Randomized multicenter phase III study of a modified docetaxel and cisplatin plus fluorouracil regimen compared with cisplatin and fluorouracil as first-line therapy for advanced or locally recurrent gastric cancerReportar como inadecuado




Randomized multicenter phase III study of a modified docetaxel and cisplatin plus fluorouracil regimen compared with cisplatin and fluorouracil as first-line therapy for advanced or locally recurrent gastric cancer - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

Gastric Cancer

, Volume 19, Issue 1, pp 234–244

First Online: 21 January 2015Received: 09 June 2014Accepted: 29 December 2014DOI: 10.1007-s10120-015-0457-4

Cite this article as: Wang, J., Xu, R., Li, J. et al. Gastric Cancer 2016 19: 234. doi:10.1007-s10120-015-0457-4

Abstract

BackgroundThe V325 study showed that docetaxel, cisplatin, and fluorouracil DCF prolonged overall survival OS of patients with advanced gastric cancer, but with a high incidence of dose-limiting toxicities. We investigated the efficacy and safety of a modified DCF mDCF regimen for Chinese patients with advanced gastric cancer.

MethodsUntreated advanced gastric cancer patients randomly received docetaxel and cisplatin at 60 mg-m day 1 followed by fluorouracil at 600 mg-m-day days 1–5; mDCF regimen or cisplatin at 75 mg-m day 1 followed by fluorouracil at 600 mg-m-day days 1–5; CF every 3 weeks. The primary end point was progression-free survival PFS. The secondary end points were OS, overall response rate ORR, time-to-treatment failure TTF, and safety.

ResultsIn total, 243 patients were randomized to treatment mDCF regimen 121; CF 122. Compared with CF, the mDCF regimen significantly improved PFS and OS: the median PFS was 7.2 and 4.9 months, respectively hazard ratio HR 0.58, log-rank P = 0.0008, and the median OS was 10.2 and 8.5 months, respectively HR = 0.71, P = 0.0319. Additionally, the mDCF regimen improved the parameters used as secondary objectives: the ORR was 48.7 % with the mDCF regimen versus 33.9 % with CF P = 0.0244; the median TTF was 3.4 months with the mDCF regimen and 2.4 months with CF HR = 0.67, P = 0.0027. Grade 3 and grade 4 treatment-related adverse events occurred in 77.3 % of patients who received the mDCF regimen versus 46.1 % of patients who received CF P < 0.001.

ConclusionsThe mDCF regimen, compared with CF, significantly prolonged PFS and OS and enhanced ORR of Chinese patients with advanced gastric cancer. The mDCF regimen achieved efficacy comparable to that of DCF but with fewer toxicities, which is appropriate for the Chinese population.

KeywordsAdvanced gastric cancer Modified docetaxel and cisplatin plus fluorouracil regimen Progression-free survival Overall survival Safety J. Wang and R. Xu contributed equally to this work.

Electronic supplementary materialThe online version of this article doi:10.1007-s10120-015-0457-4 contains supplementary material, which is available to authorized users.

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Autor: Jinwan Wang - Ruihua Xu - Jian Li - Yuxian Bai - Tianshu Liu - Shunchang Jiao - Guanghai Dai - Jianming Xu - Yunpeng Liu

Fuente: https://link.springer.com/







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