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

SUBMITTER: Hong S 

PROVIDER: S-EPMC8500603 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature