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.
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.
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DOI：
10.1200/jco.21.00396
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发表时间：
2021-10-10
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影响因子：
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通讯作者：
Zhang L
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作者：
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
GEM20110714（ClinicalTrials.gov标识符：NCT 01528618），第一项复发或转移性鼻咽癌（NPC）全身化疗的随机、III期研究，报告了吉西他滨联合顺铂（GP）与氟尿嘧啶联合顺铂相比，无进展生存期显著改善（FP;风险比，0.55; 95%CI，0.44至0.68; P <0.001）。此处列出了总生存期（OS）最终分析的数据。从2012年2月至2015年10月，362名患者被随机分配接受GP治疗，（第1天和第8天吉西他滨1 g/m2每日一次，第1天顺铂80 mg/m2每日一次; n = 181）或FP（氟尿嘧啶4 g/m2持续静脉输注96小时，顺铂80 mg/m2，第1天，每日1次; n = 181），每21天1次。主要终点是无进展生存期，这是以前报道过的; OS是次要终点。GP组和FP组的中位随访时间分别为69.5个月和69.7个月，GP组和FP组分别有148例（81.8%）和166例（91.7%）死亡。OS的估计风险比为0.72（95% CI，0.58 - 0.90;双侧P = 0.004）。GP组的中位OS为22.1个月（95% CI，19.2至25.0个月），FP组为18.6个月（95% CI，15.4至21.7个月）。1年、3年和5年的OS概率分别为79.9%和71.8%、31.0%和20.4%以及19.2%和7.8%。GP组和FP组分别有51.9%和55.2%的患者接受了研究后治疗。在既往未经治疗的晚期鼻咽癌患者中，接受GP治疗的患者的OS长于接受FP治疗的患者。吉西他滨联合顺铂应被视为这些患者的首选一线治疗方案。
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. 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. 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. 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.