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 & 2 others Yeul Hong Kim, Yuh Sakata

Research output: Contribution to journalArticle

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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<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
Volume18
Issue number4
DOIs
Publication statusPublished - 2015 Oct 25

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irinotecan
Stomach Neoplasms
Disease-Free Survival
Therapeutics
Epidermal Growth Factor Receptor
nimotuzumab

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Gastroenterology
  • Cancer Research

Cite this

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

In: Gastric Cancer, Vol. 18, No. 4, 25.10.2015, p. 824-832.

Research output: Contribution to journalArticle

Satoh, T, Lee, KH, Rha, SY, Sasaki, Y, Park, SH, Komatsu, Y, Yasui, H, Kim, TY, Yamaguchi, K, Fuse, N, Yamada, Y, Ura, T, Kim, SY, Munakata, M, Saitoh, S, Nishio, K, Morita, S, Yamamoto, E, Zhang, Q, Kim, JM, Kim, YH & 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, vol. 18, no. 4, pp. 824-832. https://doi.org/10.1007/s10120-014-0420-9
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. / Randomized phase II trial of nimotuzumab plus irinotecan versus irinotecan alone as second-line therapy for patients with advanced gastric cancer. In: Gastric Cancer. 2015 ; Vol. 18, No. 4. pp. 824-832.
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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/m2 biweekly) or IRI (irinotecan 150 mg/m2 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.",
keywords = "Advanced gastric cancer, Anti-EGFR, Irinotecan, Nimotuzumab, Second-line therapy",
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T1 - Randomized phase II trial of nimotuzumab plus irinotecan versus irinotecan alone as second-line therapy for patients with advanced gastric cancer

AU - Satoh, Taroh

AU - Lee, Kyung Hee

AU - Rha, Sun Young

AU - Sasaki, Yasutsuna

AU - Park, Se Hoon

AU - Komatsu, Yoshito

AU - Yasui, Hirofumi

AU - Kim, Tae You

AU - Yamaguchi, Kensei

AU - Fuse, Nozomu

AU - Yamada, Yasuhide

AU - Ura, Takashi

AU - Kim, Si Young

AU - Munakata, Masaki

AU - Saitoh, Soh

AU - Nishio, Kazuto

AU - Morita, Satoshi

AU - Yamamoto, Eriko

AU - Zhang, Qingwei

AU - Kim, Jung mi

AU - Kim, Yeul Hong

AU - Sakata, Yuh

PY - 2015/10/25

Y1 - 2015/10/25

N2 - 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/m2 biweekly) or IRI (irinotecan 150 mg/m2 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.

AB - 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/m2 biweekly) or IRI (irinotecan 150 mg/m2 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.

KW - Advanced gastric cancer

KW - Anti-EGFR

KW - Irinotecan

KW - Nimotuzumab

KW - Second-line therapy

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U2 - 10.1007/s10120-014-0420-9

DO - 10.1007/s10120-014-0420-9

M3 - Article

VL - 18

SP - 824

EP - 832

JO - Gastric Cancer

JF - Gastric Cancer

SN - 1436-3291

IS - 4

ER -