 36
 +
====Radiotherapy====
 +
*Concurrent [[External_beam_radiotherapy|radiation therapy]]
 +
'''One course'''
 +
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen variant #4, 100 mg/m<sup>2</sup> x 2 {{#subobject:b44282|Variant=1}}===
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
 
!style="width: 20%"|Study
 
!style="width: 20%"|Study
 +
!style="width: 20%"|Dates of enrollment
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|Comparator
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
!style="width: 20%"|Years of study
 
 
|-
 
|-
|[https://ascopubs.org/doi/full/10.1200/JCO.2017.75.6155 Goetz et al. 2017 (MONARCH 3)]
+
|[http://link.springer.com/article/10.1007/s00280-009-1152-0 Bae et al. 2010]
| style="background-color:#1a9851" |Phase III (E)
+
|2004-2008
|[[#Anastrozole_monotherapy_3|Anastrozole]]
+
|style="background-color:#91cf61"|Phase 2
| style="background-color:#1a9850" |Superior PFS
+
|style="background-color:#d3d3d3"|
|2014-2015
+
|style="background-color:#d3d3d3"|
 +
|-
 +
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8974421/ Xia et al. 2021]
 +
|2011-2016
 +
|style="background-color:#1a9851"|Phase 3 (E-switch-ic)
 +
|[[#Cisplatin_.26_RT|Cisplatin & RT]]; weekly x 6
 +
|style="background-color:#eeee01"|Non-inferior FFS (primary endpoint)<br>FFS36: 85.4% vs 85.6%<br>(HR 1.00, 95% CI 0.66-1.52)
 
|-
 
|-
 
|}
 
|}
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
*[[Abemaciclib (Verzenio)]] 150 mg PO twice per day
+
*[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV once per day on on days 1 & 29
 +
====Radiotherapy====
 +
*Concurrent [[External_beam_radiotherapy|radiation therapy]] by the following study-specific criteria:
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|RT dose per fraction
 +
!style="width: 20%"|Number of fractions
 +
!style="width: 20%"|Total RT dose
 +
!style="width: 20%"|Schedule
 +
|-
 +
|Bae et al. 2010
 +
|180 to 200 cGy
 +
|35 to 38
 +
|6840 cGy
 +
|5 days per week
 +
|-
 +
|Xia et al. 2021
 +
|Unspecified
 +
|30 to 33
 +
|6600 to 7000 cGy
 +
|5 days per week
 +
|-
 +
|}
 +
'''8-week course'''
 +
</div></div><br>
 +
<div class="toccolours" style="background-color:#eeeeee">
  
====Hormonotherapy====
+
===Regimen variant #5, 100 mg/m<sup>2</sup> x 3 {{#subobject:aca3c0|Variant=1}}===
*[[Anastrozole (Arimidex)]] 1 mg PO once per day
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 
+
!style="width: 20%"|Study
'''28-day cycles'''
+
!style="width: 20%"|Dates of enrollment
 
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
===References===
+
!style="width: 20%"|Comparator
# '''MONARCH 3:''' Goetz MP, Toi M, Campone M, Sohn J, Paluch-Shimon S, Huober J, Park IH, Trédan O, Chen SC, Manso L, Freedman OC, Garnica Jaliffe G, Forrester T, Frenzel M, Barriga S, Smith IC, Bourayou N, Di Leo A. MONARCH 3: abemaciclib as initial therapy for advanced breast cancer. J Clin Oncol. 2017 Nov 10;35(32):3638-3646. Epub 2017 Oct 2. [https://ascopubs.org/doi/full/10.1200/JCO.2017.75.6155 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/28968163 PubMed]
+
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
+
|-
==Sunitinib monotherapy {{#subobject:cf6852|Regimen=1}}==
+
|[https://doi.org/10.1200/jco.1998.16.4.1310 Al-Sarraf et al. 1998 (Intergroup 0099)]
{| class="wikitable" style="float:right; margin-left: 5px;"
+
|1989-1995
 +
|style="background-color:#1a9851"|Phase 3 (E-esc)
 +
|[[#Radiation_therapy|Radiation therapy]]
 +
|style="background-color:#1a9850"|Superior OS
 +
|-
 +
|[https://doi.org/10.1200/JCO.2005.16.790 Wee et al. 2005]
 +
|1997-2003
 +
|style="background-color:#1a9851"|Phase 3 (E-esc)
 +
|[[#Radiation_therapy|Radiation therapy]]
 +
|style="background-color:#1a9850"|Superior OS (primary endpoint)<br>OS36: 85% vs 80%<br>(HR 0.51, 95% CI 0.31-0.81)
 +
|-
 +
|[https://doi.org/10.1016/j.ejca.2007.03.022 Chitapanarux et al. 2007]
 +
|1999-2004
 +
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Carboplatin_.26_RT|Carboplatin & RT]], then [[#Carboplatin_.26_Fluorouracil|Carboplatin & 5-FU]]
 +
|style="background-color:#eeee01"|Seems to have non-inferior OS36
 
|-
 
|-
|[[#top|back to top]]
+
|[https://academic.oup.com/jnci/article-lookup/doi/10.1093/jnci/djq258 Lee et al. 2010 (NPC-9901)]
|}
+
|1999-2004
===Regimen {{#subobject:3c0a01|Variant=1}}===
+
|style="background-color:#1a9851"|Phase 3 (E-esc)
{| class="wikitable" style="width: 100%; text-align:center;"
+
|[[#Radiation_therapy|Radiation therapy]]
! style="width: 20%" |Study
+
|style="background-color:#91cf60"|Seems to have superior OS<sup>1</sup> (secondary endpoint)<br>OS120: 62% vs 49%<br>(HR 0.74, 95% CI 0.56-1.00)
! style="width: 20%" |[[Levels_of_Evidence#Evidence|Evidence]]
 
! style="width: 20%" |Comparator
 
! style="width: 20%" |[[Levels_of_Evidence#Efficacy|Efficacy]]
 
! style="width: 20%" |[[Levels_of_Evidence#Toxicity|Toxicity]]
 
 
|-
 
|-
| rowspan="2" |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878938/ Haas et al. 2016 (ECOG-ACRIN E2805)]
+
|[https://doi.org/10.1016/S1470-2045(18)30104-9 Tang et al. 2018]
| rowspan="2" style="background-color:#1a9851" |Phase III (E)
+
|2004-2012
|[[#Placebo|1. Placebo]]
+
|style="background-color:#1a9851"|Phase 3 (C)
| style="background-color:#ffffbf" |Seems not superior
+
|[[#Nedaplatin_.26_RT|Nedaplatin & RT]]
|
+
|style="background-color:#eeee01"|Non-inferior PFS24
 
|-
 
|-
|2. Sorafenib
+
|[https://doi.org/10.1016/S1470-2045(16)30410-7 Sun et al. 2016 (YP2010171)]
| style="background-color:#ffffbf" |Seems not superior
+
|2011-2013
|
+
|style="background-color:#91cf61"|Non-randomized part of phase 3 RCT
 +
|style="background-color:#d3d3d3"|
 +
|style="background-color:#d3d3d3"|
 
|-
 
|-
|[https://www.nejm.org/doi/full/10.1056/NEJMoa1611406 Ravaud et al. 2016 (S-TRAC)]
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9399866/ Tang et al. 2022 (SYSUCC IRNPC15)]
| style="background-color:#1a9851" |Phase III (E)
+
|2015-2020
|[[#Placebo|Placebo]]
+
|style="background-color:#1a9851"|Phase 3 (C)
| style="background-color:#91cf60" |Seems to have superior DFS
+
|[[#Cisplatin_.26_RT|Cisplatin & RT]]
| style="background-color:#d73027" |More toxicity
+
|style="background-color:#eeee01"|Non-inferior FFS
 
|-
 
|-
 
|}
 
|}
 +
''<sup>1</sup>Reported efficacy for NPC-9901 is based on the 2016 update.''<br>
 +
''Note: Intergroup 0099 involved patients with stage III and IV nasopharynx cancers without evidence of metastases.''
 +
<div class="toccolours" style="background-color:#cbd5e8">
 
====Preceding treatment====
 
====Preceding treatment====
*[[Surgery]]
+
*YP2010171: [[#DCF|TPF]] induction versus [[Nasopharyngeal_carcinoma_-_null_regimens#No_induction|no induction]]
 +
</div>
 +
<div class="toccolours" style="background-color:#b3e2cd">
 
====Chemotherapy====
 
====Chemotherapy====
*[[Sunitinib (Sutent)]] 50 mg PO once per day on days 1 to 28
+
*[[Cisplatin (Platinol)]] 100 mg/m<sup>2</sup> IV once per day on days 1, 22, 43
 +
**Wee et al. 2005 gave 25 mg/m<sup>2</sup> IV once per day on days 1 to 4, 22 to 25, 43 to 46
 +
====Supportive therapy====
 +
*Best described by Al-Sarraf et al. 1998
 +
*Forced hydration: 5% dextrose in 1/2 normal saline with 40 mEq KCl, 2000 mL IV continuous infusion over 24 hours given twice, prior to cisplatin and after the second mannitol infusion
 +
*Mannitol 12.5 g IV bolus once on day 1, prior to cisplatin
 +
*5% dextrose in 1/2 normal saline with 30 mEq KCl and mannitol 25 g, 1000 mL IV over 4 hours immediately after cisplatin
 +
*[[:Category:Emesis prevention|Antiemetic]] such as [[Prochlorperazine (Compazine)]] 25 mg rectal suppository given once on day 1; 30 minutes prior to cisplatin
 +
*[[Prochlorperazine (Compazine)]] 10 mg IM every 4 hours as needed for nausea after cisplatin
 +
====Radiotherapy====
 +
*Concurrent [[External_beam_radiotherapy|radiation therapy]] by the following study-specific criteria:
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 20%"|Study
 +
!style="width: 20%"|RT dose per fraction
 +
!style="width: 20%"|Number of fractions
 +
!style="width: 20%"|Total RT dose
 +
!style="width: 20%"|Schedule
 +
|-
 +
|Intergroup 0099
 +
|180 to 200 cGy
 +
|35 to 39
 +
|7000 cGy
 +
|Unspecified
 +
|-
 +
|Chitapanarux et al. 2007
 +
|200 cGy
 +
|35
 +
|7000 cGy
 +
|-
 +
|}
 +
*Additional radiotherapy notes:
 +
**Intergroup 0099: Minimum total dose to neck nodes is 5000 cGy for N0 disease; 6600 cGy for nodes less than or equal to 2 cm in size; 7000 cGy for nodes greater than 2 cm.
 +
**Wee et al. 2005, NPC-9901, Tang et al. 2018, YP2010171, SYSUCC IRNPC15: see papers for details (to be added here, eventually)
 +
'''7-week course'''
 +
</div>
 +
<div class="toccolours" style="background-color:#cbd5e7">
  
'''42-day cycles, given for up to 1 year'''
+
====Subsequent treatment====
 +
*Intergroup 0099, Wee et al. 2005, NPC-9901: [[#Cisplatin_.26_Fluorouracil_.28CF.29_2|CF]] consolidation
 +
*SYSUCC IRNPC15: No further treatment
 +
</div></div>
  
 
===References===
 
===References===
# '''ECOG-ACRIN E2805:''' Haas NB, Manola J, Uzzo RG, Flaherty KT, Wood CG, Kane C, Jewett M, Dutcher JP, Atkins MB, Pins M, Wilding G, Cella D, Wagner L, Matin S, Kuzel TM, Sexton WJ, Wong YN, Choueiri TK, Pili R, Puzanov I, Kohli M, Stadler W, Carducci M, Coomes R, DiPaola RS. Adjuvant sunitinib or sorafenib for high-risk, non-metastatic renal-cell carcinoma (ECOG-ACRIN E2805): a double-blind, placebo-controlled, randomised, phase 3 trial. Lancet. 2016 May 14;387(10032):2008-16. Epub 2016 Mar 9. Erratum in: Lancet. 2016 May 14;387(10032):1998. [https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(16)00559-6/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4878938/ link to PMC article] [https://www.ncbi.nlm.nih.gov/pubmed/26969090 PubMed]
+
# '''Intergroup 0099:''' Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, Forastiere AA, Adams G, Sakr WA, Schuller DE, Ensley JF. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099. J Clin Oncol. 1998 Apr;16(4):1310-7. [https://doi.org/10.1200/jco.1998.16.4.1310 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/9552031/ PubMed]
# '''S-TRAC:''' Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Martini JF, Ramaswamy K, Casey M, Staehler M, Patard JJ; S-TRAC Investigators. Adjuvant sunitinib in high-risk renal-cell carcinoma after nephrectomy. N Engl J Med. 2016 Dec 8;375(23):2246-2254. Epub 2016 Oct 9. [https://www.nejm.org/doi/full/10.1056/NEJMoa1611406 link to original article] '''contains verified protocol''' [https://www.ncbi.nlm.nih.gov/pubmed/27718781 PubMed]
+
# Chan AT, Teo PM, Ngan RK, Leung TW, Lau WH, Zee B, Leung SF, Cheung FY, Yeo W, Yiu HH, Yu KH, Chiu KW, Chan DT, Mok T, Yuen KT, Mo F, Lai M, Kwan WH, Choi P, Johnson PJ. Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2038-44. [https://doi.org/10.1200/JCO.2002.08.149 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11956263/ PubMed]
## '''Update:''' Motzer RJ, Ravaud A, Patard JJ, Pandha HS, George DJ, Patel A, Chang YH, Escudier B, Donskov F, Magheli A, Carteni G, Laguerre B, Tomczak P, Breza J, Gerletti P, Lechuga M, Lin X, Casey M, Serfass L, Pantuck AJ, Staehler M. Adjuvant sunitinib for high-risk renal cell carcinoma after nephrectomy: subgroup analyses and updated overall survival results. Eur Urol. 2018 Jan;73(1):62-68. Epub 2017 Sep 26. [http://www.europeanurology.com/article/S0302-2838(17)30772-8/fulltext link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/28967554 PubMed]
+
## '''Update:''' Chan AT, Leung SF, Ngan RK, Teo PM, Lau WH, Kwan WH, Hui EP, Yiu HY, Yeo W, Cheung FY, Yu KH, Chiu KW, Chan DT, Mok TS, Yau S, Yuen KT, Mo FK, Lai MM, Ma BB, Kam MK, Leung TW, Johnson PJ, Choi PH, Zee BC. Overall survival after concurrent cisplatin-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst. 2005 Apr 6;97(7):536-9. [http://jnci.oxfordjournals.org/content/97/7/536.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/15812080/ PubMed]
 +
# Wee J, Tan EH, Tai BC, Wong HB, Leong SS, Tan T, Chua ET, Yang E, Lee KM, Fong KW, Tan HS, Lee KS, Loong S, Sethi V, Chua EJ, Machin D. Randomized trial of radiotherapy versus concurrent chemoradiotherapy followed by adjuvant chemotherapy in patients with American Joint Committee on Cancer/International Union against cancer stage III and IV nasopharyngeal cancer of the endemic variety. J Clin Oncol. 2005 Sep 20;23(27):6730-8. [https://doi.org/10.1200/JCO.2005.16.790 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16170180/ PubMed]
 +
# Chitapanarux I, Lorvidhaya V, Kamnerdsupaphon P, Sumitsawan Y, Tharavichitkul E, Sukthomya V, Ford J. Chemoradiotherapy comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: randomised, non-inferiority, open trial. Eur J Cancer. 2007 Jun;43(9):1399-406. Epub 2007 Apr 27. [https://doi.org/10.1016/j.ejca.2007.03.022 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/17467265/ PubMed]
 +
# Bae WK, Hwang JE, Shim HJ, Cho SH, Lee JK, Lim SC, Chung WK, Chung IJ. Phase II study of docetaxel, cisplatin, and 5-FU induction chemotherapy followed by chemoradiotherapy in locoregionally advanced nasopharyngeal cancer. Cancer Chemother Pharmacol. 2010 Feb;65(3):589-95. [http://link.springer.com/article/10.1007/s00280-009-1152-0 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/19830427/ PubMed]
 +
# '''NPC-9901:''' Lee AW, Tung SY, Chua DT, Ngan RK, Chappell R, Tung R, Siu L, Ng WT, Sze WK, Au GK, Law SC, O'Sullivan B, Yau TK, Leung TW, Au JS, Sze WM, Choi CW, Fung KK, Lau JT, Lau WH. Randomized trial of radiotherapy plus concurrent-adjuvant chemotherapy vs radiotherapy alone for regionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst. 2010 Aug 4;102(15):1188-98. Epub 2010 Jul 15. [https://academic.oup.com/jnci/article-lookup/doi/10.1093/jnci/djq258 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/20634482/ PubMed] HARECCTR0500023
 +
## '''Update:''' Lee AWM, Tung SY, Ng WT, Lee V, Ngan RKC, Choi HCW, Chan LLK, Siu LL, Ng AWY, Leung TW, Yiu HHY, O'Sullivan B, Chappell R. A multicenter, phase 3, randomized trial of concurrent chemoradiotherapy plus adjuvant chemotherapy versus radiotherapy alone in patients with regionally advanced nasopharyngeal carcinoma: 10-year outcomes for efficacy and toxicity. Cancer. 2017 Nov 1;123(21):4147-4157. Epub 2017 Jun 29. [https://onlinelibrary.wiley.com/wol1/doi/10.1002/cncr.30850 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28662313/ PubMed]
 +
# Chen QY, Wen YF, Guo L, Liu H, Huang PY, Mo HY, Li NW, Xiang YQ, Luo DH, Qiu F, Sun R, Deng MQ, Chen MY, Hua YJ, Guo X, Cao KJ, Hong MH, Qian CN, Mai HQ. Concurrent chemoradiotherapy vs radiotherapy alone in stage II nasopharyngeal carcinoma: phase III randomized trial. J Natl Cancer Inst. 2011 Dec 7;103(23):1761-70. Epub 2011 Nov 4. [https://academic.oup.com/jnci/article/103/23/1761/2516849 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22056739/ PubMed]
 +
## '''Update:''' Li XY, Chen QY, Sun XS, Liu SL, Yan JJ, Guo SS, Liu LT, Xie HJ, Tang QN, Liang YJ, Wen YF, Guo L, Mo HY, Chen MY, Sun Y, Ma J, Tang LQ, Mai HQ. Ten-year outcomes of survival and toxicity for a phase III randomised trial of concurrent chemoradiotherapy versus radiotherapy alone in stage II nasopharyngeal carcinoma. Eur J Cancer. 2019 Mar;110:24-31. Epub 2019 Feb 7. [https://doi.org/10.1016/j.ejca.2018.10.020 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30739837/ PubMed]
 +
# '''YP2008004:''' Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2012 Feb;13(2):163-71. Epub 2011 Dec 7. [https://doi.org/10.1016/S1470-2045(11)70320-5 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22154591/ PubMed] [https://clinicaltrials.gov/study/NCT00677118 NCT00677118]
 +
## '''Update:''' Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial. Eur J Cancer. 2017 Apr;75:150-158. Epub 2017 Feb 22. [https://doi.org/10.1016/j.ejca.2017.01.002 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28235726/ PubMed]
 +
# Tan T, Lim WT, Fong KW, Cheah SL, Soong YL, Ang MK, Ng QS, Tan D, Ong WS, Tan SH, Yip C, Quah D, Soo KC, Wee J. Concurrent chemo-radiation with or without induction gemcitabine, Carboplatin, and Paclitaxel: a randomized, phase 2/3 trial in locally advanced nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):952-60. [https://doi.org/10.1016/j.ijrobp.2015.01.002 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/25832687/ PubMed]
 +
# '''YP2010171:''' Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. Epub 2016 Sep 26. [https://doi.org/10.1016/S1470-2045(16)30410-7 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/27686945/ PubMed] [https://clinicaltrials.gov/study/NCT01245959 NCT01245959]
 +
## '''Update:''' Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J, Sun Y. Concurrent chemoradiotherapy with/without induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: long-term results of phase 3 randomized controlled trial. Int J Cancer. 2019 Jul 1;145(1):295-305. Epub 2019 Jan 24. [https://doi.org/10.1002/ijc.32099 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30613964/ PubMed]
 +
# '''RDDA2017000111:''' Cao SM, Yang Q, Guo L, Mai HQ, Mo HY, Cao KJ, Qian CN, Zhao C, Xiang YQ, Zhang XP, Lin ZX, Li WX, Liu Q, Qiu F, Sun R, Chen QY, Huang PY, Luo DH, Hua YJ, Wu YS, Lv X, Wang L, Xia WX, Tang LQ, Ye YF, Chen MY, Guo X, Hong MH. Neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: A phase III multicentre randomised controlled trial. Eur J Cancer. 2017 Apr;75:14-23. Epub 2017 Feb 16. [https://doi.org/10.1016/j.ejca.2016.12.039 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28214653/ PubMed]
 +
# Tang LQ, Chen DP, Guo L, Mo HY, Huang Y, Guo SS, Qi B, Tang QN, Wang P, Li XY, Li JB, Liu Q, Gao YH, Xie FY, Liu LT, Li Y, Liu SL, Xie HJ, Liang YJ, Sun XS, Yan JJ, Wu YS, Luo DH, Huang PY, Xiang YQ, Sun R, Chen MY, Lv X, Wang L, Xia WX, Zhao C, Cao KJ, Qian CN, Guo X, Hong MH, Nie ZQ, Chen QY, Mai HQ. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2018 Apr;19(4):461-473. Epub 2018 Feb 28. [https://doi.org/10.1016/S1470-2045(18)30104-9 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/29501366/ PubMed] [https://clinicaltrials.gov/study/NCT01540136 NCT01540136]
 +
#Xia WX, Lv X, Liang H, Liu GY, Sun R, Zeng Q, Li SW, Mo HY, Han F, Luo DH, Liu Q, Shi MY, Ye YF, Yang J, Ke LR, Qiang MY, Qiu WZ, Yu YH, Liu KY, Huang XJ, Li WZ, Lv SH, Cai ZC, Miao JJ, Guo L, Chen MY, Cao KJ, Wang L, Zhao C, Huang PY, Chen QY, Hua YJ, Tang LQ, Qian CN, Mai HQ, Guo X, Xiang YQ. A Randomized Controlled Trial Comparing Two Different Schedules for Cisplatin Treatment in Patients with Locoregionally Advanced Nasopharyngeal Cancer. Clin Cancer Res. 2021 Aug 1;27(15):4186-4194. Epub 2021 Jun 3. [https://doi.org/10.1158/1078-0432.ccr-20-4532 link to original article] '''contains dosing details in abstract''' [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8974421/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/34083231/ PubMed] ChiCTR-TRC-12001979
 +
# '''SYSUCC IRNPC15:''' Tang LL, Guo R, Zhang N, Deng B, Chen L, Cheng ZB, Huang J, Hu WH, Huang SH, Luo WJ, Liang JH, Zheng YM, Zhang F, Mao YP, Li WF, Zhou GQ, Liu X, Chen YP, Xu C, Lin L, Liu Q, Du XJ, Zhang Y, Sun Y, Ma J. Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA. 2022 Aug 23;328(8):728-736. [https://doi.org/10.1001/jama.2022.13997 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9399866/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/35997729/ PubMed] [https://clinicaltrials.gov/study/NCT02633202 NCT02633202]
  
 
+
==Cisplatin & Fluorouracil (CF) & RT {{#subobject:4c4db1|Regimen=1}}==
==BEACOPP 4+4==
+
CF & RT: '''<u>C</u>'''isplatin, '''<u>F</u>'''luorouracil, '''<u>R</u>'''adiation '''<u>T</u>'''herapy
 
+
<div class="toccolours" style="background-color:#eeeeee">
===Variant #1, CI Ara-C (100 mg/m<sup>2</sup>) {{#subobject:bb27bc|Variant=1}}===
+
===Regimen {{#subobject:59e75d|Variant=1}}===
{| class="mw-collapsible mw-collapsed wikitable" style="width: 100%; text-align:center;"  
+
{| class="wikitable sortable" style="width: 100%; text-align:center;"  
!style="width: 25%"|Study
+
!style="width: 20%"|Study
!style="width: 25%"|[[Levels_of_Evidence#Evidence|Evidence]]
+
!style="width: 20%"|Dates of enrollment
!style="width: 25%"|Comparator
+
!style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]]
!style="width: 25%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
+
!style="width: 20%"|Comparator
 +
!style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]]
 
|-
 
|-
| rowspan="3" |[http://www.bloodjournal.org/content/58/6/1203.long Rai et al. 1981 (CALGB 7421)]
+
|[https://doi.org/10.1200/JCO.2003.06.158 Lin et al. 2003]
| rowspan="3" style="background-color:#1a9851" |Phase III
+
|1993-1999
|7+3d (bolus Ara-C)
+
|style="background-color:#1a9851"|Phase 3 (E-esc)
| style="background-color:#91cf60" |Seems to have superior CR rate
+
|[[#Radiation_therapy|RT]]
 +
| style="background-color:#1a9850" |Superior OS
 
|-
 
|-
|5+2d
+
|}
| style="background-color:#1a9850" |Superior CR rate
+
<div class="toccolours" style="background-color:#b3e2cd">
 +
====Chemotherapy====
 +
*[[Cisplatin (Platinol)]] 20 mg/m<sup>2</sup> IV once per day on days 1 to 5, 29 to 33
 +
*[[Fluorouracil (5-FU)]] 400 mg/m<sup>2</sup>/day IV continuous infusion over 96 hours, started on days 1 & 29 (total dose: 3200 mg/m<sup>2</sup>)
 +
====Radiotherapy====
 +
*Concurrent [[External_beam_radiotherapy|radiation therapy]]:
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 25%"|RT dose per fraction
 +
!style="width: 25%"|Number of fractions
 +
!style="width: 25%"|Total RT dose
 +
!style="width: 25%"|Schedule
 
|-
 
|-
|5+2d (bolus Ara-C)
+
|Unspecified
| style="background-color:#1a9850" |Superior CR rate
+
|Unspecified
 +
|7000 to 7400 cGy
 +
|Unspecified
 
|-
 
|-
| rowspan="2" |[http://www.bloodjournal.org/content/60/2/454.long Yates et al. 1982 (CALGB 7721)]
+
|}
| rowspan="2" style="background-color:#1a9851" |Phase III
+
'''7- to 8-week course'''
|7+3d, low-dose dauno (30 mg/m<sup>2</sup>)
+
</div></div>
| style="background-color:#ffffbf" |Seems not superior
+
 
 +
===References===
 +
# Lin JC, Jan JS, Hsu CY, Liang WM, Jiang RS, Wang WY. Phase III study of concurrent chemoradiotherapy versus radiotherapy alone for advanced nasopharyngeal carcinoma: positive effect on overall and progression-free survival. J Clin Oncol. 2003 Feb 15;21(4):631-7. [https://doi.org/10.1200/JCO.2003.06.158 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/12586799/ PubMed]
 +
==Nedaplatin & RT {{#subobject:ned61f|Regimen=1}}==
 +
Nedaplatin & RT: Cisplatin & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:acned0|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]]
 
|-
 
|-
|7+3a (30 mg/m<sup>2</sup>)
+
|[https://doi.org/10.1016/S1470-2045(18)30104-9 Tang et al. 2018]
| style="background-color:#ffffbf" |Seems not superior
+
|2004-2012
 +
|style="background-color:#1a9851"|Phase 3 (E-switch-ic)
 +
|[[#Cisplatin_.26_RT|Cisplatin & RT]]
 +
|style="background-color:#eeee01"|Non-inferior PFS24 (primary endpoint)<br>PFS24: 88% vs 89.9%
 
|-
 
|-
| rowspan="2" |[http://www.bloodjournal.org/content/69/5/1441.long Preisler et al. 1987 (CALGB 7921)]
+
|}
| rowspan="2" style="background-color:#1a9851" |Phase III
+
<div class="toccolours" style="background-color:#b3e2cd">
|10+3d
+
====Chemotherapy====
| style="background-color:#ffffbf" |Seems not superior
+
*[[Nedaplatin (Aqupla)]] 100 mg/m<sup>2</sup> IV once per day on days 1, 22, 43
 +
====Radiotherapy====
 +
*Concurrent [[External_beam_radiotherapy|radiation therapy]]
 +
'''One course'''
 +
</div></div>
 +
===References===
 +
# Tang LQ, Chen DP, Guo L, Mo HY, Huang Y, Guo SS, Qi B, Tang QN, Wang P, Li XY, Li JB, Liu Q, Gao YH, Xie FY, Liu LT, Li Y, Liu SL, Xie HJ, Liang YJ, Sun XS, Yan JJ, Wu YS, Luo DH, Huang PY, Xiang YQ, Sun R, Chen MY, Lv X, Wang L, Xia WX, Zhao C, Cao KJ, Qian CN, Guo X, Hong MH, Nie ZQ, Chen QY, Mai HQ. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2018 Apr;19(4):461-473. Epub 2018 Feb 28. [https://doi.org/10.1016/S1470-2045(18)30104-9 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/29501366/ PubMed] [https://clinicaltrials.gov/study/NCT01540136 NCT01540136]
 +
==Oxaliplatin & RT {{#subobject:308944|Regimen=1}}==
 +
Oxaliplatin & RT: Oxaliplatin & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===Regimen {{#subobject:9ab499|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]]
 
|-
 
|-
|TAD
+
|[https://doi.org/10.1200/JCO.2004.00.3863 Zhang et al. 2005]
| style="background-color:#ffffbf" |Seems not superior
+
|2001-2003
 +
|style="background-color:#1a9851"|Phase 3 (E-esc)
 +
|[[#Radiation_therapy_2|RT]]
 +
| style="background-color:#1a9850" |Superior OS<sup>1</sup> (primary endpoint)<br>OS84: 71.3% vs 56.3%<br>(HR 0.54, 95% CI 0.31-0.94)
 
|-
 
|-
|[http://www.bloodjournal.org/content/79/2/313 Wiernik et al. 1992]
+
|}
| style="background-color:#1a9851" |Phase III
+
''<sup>1</sup>Reported efficacy is based on the 2013 update.''
|[[#7.2B3i|7+3i]]
+
<div class="toccolours" style="background-color:#b3e2cd">
| style="background-color:#fc8d59" |Seems to have inferior OS
+
====Chemotherapy====
 +
*[[Oxaliplatin (Eloxatin)]] 70 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22, 29, 36
 +
====Radiotherapy====
 +
*Concurrent [[External_beam_radiotherapy|radiation therapy]] to primary tumor:
 +
{| class="wikitable sortable" style="width: 100%; text-align:center;"
 +
!style="width: 25%"|RT dose per fraction
 +
!style="width: 25%"|Number of fractions
 +
!style="width: 25%"|Total RT dose
 +
!style="width: 25%"|Schedule
 
|-
 
|-
|[http://www.bloodjournal.org/content/103/2/479.long Rowe et al. 2004]
+
|Unspecified
| style="background-color:#1a9851" |Phase III
+
|Unspecified
|7+3d + GM-CSF<br> [[#7.2B3i|7+3i]]<br> 7+3i + GM-CSF<br> [[#7.2B3m|7+3m]]<br> 7+3m + GM-CSF
+
|7000 to 7400 cGy
| style="background-color:#ffffbf" |Seems not superior
+
|Unspecified
 
|-
 
|-
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4480917/ Fernandez et al. 2009 (ECOG E1900)]
+
|}
| style="background-color:#1a9851" |Phase III (C)
+
'''6-week course'''
|[[#7.2B3d_.28high-dose.29|7+3d (high-dose)]]
+
</div></div>
| style="background-color:#d73027" |Inferior OS
+
===References===
 +
# Zhang L, Zhao C, Peng PJ, Lu LX, Huang PY, Han F, Wu SX. Phase III study comparing standard radiotherapy with or without weekly oxaliplatin in treatment of locoregionally advanced nasopharyngeal carcinoma: preliminary results. J Clin Oncol. 2005 Nov 20;23(33):8461-8. Epub 2005 Oct 17. [https://doi.org/10.1200/JCO.2004.00.3863 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16230677/ PubMed]
 +
## '''Update:''' Wu X, Huang PY, Peng PJ, Lu LX, Han F, Wu SX, Hou X, Zhao HY, Huang Y, Fang WF, Zhao YY, Xue C, Hu ZH, Zhang J, Zhang JW, Ma YX, Liang WH, Zhao C, Zhang L. Long-term follow-up of a phase III study comparing radiotherapy with or without weekly oxaliplatin for locoregionally advanced nasopharyngeal carcinoma. Ann Oncol. 2013 Aug;24(8):2131-6. Epub 2013 May 9. [https://doi.org/10.1093/annonc/mdt163 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23661293/ PubMed]
 +
 
 +
==Radiation therapy {{#subobject:5ac377|Regimen=1}}==
 +
<div class="toccolours" style="background-color:#eeeeee">
 +
===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://www.ncbi.nlm.nih.gov/pmc/articles/PMC4504945/ Dombret et al. 2015 (AZA-AML-001)]
+
|[https://doi.org/10.1200/jco.1998.16.4.1310 Al-Sarraf et al. 1998 (Intergroup 0099)]
| style="background-color:#1a9851" |Phase III (C)
+
|1989-1995
|[[#Azacitidine_monotherapy|Azacitidine]]
+
|style="background-color:#1a9851"|Phase 3 (C)
| style="background-color:#fee08b" |Might have inferior OS
+
|[[#Cisplatin_.26_RT|Cisplatin & RT]], then [[#Cisplatin_.26_Fluorouracil_.28CF.29_2|CF]]
 +
|style="background-color:#d73027"|Inferior OS
 
|-
 
|-
|}
+
|[https://doi.org/10.1200/JCO.2002.08.149 Chan et al. 2002]
''Note: this was the lower bound of the allowable daunorubicin dose in AZA-AML-001.''
+
|1994-1999
<div class="toccolours" style="width:100%; overflow:auto;">
+
|style="background-color:#1a9851"|Phase 3 (C)
 
+
|[[#Cisplatin_.26_RT|Cisplatin & RT]]
====Chemotherapy====
+
|style="background-color:#fee08b"|Might have inferior OS<sup>1</sup>
*[[Cytarabine (Ara-C)]] 100 mg/m<sup>2</sup>/day IV continuous infusion on days 1 to 7 (total dose: 700 mg/m<sup>2</sup>)
 
*[[Daunorubicin (Cerubidine)]] 45 mg/m<sup>2</sup> IV once per day on days 1 to 3
 
 
 
'''7-day course'''
 
</div>
 
====Subsequent treatment====
 
*Rowe et al. 2004: Patients with persistent disease at day 14 (greater than 5% blasts) underwent an identical second cycle of 7+3i
 
 
 
albjablja;ldkjgs
 
 
 
{| class="wikitable" style="width: 100%; text-align:center;"  
 
!Efficacy
 
!p-value
 
!Narrative description
 
 
|-
 
|-
|ORR > 20%
+
|[https://doi.org/10.1200/JCO.2005.16.790 Wee et al. 2005]
|≤ 0.01
+
|1997-2003
|style="background-color:#1a9850"|Likely to have true ORR >20%
+
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Cisplatin_.26_RT|Cisplatin & RT]]
 +
|style="background-color:#d73027"|Inferior OS
 
|-
 
|-
|ORR > 20%
+
|[https://academic.oup.com/jnci/article-lookup/doi/10.1093/jnci/djq258 Lee et al. 2010 (NPC-9901)]
|> 0.01 and ≤ 0.10
+
|1999-2004
|style="background-color:#91cf60"|Might have true ORR >20%
+
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Cisplatin_.26_RT|Cisplatin & RT]]
 +
|style="background-color:#fc8d59"|Seems to have inferior OS<sup>2</sup>
 
|-
 
|-
|ORR > 20%
+
|[https://academic.oup.com/jnci/article/103/23/1761/2516849 Chen et al. 2011]
|> 0.10
+
|2003-2007
|style="background-color:#d9ef8b"|Potentially has true ORR >20%
+
|style="background-color:#1a9851"|Phase 3 (C)
 +
|[[#Cisplatin_.26_RT|Cisplatin & RT]]
 +
|style="background-color:#d73027"|Inferior OS
 
|-
 
|-
|ORR < 20%
+
|[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9399866/ Tang et al. 2022 (SYSUCC IRNPC15)]
|N/A
+
|2015-2020
|style="background-color:#ffffbf"|Unlikely to have true ORR >20%
+
|style="background-color:#1a9851"|Phase 3 (E-de-esc)
 +
|[[#Cisplatin_.26_RT|Cisplatin & RT]]
 +
|style="background-color:#eeee01"|Non-inferior FFS (primary endpoint)<br>FFS36: 90.5% vs 91.9%<br>(HR 1.36, 95% CI 0.70-2.66)
 
|-
 
|-
 
|}
 
|}
 
+
''<sup>1</sup>Reported efficacy for Chan et al. 2002 is based on the 2005 update.''<br>
 
+
''<sup>2</sup>Reported efficacy for NPC-9901 is based on the 2016 update.''
 
+
<div class="toccolours" style="background-color:#b3e2cd">
[[Category:Null pages]]
+
====Radiotherapy====
 +
*[[External beam radiotherapy]]
 +
</div></div>
 +
===References===
 +
# '''Intergroup 0099:''' Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, Forastiere AA, Adams G, Sakr WA, Schuller DE, Ensley JF. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099. J Clin Oncol. 1998 Apr;16(4):1310-7. [https://doi.org/10.1200/jco.1998.16.4.1310 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/9552031/ PubMed]
 +
# Chan AT, Teo PM, Ngan RK, Leung TW, Lau WH, Zee B, Leung SF, Cheung FY, Yeo W, Yiu HH, Yu KH, Chiu KW, Chan DT, Mok T, Yuen KT, Mo F, Lai M, Kwan WH, Choi P, Johnson PJ. Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2038-44. [https://doi.org/10.1200/JCO.2002.08.149 link to original article] [https://pubmed.ncbi.nlm.nih.gov/11956263/ PubMed]
 +
## '''Update:''' Chan AT, Leung SF, Ngan RK, Teo PM, Lau WH, Kwan WH, Hui EP, Yiu HY, Yeo W, Cheung FY, Yu KH, Chiu KW, Chan DT, Mok TS, Yau S, Yuen KT, Mo FK, Lai MM, Ma BB, Kam MK, Leung TW, Johnson PJ, Choi PH, Zee BC. Overall survival after concurrent cisplatin-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst. 2005 Apr 6;97(7):536-9. [http://jnci.oxfordjournals.org/content/97/7/536.long link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/15812080/ PubMed]
 +
# Wee J, Tan EH, Tai BC, Wong HB, Leong SS, Tan T, Chua ET, Yang E, Lee KM, Fong KW, Tan HS, Lee KS, Loong S, Sethi V, Chua EJ, Machin D. Randomized trial of radiotherapy versus concurrent chemoradiotherapy followed by adjuvant chemotherapy in patients with American Joint Committee on Cancer/International Union against cancer stage III and IV nasopharyngeal cancer of the endemic variety. J Clin Oncol. 2005 Sep 20;23(27):6730-8. [https://doi.org/10.1200/JCO.2005.16.790 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16170180/ PubMed]
 +
# Zhang L, Zhao C, Peng PJ, Lu LX, Huang PY, Han F, Wu SX. Phase III study comparing standard radiotherapy with or without weekly oxaliplatin in treatment of locoregionally advanced nasopharyngeal carcinoma: preliminary results. J Clin Oncol. 2005 Nov 20;23(33):8461-8. Epub 2005 Oct 17. [https://doi.org/10.1200/JCO.2004.00.3863 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/16230677/ PubMed]
 +
## '''Update:''' Wu X, Huang PY, Peng PJ, Lu LX, Han F, Wu SX, Hou X, Zhao HY, Huang Y, Fang WF, Zhao YY, Xue C, Hu ZH, Zhang J, Zhang JW, Ma YX, Liang WH, Zhao C, Zhang L. Long-term follow-up of a phase III study comparing radiotherapy with or without weekly oxaliplatin for locoregionally advanced nasopharyngeal carcinoma. Ann Oncol. 2013 Aug;24(8):2131-6. Epub 2013 May 9. [https://doi.org/10.1093/annonc/mdt163 link to original article] [https://pubmed.ncbi.nlm.nih.gov/23661293/ PubMed]
 +
# '''NPC-9901:''' Lee AW, Tung SY, Chua DT, Ngan RK, Chappell R, Tung R, Siu L, Ng WT, Sze WK, Au GK, Law SC, O'Sullivan B, Yau TK, Leung TW, Au JS, Sze WM, Choi CW, Fung KK, Lau JT, Lau WH. Randomized trial of radiotherapy plus concurrent-adjuvant chemotherapy vs radiotherapy alone for regionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst. 2010 Aug 4;102(15):1188-98. Epub 2010 Jul 15. [https://academic.oup.com/jnci/article-lookup/doi/10.1093/jnci/djq258 link to original article] '''contains partial protocol''' [https://pubmed.ncbi.nlm.nih.gov/20634482/ PubMed] HARECCTR0500023
 +
## '''Update:''' Lee AWM, Tung SY, Ng WT, Lee V, Ngan RKC, Choi HCW, Chan LLK, Siu LL, Ng AWY, Leung TW, Yiu HHY, O'Sullivan B, Chappell R. A multicenter, phase 3, randomized trial of concurrent chemoradiotherapy plus adjuvant chemotherapy versus radiotherapy alone in patients with regionally advanced nasopharyngeal carcinoma: 10-year outcomes for efficacy and toxicity. Cancer. 2017 Nov 1;123(21):4147-4157. Epub 2017 Jun 29. [https://onlinelibrary.wiley.com/wol1/doi/10.1002/cncr.30850 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28662313/ PubMed]
 +
# Chen QY, Wen YF, Guo L, Liu H, Huang PY, Mo HY, Li NW, Xiang YQ, Luo DH, Qiu F, Sun R, Deng MQ, Chen MY, Hua YJ, Guo X, Cao KJ, Hong MH, Qian CN, Mai HQ. Concurrent chemoradiotherapy vs radiotherapy alone in stage II nasopharyngeal carcinoma: phase III randomized trial. J Natl Cancer Inst. 2011 Dec 7;103(23):1761-70. Epub 2011 Nov 4. [https://academic.oup.com/jnci/article/103/23/1761/2516849 link to original article] '''contains dosing details in abstract''' [https://pubmed.ncbi.nlm.nih.gov/22056739/ PubMed]
 +
## '''Update:''' Li XY, Chen QY, Sun XS, Liu SL, Yan JJ, Guo SS, Liu LT, Xie HJ, Tang QN, Liang YJ, Wen YF, Guo L, Mo HY, Chen MY, Sun Y, Ma J, Tang LQ, Mai HQ. Ten-year outcomes of survival and toxicity for a phase III randomised trial of concurrent chemoradiotherapy versus radiotherapy alone in stage II nasopharyngeal carcinoma. Eur J Cancer. 2019 Mar;110:24-31. Epub 2019 Feb 7. [https://doi.org/10.1016/j.ejca.2018.10.020 link to original article] [https://pubmed.ncbi.nlm.nih.gov/30739837/ PubMed]
 +
# '''SYSUCC 5010:''' You R, Liu YP, Huang PY, Zou X, Sun R, He YX, Wu YS, Shen GP, Zhang HD, Duan CY, Tan SH, Cao JY, Li JB, Xie YL, Zhang YN, Wang ZQ, Yang Q, Lin M, Jiang R, Zhang MX, Hua YJ, Tang LQ, Zhuang AH, Chen QY, Guo L, Mo HY, Chen Y, Mai HQ, Ling L, Liu Q, Chua MLK, Chen MY. Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1345-1352. [https://doi.org/10.1001/jamaoncol.2020.1808 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7378870/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/32701129/ PubMed] [https://clinicaltrials.gov/study/NCT02111460 NCT02111460]
 +
# '''SYSUCC IRNPC15:''' Tang LL, Guo R, Zhang N, Deng B, Chen L, Cheng ZB, Huang J, Hu WH, Huang SH, Luo WJ, Liang JH, Zheng YM, Zhang F, Mao YP, Li WF, Zhou GQ, Liu X, Chen YP, Xu C, Lin L, Liu Q, Du XJ, Zhang Y, Sun Y, Ma J. Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA. 2022 Aug 23;328(8):728-736. [https://doi.org/10.1001/jama.2022.13997 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9399866/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/35997729/ PubMed] [https://clinicaltrials.gov/study/NCT02633202 NCT02633202]

Latest revision as of 12:51, 24 April 2024

Locally advanced disease, definitive chemoradiotherapy

Carboplatin & RT

Carboplatin & RT: Carboplatin & Radiation Therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Chitapanarux et al. 2007 1999-2004 Phase 3 (E-switch-ic) Cisplatin & RT, then CF Seems to have non-inferior OS36

Chemotherapy

Radiotherapy

RT dose per fraction Number of fractions Total RT dose Schedule
200 cGy 35 7000 cGy 5 days per week

7-week course

Subsequent treatment

References

  1. Chitapanarux I, Lorvidhaya V, Kamnerdsupaphon P, Sumitsawan Y, Tharavichitkul E, Sukthomya V, Ford J. Chemoradiotherapy comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: randomised, non-inferiority, open trial. Eur J Cancer. 2007 Jun;43(9):1399-406. Epub 2007 Apr 27. link to original article contains dosing details in manuscript PubMed

Cisplatin & RT

Cisplatin & RT: Cisplatin & Radiation Therapy

Regimen variant #1, 30 mg/m2 weekly dosing

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Chen et al. 2011 2003-2007 Phase 3 (E-esc) Radiation therapy Superior OS (primary endpoint)
OS60: 94.5% vs 85.8%
(HR 0.30, 95% CI 0.12-0.76)

Chemotherapy

Radiotherapy

RT dose per fraction Number of fractions Total RT dose Schedule
200 cGy 34 to 35 6800 to 7000 cGy 5 days per week

7-week course


Regimen variant #2, 40 mg/m2 weekly dosing

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Chan et al. 2002 1994-1999 Phase 3 (E-esc) Radiation therapy Might have superior OS1
Tan et al. 2015 2004-2012 Non-randomized part of phase 2/3 RCT
Chen et al. 2011 (YP2008004) 2006-2010 Non-randomized part of phase 3 RCT

1Reported efficacy for Chan et al. 2002 is based on the 2005 update.
Note: See Chan et al. 2005 for additional information about boost doses.

Preceding treatment

Chemotherapy

Radiotherapy

RT dose per fraction Number of fractions Total RT dose Schedule
200 cGy 33 6600 cGy 5 days per week

6.5-week course

Subsequent treatment


Regimen variant #3, 40 mg/m2 weekly dosing x 6

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Xia et al. 2021 2011-2016 Phase 3 (C) Cisplatin & RT; q3wk x 2 Non-inferior FFS

Chemotherapy

Radiotherapy

One course


Regimen variant #4, 100 mg/m2 x 2

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Bae et al. 2010 2004-2008 Phase 2
Xia et al. 2021 2011-2016 Phase 3 (E-switch-ic) Cisplatin & RT; weekly x 6 Non-inferior FFS (primary endpoint)
FFS36: 85.4% vs 85.6%
(HR 1.00, 95% CI 0.66-1.52)

Chemotherapy

Radiotherapy

Study RT dose per fraction Number of fractions Total RT dose Schedule
Bae et al. 2010 180 to 200 cGy 35 to 38 6840 cGy 5 days per week
Xia et al. 2021 Unspecified 30 to 33 6600 to 7000 cGy 5 days per week

8-week course


Regimen variant #5, 100 mg/m2 x 3

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Al-Sarraf et al. 1998 (Intergroup 0099) 1989-1995 Phase 3 (E-esc) Radiation therapy Superior OS
Wee et al. 2005 1997-2003 Phase 3 (E-esc) Radiation therapy Superior OS (primary endpoint)
OS36: 85% vs 80%
(HR 0.51, 95% CI 0.31-0.81)
Chitapanarux et al. 2007 1999-2004 Phase 3 (C) Carboplatin & RT, then Carboplatin & 5-FU Seems to have non-inferior OS36
Lee et al. 2010 (NPC-9901) 1999-2004 Phase 3 (E-esc) Radiation therapy Seems to have superior OS1 (secondary endpoint)
OS120: 62% vs 49%
(HR 0.74, 95% CI 0.56-1.00)
Tang et al. 2018 2004-2012 Phase 3 (C) Nedaplatin & RT Non-inferior PFS24
Sun et al. 2016 (YP2010171) 2011-2013 Non-randomized part of phase 3 RCT
Tang et al. 2022 (SYSUCC IRNPC15) 2015-2020 Phase 3 (C) Cisplatin & RT Non-inferior FFS

1Reported efficacy for NPC-9901 is based on the 2016 update.
Note: Intergroup 0099 involved patients with stage III and IV nasopharynx cancers without evidence of metastases.

Preceding treatment

Chemotherapy

  • Cisplatin (Platinol) 100 mg/m2 IV once per day on days 1, 22, 43
    • Wee et al. 2005 gave 25 mg/m2 IV once per day on days 1 to 4, 22 to 25, 43 to 46

Supportive therapy

  • Best described by Al-Sarraf et al. 1998
  • Forced hydration: 5% dextrose in 1/2 normal saline with 40 mEq KCl, 2000 mL IV continuous infusion over 24 hours given twice, prior to cisplatin and after the second mannitol infusion
  • Mannitol 12.5 g IV bolus once on day 1, prior to cisplatin
  • 5% dextrose in 1/2 normal saline with 30 mEq KCl and mannitol 25 g, 1000 mL IV over 4 hours immediately after cisplatin
  • Antiemetic such as Prochlorperazine (Compazine) 25 mg rectal suppository given once on day 1; 30 minutes prior to cisplatin
  • Prochlorperazine (Compazine) 10 mg IM every 4 hours as needed for nausea after cisplatin

Radiotherapy

Study RT dose per fraction Number of fractions Total RT dose Schedule
Intergroup 0099 180 to 200 cGy 35 to 39 7000 cGy Unspecified
Chitapanarux et al. 2007 200 cGy 35 7000 cGy
  • Additional radiotherapy notes:
    • Intergroup 0099: Minimum total dose to neck nodes is 5000 cGy for N0 disease; 6600 cGy for nodes less than or equal to 2 cm in size; 7000 cGy for nodes greater than 2 cm.
    • Wee et al. 2005, NPC-9901, Tang et al. 2018, YP2010171, SYSUCC IRNPC15: see papers for details (to be added here, eventually)

7-week course

Subsequent treatment

  • Intergroup 0099, Wee et al. 2005, NPC-9901: CF consolidation
  • SYSUCC IRNPC15: No further treatment

References

  1. Intergroup 0099: Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, Forastiere AA, Adams G, Sakr WA, Schuller DE, Ensley JF. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099. J Clin Oncol. 1998 Apr;16(4):1310-7. link to original article contains dosing details in manuscript PubMed
  2. Chan AT, Teo PM, Ngan RK, Leung TW, Lau WH, Zee B, Leung SF, Cheung FY, Yeo W, Yiu HH, Yu KH, Chiu KW, Chan DT, Mok T, Yuen KT, Mo F, Lai M, Kwan WH, Choi P, Johnson PJ. Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2038-44. link to original article PubMed
    1. Update: Chan AT, Leung SF, Ngan RK, Teo PM, Lau WH, Kwan WH, Hui EP, Yiu HY, Yeo W, Cheung FY, Yu KH, Chiu KW, Chan DT, Mok TS, Yau S, Yuen KT, Mo FK, Lai MM, Ma BB, Kam MK, Leung TW, Johnson PJ, Choi PH, Zee BC. Overall survival after concurrent cisplatin-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst. 2005 Apr 6;97(7):536-9. link to original article contains dosing details in manuscript PubMed
  3. Wee J, Tan EH, Tai BC, Wong HB, Leong SS, Tan T, Chua ET, Yang E, Lee KM, Fong KW, Tan HS, Lee KS, Loong S, Sethi V, Chua EJ, Machin D. Randomized trial of radiotherapy versus concurrent chemoradiotherapy followed by adjuvant chemotherapy in patients with American Joint Committee on Cancer/International Union against cancer stage III and IV nasopharyngeal cancer of the endemic variety. J Clin Oncol. 2005 Sep 20;23(27):6730-8. link to original article PubMed
  4. Chitapanarux I, Lorvidhaya V, Kamnerdsupaphon P, Sumitsawan Y, Tharavichitkul E, Sukthomya V, Ford J. Chemoradiotherapy comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: randomised, non-inferiority, open trial. Eur J Cancer. 2007 Jun;43(9):1399-406. Epub 2007 Apr 27. link to original article contains dosing details in manuscript PubMed
  5. Bae WK, Hwang JE, Shim HJ, Cho SH, Lee JK, Lim SC, Chung WK, Chung IJ. Phase II study of docetaxel, cisplatin, and 5-FU induction chemotherapy followed by chemoradiotherapy in locoregionally advanced nasopharyngeal cancer. Cancer Chemother Pharmacol. 2010 Feb;65(3):589-95. link to original article contains dosing details in manuscript PubMed
  6. NPC-9901: Lee AW, Tung SY, Chua DT, Ngan RK, Chappell R, Tung R, Siu L, Ng WT, Sze WK, Au GK, Law SC, O'Sullivan B, Yau TK, Leung TW, Au JS, Sze WM, Choi CW, Fung KK, Lau JT, Lau WH. Randomized trial of radiotherapy plus concurrent-adjuvant chemotherapy vs radiotherapy alone for regionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst. 2010 Aug 4;102(15):1188-98. Epub 2010 Jul 15. link to original article contains partial protocol PubMed HARECCTR0500023
    1. Update: Lee AWM, Tung SY, Ng WT, Lee V, Ngan RKC, Choi HCW, Chan LLK, Siu LL, Ng AWY, Leung TW, Yiu HHY, O'Sullivan B, Chappell R. A multicenter, phase 3, randomized trial of concurrent chemoradiotherapy plus adjuvant chemotherapy versus radiotherapy alone in patients with regionally advanced nasopharyngeal carcinoma: 10-year outcomes for efficacy and toxicity. Cancer. 2017 Nov 1;123(21):4147-4157. Epub 2017 Jun 29. link to original article PubMed
  7. Chen QY, Wen YF, Guo L, Liu H, Huang PY, Mo HY, Li NW, Xiang YQ, Luo DH, Qiu F, Sun R, Deng MQ, Chen MY, Hua YJ, Guo X, Cao KJ, Hong MH, Qian CN, Mai HQ. Concurrent chemoradiotherapy vs radiotherapy alone in stage II nasopharyngeal carcinoma: phase III randomized trial. J Natl Cancer Inst. 2011 Dec 7;103(23):1761-70. Epub 2011 Nov 4. link to original article contains dosing details in abstract PubMed
    1. Update: Li XY, Chen QY, Sun XS, Liu SL, Yan JJ, Guo SS, Liu LT, Xie HJ, Tang QN, Liang YJ, Wen YF, Guo L, Mo HY, Chen MY, Sun Y, Ma J, Tang LQ, Mai HQ. Ten-year outcomes of survival and toxicity for a phase III randomised trial of concurrent chemoradiotherapy versus radiotherapy alone in stage II nasopharyngeal carcinoma. Eur J Cancer. 2019 Mar;110:24-31. Epub 2019 Feb 7. link to original article PubMed
  8. YP2008004: Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2012 Feb;13(2):163-71. Epub 2011 Dec 7. link to original article contains dosing details in abstract PubMed NCT00677118
    1. Update: Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial. Eur J Cancer. 2017 Apr;75:150-158. Epub 2017 Feb 22. link to original article PubMed
  9. Tan T, Lim WT, Fong KW, Cheah SL, Soong YL, Ang MK, Ng QS, Tan D, Ong WS, Tan SH, Yip C, Quah D, Soo KC, Wee J. Concurrent chemo-radiation with or without induction gemcitabine, Carboplatin, and Paclitaxel: a randomized, phase 2/3 trial in locally advanced nasopharyngeal carcinoma. Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):952-60. link to original article contains dosing details in abstract PubMed
  10. YP2010171: Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. Epub 2016 Sep 26. link to original article contains dosing details in manuscript PubMed NCT01245959
    1. Update: Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J, Sun Y. Concurrent chemoradiotherapy with/without induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: long-term results of phase 3 randomized controlled trial. Int J Cancer. 2019 Jul 1;145(1):295-305. Epub 2019 Jan 24. link to original article PubMed
  11. RDDA2017000111: Cao SM, Yang Q, Guo L, Mai HQ, Mo HY, Cao KJ, Qian CN, Zhao C, Xiang YQ, Zhang XP, Lin ZX, Li WX, Liu Q, Qiu F, Sun R, Chen QY, Huang PY, Luo DH, Hua YJ, Wu YS, Lv X, Wang L, Xia WX, Tang LQ, Ye YF, Chen MY, Guo X, Hong MH. Neoadjuvant chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: A phase III multicentre randomised controlled trial. Eur J Cancer. 2017 Apr;75:14-23. Epub 2017 Feb 16. link to original article PubMed
  12. Tang LQ, Chen DP, Guo L, Mo HY, Huang Y, Guo SS, Qi B, Tang QN, Wang P, Li XY, Li JB, Liu Q, Gao YH, Xie FY, Liu LT, Li Y, Liu SL, Xie HJ, Liang YJ, Sun XS, Yan JJ, Wu YS, Luo DH, Huang PY, Xiang YQ, Sun R, Chen MY, Lv X, Wang L, Xia WX, Zhao C, Cao KJ, Qian CN, Guo X, Hong MH, Nie ZQ, Chen QY, Mai HQ. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2018 Apr;19(4):461-473. Epub 2018 Feb 28. link to original article contains dosing details in abstract PubMed NCT01540136
  13. Xia WX, Lv X, Liang H, Liu GY, Sun R, Zeng Q, Li SW, Mo HY, Han F, Luo DH, Liu Q, Shi MY, Ye YF, Yang J, Ke LR, Qiang MY, Qiu WZ, Yu YH, Liu KY, Huang XJ, Li WZ, Lv SH, Cai ZC, Miao JJ, Guo L, Chen MY, Cao KJ, Wang L, Zhao C, Huang PY, Chen QY, Hua YJ, Tang LQ, Qian CN, Mai HQ, Guo X, Xiang YQ. A Randomized Controlled Trial Comparing Two Different Schedules for Cisplatin Treatment in Patients with Locoregionally Advanced Nasopharyngeal Cancer. Clin Cancer Res. 2021 Aug 1;27(15):4186-4194. Epub 2021 Jun 3. link to original article contains dosing details in abstract link to PMC article PubMed ChiCTR-TRC-12001979
  14. SYSUCC IRNPC15: Tang LL, Guo R, Zhang N, Deng B, Chen L, Cheng ZB, Huang J, Hu WH, Huang SH, Luo WJ, Liang JH, Zheng YM, Zhang F, Mao YP, Li WF, Zhou GQ, Liu X, Chen YP, Xu C, Lin L, Liu Q, Du XJ, Zhang Y, Sun Y, Ma J. Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA. 2022 Aug 23;328(8):728-736. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02633202

Cisplatin & Fluorouracil (CF) & RT

CF & RT: Cisplatin, Fluorouracil, Radiation Therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Lin et al. 2003 1993-1999 Phase 3 (E-esc) RT Superior OS

Chemotherapy

Radiotherapy

RT dose per fraction Number of fractions Total RT dose Schedule
Unspecified Unspecified 7000 to 7400 cGy Unspecified

7- to 8-week course

References

  1. Lin JC, Jan JS, Hsu CY, Liang WM, Jiang RS, Wang WY. Phase III study of concurrent chemoradiotherapy versus radiotherapy alone for advanced nasopharyngeal carcinoma: positive effect on overall and progression-free survival. J Clin Oncol. 2003 Feb 15;21(4):631-7. link to original article contains dosing details in abstract PubMed

Nedaplatin & RT

Nedaplatin & RT: Cisplatin & Radiation Therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Tang et al. 2018 2004-2012 Phase 3 (E-switch-ic) Cisplatin & RT Non-inferior PFS24 (primary endpoint)
PFS24: 88% vs 89.9%

Chemotherapy

Radiotherapy

One course

References

  1. Tang LQ, Chen DP, Guo L, Mo HY, Huang Y, Guo SS, Qi B, Tang QN, Wang P, Li XY, Li JB, Liu Q, Gao YH, Xie FY, Liu LT, Li Y, Liu SL, Xie HJ, Liang YJ, Sun XS, Yan JJ, Wu YS, Luo DH, Huang PY, Xiang YQ, Sun R, Chen MY, Lv X, Wang L, Xia WX, Zhao C, Cao KJ, Qian CN, Guo X, Hong MH, Nie ZQ, Chen QY, Mai HQ. Concurrent chemoradiotherapy with nedaplatin versus cisplatin in stage II-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised phase 3 trial. Lancet Oncol. 2018 Apr;19(4):461-473. Epub 2018 Feb 28. link to original article contains dosing details in abstract PubMed NCT01540136

Oxaliplatin & RT

Oxaliplatin & RT: Oxaliplatin & Radiation Therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Zhang et al. 2005 2001-2003 Phase 3 (E-esc) RT Superior OS1 (primary endpoint)
OS84: 71.3% vs 56.3%
(HR 0.54, 95% CI 0.31-0.94)

1Reported efficacy is based on the 2013 update.

Chemotherapy

Radiotherapy

RT dose per fraction Number of fractions Total RT dose Schedule
Unspecified Unspecified 7000 to 7400 cGy Unspecified

6-week course

References

  1. Zhang L, Zhao C, Peng PJ, Lu LX, Huang PY, Han F, Wu SX. Phase III study comparing standard radiotherapy with or without weekly oxaliplatin in treatment of locoregionally advanced nasopharyngeal carcinoma: preliminary results. J Clin Oncol. 2005 Nov 20;23(33):8461-8. Epub 2005 Oct 17. link to original article contains dosing details in manuscript PubMed
    1. Update: Wu X, Huang PY, Peng PJ, Lu LX, Han F, Wu SX, Hou X, Zhao HY, Huang Y, Fang WF, Zhao YY, Xue C, Hu ZH, Zhang J, Zhang JW, Ma YX, Liang WH, Zhao C, Zhang L. Long-term follow-up of a phase III study comparing radiotherapy with or without weekly oxaliplatin for locoregionally advanced nasopharyngeal carcinoma. Ann Oncol. 2013 Aug;24(8):2131-6. Epub 2013 May 9. link to original article PubMed

Radiation therapy

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Al-Sarraf et al. 1998 (Intergroup 0099) 1989-1995 Phase 3 (C) Cisplatin & RT, then CF Inferior OS
Chan et al. 2002 1994-1999 Phase 3 (C) Cisplatin & RT Might have inferior OS1
Wee et al. 2005 1997-2003 Phase 3 (C) Cisplatin & RT Inferior OS
Lee et al. 2010 (NPC-9901) 1999-2004 Phase 3 (C) Cisplatin & RT Seems to have inferior OS2
Chen et al. 2011 2003-2007 Phase 3 (C) Cisplatin & RT Inferior OS
Tang et al. 2022 (SYSUCC IRNPC15) 2015-2020 Phase 3 (E-de-esc) Cisplatin & RT Non-inferior FFS (primary endpoint)
FFS36: 90.5% vs 91.9%
(HR 1.36, 95% CI 0.70-2.66)

1Reported efficacy for Chan et al. 2002 is based on the 2005 update.
2Reported efficacy for NPC-9901 is based on the 2016 update.

References

  1. Intergroup 0099: Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, Forastiere AA, Adams G, Sakr WA, Schuller DE, Ensley JF. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099. J Clin Oncol. 1998 Apr;16(4):1310-7. link to original article contains dosing details in manuscript PubMed
  2. Chan AT, Teo PM, Ngan RK, Leung TW, Lau WH, Zee B, Leung SF, Cheung FY, Yeo W, Yiu HH, Yu KH, Chiu KW, Chan DT, Mok T, Yuen KT, Mo F, Lai M, Kwan WH, Choi P, Johnson PJ. Concurrent chemotherapy-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: progression-free survival analysis of a phase III randomized trial. J Clin Oncol. 2002 Apr 15;20(8):2038-44. link to original article PubMed
    1. Update: Chan AT, Leung SF, Ngan RK, Teo PM, Lau WH, Kwan WH, Hui EP, Yiu HY, Yeo W, Cheung FY, Yu KH, Chiu KW, Chan DT, Mok TS, Yau S, Yuen KT, Mo FK, Lai MM, Ma BB, Kam MK, Leung TW, Johnson PJ, Choi PH, Zee BC. Overall survival after concurrent cisplatin-radiotherapy compared with radiotherapy alone in locoregionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst. 2005 Apr 6;97(7):536-9. link to original article contains dosing details in manuscript PubMed
  3. Wee J, Tan EH, Tai BC, Wong HB, Leong SS, Tan T, Chua ET, Yang E, Lee KM, Fong KW, Tan HS, Lee KS, Loong S, Sethi V, Chua EJ, Machin D. Randomized trial of radiotherapy versus concurrent chemoradiotherapy followed by adjuvant chemotherapy in patients with American Joint Committee on Cancer/International Union against cancer stage III and IV nasopharyngeal cancer of the endemic variety. J Clin Oncol. 2005 Sep 20;23(27):6730-8. link to original article PubMed
  4. Zhang L, Zhao C, Peng PJ, Lu LX, Huang PY, Han F, Wu SX. Phase III study comparing standard radiotherapy with or without weekly oxaliplatin in treatment of locoregionally advanced nasopharyngeal carcinoma: preliminary results. J Clin Oncol. 2005 Nov 20;23(33):8461-8. Epub 2005 Oct 17. link to original article contains dosing details in manuscript PubMed
    1. Update: Wu X, Huang PY, Peng PJ, Lu LX, Han F, Wu SX, Hou X, Zhao HY, Huang Y, Fang WF, Zhao YY, Xue C, Hu ZH, Zhang J, Zhang JW, Ma YX, Liang WH, Zhao C, Zhang L. Long-term follow-up of a phase III study comparing radiotherapy with or without weekly oxaliplatin for locoregionally advanced nasopharyngeal carcinoma. Ann Oncol. 2013 Aug;24(8):2131-6. Epub 2013 May 9. link to original article PubMed
  5. NPC-9901: Lee AW, Tung SY, Chua DT, Ngan RK, Chappell R, Tung R, Siu L, Ng WT, Sze WK, Au GK, Law SC, O'Sullivan B, Yau TK, Leung TW, Au JS, Sze WM, Choi CW, Fung KK, Lau JT, Lau WH. Randomized trial of radiotherapy plus concurrent-adjuvant chemotherapy vs radiotherapy alone for regionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst. 2010 Aug 4;102(15):1188-98. Epub 2010 Jul 15. link to original article contains partial protocol PubMed HARECCTR0500023
    1. Update: Lee AWM, Tung SY, Ng WT, Lee V, Ngan RKC, Choi HCW, Chan LLK, Siu LL, Ng AWY, Leung TW, Yiu HHY, O'Sullivan B, Chappell R. A multicenter, phase 3, randomized trial of concurrent chemoradiotherapy plus adjuvant chemotherapy versus radiotherapy alone in patients with regionally advanced nasopharyngeal carcinoma: 10-year outcomes for efficacy and toxicity. Cancer. 2017 Nov 1;123(21):4147-4157. Epub 2017 Jun 29. link to original article PubMed
  6. Chen QY, Wen YF, Guo L, Liu H, Huang PY, Mo HY, Li NW, Xiang YQ, Luo DH, Qiu F, Sun R, Deng MQ, Chen MY, Hua YJ, Guo X, Cao KJ, Hong MH, Qian CN, Mai HQ. Concurrent chemoradiotherapy vs radiotherapy alone in stage II nasopharyngeal carcinoma: phase III randomized trial. J Natl Cancer Inst. 2011 Dec 7;103(23):1761-70. Epub 2011 Nov 4. link to original article contains dosing details in abstract PubMed
    1. Update: Li XY, Chen QY, Sun XS, Liu SL, Yan JJ, Guo SS, Liu LT, Xie HJ, Tang QN, Liang YJ, Wen YF, Guo L, Mo HY, Chen MY, Sun Y, Ma J, Tang LQ, Mai HQ. Ten-year outcomes of survival and toxicity for a phase III randomised trial of concurrent chemoradiotherapy versus radiotherapy alone in stage II nasopharyngeal carcinoma. Eur J Cancer. 2019 Mar;110:24-31. Epub 2019 Feb 7. link to original article PubMed
  7. SYSUCC 5010: You R, Liu YP, Huang PY, Zou X, Sun R, He YX, Wu YS, Shen GP, Zhang HD, Duan CY, Tan SH, Cao JY, Li JB, Xie YL, Zhang YN, Wang ZQ, Yang Q, Lin M, Jiang R, Zhang MX, Hua YJ, Tang LQ, Zhuang AH, Chen QY, Guo L, Mo HY, Chen Y, Mai HQ, Ling L, Liu Q, Chua MLK, Chen MY. Efficacy and Safety of Locoregional Radiotherapy With Chemotherapy vs Chemotherapy Alone in De Novo Metastatic Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2020 Sep 1;6(9):1345-1352. link to original article link to PMC article PubMed NCT02111460
  8. SYSUCC IRNPC15: Tang LL, Guo R, Zhang N, Deng B, Chen L, Cheng ZB, Huang J, Hu WH, Huang SH, Luo WJ, Liang JH, Zheng YM, Zhang F, Mao YP, Li WF, Zhou GQ, Liu X, Chen YP, Xu C, Lin L, Liu Q, Du XJ, Zhang Y, Sun Y, Ma J. Effect of Radiotherapy Alone vs Radiotherapy With Concurrent Chemoradiotherapy on Survival Without Disease Relapse in Patients With Low-risk Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA. 2022 Aug 23;328(8):728-736. link to original article link to PMC article PubMed NCT02633202