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Clinical Trial
. 2015 Oct;18(4):824-32.
doi: 10.1007/s10120-014-0420-9. Epub 2014 Sep 5.

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

Taroh Satoh  1 , Kyung Hee Lee  2 , Sun Young Rha  3 , Yasutsuna Sasaki  4 , Se Hoon Park  5 , Yoshito Komatsu  6 , Hirofumi Yasui  7 , Tae-You Kim  8 , Kensei Yamaguchi  9 , Nozomu Fuse  10 , Yasuhide Yamada  11 , Takashi Ura  12 , Si-Young Kim  13 , Masaki Munakata  14 , Soh Saitoh  15 , Kazuto Nishio  16 , Satoshi Morita  17 , Eriko Yamamoto  18 , Qingwei Zhang  19 , Jung-mi Kim  20 , Yeul Hong Kim  21 , Yuh Sakata  14
Affiliations
Clinical Trial

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

Taroh Satoh et al. Gastric Cancer. 2015 Oct.

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.

Keywords: Advanced gastric cancer; Anti-EGFR; Irinotecan; Nimotuzumab; Second-line therapy.

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Figures

Fig. 1
Fig. 1
CONSORT diagram. N-IRI nimotuzumab plus irinotecan, IRI irinotecan alone
Fig. 2
Fig. 2
Kaplan–Meier estimates of progression-free survival (a) and overall survival (b). N-IRI nimotuzumab plus irinotecan, IRI irinotecan alone
Fig. 3
Fig. 3
Subset forest plots for progression-free survival (a) and overall survival (b). N-IRI nimotuzumab plus irinotecan, IRI irinotecan alone, EGFR epidermal growth factor receptor, IHC immunohistochemistry, ECOG Eastern Cooperative Oncology Group, PS performance status
See this image and copyright information in PMC

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