title: Phase II study on the combination of irinotecan plus cisplatin as a second-line therapy in patients with advanced or recurrent gastric cancer.
abstract: A pilot phase II study was conducted to evaluate the efficacy and safety of the combined administration of irinotecan (CPT-11) plus cisplatin (CDDP) as a second-line therapy for advanced or recurrent gastric cancer. Between November, 2006 and May, 2009, 18 patients were enrolled in this study. The patients were required to have received prior chemotherapy with S-1 (n=17), an orally administered 5-fluorouracil (5-FU) prodrug, or S-1 plus CDDP (n=1). CPT-11 and CDDP were administered at a dose of 60 and 30 mg/m2, respectively, on days 1 and 15 of a 4-week treatment cycle. The regimen was repeated until the occurrence of unacceptable toxicity, disease progression, or patient refusal. The primary endpoint of this study was the response rate (RR). In the second-line setting, 2 cases of complete response (CR), 1 of partial response (PR) and 7 of stable disease (SD) were identified. The RR was 16.7% and the disease control rate (DCR) was 55.6%. The median survival time (MST) and progression-free survival (PFS) was 282 and 111 days, respectively. As regards hematological toxicity, the major adverse effect during the second-line of chemotherapy was grade 3-4 leukopenia (22.2%). In addition, with regard to non-hematological toxicities, the major adverse effect during the second-line chemotherapy was grade 3-4 loss of appetite (11.1%). There was no mortality attributable to the adverse effects of the drugs. Findings of the present study suggested that CPT-11 and CDDP combination therapy in a second-line setting is an effective regimen in the treatment of advanced gastric cancer.
authors.affiliation: Department of Surgery, School of Medicine, Kanazawa-ku, Yokohama 236-0004;
authors.forename: Yasushi
authors.initials: Y
authors.lastname: Rino
authors.affiliation: Department of Surgery, School of Medicine, Kanazawa-ku, Yokohama 236-0004;
authors.forename: Norio
authors.initials: N
authors.lastname: Yukawa
authors.affiliation: Department of Surgery, School of Medicine, Kanazawa-ku, Yokohama 236-0004;
authors.forename: Tsutomu
authors.initials: T
authors.lastname: Sato
authors.affiliation: Department of Gastroenterology, Medical Center, Yokohama City University, Minami-ku, Yokohama 232-0024;
authors.forename: Takashi
authors.initials: T
authors.lastname: Oshima
authors.affiliation: Department of Surgery, Kamishirane Hospital, Asahi-ku, Yokohama 241-0002;
authors.forename: Hiroyasu
authors.initials: H
authors.lastname: Tanabe
authors.affiliation: Department of Surgery, Kanagawa Prefectural Ashigarakami Hospital, Ashigarakami-gun, Kanagawa 258-0003;
authors.forename: Yuji
authors.initials: Y
authors.lastname: Yamamoto
authors.affiliation: Department of Surgery, Yokohama Minami Kyosai Hospital, Kanazawa-ku, Yokohama 236-0037;
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Matsukawa
authors.affiliation: Department of Surgery, Hiratsuka Kyosai Hospital, Hiratsuka, Kanagawa 254-0047;
authors.forename: Ryuji
authors.initials: R
authors.lastname: Shiraishi
authors.affiliation: Saiseikai Yokohamasi Nanbu Hospital, Konan-ku, Yokohama 234-0054, Japan.
authors.forename: Toshio
authors.initials: T
authors.lastname: Imada
authors.affiliation: Department of Surgery, School of Medicine, Kanazawa-ku, Yokohama 236-0004;
authors.forename: Munetaka
authors.initials: M
authors.lastname: Masuda
keywords: advanced gastric cancer; cisplatin; irinotecan; phase II study; recurrent gastric cancer; second-line chemotherapy