A multicenter phase II study of TAS-102 monotherapy in patients with pre-treated advanced gastric cancer (EPOC1201)

Publication date: July 2016
Source:European Journal of Cancer, Volume 62
Author(s): Hideaki Bando, Toshihiko Doi, Kei Muro, Hirofumi Yasui, Tomohiro Nishina, Kensei Yamaguchi, Shunji Takahashi, Shogo Nomura, Hirofumi Kuno, Kohei Shitara, Akihiro Sato, Atsushi Ohtsu
AimAmerican phase I studies have reported that the recommended dose of TAS-102 (trifluridine/tipiracil) was 25 mg/m² twice a day (b.i.d.), although this schedule did not provide clinically relevant improvements in a phase II study of advanced gastric cancer (AGC). However, a pivotal phase III study revealed that TAS-102 at 35 mg/m² b.i.d. provided a clinically relevant improvement in overall survival (OS) among patients with metastatic colorectal cancer. Therefore, we re-evaluated the efficacy, safety, and pharmacokinetic parameters of TAS-102 at 35 mg/m² b.i.d among Japanese patients with AGC.MethodsAll patients had undergone one or two previous chemotherapy regimens that contained fluoropyrimidine, platinum agents, and taxanes or irinotecan. The primary end-point target was a disease control rate (DCR) of ≥50% after 8 weeks of the 35 mg/m² b.i.d. schedule.ResultsTwenty-nine patients were assessable after completing the 35 mg/m² b.i.d. schedule. The investigator-determined DCR was 65.5% (95% confidence interval [CI], 45.7–82.1%) and the independent central review's DCR was 51.9% (95% CI, 31.9–71.3%); both results exceeded the primary end-point target. The median progression-free survival and OS were 2.9 months (95% CI, 1.1–5.3 months) and 8.7 months (95% CI, 5.7–14.9 months), respectively. The grade III/IV adverse events included neutropenia (69.0%), leucopaenia (41.4%), anaemia (20.7%), and anorexia (10.3%). No AGC-specific toxicities were detected.ConclusionsThe 35 mg/m² b.i.d. dose of TAS-102 provided positive efficacy and an acceptable toxicity profile in patients with AGC. A randomised, double-blind, placebo-controlled, phase III study is ongoing to validate these findings.Clinical trial registration numberUMIN000007421



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