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| − | =Locally advanced disease, definitive chemoradiotherapy=
| + | ==Carboplatin & Paclitaxel (CP) & Nivolumab {{#subobject:3a6hg7|Regimen=1}}== |
| − | ==Carboplatin & RT {{#subobject:56c4ee|Regimen=1}}== | + | CP & Nivolumab: '''<u>C</u>'''arboplatin, '''<u>P</u>'''aclitaxel, Nivolumab |
| − | Carboplatin & RT: Carboplatin & '''<u>R</u>'''adiation '''<u>T</u>'''herapy
| |
| | <div class="toccolours" style="background-color:#eeeeee"> | | <div class="toccolours" style="background-color:#eeeeee"> |
| − | ===Regimen {{#subobject:3794ff|Variant=1}}=== | + | ===Regimen variant #1, 5/175/360 {{#subobject:59hhq7|Variant=1}}=== |
| | {| class="wikitable sortable" style="width: 100%; text-align:center;" | | {| class="wikitable sortable" style="width: 100%; text-align:center;" |
| | !style="width: 20%"|Study | | !style="width: 20%"|Study |
| Line 11: |
Line 10: |
| | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] |
| | |- | | |- |
| − | |[https://doi.org/10.1016/j.ejca.2007.03.022 Chitapanarux et al. 2007] | + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9844511/ Forde et al. 2022 (CheckMate 816)] |
| − | |1999-2004 | + | {| class="wikitable" style="margin:auto; color:black; background-color:#d3d3d3" |
| − | |style="background-color:#1a9851"|Phase 3 (E-switch-ic)
| + | |[[File:HopeAI.png|link=https://hemonc.org|alt=Alt text|Title=text|frameless|150px|center]] |
| − | |[[#Cisplatin_.26_RT|Cisplatin & RT]], then [[#Cisplatin_.26_Fluorouracil_.28CF.29_2|CF]] | |
| − | |style="background-color:#eeee01"|Seems to have non-inferior OS36 | |
| | |- | | |- |
| − | |} | + | |Click to learn more! |
| − | <div class="toccolours" style="background-color:#b3e2cd">
| |
| − | ====Chemotherapy====
| |
| − | *[[Carboplatin (Paraplatin)]] 100 mg/m<sup>2</sup> IV over 60 minutes once per day on days 1, 8, 15, 22, 29, 36
| |
| − | ====Radiotherapy====
| |
| − | *Concurrent [[External_beam_radiotherapy|radiation therapy]] to the 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
| |
| − | |-
| |
| − | |200 cGy
| |
| − | |35
| |
| − | |7000 cGy
| |
| − | |5 days per week
| |
| − | |-
| |
| − | |}
| |
| − | '''7-week course'''
| |
| − | </div>
| |
| − | <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] '''dosing details in manuscript have been reviewed by our editors''' [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)
| |
| − | |-
| |
| − | |}
| |
| − | <div class="toccolours" style="background-color:#b3e2cd">
| |
| − | ====Chemotherapy====
| |
| − | *[[Cisplatin (Platinol)]] 30 mg/m<sup>2</sup> IV once per day on days 1, 8, 15, 22, 29, 36, 43
| |
| − | ====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
| |
| − | |-
| |
| − | |200 cGy
| |
| − | |34 to 35
| |
| − | |6800 to 7000 cGy
| |
| − | |5 days per week
| |
| − | |-
| |
| − | |}
| |
| − | '''7-week course'''
| |
| − | </div></div><br>
| |
| − | <div class="toccolours" style="background-color:#eeeeee">
| |
| − | | |
| − | ===Regimen variant #2, 40 mg/m<sup>2</sup> weekly dosing {{#subobject:b41045|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/10.1200/JCO.2002.08.149 Chan et al. 2002]
| |
| − | |1994-1999
| |
| − | |style="background-color:#1a9851"|Phase 3 (E-esc)
| |
| − | |[[#Radiation_therapy|Radiation therapy]]
| |
| − | |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]
| |
| − | |2004-2012
| |
| − | |style="background-color:#91cf61"|Non-randomized part of phase 2/3 RCT
| |
| − | |style="background-color:#d3d3d3"|
| |
| − | |style="background-color:#d3d3d3"|
| |
| − | |-
| |
| − | |[https://doi.org/10.1016/S1470-2045(11)70320-5 Chen et al. 2011 (YP2008004)]
| |
| − | |2006-2010
| |
| − | |style="background-color:#91cf61"|Non-randomized part of phase 3 RCT
| |
| − | |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====
| |
| − | *[[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====
| |
| − | *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
| |
| − | |-
| |
| − | |200 cGy
| |
| − | |33
| |
| − | |6600 cGy
| |
| − | |5 days per week
| |
| − | |-
| |
| − | |}
| |
| − | '''6.5-week course'''
| |
| − | </div>
| |
| − | <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
| |
| − | |-
| |
| − | |}
| |
| − | <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%"|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]]
| |
| − | |-
| |
| − | |[http://link.springer.com/article/10.1007/s00280-009-1152-0 Bae et al. 2010]
| |
| − | |2004-2008
| |
| − | |style="background-color:#91cf61"|Phase 2
| |
| − | |style="background-color:#d3d3d3"|
| |
| − | |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====
| |
| − | *[[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">
| |
| − | | |
| − | ===Regimen variant #5, 100 mg/m<sup>2</sup> x 3 {{#subobject:aca3c0|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/10.1200/jco.1998.16.4.1310 Al-Sarraf et al. 1998 (Intergroup 0099)]
| |
| − | |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
| |
| − | |-
| |
| − | |[https://academic.oup.com/jnci/article-lookup/doi/10.1093/jnci/djq258 Lee et al. 2010 (NPC-9901)]
| |
| − | |1999-2004
| |
| − | |style="background-color:#1a9851"|Phase 3 (E-esc)
| |
| − | |[[#Radiation_therapy|Radiation therapy]]
| |
| − | |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)
| |
| − | |-
| |
| − | |[https://doi.org/10.1016/S1470-2045(18)30104-9 Tang et al. 2018]
| |
| − | |2004-2012
| |
| − | |style="background-color:#1a9851"|Phase 3 (C)
| |
| − | |[[#Nedaplatin_.26_RT|Nedaplatin & RT]]
| |
| − | |style="background-color:#eeee01"|Non-inferior PFS24
| |
| − | |-
| |
| − | |[https://doi.org/10.1016/S1470-2045(16)30410-7 Sun et al. 2016 (YP2010171)]
| |
| − | |2011-2013
| |
| − | |style="background-color:#91cf61"|Non-randomized part of phase 3 RCT
| |
| − | |style="background-color:#d3d3d3"|
| |
| − | |style="background-color:#d3d3d3"|
| |
| − | |-
| |
| − | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9399866/ Tang et al. 2022 (SYSUCC IRNPC15)]
| |
| − | |2015-2020
| |
| − | |style="background-color:#1a9851"|Phase 3 (C)
| |
| − | |[[#Cisplatin_.26_RT|Cisplatin & RT]]
| |
| − | |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====
| |
| − | *YP2010171: [[#DCF|TPF]] induction versus [[Nasopharyngeal_carcinoma_-_null_regimens#No_induction|no induction]]
| |
| − | </div>
| |
| − | <div class="toccolours" style="background-color:#b3e2cd">
| |
| − | ====Chemotherapy====
| |
| − | *[[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:
| + | |2017-2019 |
| − | **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.
| + | | style="background-color:#1a9851" |Phase 3 (E-RT-esc) |
| − | **Wee et al. 2005, NPC-9901, Tang et al. 2018, YP2010171, SYSUCC IRNPC15: see papers for details (to be added here, eventually)
| + | |1a. [[#Carboplatin_.26_Paclitaxel_.28CP.29|CP]]<br>1b. [[#Cisplatin_.26_Vinorelbine_.28CVb.29|CVb]]<br>1c. [[#Cisplatin_.26_Docetaxel_.28DC.29|DC]] |
| − | '''7-week course'''
| + | | style="background-color:#1a9850" |Superior EFS (co-primary endpoint)<br>Median EFS: 31.6 vs 20.8 mo<br>(HR 0.63, 97.38% CI 0.43-0.91)<br><br>Superior pCR rate (co-primary endpoint)<br>pCR rate: 24% vs 2.2%<br>(OR 13.94, 99% CI 3.49-55.75) |
| − | </div>
| |
| − | <div class="toccolours" style="background-color:#cbd5e7">
| |
| − | | |
| − | ====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===
| |
| − | # '''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] '''dosing details in manuscript have been reviewed by our editors''' [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] '''dosing details in manuscript have been reviewed by our editors''' [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] '''dosing details in manuscript have been reviewed by our editors''' [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] '''dosing details in manuscript have been reviewed by our editors''' [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] '''dosing details in manuscript have been reviewed by our editors''' [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] '''dosing details in manuscript have been reviewed by our editors''' [https://pubmed.ncbi.nlm.nih.gov/35997729/ PubMed] [https://clinicaltrials.gov/study/NCT02633202 NCT02633202]
| |
| − | | |
| − | ==Cisplatin & Fluorouracil (CF) & RT {{#subobject:4c4db1|Regimen=1}}==
| |
| − | 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">
| |
| − | ===Regimen {{#subobject:59e75d|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/10.1200/JCO.2003.06.158 Lin et al. 2003]
| |
| − | |1993-1999
| |
| − | |style="background-color:#1a9851"|Phase 3 (E-esc) | |
| − | |[[#Radiation_therapy|RT]]
| |
| − | | style="background-color:#1a9850" |Superior OS
| |
| − | |-
| |
| − | |}
| |
| − | <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
| |
| − | |-
| |
| − | |Unspecified
| |
| − | |Unspecified
| |
| − | |7000 to 7400 cGy
| |
| − | |Unspecified
| |
| − | |- | |
| − | |}
| |
| − | '''7- to 8-week course'''
| |
| − | </div></div>
| |
| − | | |
| − | ===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]]
| |
| − | |-
| |
| − | |[https://doi.org/10.1016/S1470-2045(18)30104-9 Tang et al. 2018]
| |
| − | |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%
| |
| − | |-
| |
| − | |}
| |
| − | <div class="toccolours" style="background-color:#b3e2cd">
| |
| − | ====Chemotherapy====
| |
| − | *[[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]]
| |
| − | |-
| |
| − | |[https://doi.org/10.1200/JCO.2004.00.3863 Zhang et al. 2005]
| |
| − | |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) | |
| − | |-
| |
| − | |}
| |
| − | ''<sup>1</sup>Reported efficacy is based on the 2013 update.''
| |
| − | <div class="toccolours" style="background-color:#b3e2cd">
| |
| − | ====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
| |
| − | |-
| |
| − | |Unspecified
| |
| − | |Unspecified
| |
| − | |7000 to 7400 cGy
| |
| − | |Unspecified
| |
| − | |-
| |
| − | |}
| |
| − | '''6-week course'''
| |
| − | </div></div>
| |
| − | ===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] '''dosing details in manuscript have been reviewed by our editors''' [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://doi.org/10.1200/jco.1998.16.4.1310 Al-Sarraf et al. 1998 (Intergroup 0099)]
| |
| − | |1989-1995
| |
| − | |style="background-color:#1a9851"|Phase 3 (C)
| |
| − | |[[#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]
| |
| − | |1994-1999
| |
| − | |style="background-color:#1a9851"|Phase 3 (C)
| |
| − | |[[#Cisplatin_.26_RT|Cisplatin & RT]]
| |
| − | |style="background-color:#fee08b"|Might have inferior OS<sup>1</sup>
| |
| − | |-
| |
| − | |[https://doi.org/10.1200/JCO.2005.16.790 Wee et al. 2005]
| |
| − | |1997-2003
| |
| − | |style="background-color:#1a9851"|Phase 3 (C)
| |
| − | |[[#Cisplatin_.26_RT|Cisplatin & RT]]
| |
| − | |style="background-color:#d73027"|Inferior OS
| |
| − | |-
| |
| − | |[https://academic.oup.com/jnci/article-lookup/doi/10.1093/jnci/djq258 Lee et al. 2010 (NPC-9901)]
| |
| − | |1999-2004
| |
| − | |style="background-color:#1a9851"|Phase 3 (C)
| |
| − | |[[#Cisplatin_.26_RT|Cisplatin & RT]]
| |
| − | |style="background-color:#fc8d59"|Seems to have inferior OS<sup>2</sup>
| |
| − | |-
| |
| − | |[https://academic.oup.com/jnci/article/103/23/1761/2516849 Chen et al. 2011]
| |
| − | |2003-2007
| |
| − | |style="background-color:#1a9851"|Phase 3 (C)
| |
| − | |[[#Cisplatin_.26_RT|Cisplatin & RT]]
| |
| − | |style="background-color:#d73027"|Inferior OS
| |
| − | |-
| |
| − | |[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9399866/ Tang et al. 2022 (SYSUCC IRNPC15)]
| |
| − | |2015-2020
| |
| − | |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> | + | ''Note: there were additional comparator options depending on histology; see the respective histology-specific pages for more details.'' |
| − | ''<sup>2</sup>Reported efficacy for NPC-9901 is based on the 2016 update.''
| + | <div class="toccolours" style="background-color:#fdcdac"> |
| − | <div class="toccolours" style="background-color:#b3e2cd"> | + | ====Biomarker eligibility criteria==== |
| − | ====Radiotherapy==== | + | *CheckMate 816: No sensitizing EGFR or ALK mutations |
| − | *[[External beam radiotherapy]] | |
| | </div></div> | | </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] '''dosing details in manuscript have been reviewed by our editors''' [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] '''dosing details in manuscript have been reviewed by our editors''' [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] '''dosing details in manuscript have been reviewed by our editors''' [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]
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| − | # '''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]
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| − | # '''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]
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