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

被引：88

作者：

Satoh, Taroh ^{[1
]}

Lee, Kyung Hee ^{[2
]}

Rha, Sun Young ^{[3
]}

Sasaki, Yasutsuna ^{[4
]}

Park, Se Hoon ^{[5
]}

Komatsu, Yoshito ^{[6
]}

Yasui, Hirofumi ^{[7
]}

Kim, Tae-You ^{[8
]}

Yamaguchi, Kensei ^{[9
]}

Fuse, Nozomu ^{[10
]}

Yamada, Yasuhide ^{[11
]}

Ura, Takashi ^{[12
]}

Kim, Si-Young ^{[13
]}

Munakata, Masaki ^{[14
]}

Saitoh, Soh ^{[15
]}

Nishio, Kazuto ^{[16
]}

Morita, Satoshi ^{[17
]}

Yamamoto, Eriko ^{[18
]}

Zhang, Qingwei ^{[19
]}

Kim, Jung-mi ^{[20
]}

Kim, Yeul Hong ^{[21
]}

Sakata, Yuh ^{[14
]}

机构：

[1] Kinki Univ, Fac Med, Med Oncol, Osaka, Japan

[2] Yeungnam Univ Hosp, Internal Med, Hematooncol, Daegu, South Korea

[3] Yonsei Univ, Coll Med, Yonsei Canc Res Inst, Med Oncol,Internal Med, Seoul, South Korea

[4] Saitama Med Univ, Int Med Ctr, Med Oncol, Saitama, Japan

[5] Sungkyunkwan Univ, Samsung Med Ctr, Dept Med, Div Hematoloncol, Seoul, South Korea

[6] Hokkaido Univ Hosp, Div Canc Chemotherapy, Sapporo, Hokkaido, Japan

[7] Shizuoka Canc Ctr, Div GI Oncol, Shizuoka, Japan

[8] Seoul Natl Univ Hosp, Internal Med, Hematol Oncol, Seoul 110744, South Korea

[9] Saitama Canc Ctr, Dept Gastroenterol, Saitama, Japan

[10] Natl Canc Ctr Hosp East, Gastrointestinal Oncol, Chiba, Japan

[11] Natl Canc Ctr, Gastrointestinal Oncol, Tokyo, Japan

[12] Aichi Canc Ctr Hosp, Dept Clin Oncol, Nagoya, Aichi, Japan

[13] Kyung Hee Univ Hosp, Dept Med Oncol & Hematol, Seoul, South Korea

[14] Misawa Municipal Hosp, Internal Med, Aomori, Japan

[15] Aomori Prefectural Cent Hosp, Med Oncol & Gastroenterol, Aomori, Japan

[16] Kinki Univ, Sch Med, Dept Genome Biol, Osaka 589, Japan

[17] Yokohama City Univ, Dept Biostat & Epidemiol, Yokohama, Kanagawa, Japan

[18] Daiichi Sankyo Co Ltd, Clin Dev Dept 2, Tokyo, Japan

[19] Daiichi Sankyo Co Ltd, Clin Data & Biostat Dept, Tokyo, Japan

[20] Kuhnil Pharm Co Ltd, Med & Regulatory Affairs Dept, Seoul, South Korea

[21] Korea Univ, Anam Hosp, Dept Internal Med, Sect Hematooncol, Seoul 136705, South Korea

来源：

GASTRIC CANCER | 2015年 / 18卷 / 04期

关键词：

Nimotuzumab; Anti-EGFR; Irinotecan; Second-line therapy; Advanced gastric cancer; GROWTH-FACTOR RECEPTOR; ADVANCED ESOPHAGOGASTRIC CANCER; MONOCLONAL-ANTIBODY H-R3; CELL LUNG-CANCER; SUPPORTIVE CARE; CHEMOTHERAPY PLUS; 1ST-LINE THERAPY; EGFR ANTIBODY; CISPLATIN; CAPECITABINE;

D O I：

10.1007/s10120-014-0420-9

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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. 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. 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. 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.

引用

页码：824 / 832

页数：9

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