Display Settings:


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.



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


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).


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.


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.


Cisplatin; Gastric cancer; Irinotecan; Second-line chemotherapy

[PubMed - indexed for MEDLINE]
PubMed Commons home

PubMed Commons

How to join PubMed Commons

    Supplemental Content

    Full text links

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