Randomized Phase II Trial of CapOX plus Bevacizumab and CapIRI plus Bevacizumab as First-Line Treatment for Japanese Patients with Metastatic Colorectal Cancer (CCOG-1201 Study)

被引：15

作者：

Nakayama, Goro ^{[1
]}

Mitsuma, Ayako ^{[2
]}

Sunagawa, Yuki ^{[3
]}

Ishigure, Kiyoshi ^{[4
]}

Yokoyama, Hiroyuki ^{[5
]}

Matsui, Takanori ^{[6
]}

Nakayama, Hiroshi ^{[7
]}

Nakata, Kazuhiko ^{[8
]}

Ishiyama, Akiharu ^{[9
]}

Asada, Takahiro ^{[10
]}

Umeda, Shinichi ^{[1
]}

Ezaka, Kazuhiro ^{[1
]}

Hattori, Norifumi ^{[1
]}

Takami, Hideki ^{[1
]}

Kobayashi, Daisuke ^{[1
]}

Tanaka, Chie ^{[1
]}

Kanda, Mitsuro ^{[1
]}

Yamada, Suguru ^{[1
]}

Koike, Masahiko ^{[1
]}

Fujiwara, Michitaka ^{[1
]}

Fujii, Tsutomu ^{[11
]}

Murotani, Kenta ^{[12
]}

Ando, Yuichi ^{[2
]}

Kodera, Yasuhiro ^{[1
]}

机构：

[1] Nagoya Univ, Grad Sch Med, Dept Gastroenterol Surg, Nagoya, Aichi, Japan

[2] Nagoya Univ Hosp, Dept Clin Oncol & Chemotherapy, Nagoya, Aichi, Japan

[3] Yokkaichi Municipal Hosp, Dept Surg, Yokaichi, Japan

[4] Konan Kosei Hosp, Dept Surg, Konan, Japan

[5] Komaki City Hosp, Dept Surg, Komaki, Japan

[6] Aichi Hosp, Aichi Canc Ctr, Dept Gastroenterol Surg, Okazaki, Aichi, Japan

[7] Nagoya Med Ctr, Dept Surg, Nagoya, Aichi, Japan

[8] Chuno Kosei Hosp, Dept Surg, Seki, Japan

[9] Okazaki City Hosp, Dept Surg, Okazaki, Aichi, Japan

[10] Tajimi Hosp, Dept Surg, Tajimi, Japan

[11] Toyama Univ, Grad Sch Med & Pharmaceut Sci, Dept Surg & Sci, Toyama, Japan

[12] Aichi Med Univ, Clin Res Ctr, Div Biostat, Nagakute, Aichi, Japan

来源：

ONCOLOGIST | 2018年 / 23卷 / 08期

关键词：

Metastatic colorectal cancer; Capecitabine; Irinotecan; Oxaliplatin; Bevacizumab; UGT1A1; IRINOTECAN; CAPECITABINE; OXALIPLATIN; CHEMOTHERAPY; LEUCOVORIN; FLUOROURACIL; COMBINATION; THERAPY; 5-FLUOROURACIL; FOLFIRI;

D O I：

10.1634/theoncologist.2017-0640

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

PurposeThe aim of this randomized, multicenter, noncomparative, phase II trial was to investigate the efficacy and safety of two potential first-line treatments, capecitabine and oxaliplatin (CapOX) plus bevacizumab (BEV) and capecitabine and irinotecan (CapIRI) plus bevacizumab, in Japanese patients with metastatic colorectal cancer (mCRC). Patients and MethodsPatients with untreated mCRC were randomly assigned to receive either CapOX plus bevacizumab (CapOX/BEV arm: bevacizumab 7.5 mg/kg and oxaliplatin 130 mg/m(2) on day 1 and oral capecitabine 2,000 mg/m(2) on days 1-14, every 3 weeks) or CapIRI plus bevacizumab (CapIRI/BEV arm: bevacizumab 7.5 mg/kg and irinotecan 200 mg/m(2) on day 1 and capecitabine 1,600 mg/m(2) on days 1-14, every 3 weeks). The primary endpoint was overall response rate (ORR), and the secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. ResultsA total of 107 patients were enrolled. The intent-to-treat population comprised 54 patients in the CapOX/BEV arm and 53 patients in the CapIRI/BEV arm. The median follow-up period was 35.5 months. ORR was 56% in the CapOX/BEV arm and 55% in the CapIRI/BEV arm. Median PFS and OS were 12.4 and 26.7 months in the CapOX/BEV arm and 11.5 and 28.7 months in the CapIRI/BEV arm, respectively. The frequencies of hematological and nonhematological adverse events above grade 3 were 13% and 30% in the CapOX/BEV arm and 25% and 23% in the CapIRI/BEV arm, respectively. ConclusionCapOX plus bevacizumab and CapIRI plus bevacizumab are equally effective and feasible as the first-line treatments in Japanese patients with mCRC. Implications for PracticeThe CCOG-1201 study was designed to evaluate the efficacy and safety of capecitabine and oxaliplatin plus bevacizumab and capecitabine and irinotecan plus bevacizumab as a first-line treatment in Japanese patients with metastatic colorectal cancer. This article reports on the trial and efforts to define the role of these regimens, including the effect of KRAS status and UGT1A1 polymorphisms in metastatic colorectal cancer.

引用

页码：919 / 927

页数：9

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