Katsuhiko Higuchi1, Satoshi Tanabe2, Ken Shimada3, Hisashi Hosaka4, Eisaku Sasaki5, Norisuke Nakayama6, Yuiti Takeda7, Toshikazu Moriwaki8, Kenji Amagai9, Takashi Sekikawa10, Toshikazu Sakuyama11, Tatsuo Kanda12, Tohru Sasaki2, Mizutomo Azuma2, Fumiaki Takahashi13, Masahiro Takeuchi13, Wasaburo Koizumi2. 1. Department of Gastroenterology, Kitasato University East Hospital, Kanagawa, Japan. Electronic address: k.higu@kitasato-u.ac.jp. 2. Department of Gastroenterology, Kitasato University East Hospital, Kanagawa, Japan. 3. Department of Internal Medicine, Showa University Northern Yokohama Hospital, Kanagawa, Japan. 4. Department of Gastroenterology, Gunma Prefectural Cancer Center, Gunma, Japan. 5. Department of Chemotherapy, Tokyo Metropolitan Cancer and Infectious Diseases Center, Komagome Hospital, Tokyo, Japan. 6. Department of Gastroenterology, Kanagawa Cancer Center Hospital, Kanagawa, Japan. 7. Department of Gastroenterology, Showa General Hospital, Tokyo, Japan. 8. Division of Gastroenterology, University of Tsukuba Hospital, Ibaraki, Japan. 9. Department of Gastroenterology, Ibaraki Prefectural Central Hospital and Cancer Center, Ibaraki, Japan. 10. Department of Gastroenterology, Showa University Toyosu Hospital, Tokyo, Japan. 11. Division of Oncology, Department of Internal Medicine, Jikei University School of Medicine, Tokyo, Japan. 12. Division of Digestive and General Surgery, Niigata University Medical and Dental Hospital, Niigata, Japan. 13. Department 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.
RCT Entities:
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.
Authors: Mehmet Ali Nahit Sendur; Nuriye Ozdemir; Tahsin Özatlı; Ozan Yazıcı; Sercan Aksoy; Ahmet Siyar Ekinci; Doğan Yazılıtaş; Yusuf Günaydın; Berna Oksuzoglu; Mustafa Benekli; Nurullah Zengin Journal: Med Oncol Date: 2014-08-07 Impact factor: 3.064
Authors: Humaid O Al-Shamsi; Yazan Fahmawi; Ibrahim Dahbour; Aziz Tabash; Jane E Rogers; Jeannette Elizabeth Mares; Mariela A Blum; Jeannelyn Estrella; Aurelio Matamoros; Tara Sagebiel; Catherine E Devine; Brian D Badgwell; Quan D Lin; Prajnan Das; Jaffer A Ajani Journal: J Gastrointest Oncol Date: 2016-08