A phase II study of bevacizumab with modified OPTIMOX1 as first-line therapy for metastatic colorectal cancer: the TCOG-GI 0802 study

被引：2

作者：

Nakayama, Norisuke ^{[1
]}

Sato, Atsushi ^{[2
]}

Tanaka, Soichi ^{[3
]}

Shimada, Ken ^{[4
]}

Konishi, Kazuo ^{[5
]}

Sasaki, Eisaku ^{[6
]}

Hibi, Kenji ^{[7
]}

Ichikawa, Hiroko ^{[8
]}

Kikuchi, Yoshinori ^{[9
]}

Sakuyama, Toshikazu ^{[10
]}

Sekikawa, Takashi ^{[11
]}

Hayashi, Kazuhiko ^{[12
]}

Nishina, Haruhiro ^{[13
]}

机构：

[1] Kanagawa Canc Ctr Hosp, Dept Gastroenterol, Asahi Ku, Yokohama, Kanagawa 2418515, Japan

[2] Hirosaki Univ, Dept Med Oncol, Grad Sch Med, Hirosaki, Aomori 0368562, Japan

[3] Matsuda Hosp, Unit Coloproctol, Hamamatsu, Shizuoka 4328061, Japan

[4] Showa Univ, Dept Internal Med, Northern Yokohama Hosp, Yokohama, Kanagawa 2248503, Japan

[5] Showa Univ, Div Gastroenterol, Dept Med, Sch Med, Tokyo 1428666, Japan

[6] Tokyo Metropolitan Canc & Infect Dis Ctr Komagome, Dept Chemotherapy, Tokyo 1138677, Japan

[7] Showa Univ, Dept Surg, Fujigaoka Hosp, Yokohama, Kanagawa 2278501, Japan

[8] Tokyo Rinkai Hosp, Div Gastroenterol, Tokyo 1340086, Japan

[9] Toho Univ, Dept Clin Oncol, Grad Sch Med, Tokyo 1438541, Japan

[10] Jikei Univ, Div Clin Oncol Hematol, Dept Internal Med, Sch Med, Tokyo 1058471, Japan

[11] Showa Univ, Dept Internal Med, Toyosu Hosp, Tokyo 1358577, Japan

[12] Tokyo Womens Med Univ Hosp, Dept Chemotherapy & Palliat Care, Tokyo 1628666, Japan

[13] Koto Hosp, Div Surg, Tokyo 1360072, Japan

来源：

INVESTIGATIONAL NEW DRUGS | 2015年 / 33卷 / 04期

关键词：

Bevacizumab; mOPTIMOX1; Colorectal cancer; DOUBLE-BLIND; OXALIPLATIN; FLUOROURACIL; LEUCOVORIN; TRIAL; GERCOR;

D O I：

10.1007/s10637-015-0239-1

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

Background Although bevacizumab plus FOLFOX is a standard treatment for metastatic colorectal cancer, oxaliplatin must be withdrawn in many patients because of cumulative neurotoxicity. We postulated that a reduced dose of oxaliplatin and modified treatment schedule would prolong the time to treatment failure and evaluated bevacizumab combined with a modified OPTIMOX1 regimen (mOPTIMOX1, oxaliplatin dose: 85 mg/m(2)). Methods Eligible patients had a histologically confirmed diagnosis of metastatic colorectal cancer and a performance status of 0-1. Patients were excluded if they had grade 1 or higher peripheral sensory neuropathy or had previously received chemotherapy for metastatic colorectal cancer. Patients received bevacizumab plus mFOLFOX6 every 2 weeks for 6 cycles, followed by 12 cycles of a simplified biweekly regimen of leucovorin and fluorouracil (sLV5FU2) plus bevacizumab. Oxaliplatin was then reintroduced, and bevacizumab plus mFOLFOX6 was continued until progressive disease. Results The median duration of disease control was 11.7 months (95 % confidence interval [CI], 9.7-13.5 months). The median overall survival was 23.1 months (95 % CI, 18.8-27.9 months). The overall response rate according to both the RECIST and WHO criteria was 51.3 %. The most common grade 3 or 4 toxicities were neutropaenia (32.5 %), hypertension (17.5 %), leukocytopaenia, sensory neuropathy, and diarrhoea (10.0 %). There were no treatment-related deaths. Conclusions Bevacizumab plus mFOLFOX6 was well tolerated, and patients could continue chemotherapy for longer than with conventional FOLFOX regimens. This regimen might be an effective treatment option for patients with metastatic colorectal cancer.

引用

页码：954 / 962

页数：9

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