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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)

European Journal of Cancer, Volume 50, Issue 8, May 2014, Pages 1437 - 1445

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 60 mg/m2 plus cisplatin 30 mg/m2, every 2 weeks) or irinotecan alone (irinotecan 150 mg/m2, every 2 weeks). 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 (3.8 months [95% confidence interval (CI) 3.0–4.7]) than in the irinotecan group (2.8 months [2] and [3]; hazard ratio 0.68, 95% CI 0.47–0.98; P = 0.0398). Median overall survival was 10.7 months in the BIRIP group and 10.1 months 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.

Keywords: Gastric cancer, Second-line chemotherapy, Irinotecan, Cisplatin.

Footnotes

a Department of Gastroenterology, Kitasato University East Hospital, Kanagawa, Japan

b Department of Internal Medicine, Showa University Northern Yokohama Hospital, Kanagawa, Japan

c Department of Gastroenterology, Gunma Prefectural Cancer Center, Gunma, Japan

d Department of Chemotherapy, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan

e Department of Gastroenterology, Kanagawa Cancer Center Hospital, Kanagawa, Japan

f Department of Gastroenterology, Showa General Hospital, Tokyo, Japan

g Division of Gastroenterology, University of Tsukuba Hospital, Ibaraki, Japan

h Department of Gastroenterology, Ibaraki Prefectural Central Hospital and Cancer Center, Ibaraki, Japan

i Department of Gastroenterology, Showa University Toyosu Hospital, Tokyo, Japan

j Division of Oncology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan

k Division of Digestive and General Surgery, Niigata University Medical and Dental Hospital, Niigata, Japan

l Department of Clinical Medicine (Biostatistics), Kitasato University School of Pharmacy, Tokyo, Japan

Corresponding author: Address: Department of Gastroenterology, Kitasato University East Hospital, 2-1-1, Asamizodai, Minami-ku, Sagamihara, Kanagawa 252-0380, Japan. Tel.: +81 42 748 9111; fax: +81 42 749 8690.