DOSE ESCALATED WEEKLY PACLITAXEL

Br J Cancer. 2013 Nov 26. doi: 10.1038/bjc.2013.726. [Epub ahead of print]

Randomised phase II study comparing dose-escalated weekly paclitaxel vs standard-dose weekly paclitaxel for patients with previously treated advanced gastric cancer.

Shitara K, Yuki S, Tahahari D, Nakamura M, Kondo C, Tsuda T, Kii T, Tsuji Y, Utsunomiya S, Ichikawa D, Hosokawa A, Ishiguro A, Sakai D, Hironaka S, Oze I,Matsuo K, Muro K.

Source

1] Department of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan [2] Department of Gastroenterology and Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.

Abstract

Background:This randomised phase II trial compared dose-escalated weekly paclitaxel (wPTX) vs standard-dose wPTX for patients with previously treated advanced gastric cancer (AGC).Methods:Ninety patients were randomised to a standard dose of wPTX (80 mg m-2) or an escalated dose of wPTX (80-120 mg m-2) to assess the superiority of overall survival (OS) with a one-sided alpha error of 0.3 and a power of 0.8.Results:The median OS showed a trend towards longer survival in the dose-escalated arm (11.8 vs 9.6 months; hazard ratio (HR), 0.75; one-sided P=0.12), although it was statistically not significant. The median progression-free survival (PFS) was significantly longer in the dose-escalated arm (4.3 vs 2.5 months, HR, 0.55; P=0.017). Objective response rate was 30.3% with dose escalation and 17.1% with standard dose (P=0.2). The frequency of all grades of neutropenia was significantly higher with dose escalation (88.7% vs 60.0%, P=0.002); however, no significant difference was observed in the proportion of patients experiencing grade 3 or more (40.9% vs 31.1%, P=0.34).Conclusion:Dose-escalated wPTX in patients with pretreated AGC met our predefined threshold of primary end point, OS (P<0 .3="" 2013="" 26="" a="" advance="" better="" bjc.2013.726="" cancer="" did="" doi:10.1038="" dose="" escalation.british="" however="" it="" journal="" longer="" not="" november="" of="" online="" os.="" p="" progression-free="" publication="" show="" significantly="" survival="" was="" with="" www.bjcancer.com.="">