Safety analysis of weekly paclitaxel plus S-1 versus paclitaxel plus 5-fluorouracil/calcium folinate as first-line therapy in advanced gastric cancer: a multicenter open random phase II trial

Autor: Nong Xu, Jian Ping Xiong, Ding Zhi Huang, Yang Zhang, Zhuang Yu, Yi Ba, Zhong He Yu, Ting Deng, Zeng Qing Guo, Rong Sheng Zheng, Mei Ling Wang, Chun Hong Hu, Yang Yao, Zhao Yan, Zhi Xiang Zhuang, Hui Ping Wan, Ji Chang Meng
Rok vydání: 2013
Předmět:
Zdroj: Journal of chemotherapy (Florence, Italy). 25(1)
ISSN: 1973-9478
Popis: To report the results of a safety analysis from a phase II trial comparing administration of weekly paclitaxel plus S-1 (TS) versus paclitaxel plus 5-fluorouracil (5-FU)/calcium folinate (LV) (TLF) as first-line therapy for advanced gastric cancer.Patients (n = 240) with previously untreated advanced gastric cancer were randomly assigned to receive either TS or TLF in a 28-day cycle for six cycles.The clinical features of both sets of patients were similar, with the exception of the incidence of prior chemotherapy (P0·05). Most treatment-related adverse events occurred at similar rates in both treatment arms. However, patients receiving TS experienced an increase in all-grade especially grade 3/4 neutropenia, with an incidence of 43·7% in the TS arm and 16·3% in the TLF arm, respectively (P0·05). Other severe adverse events were infrequent and not significantly different between the groups.The safety and tolerance of weekly paclitaxel plus S-1 or 5-FU/LV is well in untreated advanced gastric cancer patients.
Databáze: OpenAIRE