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Randomized phase II trial of nimotuzumab plus irinotecan versus irinotecan alone as second-line therapy for patients with advanced gastric cancer

Authors
 Taroh Satoh ; Kyung Hee Lee ; Yuh Sakata ; Yeul Hong Kim ; Jung-mi Kim ; Qingwei Zhang ; Eriko Yamamoto ; Satoshi Morita ; Kazuto Nishio ; Soh Saitoh ; Masaki Munakata ; Si-Young Kim ; Takashi Ura ; Yasuhide Yamada ; Nozomu Fuse ; Kensei Yamaguchi ; Tae-You Kim ; Hirofumi Yasui ; Yoshito Komatsu ; Se Hoon Park ; Yasutsuna Sasaki ; Sun Young Rha 
Citation
 Gastric Cancer, Vol.18(4) : 824~832, 2015 
Journal Title
 Gastric Cancer 
ISSN
 1436-3291 
Issue Date
2015
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.
URI
http://ir.ymlib.yonsei.ac.kr/handle/22282913/141623
DOI
10.1007/s10120-014-0420-9
Appears in Collections:
1. 연구논문 > 1. College of Medicine > Dept. of Internal Medicine
Yonsei Authors
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