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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

 Taroh Satoh  ;  Kyung Hee Lee  ;  Sun Young Rha  ;  Yasutsuna Sasaki  ;  Se Hoon Park  ;  Yoshito Komatsu  ;  Hirofumi Yasui  ;  Tae-You Kim  ;  Kensei Yamaguchi  ;  Nozomu Fuse  ;  Yasuhide Yamada  ;  Takashi Ura  ;  Si-Young Kim  ;  Masaki Munakata  ;  Soh Saitoh  ;  Kazuto Nishio  ;  Satoshi Morita  ;  Eriko Yamamoto  ;  Qingwei Zhang  ;  Jung-mi Kim  ;  Yeul Hong Kim  ;  Yuh Sakata 
 GASTRIC CANCER, Vol.18(4) : 824-832, 2015 
Journal Title
Issue Date
Adenocarcinoma/drug therapy* ; Adenocarcinoma/genetics ; Adenocarcinoma/mortality ; Adult ; Aged ; Antibodies, Monoclonal, Humanized/administration & dosage ; Antibodies, Monoclonal, Humanized/adverse effects ; Antineoplastic Combined Chemotherapy Protocols/therapeutic use* ; Camptothecin/administration & dosage ; Camptothecin/adverse effects ; Camptothecin/analogs & derivatives ; DNA Mutational Analysis ; Disease-Free Survival ; Female ; Genes, ras/genetics ; Humans ; Immunohistochemistry ; In Situ Hybridization, Fluorescence ; Kaplan-Meier Estimate ; Male ; Middle Aged ; Neoplasm Recurrence, Local/drug therapy* ; Neoplasm Recurrence, Local/genetics ; Neoplasm Recurrence, Local/mortality ; Polymerase Chain Reaction ; Receptor, Epidermal Growth Factor/biosynthesis ; Receptor, Epidermal Growth Factor/genetics ; Receptor, ErbB-2/biosynthesis ; Salvage Therapy/methods ; Stomach Neoplasms/drug therapy* ; Stomach Neoplasms/genetics ; Stomach Neoplasms/mortality ; Treatment Outcome
Advanced gastric cancer ; Anti-EGFR ; Irinotecan ; Nimotuzumab ; Second-line therapy
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.
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Yonsei Authors
Rha, Sun Young(라선영) ORCID logo https://orcid.org/0000-0002-2512-4531
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