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.

Abstract

PURPOSE:

GEM20110714 (ClinicalTrials.gov identifier: NCT01528618), the first randomized, phase III study of systemic chemotherapy in recurrent or metastatic nasopharyngeal carcinoma (NPC), reported significant progression-free survival improvement with gemcitabine plus cisplatin (GP) versus fluorouracil plus cisplatin (FP; hazard ratio, 0.55; 95% CI, 0.44 to 0.68; P < .001). Data from the final analysis of overall survival (OS) are presented here.

METHODS:

From February 2012 to October 2015, 362 patients were randomly assigned to receive either GP (gemcitabine 1 g/m2 once daily on days 1 and 8 and cisplatin 80 mg/m2 once daily on day 1; n = 181) or FP (fluorouracil 4 g/m2 in continuous intravenous infusion over 96 hours and cisplatin 80 mg/m2 once daily on day 1; n = 181) once every 21 days. The primary end point was progression-free survival, which has been previously reported; OS was a secondary end point.

RESULTS:

After a median follow-up time of 69.5 months with GP and 69.7 months with FP, 148 (81.8%) and 166 (91.7%) deaths occurred in the GP and FP arms, respectively. The estimated hazard ratio for OS was 0.72 (95% CI, 0.58 to 0.90; two-sided P = .004). The median OS was 22.1 months (95% CI, 19.2 to 25.0 months) with GP versus 18.6 months (95% CI, 15.4 to 21.7 months) with FP. The OS probabilities at 1, 3, and 5 years were 79.9% versus 71.8%, 31.0% versus 20.4%, and 19.2% versus 7.8%, respectively. Poststudy therapy was administered in 51.9% and 55.2% of patients in the GP and FP arms, respectively.

CONCLUSION:

Among patients with previously untreated advanced nasopharyngeal carcinoma, those who receive GP have longer OS than those receive FP. Gemcitabine plus cisplatin should be considered a preferred front-line option for these patients.

• Authors: Shaodong Hong, Yaxiong Zhang, Gengsheng Yu, Peijian Peng, Jiewen Peng, Jun Jia, Xuan Wu, Yan Huang, Yunpeng Yang, Qing Lin, Xuping Xi, Mingjun Xu, Dongping Chen, Xiaojun Lu, Rensheng Wang, Xiaolong Cao, Xiaozhong Chen, Zhixiong Lin, Jianping Xiong, Qin Lin, Conghua Xie, Zhihua Li, Jianji Pan, Jingao Li, Shixiu Wu, Yingni Lian, Quanlie Yang, Chong Zhao, Wenfeng Fang, Li Zhang
• Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology (J Clin Oncol) Vol. 39 Issue 29 Pg. 3273-3282 (10 10 2021) ISSN: 1527-7755 [Electronic] United States
• PMID: 34379443 (Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Deoxycytidine
• Cisplatin
• Fluorouracil
• Gemcitabine

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (therapeutic use)
• Cisplatin (administration & dosage)
• Deoxycytidine (administration & dosage, analogs & derivatives)
• Female
• Fluorouracil (administration & dosage)
• Humans
• Male
• Middle Aged
• Nasopharyngeal Carcinoma (drug therapy, mortality)
• Nasopharyngeal Neoplasms (drug therapy, mortality)
• Neoplasm Recurrence, Local (drug therapy, mortality)
• Young Adult
• Gemcitabine