Display Settings:

Format

Send to:

Choose Destination
Eur J Cancer. 2014 May;50(8):1437-45. doi: 10.1016/j.ejca.2014.01.020. Epub 2014 Feb 20.

Biweekly irinotecan plus cisplatin versus irinotecan alone as second-line treatment for advanced gastric cancer: a randomised phase III trial (TCOG GI-0801/BIRIP trial).

Author information

  • 1Department of Gastroenterology, Kitasato University East Hospital, Kanagawa, Japan. Electronic address: k.higu@kitasato-u.ac.jp.
  • 2Department of Gastroenterology, Kitasato University East Hospital, Kanagawa, Japan.
  • 3Department of Internal Medicine, Showa University Northern Yokohama Hospital, Kanagawa, Japan.
  • 4Department of Gastroenterology, Gunma Prefectural Cancer Center, Gunma, Japan.
  • 5Department of Chemotherapy, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan.
  • 6Department of Gastroenterology, Kanagawa Cancer Center Hospital, Kanagawa, Japan.
  • 7Department of Gastroenterology, Showa General Hospital, Tokyo, Japan.
  • 8Division of Gastroenterology, University of Tsukuba Hospital, Ibaraki, Japan.
  • 9Department of Gastroenterology, Ibaraki Prefectural Central Hospital and Cancer Center, Ibaraki, Japan.
  • 10Department of Gastroenterology, Showa University Toyosu Hospital, Tokyo, Japan.
  • 11Division of Oncology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan.
  • 12Division of Digestive and General Surgery, Niigata University Medical and Dental Hospital, Niigata, Japan.
  • 13Department of Clinical Medicine (Biostatistics), Kitasato University School of Pharmacy, Tokyo, Japan.

Abstract

PURPOSE:

We compared biweekly irinotecan plus cisplatin (BIRIP) with irinotecan alone as the second-line chemotherapy (SLC) for advanced gastric cancer (AGC).

METHODS:

Patients with metastatic or recurrent gastric cancer refractory to S-1-based first-line chemotherapy were randomly assigned to receive BIRIP (irinotecan 60mg/m(2) plus cisplatin 30mg/m(2), every 2weeks) or irinotecan alone (irinotecan 150mg/m(2), every 2weeks). The primary end-point was to show the superiority of BIRIP to irinotecan in terms of progression free survival (PFS).

RESULTS:

130 patients were enrolled. PFS was significantly longer in the BIRIP group (3.8months [95% confidence interval (CI) 3.0-4.7]) than in the irinotecan group (2.8months [2.1-3.3]; hazard ratio 0.68, 95% CI 0.47-0.98; P=0.0398). Median overall survival was 10.7months in the BIRIP group and 10.1months in the irinotecan group (HR 1.00, 95% CI 0.69-1.44, P=0.9823). The objective response rate was 22% in the BIRIP group and 16% in the irinotecan group (P=0.4975). However, the disease control rate was significantly better in the BIRIP group (75%) than in the irinotecan group (54%, P=0.0162). The incidences of grade 3 or worse adverse events did not differ between the two groups. Any grade elevation of serum creatinine was more common in the BIRIP group (25% versus 8%, P=0.009), but any grade diarrhoea (17% versus 42%, P=0.002) was more common in the irinotecan group.

CONCLUSION:

BIRIP significantly prolonged PFS as compared with irinotecan alone and was tolerated as SLC, but did not demonstrate the survival benefit in this trial.

Copyright © 2014 Elsevier Ltd. All rights reserved.

KEYWORDS:

Cisplatin; Gastric cancer; Irinotecan; Second-line chemotherapy

PMID:
24560487
[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

0 comments
How to join PubMed Commons

    Supplemental Content

    Full text links

    Icon for Elsevier Science
    Loading ...
    Write to the Help Desk