Nasopharyngeal carcinoma

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 Michael K. Gibson, MD, PhD, FACP
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26 regimens on this page
38 variants on this page

Note: this page has regimens specific to nasopharyngeal carcinoma; more general regimens are available on the head and neck cancer page.


Guidelines

ASCO/CSCO

EHNS/ESMO/ESTRO

NCCN

Locally advanced disease, induction

Cisplatin & Epirubicin

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Chua et al. 1998 (AOCOA) 1989-1993 Phase III (E-esc) No induction Might have superior OS1

1Reported efficacy is based on the 2005 pooled update.

Chemotherapy

Subsequent treatment

References

  1. 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 PubMed
    1. 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)

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CF: Cisplatin & Fluorouracil
PF: Platinol (Cisplatin) & Fluorouracil

Regimen variant #1, 80/4000 x 2

Study Years of enrollment Evidence Comparator Comparative Efficacy
Cao et al. 2017 (RDDA2017000111) 2008-2015 Phase III (E-esc) No induction Seems to have superior OS1

1Reported efficacy is based on the 2019 update.

Chemotherapy

21-day cycle for 2 cycles

Subsequent treatment

Regimen variant #2, 100/4000 x 2

Study Years of enrollment Evidence Comparator Comparative Efficacy
Lv et al. 2021 2013-2015 Phase III (C) Lobaplatin & Fluorouracil Non-inferior PFS60

Chemotherapy

21-day cycle for 2 cycles

Subsequent treatment

Regimen variant #3, 100/5000 x 6

Study Years of enrollment Evidence
You et al. 2020 (SYSUCC 5010) 2013-NR in abstract Non-randomized portion of RCT

Chemotherapy

21-day cycle for 6 cycles

Subsequent treatment

References

  1. 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 contains protocol PubMed NCT00705627
    1. 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
  2. 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 contains protocol PubMed NCT02111460
  3. 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 contains protocol PubMed ChiCTR-TRC-13003285

Cisplatin & Gemcitabine (GC)

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Zhang et al. 2019 (B2013-022-01) 2013-2016 Phase III (E-esc) No induction Superior OS

Chemotherapy

21-day cycle for 3 cycles

Subsequent treatment

References

  1. 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 contains protocol PubMed NCT01872962

DCF

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DCF: Docetaxel, Cisplatin, Fluorouracil
TPF: Taxotere (Docetaxel), Platinol (Cisplatin), Fluorouracil

Regimen variant #1, 60/60/3000

Study Years of enrollment Evidence Comparator Comparative Efficacy
Sun et al. 2016 (YP2010171) 2011-2013 Phase III (E-esc) No induction Seems to have superior OS1

1Reported efficacy for YP2010171 is based on the 2019 update.

Chemotherapy

21-day cycle for 3 cycles

Subsequent treatment

Regimen variant #2, 70/75/4000

Study Evidence
Bae et al. 2010 Phase II

This study only involved patients with locoregionally advanced nasopharyngeal cancer.

Chemotherapy

  • Docetaxel (Taxotere) 70 mg/m2 in 300 mL normal saline 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 medications

21-day cycle for 3 cycles

Subsequent treatment

References

  1. Bae WK, Hwang JE, Shim HJ, Cho SH, Lee JK, Lim SC, Chung WK, Chung IJ. Phase II study of docetaxel, cisplatin, and 5-FU induction chemotherapy followed by chemoradiotherapy in locoregionally advanced nasopharyngeal cancer. Cancer Chemother Pharmacol. 2010 Feb;65(3):589-95. link to original article contains verified protocol PubMed
  2. YP2010171: Sun Y, Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J. Induction chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in locoregionally advanced nasopharyngeal carcinoma: a phase 3, multicentre, randomised controlled trial. Lancet Oncol. 2016 Nov;17(11):1509-1520. Epub 2016 Sep 26. link to original article contains verified protocol PubMed NCT01245959
    1. Update: Li WF, Chen NY, Zhang N, Hu GQ, Xie FY, Sun Y, Chen XZ, Li JG, Zhu XD, Hu CS, Xu XY, Chen YY, Hu WH, Guo L, Mo HY, Chen L, Mao YP, Sun R, Ai P, Liang SB, Long GX, Zheng BM, Feng XL, Gong XC, Li L, Shen CY, Xu JY, Guo Y, Chen YM, Zhang F, Lin L, Tang LL, Liu MZ, Ma J, Sun Y. Concurrent chemoradiotherapy with/without induction chemotherapy in locoregionally advanced nasopharyngeal carcinoma: long-term results of phase 3 randomized controlled trial. Int J Cancer. 2019 Jul 1;145(1):295-305. Epub 2019 Jan 24. link to original article PubMed

Locally advanced disease, definitive chemoradiotherapy

Carboplatin & RT

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Carboplatin & RT: Carboplatin & Radiation Therapy

Regimen

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

Chemotherapy

Radiotherapy

  • Concurrent radiation therapy to the primary tumor, 2 Gy fractions x 35 fractions (total dose: 70 Gy)

7-week course

Subsequent treatment

References

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

Cisplatin & RT

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Cisplatin & RT: Cisplatin & Radiation Therapy

Regimen variant #1, 30 mg/m2 weekly dosing

Study Years of enrollment Evidence Comparator Comparative Efficacy
Chen et al. 2011 2003-2007 Phase III (E-esc) Radiation therapy Superior OS

Chemotherapy

Radiotherapy

7-week course

Regimen variant #2, 40 mg/m2 weekly dosing

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

1Reported efficacy for Chan et al. 2002 is based on the 2005 update.

Preceding treatment

  • Tan et al. 2015: GCP x 3 versus no induction therapy

Chemotherapy

Radiotherapy

  • Concurrent radiation therapy, 2 Gy fractions x 33 fractions (total dose: 66 Gy). See Chan et al. 2005 for additional information about boost doses.

6.5-week course

Subsequent treatment

Regimen variant #3, 100 mg/m2 x 2

Study Evidence
Bae et al. 2010 Phase II

Chemotherapy

21-day cycle for 2 cycles

Radiotherapy

5.5-week course

Regimen variant #4, 100 mg/m2 x 3

Study Years of enrollment Evidence Comparator Comparative Efficacy
Al-Sarraf et al. 1998 (Intergroup 0099) 1989-1995 Phase III (E-esc) Radiation therapy Superior OS
Wee et al. 2005 1997-2003 Phase III (E-esc) Radiation therapy Superior OS
Chitapanarux et al. 2007 1999-2004 Phase III (C) Carboplatin & RT, then Carboplatin & 5-FU Seems to have non-inferior OS36
Lee et al. 2010 (NPC-9901) 1999-2004 Phase III (E-esc) Radiation therapy Seems to have superior OS1
(HR 0.74, 95% CI 0.56-1.00)
Tang et al. 2018 2004-2012 Phase III (C) Nedaplatin & RT Non-inferior PFS at 2 y
Sun et al. 2016 (YP2010171) 2011-2013 Non-randomized portion of RCT

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.

Chemotherapy

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

Supportive medications

21-day cycle for 3 cycles

Radiotherapy

  • Concurrent radiation therapy with one of the following:
    • Intergroup 0099: 1.8 to 2 Gy fractions x 35 to 39 fractions to the primary tumor (total dose: 70 Gy). Minimum total dose to neck nodes is 50 Gy for N0 disease; 66 Gy for nodes less than or equal to 2 cm in size; 70 Gy for nodes greater than 2 cm.
    • Chitapanarux et al. 2007: 2 Gy fractions x 35 fractions (total dose: 70 Gy)
    • YP2010171: see paper for details

7-week course

Subsequent treatment

References

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

Cisplatin & Fluorouracil (CF) & RT

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CF & RT: Cisplatin, Fluorouracil, Radiation Therapy

Regimen

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

Chemotherapy

28-day cycle for 2 cycles

Radiotherapy

7- to 8-week course

References

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

Oxaliplatin & RT

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Oxaliplatin & RT: Oxaliplatin & Radiation Therapy

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Zhang et al. 2005 2001-2003 Phase III (E-esc) RT Seems to have superior OS1

1Reported efficacy is based on the 2013 update.

Chemotherapy

Radiotherapy

6-week course

References

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

Radiation therapy

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Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Al-Sarraf et al. 1998 (Intergroup 0099) 1989-1995 Phase III (C) Cisplatin & RT, then CF Inferior OS
Chan et al. 2002 1994-1999 Phase III (C) Cisplatin & RT Might have inferior OS1
Wee et al. 2005 1997-2003 Phase III (C) Cisplatin & RT Inferior OS
Lee et al. 2010 (NPC-9901) 1999-2004 Phase III (C) Cisplatin & RT Seems to have inferior OS2
Chen et al. 2011 2003-2007 Phase III (C) Cisplatin & RT Inferior OS

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

Radiotherapy

References

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

Adjuvant therapy

Carboplatin & Fluorouracil

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Regimen

Study Evidence
Chitapanarux et al. 2007 Non-randomized portion of RCT

Preceding treatment

Chemotherapy

28-day cycle for 3 cycles

References

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

Cisplatin & Fluorouracil (CF)

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Cisplatin and Fluorouracil

Regimen variant #1, 80/4000, 4 days of 5-FU

Study Years of enrollment Evidence Comparator Comparative Efficacy
Al-Sarraf et al. 1998 (Intergroup 0099) 1989-1995 Non-randomized portion of RCT
Wee et al. 2005 1997-2003 Non-randomized portion of RCT
Chitapanarux et al. 2007 1999-2004 Phase III (C) Carboplatin & RT, then Carboplatin & 5-FU Seems to have non-inferior OS36
Lee et al. 2010 (NPC-9901) 1999-2004 Non-randomized portion of RCT

Preceding treatment

Chemotherapy

28-day cycle for 3 cycles

Regimen variant #2, 80/4000, 5 days of 5-FU

Study Years of enrollment Evidence Comparator Comparative Efficacy
Chen et al. 2011 (YP2008004) 2006-2010 Phase III (E-esc) No further treatment Did not meet primary endpoint of FFS

Preceding treatment

Chemotherapy

28-day cycle for 3 cycles

References

  1. Intergroup 0099: Al-Sarraf M, LeBlanc M, Giri PG, Fu KK, Cooper J, Vuong T, Forastiere AA, Adams G, Sakr WA, Schuller DE, Ensley JF. Chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized Intergroup study 0099. J Clin Oncol. 1998 Apr;16(4):1310-7. link to original article contains verified protocol PubMed
  2. 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 contains protocol PubMed
  3. Chitapanarux I, Lorvidhaya V, Kamnerdsupaphon P, Sumitsawan Y, Tharavichitkul E, Sukthomya V, Ford J. Chemoradiotherapy comparing cisplatin versus carboplatin in locally advanced nasopharyngeal cancer: randomised, non-inferiority, open trial. Eur J Cancer. 2007 Jun;43(9):1399-406. Epub 2007 Apr 27. link to original article contains verified protocol PubMed
  4. NPC-9901: Lee AW, Tung SY, Chua DT, Ngan RK, Chappell R, Tung R, Siu L, Ng WT, Sze WK, Au GK, Law SC, O'Sullivan B, Yau TK, Leung TW, Au JS, Sze WM, Choi CW, Fung KK, Lau JT, Lau WH. Randomized trial of radiotherapy plus concurrent-adjuvant chemotherapy vs radiotherapy alone for regionally advanced nasopharyngeal carcinoma. J Natl Cancer Inst. 2010 Aug 4;102(15):1188-98. Epub 2010 Jul 15. link to original article contains partial protocol PubMed HARECCTR0500023
    1. Update: Lee AWM, Tung SY, Ng WT, Lee V, Ngan RKC, Choi HCW, Chan LLK, Siu LL, Ng AWY, Leung TW, Yiu HHY, O'Sullivan B, Chappell R. A multicenter, phase 3, randomized trial of concurrent chemoradiotherapy plus adjuvant chemotherapy versus radiotherapy alone in patients with regionally advanced nasopharyngeal carcinoma: 10-year outcomes for efficacy and toxicity. Cancer. 2017 Nov 1;123(21):4147-4157. Epub 2017 Jun 29. link to original article PubMed
  5. YP2008004: Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Concurrent chemoradiotherapy plus adjuvant chemotherapy versus concurrent chemoradiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma: a phase 3 multicentre randomised controlled trial. Lancet Oncol. 2012 Feb;13(2):163-71. Epub 2011 Dec 7. link to original article contains protocol PubMed NCT00677118
    1. Update: Chen L, Hu CS, Chen XZ, Hu GQ, Cheng ZB, Sun Y, Li WX, Chen YY, Xie FY, Liang SB, Chen Y, Xu TT, Li B, Long GX, Wang SY, Zheng BM, Guo Y, Sun Y, Mao YP, Tang LL, Chen YM, Liu MZ, Ma J. Adjuvant chemotherapy in patients with locoregionally advanced nasopharyngeal carcinoma: Long-term results of a phase 3 multicentre randomised controlled trial. Eur J Cancer. 2017 Apr;75:150-158. Epub 2017 Feb 22. link to original article PubMed

Recurrent or metastatic disease

Cisplatin & Fluorouracil (CF)

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CF: Cisplatin & Fluorouracil
FP: Fluorouracil & Platinol

Regimen variant #1, 80/4000

Study Years of enrollment Evidence Comparator Comparative Efficacy
Zhang et al. 2016 (GEM20110714) 2012-2015 Phase III (C) Cisplatin & Gemcitabine Inferior PFS

Note: to our knowledge, this regimen was not tested as an experimental arm in an RCT prior to becoming a standard comparator arm.

Chemotherapy

21-day cycle for up to 6 cycles

Regimen variant #2, 100/5000

Study Evidence
Au & Ang 1994 Non-randomized portion of RCT

Chemotherapy

21-day cycles

References

  1. 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 contains protocol PubMed
  2. 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 contains protocol PubMed NCT01528618

Cisplatin & Gemcitabine (GC)

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GP: Gemcitabine & Platinol (Cisplatin)

Regimen

Study Years of enrollment Evidence Comparator Comparative Efficacy
Zhang et al. 2016 (GEM20110714) 2012-2015 Phase III (E-switch-ic) CF Superior PFS

Chemotherapy

21-day cycle for up to 6 cycles

References

  1. 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 contains protocol PubMed NCT01528618

Gemcitabine monotherapy

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Regimen

Study Evidence
Zhang et al. 2007 Phase II

This study only involved patients who had already received previous platinum-based chemotherapy.

Chemotherapy

  • Gemcitabine (Gemzar) 1000 mg/m2 in 100 mL normal saline IV over 30 minutes once per day on days 1, 8, 15

Supportive medications

28-day cycles

References

  1. 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 contains verified protocol PubMed
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