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 KimYeul Hong Kim, Yuh Sakata

Research output: Contribution to journalArticle

53 Citations (Scopus)


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<sup>2</sup> biweekly) or IRI (irinotecan 150 mg/m<sup>2</sup> 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.

Original languageEnglish
Pages (from-to)824-832
Number of pages9
JournalGastric Cancer
Issue number4
Publication statusPublished - 2015 Oct 25



  • Advanced gastric cancer
  • Anti-EGFR
  • Irinotecan
  • Nimotuzumab
  • Second-line therapy

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

Satoh, T., Lee, K. H., Rha, S. Y., Sasaki, Y., Park, S. H., Komatsu, Y., Yasui, H., Kim, T. Y., Yamaguchi, K., Fuse, N., Yamada, Y., Ura, T., Kim, S. Y., Munakata, M., Saitoh, S., Nishio, K., Morita, S., Yamamoto, E., Zhang, Q., ... Sakata, Y. (2015). Randomized phase II trial of nimotuzumab plus irinotecan versus irinotecan alone as second-line therapy for patients with advanced gastric cancer. Gastric Cancer, 18(4), 824-832. https://doi.org/10.1007/s10120-014-0420-9