Randomised Phase II Trial of Irinotecan Plus S-1 in Patients with Gemcitabine-refractory Pancreatic Cancer

Overview

Journal Br J Cancer

Specialty Oncology

Date 2017 Jan 13

PMID 28081543

Citations 15

Authors

T Ioka

Y Komatsu

N Mizuno

A Tsuji

S Ohkawa

M Tanaka

H Iguchi

A Ishiguro

M Kitano

T Satoh

T Yamaguchi

K Takeda

M Kida

K Eguchi

T Ito

M Munakata

T Itoi

J Furuse

C Hamada

Y Sakata

Affiliations

Soon will be listed here.

Abstract

Background: We aimed to compare the efficacy and safety of irinotecan/S-1 (IRIS) therapy with S-1 monotherapy in patients with gemcitabine-refractory pancreatic cancer.

Methods: Patients were treated with oral S-1 (80-120 mg for 14 days every 4 weeks) plus intravenous irinotecan (100 mg m on days 1 and 15 every 4 weeks; IRIS group) or oral S-1 group (80-120 mg daily for 28 days every 6 weeks). The primary endpoint was progression-free survival (PFS).

Results: Of 137 patients enrolled, 127 were eligible for efficacy. The median PFS in the IRIS group and S-1 monotherapy group were 3.5 and 1.9 months, respectively (hazard ratio (HR)=0.77; 95% confidence interval (CI), 0.53-1.11; P=0.18), while the median overall survival (OS) were 6.8 and 5.8 months, respectively (HR=0.75; 95% CI, 0.51-1.09; P=0.13). Response rate was significantly higher in the IRIS group than in the S-1 monotherapy group (18.3% vs 6.0%, P=0.03). Grade 3 or higher neutropenia and anorexia occurred more frequently in the IRIS group.

Conclusions: There was a trend for better PFS and OS in the IRIS group that could be a treatment arm in the clinical trials for gemcitabine-refractory pancreatic cancer.

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