Nasopharyngeal carcinoma
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Note: this page has regimens specific to nasopharyngeal carcinoma; more general regimens are available on the head and neck cancer page.
Last updated on 2024-07-23: 26 regimens on this page
39 variants on this page
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Guidelines
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
ASCO/CSCO
EHNS/ESMO/ESTRO
ESMO/EURACAN
- 2022: Bossi et al. ESMO–EURACAN Clinical Practice Guideline update for nasopharyngeal carcinoma: adjuvant therapy and first-line treatment of recurrent/metastatic disease PubMed
- 2021: Bossi et al. Nasopharyngeal carcinoma: ESMO-EURACAN Clinical Practice Guidelines for diagnosis, treatment and follow-up PubMed
NCCN
- NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Head and Neck Cancers.
Locally advanced disease, induction
Cisplatin & Epirubicin
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Chua et al. 1998 (AOCOA) | 1989-1993 | Phase 3 (E-esc) | No induction | Might have superior OS1 |
1Reported efficacy is based on the 2005 pooled update.
Chemotherapy
- Cisplatin (Platinol) 60 mg/m2 IV over 4 hours once on day 1
- Epirubicin (Ellence) 110 mg/m2 IV once on day 1
21-day cycle for 2 to 3 cycles
Subsequent treatment
- Definitive RT
References
- AOCOA: Chua DT, Sham JS, Choy D, Lorvidhaya V, Sumitsawan Y, Thongprasert S, Vootiprux V, Cheirsilpa A, Azhar T, Reksodiputro AH; Asian-Oceanian Clinical Oncology Association Nasopharynx Cancer Study Group. Preliminary report of the Asian-Oceanian Clinical Oncology Association randomized trial comparing cisplatin and epirubicin followed by radiotherapy versus radiotherapy alone in the treatment of patients with locoregionally advanced nasopharyngeal carcinoma. Cancer. 1998 Dec 1;83(11):2270-83. link to original article dosing details in manuscript have been reviewed by our editors PubMed
- Pooled update: Chua DT, Ma J, Sham JS, Mai HQ, Choy DT, Hong MH, Lu TX, Min HQ. Long-term survival after cisplatin-based induction chemotherapy and radiotherapy for nasopharyngeal carcinoma: a pooled data analysis of two phase III trials. J Clin Oncol. 2005 Feb 20;23(6):1118-24. Epub 2005 Jan 18. link to original article PubMed
Cisplatin & Fluorouracil (CF)
CF: Cisplatin & Fluorouracil
PF: Platinol (Cisplatin) & Fluorouracil
Regimen variant #1, 80/4000 x 2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Cao et al. 2017 (RDDA2017000111) | 2008-2015 | Phase 3 (E-esc) | No induction | Seems to have superior OS1 (secondary endpoint) OS60: 80.8% vs 76.8% |
1Reported efficacy is based on the 2019 update.
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 800 mg/m2/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 4000 mg/m2)
21-day cycle for 2 cycles
Subsequent treatment
- Definitive Cisplatin & RT
Regimen variant #2, 100/4000 x 2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Lv et al. 2021 | 2013-2015 | Phase 3 (C) | Lobaplatin & Fluorouracil | Non-inferior PFS60 |
Li et al. 2022 (SYSUCC 20160049) | 2016-2019 | Phase 3 (C) | TPC | Inferior FFS |
Chemotherapy
- Cisplatin (Platinol) 100 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 800 mg/m2/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 4000 mg/m2)
21-day cycle for 2 cycles
Subsequent treatment
- Definitive Cisplatin & RT
Regimen variant #3, 100/4000 x 3
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Jin et al. 2019 (ESNCCT) | 2012-2014 | Phase 3 (C) | TPF | Inconclusive whether non-inferior PFS |
Chemotherapy
- Cisplatin (Platinol) 100 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 800 mg/m2/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 4000 mg/m2)
21-day cycle for 3 cycles
Subsequent treatment
- Definitive Cisplatin & RT
Regimen variant #4, 100/5000 x 6
Study | Dates of enrollment | Evidence |
---|---|---|
You et al. 2020 (SYSUCC 5010) | 2014-04 to 2018-08 | Non-randomized part of phase 3 RCT |
Chemotherapy
- Cisplatin (Platinol) 100 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 5000 mg/m2)
21-day cycle for 6 cycles
Subsequent treatment
- Definitive RT versus no further treatment
References
- 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 dosing details in manuscript have been reviewed by our editors PubMed NCT00705627
- Update: Yang Q, Cao SM, Guo L, Hua YJ, Huang PY, Zhang XL, Lin M, You R, Zou X, Liu YP, Xie YL, Wang ZQ, Mai HQ, Chen QY, Tang LQ, Mo HY, Cao KJ, Qian CN, Zhao C, Xiang YQ, Zhang XP, Lin ZX, Li WX, Liu Q, Li JB, Ling L, Guo X, Hong MH, Chen MY. Induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: long-term results of a phase III multicentre randomised controlled trial. Eur J Cancer. 2019 Sep;119:87-96. Epub 2019 Aug 16. link to original article PubMed
- ESNCCT: Jin T, Qin WF, Jiang F, Jin QF, Wei QC, Jia YS, Sun XN, Li WF, Chen XZ. Cisplatin and Fluorouracil Induction Chemotherapy With or Without Docetaxel in Locoregionally Advanced Nasopharyngeal Carcinoma. Transl Oncol. 2019 Apr;12(4):633-639. Epub 2019 Feb 20. link to original article link PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT01536223
- 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 dosing details in manuscript have been reviewed by our editors PubMed NCT02111460
- Lv X, Cao X, Xia WX, Liu KY, Qiang MY, Guo L, Qian CN, Cao KJ, Mo HY, Li XM, Li ZH, Han F, He YX, Liu YM, Wu SX, Bai YR, Ke LR, Qiu WZ, Liang H, Liu GY, Miao JJ, Li WZ, Lv SH, Chen X, Zhao C, Xiang YQ, Guo X. Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy in patients with stage III-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):716-726. Epub 2021 Apr 12. link to original article dosing details in manuscript have been reviewed by our editors PubMed ChiCTR-TRC-13003285
- SYSUCC 20160049: Li WZ, Lv X, Hu D, Lv SH, Liu GY, Liang H, Ye YF, Yang W, Zhang HX, Yuan TZ, Wang DS, Lu N, Ke LR, Tang WB, Tong LH, Chen ZJ, Liu T, Cao KJ, Mo HY, Guo L, Zhao C, Chen MY, Chen QY, Huang PY, Sun R, Qiu F, Luo DH, Wang L, Hua YJ, Tang LQ, Qian CN, Mai HQ, Guo X, Xiang YQ, Xia WX. Effect of Induction Chemotherapy With Paclitaxel, Cisplatin, and Capecitabine vs Cisplatin and Fluorouracil on Failure-Free Survival for Patients With Stage IVA to IVB Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 May 1;8(5):706-714. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT02940925
Cisplatin & Gemcitabine (GC)
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Zhang et al. 2019 (B2013-022-01) | 2013-2016 | Phase 3 (E-esc) | No induction | Superior RFS (primary endpoint) RFS36: 85.3% vs 76.5% (sHR 0.51, 95% CI 0.34-0.77) Superior OS1 (secondary endpoint) OS60: 87.9% vs 78.8% (HR 0.51, 95% CI 0.34-0.78) |
Liu et al. 2024 (CONTINUUMNPC) | 2018-12-21 to 2020-03-31 | Phase 3 (C) | GC & Sintilimab | Inferior EFS (primary endpoint) |
1Reported efficacy is based on the 2022 update.
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
21-day cycle for 3 cycles
Subsequent treatment
- Definitive Cisplatin & RT
References
- B2013-022-01: Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Tang LL, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Chua MLK, Xie FY, Sun Y, Ma J. Gemcitabine and cisplatin induction chemotherapy in nasopharyngeal carcinoma. N Engl J Med. 2019 Sep 19;381(12):1124-1135. Epub 2019 May 31. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT01872962
- Update: Zhang Y, Chen L, Hu GQ, Zhang N, Zhu XD, Yang KY, Jin F, Shi M, Chen YP, Hu WH, Cheng ZB, Wang SY, Tian Y, Wang XC, Sun Y, Li JG, Li WF, Li YH, Mao YP, Zhou GQ, Sun R, Liu X, Guo R, Long GX, Liang SQ, Li L, Huang J, Long JH, Zang J, Liu QD, Zou L, Su QF, Zheng BM, Xiao Y, Guo Y, Han F, Mo HY, Lv JW, Du XJ, Xu C, Liu N, Li YQ, Xie FY, Sun Y, Ma J, Tang LL. Final Overall Survival Analysis of Gemcitabine and Cisplatin Induction Chemotherapy in Nasopharyngeal Carcinoma: A Multicenter, Randomized Phase III Trial. J Clin Oncol. 2022 Aug 1;40(22):2420-2425. Epub 2022 Jun 16. link to original article PubMed
- CONTINUUMNPC: Liu X, Zhang Y, Yang KY, Zhang N, Jin F, Zou GR, Zhu XD, Xie FY, Liang XY, Li WF, He ZY, Chen NY, Hu WH, Wu HJ, Shi M, Zhou GQ, Mao YP, Guo R, Sun R, Huang J, Liang SQ, Wu WL, Su Z, Li L, Ai P, He YX, Zang J, Chen L, Lin L, Huang SH, Xu C, Lv JW, Li YQ, Hong SB, Jie YS, Li H, Huang SW, Liang YL, Wang YQ, Peng YL, Zhu JH, Zang SB, Liu SR, Lin QG, Li HJ, Tian L, Liu LZ, Zhao HY, Lin AH, Li JB, Liu N, Tang LL, Chen YP, Sun Y, Ma J. Induction-concurrent chemoradiotherapy with or without sintilimab in patients with locoregionally advanced nasopharyngeal carcinoma in China (CONTINUUM): a multicentre, open-label, parallel-group, randomised, controlled, phase 3 trial. Lancet. 2024 Jun 22;403(10445):2720-2731. Epub 2024 May 30. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03700476
DCF
DCF: Docetaxel, Cisplatin, Fluorouracil
TPF: Taxotere (Docetaxel), Platinol (Cisplatin), Fluorouracil
Regimen variant #1, 60/60/3000
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Sun et al. 2016 (YP2010171) | 2011-2013 | Phase 3 (E-esc) | No induction | Seems to have superior FFS (primary endpoint) FFS36: 80% vs 72% (HR 0.68, 95% CI 0.48-0.97) Seems to have superior OS1 (secondary endpoint) OS60: 85.6% vs 77.7% (HR 0.65, 95% CI 0.43-0.98) |
Dai et al. 2024 (GLMU-01) | 2015-04 to 2018-03 | Non-randomized part of RCT |
1Reported efficacy for YP2010171 is based on the 2019 update.
Chemotherapy
- Docetaxel (Taxotere) 60 mg/m2 IV once on day 1
- Cisplatin (Platinol) 60 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 600 mg/m2/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 3000 mg/m2)
21-day cycle for 3 cycles
Subsequent treatment
- YP2010171: Definitive Cisplatin & RT
- GLMU-01: Definitive Cisplatin & RT versus RT
Regimen variant #2, 70/75/4000
Study | Dates of enrollment | Evidence |
---|---|---|
Bae et al. 2010 | 2004-04 to 2008-07 | Phase 2 |
Eligibility criteria
- Locoregionally advanced nasopharyngeal cancer
Chemotherapy
- Docetaxel (Taxotere) 70 mg/m2 IV over 60 minutes once on day 1, given first
- Cisplatin (Platinol) 75 mg/m2 IV over 3 hours once on day 1, given second
- Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours, started on day 1, given third (total dose per cycle: 4000 mg/m2)
Supportive therapy
- Dexamethasone (Decadron) 20 mg IV once on day 1; 30 minutes prior to docetaxel
- Ranitidine (Zantac) 50 mg IV once on day 1; 30 minutes prior to docetaxel
- Chlorpheniramine (Chlor-Trimeton) 5 mg IV once on day 1; 30 minutes prior to docetaxel
- Posthydration after cisplatin with normal saline (volume/rate not specified)
- Ondansetron (Zofran) 8 mg IV "was routinely given"
- Levofloxacin (Levaquin) 500 mg PO once per day on days 5 to 10
- Prophylactic G-CSF per physician's discretion
21-day cycle for 3 cycles
Subsequent treatment
- Definitive Cisplatin & RT
References
- 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 dosing details in manuscript have been reviewed by our editors 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. link to original article dosing details in manuscript have been reviewed by our editors PubMed 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. link to original article PubMed
- ESNCCT: Jin T, Qin WF, Jiang F, Jin QF, Wei QC, Jia YS, Sun XN, Li WF, Chen XZ. Cisplatin and Fluorouracil Induction Chemotherapy With or Without Docetaxel in Locoregionally Advanced Nasopharyngeal Carcinoma. Transl Oncol. 2019 Apr;12(4):633-639. Epub 2019 Feb 20. link to original article link PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT01536223
- GLMU-01: Dai J, Zhang B, Su Y, Pan Y, Ye Z, Cai R, Qin G, Kong X, Mo Y, Zhang R, Liu Z, Xie Y, Ruan X, Jiang W. Induction Chemotherapy Followed by Radiotherapy vs Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):456-463. Erratum in: JAMA Oncol. 2024 Mar 14. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT02434614
Lobaplatin & Fluorouracil
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Lv et al. 2021 | 2013-2015 | Phase 3 (E-switch-ic) | CF | Non-inferior PFS60 (primary endpoint) PFS60: 75% vs 75.5% (HR 0.98, 95% CI 0.69-1.39) |
Chemotherapy
- Lobaplatin (D-19466) 30 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 800 mg/m2/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 4000 mg/m2)
21-day cycle for 2 cycles
Subsequent treatment
- Definitive Lobaplatin & RT
References
- Lv X, Cao X, Xia WX, Liu KY, Qiang MY, Guo L, Qian CN, Cao KJ, Mo HY, Li XM, Li ZH, Han F, He YX, Liu YM, Wu SX, Bai YR, Ke LR, Qiu WZ, Liang H, Liu GY, Miao JJ, Li WZ, Lv SH, Chen X, Zhao C, Xiang YQ, Guo X. Induction chemotherapy with lobaplatin and fluorouracil versus cisplatin and fluorouracil followed by chemoradiotherapy in patients with stage III-IVB nasopharyngeal carcinoma: an open-label, non-inferiority, randomised, controlled, phase 3 trial. Lancet Oncol. 2021 May;22(5):716-726. Epub 2021 Apr 12. link to original article dosing details in manuscript have been reviewed by our editors PubMed ChiCTR-TRC-13003285
TPC
TPC: Taxol (Paclitaxel), Platinol (Cisplatin), Capecitabine
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Li et al. 2022 (SYSUCC 20160049) | 2016-2019 | Phase 3 (E-esc) | PF | Superior FFS (primary endpoint) FFS36: 83.5% vs 68.9% (HR 0.47, 95% CI 0.28-0.79) |
Chemotherapy
- Paclitaxel (Taxol) 150 mg/m2 IV over 3 hours once on day 1
- Cisplatin (Platinol) 60 mg/m2 IV once on day 1
- Capecitabine (Xeloda) 1000 mg/m2 PO twice per day on days 1 to 14
21-day cycle for 2 cycles
Subsequent treatment
- Definitive chemoradiotherapy
References
- SYSUCC 20160049: Li WZ, Lv X, Hu D, Lv SH, Liu GY, Liang H, Ye YF, Yang W, Zhang HX, Yuan TZ, Wang DS, Lu N, Ke LR, Tang WB, Tong LH, Chen ZJ, Liu T, Cao KJ, Mo HY, Guo L, Zhao C, Chen MY, Chen QY, Huang PY, Sun R, Qiu F, Luo DH, Wang L, Hua YJ, Tang LQ, Qian CN, Mai HQ, Guo X, Xiang YQ, Xia WX. Effect of Induction Chemotherapy With Paclitaxel, Cisplatin, and Capecitabine vs Cisplatin and Fluorouracil on Failure-Free Survival for Patients With Stage IVA to IVB Nasopharyngeal Carcinoma: A Multicenter Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 May 1;8(5):706-714. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT02940925
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
- Carboplatin (Paraplatin) 100 mg/m2 IV over 60 minutes once per day on days 1, 8, 15, 22, 29, 36
Radiotherapy
- Concurrent radiation therapy to the primary tumor:
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
- Carboplatin & fluorouracil consolidation, after 4 weeks
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. link to original article dosing details in manuscript have been reviewed by our editors 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
- Cisplatin (Platinol) 30 mg/m2 IV over 2 hours once per day on days 1, 8, 15, 22, 29, 36, 43
Radiotherapy
- Concurrent radiation therapy:
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
- Tan et al. 2015: GCP induction x 3 versus no induction therapy
Chemotherapy
- Cisplatin (Platinol) 40 mg/m2 IV over 2 hours once per day on days 1, 8, 15, 22, 29, 36, 43
Radiotherapy
- Concurrent radiation therapy:
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
- YP2008004: CF consolidation versus no further 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
- Cisplatin (Platinol) 40 mg/m2 IV over 2 hours once per day on days 1, 8, 15, 22, 29, 36
Radiotherapy
- Concurrent radiation therapy
One course
Regimen variant #4, 100 mg/m2 x 2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Bae et al. 2010 | 2004-04 to 2008-07 | 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
- Cisplatin (Platinol) 100 mg/m2 IV once per day on on days 1 & 29
Radiotherapy
- Concurrent radiation therapy by the following study-specific criteria:
RT 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
- YP2010171: TPF induction versus no induction
Chemotherapy
- Cisplatin (Platinol) 100 mg/m2 IV over 4 hours 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
- Concurrent radiation therapy by the following study-specific criteria:
RT study | RT dose per fraction | Number of fractions | Total RT dose | Schedule |
---|---|---|---|---|
Al-Sarraf et al. 1998 (Intergroup 0099) | 180 to 200 cGy | 35 to 39 | 7000 cGy | Unspecified |
Chitapanarux et al. 2007 | 200 cGy | 35 | 7000 cGy | Unspecified |
- 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
- 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 dosing details in manuscript have been reviewed by our editors 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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article contains partial protocol 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. link to original article 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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article 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. link to original article dosing details in manuscript have been reviewed by our editors PubMed 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. link to original article 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. link to original article dosing details in abstract have been reviewed by our editors 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. link to original article dosing details in manuscript have been reviewed by our editors PubMed 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. link to original article 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. link to original article 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. link to original article dosing details in manuscript have been reviewed by our editors PubMed 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. link to original article dosing details in abstract have been reviewed by our editors link to PMC article 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. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors 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
- Cisplatin (Platinol) 20 mg/m2 IV once per day on days 1 to 5, 29 to 33
- Fluorouracil (5-FU) 400 mg/m2/day IV continuous infusion over 96 hours, started on days 1 & 29 (total dose: 3200 mg/m2)
Radiotherapy
- Concurrent radiation therapy:
RT dose per fraction | Number of fractions | Total RT dose | Schedule |
---|---|---|---|
Unspecified | Unspecified | 7000 to 7400 cGy | Unspecified |
7- to 8-week course
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. link to original article dosing details in abstract have been reviewed by our editors 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
- Nedaplatin (Aqupla) 100 mg/m2 IV over 2 hours once per day on days 1, 22, 43
Radiotherapy
- Concurrent radiation therapy
One course
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. link to original article dosing details in manuscript have been reviewed by our editors 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
- Oxaliplatin (Eloxatin) 70 mg/m2 IV once per day on days 1, 8, 15, 22, 29, 36
Radiotherapy
- Concurrent radiation therapy to primary tumor:
RT dose per fraction | Number of fractions | Total RT dose | Schedule |
---|---|---|---|
Unspecified | Unspecified | 7000 to 7400 cGy | Unspecified |
6-week course
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. link to original article dosing details in manuscript have been reviewed by our editors 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. 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 |
Dai et al. 2024 (GLMU-01) | 2015-04 to 2018-03 | Phase 3 (E-de-esc) | Cisplatin & RT | Non-inferior PFS36 (primary endpoint) PFS36: 76.2% vs 76.8% |
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.
Preceding treatment
- GLMU-01: DCF x 3
Radiotherapy
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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article 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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article 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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article 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. link to original article contains partial protocol 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. link to original article 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. link to original article dosing details in abstract have been reviewed by our editors 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. link to original article 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. link to original article link to PMC article PubMed 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. link to original article link to PMC article PubMed NCT02633202
- GLMU-01: Dai J, Zhang B, Su Y, Pan Y, Ye Z, Cai R, Qin G, Kong X, Mo Y, Zhang R, Liu Z, Xie Y, Ruan X, Jiang W. Induction Chemotherapy Followed by Radiotherapy vs Chemoradiotherapy in Nasopharyngeal Carcinoma: A Randomized Clinical Trial. JAMA Oncol. 2024 Apr 1;10(4):456-463. Erratum in: JAMA Oncol. 2024 Mar 14. link to original article link to PMC article PubMed NCT02434614
Adjuvant therapy
Capecitabine monotherapy
Regimen variant #1, 8 cycles
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Awaiting publication (CCRT-AC-LAHR-NPC) | 2014-2018 | Phase 3 (E-esc) | Observation | Superior FFS (primary endpoint) FFS36: 88% vs 73% (HR 0.52, 95% CI 0.29-0.77) |
Preceding treatment
- Definitive Cisplatin & RT
Chemotherapy
- Capecitabine (Xeloda) 1000 mg/m2 PO twice per day on days 1 to 14
21-day cycle for 8 cycles
Regimen variant #2, 12 months
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Chen et al. 2021 (2016-FXY-075) | 2017-01-25 to 2018-10-25 | Phase 3 (E-esc) | Observation | Superior FFS (primary endpoint) FFS36: 85% vs 76% (HR 0.50, 95% CI 0.32-0.79) |
Preceding treatment
- Definitive chemoradiotherapy
References
- 2016-FXY-075: Chen YP, Liu X, Zhou Q, Yang KY, Jin F, Zhu XD, Shi M, Hu GQ, Hu WH, Sun Y, Wu HF, Wu H, Lin Q, Wang H, Tian Y, Zhang N, Wang XC, Shen LF, Liu ZZ, Huang J, Luo XL, Li L, Zang J, Mei Q, Zheng BM, Yue D, Xu J, Wu SG, Shi YX, Mao YP, Chen L, Li WF, Zhou GQ, Sun R, Guo R, Zhang Y, Xu C, Lv JW, Guo Y, Feng HX, Tang LL, Xie FY, Sun Y, Ma J. Metronomic capecitabine as adjuvant therapy in locoregionally advanced nasopharyngeal carcinoma: a multicentre, open-label, parallel-group, randomised, controlled, phase 3 trial. Lancet. 2021 Jul 24;398(10297):303-313. Epub 2021 Jun 4. link to original article dosing details in abstract have been reviewed by our editors PubMed NCT02958111
- CCRT-AC-LAHR-NPC: NCT02143388
Carboplatin & Fluorouracil
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Chitapanarux et al. 2007 | 1999-2004 | Non-randomized part of phase 3 RCT |
Preceding treatment
- Definitive Carboplatin & RT
Chemotherapy
- Carboplatin (Paraplatin) AUC 5 IV once on day 1
- Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 4000 mg/m2)
28-day cycle for 3 cycles
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. link to original article dosing details in manuscript have been reviewed by our editors PubMed
Cisplatin & Fluorouracil (CF)
Cisplatin and Fluorouracil
Regimen variant #1, 80/4000, 4 days of 5-FU
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Al-Sarraf et al. 1998 (Intergroup 0099) | 1989-1995 | Non-randomized part of phase 3 RCT | ||
Wee et al. 2005 | 1997-2003 | Non-randomized part of phase 3 RCT | ||
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 | Non-randomized part of phase 3 RCT | ||
Liu et al. 2023 (2017-FXY-077) | 2017-10-30 to 2020-07-09 | Phase 3 (C) | GC | Inferior PFS36 |
Preceding treatment
- Intergroup 0099 & Wee et al. 2005: Definitive Cisplatin & RT versus RT
- Chitapanarux et al. 2007 & NPC-9901: Definitive Cisplatin & RT
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV over 15 minutes to 4 hours once on day 1
- Wee et al. 2005 gave cisplatin in split doses over 4 days (20 mg/m2/day)
- Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 4000 mg/m2)
28-day cycle for 3 cycles
Regimen variant #2, 80/4000, 5 days of 5-FU
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Chen et al. 2011 (YP2008004) | 2006-2010 | Phase 3 (E-esc) | No further treatment | Did not meet primary endpoint of FFS |
Preceding treatment
- Definitive Cisplatin & RT
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV once on day 1
- Fluorouracil (5-FU) 800 mg/m2/day IV continuous infusion over 120 hours, started on day 1 (total dose per cycle: 4000 mg/m2)
28-day cycle for 3 cycles
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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article dosing details in manuscript have been reviewed by our editors 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. link to original article contains partial protocol 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. link to original article 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. link to original article dosing details in manuscript have been reviewed by our editors PubMed 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. link to original article PubMed
- 2017-FXY-077: Liu LT, Liu H, Huang Y, Yang JH, Xie SY, Li YY, Guo SS, Qi B, Li XY, Chen DP, Jin F, Sun XS, Yang ZC, Liu SL, Luo DH, Li JB, Liu Q, Wang P, Guo L, Mo HY, Qiu F, Yang Q, Liang YJ, Jia GD, Wen DX, Yan JJ, Zhao C, Chen QY, Sun R, Tang LQ, Mai HQ. Concurrent chemoradiotherapy followed by adjuvant cisplatin-gemcitabine versus cisplatin-fluorouracil chemotherapy for N2-3 nasopharyngeal carcinoma: a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2023 Jul;24(7):798-810. Epub 2023 Jun 5. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03321539
Cisplatin & Gemcitabine (GC)
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Liu et al. 2023 (2017-FXY-077) | 2017-10-30 to 2020-07-09 | Phase 3 (E-switch-ic) | CF | Superior PFS36 (primary endpoint) PFS36: 83.9% vs 71.5% (sHR 0.54, 95% CI 0.32-0.93) |
Preceding treatment
- Definitive Cisplatin & RT
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV over 4 hours once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV once per day on days 1 & 8
21-day cycle for 3 cycles
References
- 2017-FXY-077: Liu LT, Liu H, Huang Y, Yang JH, Xie SY, Li YY, Guo SS, Qi B, Li XY, Chen DP, Jin F, Sun XS, Yang ZC, Liu SL, Luo DH, Li JB, Liu Q, Wang P, Guo L, Mo HY, Qiu F, Yang Q, Liang YJ, Jia GD, Wen DX, Yan JJ, Zhao C, Chen QY, Sun R, Tang LQ, Mai HQ. Concurrent chemoradiotherapy followed by adjuvant cisplatin-gemcitabine versus cisplatin-fluorouracil chemotherapy for N2-3 nasopharyngeal carcinoma: a multicentre, open-label, randomised, controlled, phase 3 trial. Lancet Oncol. 2023 Jul;24(7):798-810. Epub 2023 Jun 5. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03321539
Recurrent or metastatic disease
Capecitabine monotherapy
Regimen variant #1
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Chan et al. 2023 (KEYNOTE-122) | 2016-05-05 to 2018-05-28 | Phase 3 (C) | Pembrolizumab | Did not meet primary endpoint of OS Median OS: 15.3 vs 17.2 mo (HR 1.11, 95% CI 0.84-1.49) |
Regimen variant #2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Chan et al. 2023 (KEYNOTE-122) | 2016-05-05 to 2018-05-28 | Phase 3 (C) | Pembrolizumab | Did not meet primary endpoint of OS Median OS: 15.3 vs 17.2 mo (HR 1.11, 95% CI 0.84-1.49) |
Chemotherapy
- Capecitabine (Xeloda) as follows:
- Cycle 1: 1000 mg/m2 PO twice per day on days 1 to 14
- Cycle 2 onwards: 1250 mg/m2 PO twice per day on days 1 to 14
21-day cycles
References
- KEYNOTE-122: Chan ATC, Lee VHF, Hong RL, Ahn MJ, Chong WQ, Kim SB, Ho GF, Caguioa PB, Ngamphaiboon N, Ho C, Aziz MASA, Ng QS, Saraf S, Yen CJ, Soparattanapaisarn N, Ngan RK, Kho SK, Tiambeng MLA, Yun T, Sriuranpong V, Algazi AP, Cheng A, Massarelli E, Swaby RF, Yuan J, Siu LL. Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial. Ann Oncol. 2023 Mar;34(3):251-261. Epub 2022 Dec 16. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT02611960
Cisplatin & Fluorouracil (CF)
CF: Cisplatin & Fluorouracil
FP: Fluorouracil & Platinol
Regimen variant #1, 80/4000
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Zhang et al. 2016 (GEM20110714) | 2012-2015 | Phase 3 (C) | Cisplatin & Gemcitabine | Inferior OS1 |
1Reported efficacy is based on the 2021 update.
Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT in this context, prior to becoming a standard comparator arm.
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV over 4 hours once on day 1
- Fluorouracil (5-FU) 1000 mg/m2/day IV continuous infusion over 96 hours, started on day 1 (total dose per cycle: 4000 mg/m2)
21-day cycle for up to 6 cycles
Regimen variant #2, 100/5000
Study | Dates of enrollment | Evidence |
---|---|---|
Au & Ang 1994 | 1990-1992 | Phase 2 |
Chemotherapy
- Cisplatin (Platinol) 33.3 mg/m2 IV once per day on days 1 to 3
- Fluorouracil (5-FU) 1000 mg/m2 IV once per day on days 1 to 5
21-day cycles
References
- Au E, Ang PT. A phase II trial of 5-fluorouracil and cisplatinum in recurrent or metastatic nasopharyngeal carcinoma. Ann Oncol. 1994 Jan;5(1):87-9. link to original article dosing details in abstract have been reviewed by our editors PubMed
- GEM20110714: Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma:a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. Epub 2016 Aug 23. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT01528618
- Update: Hong S, Zhang Y, Yu G, Peng P, Peng J, Jia J, Wu X, Huang Y, Yang Y, Lin Q, Xi X, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C, Fang W, Zhang L. Gemcitabine Plus Cisplatin Versus Fluorouracil Plus Cisplatin as First-Line Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: Final Overall Survival Analysis of GEM20110714 Phase III Study. J Clin Oncol. 2021 Oct 10;39(29):3273-3282. Epub 2021 Aug 11. link to original article link to PMC article PubMed
Cisplatin & Gemcitabine (GC)
GP: Gemcitabine & Platinol (Cisplatin)
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Zhang et al. 2016 (GEM20110714) | 2012-2015 | Phase 3 (E-switch-ic) | CF | Superior PFS (primary endpoint) Median PFS: 7 vs 5.6 mo (HR 0.55, 95% CI 0.44-0.68) Superior OS1 (secondary endpoint) Median OS: 22.1 vs 18.6 mo (HR 0.72, 95% CI 0.58-0.90) |
Mai et al. 2021 (JUPITER-02) | 2018-11-10 to 2019-10-20 | Phase 3 (C) | GC & Toripalimab | Seems to have inferior OS |
Yang et al. 2021 (CAPTAIN-1st) | 2018-11-13 to 2019-11-29 | Phase 3 (C) | GC & Camrelizumab | Inferior PFS |
Yang et al. 2023 (RATIONALE 309) | 2019-04-18 to 2020-09-30 | Phase 3 (C) | GC & Tislelizumab | Inferior PFS |
Liu et al. 2024 | 2019-09 to 2022-08 | Phase 3 (C) | nab-TPC | Inferior PFS |
1Reported efficacy is based on the 2021 update.
Chemotherapy
- Cisplatin (Platinol) 80 mg/m2 IV over 4 hours once on day 1
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1 & 8
21-day cycle for varying durations: 4 to 6 cycles (CAPTAIN-1st, RATIONALE 309); 6 cycles (GEM20110714, JUPITER-02, Liu et al. 2024)
References
- GEM20110714: Zhang L, Huang Y, Hong S, Yang Y, Yu G, Jia J, Peng P, Wu X, Lin Q, Xi X, Peng J, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C. Gemcitabine plus cisplatin versus fluorouracil plus cisplatin in recurrent or metastatic nasopharyngeal carcinoma:a multicentre, randomised, open-label, phase 3 trial. Lancet. 2016 Oct 15;388(10054):1883-1892. Epub 2016 Aug 23. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT01528618
- Update: Hong S, Zhang Y, Yu G, Peng P, Peng J, Jia J, Wu X, Huang Y, Yang Y, Lin Q, Xi X, Xu M, Chen D, Lu X, Wang R, Cao X, Chen X, Lin Z, Xiong J, Lin Q, Xie C, Li Z, Pan J, Li J, Wu S, Lian Y, Yang Q, Zhao C, Fang W, Zhang L. Gemcitabine Plus Cisplatin Versus Fluorouracil Plus Cisplatin as First-Line Therapy for Recurrent or Metastatic Nasopharyngeal Carcinoma: Final Overall Survival Analysis of GEM20110714 Phase III Study. J Clin Oncol. 2021 Oct 10;39(29):3273-3282. Epub 2021 Aug 11. link to original article link to PMC article [PubMed
- CAPTAIN-1st: Yang Y, Qu S, Li J, Hu C, Xu M, Li W, Zhou T, Shen L, Wu H, Lang J, Hu G, Luo Z, Fu Z, Qu S, Feng W, Chen X, Lin S, Zhang W, Li X, Sun Y, Lin Z, Lin Q, Lei F, Long J, Hong J, Huang X, Zeng L, Wang P, He X, Zhang B, Yang Q, Zhang X, Zou J, Fang W, Zhang L. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1162-1174. Epub 2021 Jun 23. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03707509
- JUPITER-02: Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi YR, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Liu Z, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Feng H, Yao S, Keegan P, Xu RH. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021 Sep;27(9):1536-1543. Epub 2021 Aug 2. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03581786
- RATIONALE 309: Yang Y, Pan J, Wang H, Zhao Y, Qu S, Chen N, Chen X, Sun Y, He X, Hu C, Lin L, Yu Q, Wang S, Wang G, Lei F, Wen J, Yang K, Lin Z, Guo Y, Chen S, Huang X, Wu Y, Liang L, Chen C, Bai F, Ma X, Zhang Y, Leaw S, Zhang L, Fang W. Tislelizumab plus chemotherapy as first-line treatment for recurrent or metastatic nasopharyngeal cancer: A multicenter phase 3 trial (RATIONALE-309). Cancer Cell. 2023 Jun 12;41(6):1061-1072.e4. Epub 2023 May 18. link to original article PubMed NCT03924986 dosing details on CT.gov have been reviewed by our editors
- Liu GY, Ye YF, Jiang YF, Chen GJ, Xia WX, Huang YS, Gao TS, Liu YM, Hou YT, Li JF, Liu JH, Lu N, Chen CL, Ke LR, Liang H, Bei WX, Li WZ, Dong SH, Liu Q, Xie C, Yao HR, Xiang YQ. Nab-paclitaxel, cisplatin, and capecitabine versus cisplatin and gemcitabine as first line chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma: randomised phase 3 clinical trial. BMJ. 2024 Jun 19;385:e077890. Erratum in: BMJ. 2024 Jun 21;385:q1381. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed ChiCTR1900027112
Cisplatin & Gemcitabine (GC) & Camrelizumab
GP & Camrelizumab: Gemcitabine, Platinol (Cisplatin), Camrelizumab
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Yang et al. 2021 (CAPTAIN-1st) | 2018-11-13 to 2019-11-29 | Phase 3 (E-RT-esc) | GC | Superior PFS (primary endpoint) Median PFS: 9.7 vs 6.9 mo (HR 0.54, 95% CI 0.39-0.76) |
Chemotherapy
- Cisplatin (Platinol) as follows:
- Cycles 1 to 4 up to 6: 80 mg/m2 IV once on day 1
- Gemcitabine (Gemzar) as follows:
- Cycles 1 to 4 up to 6: 1000 mg/m2 IV once per day on days 1 & 8
Immunotherapy
- Camrelizumab (AiRuiKa) 200 mg IV once on day 1
21-day cycle for up to 35 cycles (2 years)
References
- CAPTAIN-1st: Yang Y, Qu S, Li J, Hu C, Xu M, Li W, Zhou T, Shen L, Wu H, Lang J, Hu G, Luo Z, Fu Z, Qu S, Feng W, Chen X, Lin S, Zhang W, Li X, Sun Y, Lin Z, Lin Q, Lei F, Long J, Hong J, Huang X, Zeng L, Wang P, He X, Zhang B, Yang Q, Zhang X, Zou J, Fang W, Zhang L. Camrelizumab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (CAPTAIN-1st): a multicentre, randomised, double-blind, phase 3 trial. Lancet Oncol. 2021 Aug;22(8):1162-1174. Epub 2021 Jun 23. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03707509
Cisplatin & Gemcitabine (GC) & Toripalimab
GC & Toripalimab: Gemcitabine, Cisplatin, Toripalimab
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Mai et al. 2021 (JUPITER-02) | 2018-11-10 to 2019-10-20 | Phase 3 (E-esc) | GC | Seems to have superior OS (secondary endpoint) OS24: 77.8% vs 63.3% (HR 0.60, 95% CI 0.36-0.997) Superior PFS (primary endpoint) Median PFS: 11.7 vs 8 mo (HR 0.52, 95% CI 0.36-0.74) |
Chemotherapy
- Cisplatin (Platinol) as follows:
- Cycles 1 up to 6: 80 mg/m2 IV once on day 1
- Gemcitabine (Gemzar) as follows:
- Cycles 1 up to 6: 1000 mg/m2 IV once per day on days 1 & 8
Immunotherapy
- Toripalimab (Loqtorzi) 240 mg IV once on day 1
21-day cycle for up to 35 cycles (2 years)
References
- JUPITER-02: Mai HQ, Chen QY, Chen D, Hu C, Yang K, Wen J, Li J, Shi YR, Jin F, Xu R, Pan J, Qu S, Li P, Hu C, Liu YC, Jiang Y, He X, Wang HM, Lim WT, Liao W, He X, Chen X, Liu Z, Yuan X, Li Q, Lin X, Jing S, Chen Y, Lu Y, Hsieh CY, Yang MH, Yen CJ, Samol J, Feng H, Yao S, Keegan P, Xu RH. Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. Nat Med. 2021 Sep;27(9):1536-1543. Epub 2021 Aug 2. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT03581786
Docetaxel monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Chan et al. 2023 (KEYNOTE-122) | 2016-05-05 to 2018-05-28 | Phase 3 (C) | Pembrolizumab | Did not meet primary endpoint of OS Median OS: 15.3 vs 17.2 mo (HR 1.11, 95% CI 0.84-1.49) |
References
- KEYNOTE-122: Chan ATC, Lee VHF, Hong RL, Ahn MJ, Chong WQ, Kim SB, Ho GF, Caguioa PB, Ngamphaiboon N, Ho C, Aziz MASA, Ng QS, Saraf S, Yen CJ, Soparattanapaisarn N, Ngan RK, Kho SK, Tiambeng MLA, Yun T, Sriuranpong V, Algazi AP, Cheng A, Massarelli E, Swaby RF, Yuan J, Siu LL. Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial. Ann Oncol. 2023 Mar;34(3):251-261. Epub 2022 Dec 16. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT02611960
Gemcitabine monotherapy
Regimen variant #1
Study | Dates of enrollment | Evidence |
---|---|---|
Zhang et al. 2007 | Not reported | Phase 2 |
Prior treatment criteria
- Previous exposure to platinum-based chemotherapy
Chemotherapy
- Gemcitabine (Gemzar) 1000 mg/m2 IV over 30 minutes once per day on days 1, 8, 15
Supportive therapy
- 5-HT3 receptor antagonists prior to chemotherapy
- G-CSF and GM-CSF were not used
28-day cycles
Regimen variant #2
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Chan et al. 2023 (KEYNOTE-122) | 2016-05-05 to 2018-05-28 | Phase 3 (C) | Pembrolizumab | Did not meet primary endpoint of OS Median OS: 15.3 vs 17.2 mo (HR 1.11, 95% CI 0.84-1.49) |
References
- Zhang L, Zhang Y, Huang PY, Xu F, Peng PJ, Guan ZZ. Phase II clinical study of gemcitabine in the treatment of patients with advanced nasopharyngeal carcinoma after the failure of platinum-based chemotherapy. Cancer Chemother Pharmacol. 2008 Jan;61(1):33-8. Epub 2007 Mar 20. link to original article dosing details in manuscript have been reviewed by our editors PubMed
- KEYNOTE-122: Chan ATC, Lee VHF, Hong RL, Ahn MJ, Chong WQ, Kim SB, Ho GF, Caguioa PB, Ngamphaiboon N, Ho C, Aziz MASA, Ng QS, Saraf S, Yen CJ, Soparattanapaisarn N, Ngan RK, Kho SK, Tiambeng MLA, Yun T, Sriuranpong V, Algazi AP, Cheng A, Massarelli E, Swaby RF, Yuan J, Siu LL. Pembrolizumab monotherapy versus chemotherapy in platinum-pretreated, recurrent or metastatic nasopharyngeal cancer (KEYNOTE-122): an open-label, randomized, phase III trial. Ann Oncol. 2023 Mar;34(3):251-261. Epub 2022 Dec 16. link to original article dosing details in manuscript have been reviewed by our editors PubMed NCT02611960
Toripalimab monotherapy
Regimen
Study | Dates of enrollment | Evidence |
---|---|---|
Wang et al. 2021 (POLARIS-02) | 2016-2019 | Phase 2 |
References
- POLARIS-02: Wang FH, Wei XL, Feng J, Li Q, Xu N, Hu XC, Liao W, Jiang Y, Lin XY, Zhang QY, Yuan XL, Huang HX, Chen Y, Dai GH, Shi JH, Shen L, Yang SJ, Shu YQ, Liu YP, Wang W, Wu H, Feng H, Yao S, Xu RH. Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02). J Clin Oncol. 2021 Mar 1;39(7):704-712. Epub 2021 Jan 25. link to original article link to PMC article dosing details in manuscript have been reviewed by our editors PubMed NCT02915432
nab-TPC
nab-TPC: nab-pacliTaxel, Platinol (Cisplatin), Capecitabine
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Liu et al. 2024 | 2019-09 to 2022-08 | Phase 3 (E-esc) | GC | Superior PFS (primary endpoint) Median PFS: 11.3 vs 7.7 mo (HR 0.43, 95% CI 0.25-0.73) |
Chemotherapy
- Paclitaxel, nanoparticle albumin-bound (Abraxane) as follows:
- Cycles 1 to 4 up to 6: 200 mg/m2 IV once on day 1
- Cisplatin (Platinol) as follows:
- Cycles 1 to 4 up to 6: 60 mg/m2 IV once on day 1
- Capecitabine (Xeloda) 1000 mg/m2 PO twice per day on days 1 to 14
21-day cycle for up to 35 cycles (2 years)
References
- Liu GY, Ye YF, Jiang YF, Chen GJ, Xia WX, Huang YS, Gao TS, Liu YM, Hou YT, Li JF, Liu JH, Lu N, Chen CL, Ke LR, Liang H, Bei WX, Li WZ, Dong SH, Liu Q, Xie C, Yao HR, Xiang YQ. Nab-paclitaxel, cisplatin, and capecitabine versus cisplatin and gemcitabine as first line chemotherapy in patients with recurrent or metastatic nasopharyngeal carcinoma: randomised phase 3 clinical trial. BMJ. 2024 Jun 19;385:e077890. Erratum in: BMJ. 2024 Jun 21;385:q1381. link to original article link to PMC article contains dosing details in manuscript and supplement PubMed ChiCTR1900027112
Maintenance after first-line therapy
Capecitabine monotherapy
Regimen
Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Liu et al. 2022 (SYSUCC 2015029) | 2015-2020 | Phase 3 (E-esc) | Best supportive care | Superior PFS (primary endpoint) Median PFS: 35.9 vs 8.2 mo (HR 0.44, 95% CI 0.26-0.74) |
Preceding treatment
- First-line chemotherapy x 4 to 6 cycles
Chemotherapy
- Capecitabine (Xeloda) 1000 mg/m2 PO twice per day on days 1 to 14
21-day cycle for up to 35 cycles (2 years)
References
- SYSUCC 2015029: Liu GY, Li WZ, Wang DS, Liang H, Lv X, Ye YF, Zhao C, Ke LR, Lv SH, Lu N, Bei WX, Cai ZC, Chen X, Liang CX, Guo X, Xia WX, Xiang YQ. Effect of Capecitabine Maintenance Therapy Plus Best Supportive Care vs Best Supportive Care Alone on Progression-Free Survival Among Patients With Newly Diagnosed Metastatic Nasopharyngeal Carcinoma Who Had Received Induction Chemotherapy: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Apr 1;8(4):553-561. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article PubMed NCT02460419