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Gastric Cancer. 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.

Author information

1
Medical Oncology, Kinki University Faculty of Medicine, Osaka, Japan.
2
Hemato-Oncology, Internal Medicine, Yeungnam University Hospital, Daegu, Republic of Korea.
3
Medical Oncology, Internal Medicine, Yonsei Cancer Center, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea.
4
Medical Oncology, Saitama Medical University International Medical Center, Saitama, Japan.
5
Division of Hematology-Oncology, Department of Medicine, Sungkyunkwan University Samsung Medical Center, Seoul, Republic of Korea.
6
Division of Cancer Chemotherapy, Hokkaido University Hospital, Hokkaido, Japan.
7
Division of GI Oncology, Shizuoka Cancer Center, Shizuoka, Japan.
8
Hematology-Oncology, Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea.
9
Department of Gastroenterology, Saitama Cancer Center, Saitama, Japan.
10
Gastrointestinal Oncology, National Cancer Center Hospital East, Chiba, Japan.
11
Gastrointestinal Oncology, National Cancer Center Hospital, Tokyo, Japan.
12
Department of Clinical Oncology, Aichi Cancer Center Hospital, Aichi, Japan.
13
Department of Medical Oncology and Hematology, Kyung Hee University Hospital, Seoul, Republic of Korea.
14
Internal Medicine, Misawa Municipal Hospital, Aomori, Japan.
15
Medical Oncology and Gastroenterology, Aomori Prefectural Central Hospital, Aomori, Japan.
16
Department of Genome Biology, Kinki University School of Medicine, Osaka, Japan.
17
Department of Biostatics and Epidemiology, Yokohama City University, Kanagawa, Japan.
18
Clinical Development Department II, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
19
Clinical Data and Biostatistics Department, Daiichi Sankyo Co., Ltd., Tokyo, Japan.
20
Medical and Regulatory Affairs Department, Kuhnil Pharm. Co., Ltd., Seoul, Republic of Korea.
21
Department of Internal Medicine, Section of Hemato-Oncology, Korea University Anam Hospital, 126-1 Anam-dong 5ga, Seongbuk-gu, Seoul, 136-705, Republic of Korea. yhk0215@korea.ac.kr.

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

PMID:
25185971
PMCID:
PMC4572054
DOI:
10.1007/s10120-014-0420-9
[Indexed for MEDLINE]
Free PMC Article

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