Nasopharyngeal carcinoma - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main nasopharyngeal carcinoma page for regimens that include active anticancer treatment.
=Locally advanced disease, induction=
==No induction==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Chua et al. 1998 (AOCOA) 	1989-1993 	Phase 3 (C)	Cisplatin & Epirubicin 	Might have shorter OS1
Ma et al. 2001 	1993-07 to 1994-07 	Phase 3 (C)	Bleomycin, Cisplatin, 5-FU	Might have shorter OS1
Hong et al. 2018 (TCOG 1303) 	2003-2009 	Phase 3 (C)	MEPFL 	Seems to have shorter DFS
Cao et al. 2017 (RDDA2017000111)	2008-2015 	Phase 3 (C)	CF 	Seems to have shorter OS2
Sun et al. 2016 (YP2010171) 	2011-2013 	Phase 3 (C)	TPF 	Seems to have shorter OS3
1Reported efficacy for AOCOA and Ma et al. 2001 is based on the 2005 pooled update.
2Reported efficacy for RDDA2017000111 is based on the 2019 update.
3Reported efficacy for YP2010171 is based on the 2019 update.
No therapy given prior to definitive therapy.
====Subsequent treatment====
*AOCOA & Ma et al. 2001: Definitive RT
*YP2010171 & RDDA2017000111: Definitive Cisplatin & 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 EuroPMC
## 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 EuroPMC
# Ma J, Mai HQ, Hong MH, Min HQ, Mao ZD, Cui NJ, Lu TX, Mo HY. Results of a prospective randomized trial comparing neoadjuvant chemotherapy plus radiotherapy with radiotherapy alone in patients with locoregionally advanced nasopharyngeal carcinoma. J Clin Oncol. 2001 Mar 1;19(5):1350-7. link to original article EuroPMC 
## 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 EuroPMC
# 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 EuroPMC 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 EuroPMC
# 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 EuroPMC 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 EuroPMC
# TCOG 1303: Hong RL, Hsiao CF, Ting LL, Ko JY, Wang CW, Chang JTC, Lou PJ, Wang HM, Tsai MH, Lai SC, Liu TW. Final results of a randomized phase III trial of induction chemotherapy followed by concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone in patients with stage IVA and IVB nasopharyngeal carcinoma-Taiwan Cooperative Oncology Group (TCOG) 1303 Study. Ann Oncol. 2018 Sep 1;29(9):1972-1979. link to original article EuroPMC NCT00201396
=Adjuvant therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Chi et al. 2002 	1994-1999 	Phase 3 (C)	Cisplatin, 5-FU, LV	Did not meet primary endpoint of OS
Chen et al. 2011 (YP2008004) 	2006-2010 	Phase 3 (C)	CF 	Did not meet primary endpoint of FFS
Awaiting publication (CCRT-AC-LAHR-NPC)	2014-2018 	Phase 3 (C)	Capecitabine 	Shorter FFSFFS36: 73% vs 88%(HR 1.92, 95% CI 1.30-3.45)
Chen et al. 2021 (2016-FXY-075) 	2017-01-25 to 2018-10-25	Phase 3 (C)	Capecitabine 	Shorter FFSFFS36: 76% vs 85%(HR 2.00, 95% CI 1.27-3.12)
No further treatment.
====Preceding treatment====
*Chi et al. 2002: Definitive RT
*YP2008004 & CCRT-AC-LAHR-NPC: Definitive Cisplatin & RT
*2016-FXY-075: Definitive chemoradiotherapy
===References===
# Chi KH, Chang YC, Guo WY, Leung MJ, Shiau CY, Chen SY, Wang LW, Lai YL, Hsu MM, Lian SL, Chang CH, Liu TW, Chin YH, Yen SH, Perng CH, Chen KY. A phase III study of adjuvant chemotherapy in advanced nasopharyngeal carcinoma patients. Int J Radiat Oncol Biol Phys. 2002 Apr 1;52(5):1238-44. link to original article EuroPMC
# 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 EuroPMC 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 EuroPMC
#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 EuroPMC NCT02958111
#CCRT-AC-LAHR-NPC: NCT02143388
=Maintenance after first-line therapy=
==Observation==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Liu et al. 2022 (SYSUCC 2015029)	2015-2020 	Phase 3 (C)	Capecitabine	Shorter PFSMedian PFS: 8.2 vs 35.9 mo(HR 2.27, 95% CI 1.35-3.85)
No further antineoplastic treatment.
====Preceding treatment====
*Induction chemotherapy x 4 to 6 cycles
===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 link to PMC article EuroPMC NCT02460419
Category:Nasopharyngeal carcinoma regimens
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Category:Null regimens