Satoh, Taroh; Lee, Kyung Hee; Rha, Sun Young; Sasaki, Yasutsuna; Park, Se Hoon; Komatsu, Yoshito; Yasui, Hirofumi; Kim, Tae-You; Yamaguchi, Kensei; Fuse, Nozomu; Yamada, Yasuhide; Ura, Takashi; Kim, Si-Young; Munakata, Masaki; Saitoh, Soh; Nishio, Kazuto; Morita, Satoshi; Yamamoto, Eriko; Zhang, Qingwei; Kim, Jung-mi; Kim, Yeul Hong; Sakata, Yuh
Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association
2015Oct ; 18 ( 4 ) :824-32.
PMID : 25185971
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Satoh, Taroh - Medical Oncology, Kinki University Faculty of Medicine, Osaka, Japan.
Lee, Kyung Hee - Hemato-Oncology, Internal Medicine, Yeungnam University Hospital, Daegu, Republic of Korea.
Rha, Sun Young - Medical Oncology, Internal Medicine, Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
Sasaki, Yasutsuna - Medical Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
Park, Se Hoon - Division of Hematology-Oncology, Department of Medicine, Sungkyunkwan University Samsung Medical Center, Seoul, Republic of Korea.
Komatsu, Yoshito - Division of Cancer Chemotherapy, Hokkaido University Hospital, Hokkaido, Japan.
Yasui, Hirofumi - Division of GI Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
Kim, Tae-You - Hematology-Oncology, Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
Yamaguchi, Kensei - Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
Fuse, Nozomu - Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
Yamada, Yasuhide - Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan.
Ura, Takashi - Department of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan.
Kim, Si-Young - Department of Medical Oncology and Hematology, Kyung Hee University Hospital, Seoul, Republic of Korea.
Munakata, Masaki - Internal Medicine, Misawa Municipal Hospital, Aomori, Japan.
Saitoh, Soh - Medical Oncology and Gastroenterology, Aomori Prefectural Central Hospital, Aomori, Japan.
Nishio, Kazuto - Department of Genome Biology, Kinki University School of Medicine, Osaka, Japan.
Morita, Satoshi - Department of Biostatics and Epidemiology, Yokohama City University, Kanagawa, Japan.
Yamamoto, Eriko - Clinical Development Department II, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Zhang, Qingwei - Clinical Data and Biostatistics Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
Kim, Jung-mi - Medical and Regulatory Affairs Department, Kuhnil Pharm. Co., Ltd., Seoul, Republic of Korea.
Kim, Yeul Hong - Department of Internal Medicine, Section of Hemato-Oncology, Korea University Anam Hospital, 126-1 Anam-dong 5ga, Seongbuk-gu, Seoul, 136-705, Republic of Korea. yhk0215@korea.ac.kr.
Sakata, Yuh - Internal Medicine, Misawa Municipal Hospital, Aomori, Japan.
ABSTRACT
BACKGROUND: This multicenter, randomized phase II trial was conducted to compare the efficacy and safety of nimotuzumab plus irinotecan (N-IRI) versus irinotecan alone (IRI) in patients with advanced gastric cancer (AGC) showing disease progression after previous 5-fluorouracil-based therapy.
METHODS: Irinotecan-naive patients (n = 82) received N-IRI (nimotuzumab 400 mg weekly plus irinotecan 150 mg/m(2) biweekly) or IRI (irinotecan 150 mg/m(2) biweekly) until disease progression. The primary endpoint was progression-free survival (PFS), and the secondary endpoints were overall survival (OS), response rate (RR), safety, tolerability, and the correlation between efficacy and tumor epidermal growth factor receptor (EGFR) expression.
RESULTS: Of 83 patients, 40 and 43 patients were randomly assigned to the N-IRI and IRI groups, respectively. In the N-IRI/IRI treatment group, median PFS was 73.0/85.0 days (P = 0.5668), and median OS and RR at 18 months were 250.5/232.0 days (P = 0.9778) and 18.4/10.3 %, respectively. Median PFS and OS in the EGFR 2+/3+ subgroups were 118.5/59.0 and 358.5/229.5 days, respectively. The RR was 33.3/0.0 % in the N-IRI/IRI treatment group. The incidence of grade 3 or higher adverse events was 77.5/64.3 %. No adverse events of grade 3 or higher skin rash or grade 3 or higher infusion-related reaction were reported.
CONCLUSIONS: There was no superiority of N-IRI over IRI alone in terms of PFS in 5-fluorouracil-refractory AGC patients. However, N-IRI showed potential improvement in the EGFR 2+/3+ subgroup based on improved RR, PFS, and OS.
keyword
Advanced gastric cancer; Anti-EGFR; Irinotecan; Nimotuzumab; Second-line therapy
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