You are here

A phase I study of S-1 in combination with nab-paclitaxel in patients with unresectable or recurrent gastric cancer

Nakayama N, Ishido K, Chin K, Nishimura K, Azuma M, Matsusaka S, et al.

Gastric Cancer. 2016 May 17. [Epub ahead of print]

Abstract
 

BACKGROUND:

In Japan, S-1, an oral fluoropyrimidine, plus cisplatin is a standard regimen for advanced gastric cancer, whereas nab-paclitaxel is a treatment option. We aimed to evaluate the tolerance, pharmacokinetics, safety, and clinical efficacy of S-1 combined with nab-paclitaxel in patients with advanced gastric cancer in a phase 1 study.

METHODS:

The primary objective was to determine the maximum tolerated dose (MTD) and recommended dose (RD) of S-1 plus nab-paclitaxel. The study was designed in accordance with a standard 3 + 3 method. Patients received 3-week cycles of treatment. S-1 was administered orally at 80 mg/m2 twice daily for 14 days, and nab-paclitaxel was administered as an intravenous infusion at 180, 220, or 260 mg/m2 on day 1 or 8.

RESULTS:

Among the 16 patients enrolled, dose-limiting toxicity was observed in one patient at level 2a (S-1 80 mg/m2 twice daily plus nab-paclitaxel 220 mg/m2 on day 1). The MTD was not obtained, but the RD was established as level 3a (S-1 80 mg/m2 twice daily plus nab-paclitaxel 260 mg/m2 on day 1). The most common grade 3-4 toxicity was neutropenia (62.5 %). The overall response rate was 54.5 %. The pharmacokinetic profiles of coadministered S-1 and paclitaxel were comparable to those of nab-paclitaxel or S-1 alone.

CONCLUSIONS:

Based on the present results, the RD was determined as level 3a (S-1 80 mg/m2 twice daily plus nab-paclitaxel 260 mg/m2 on day 1). This combination therapy was well tolerated and showed antitumor efficacy in patients with advanced gastric cancer.

©PubMed Central


Search this site

Search form

ECCO2017 symposium webcast: Treatment evolution in advanced GI malignancies

Welcome and introduction - Florian Lordick

E-Alert

Subscribe to our E-Alert to keep up to date with the new items in the Resource Centre

Featured Content

New Book Content


This online Resource Centre has been sponsored by Lilly Oncology

Note that Lilly Oncology has no editorial control over the content of this Resource Centre. The Resource Centre and all content therein has been subject to an independent editorial review.

Share