Sato Atsushi, Doi Toshihiko, Boku Narikazu, Kato Ken, Komatsu Yoshito, Yamaguchi Kensei, Muro Kei, Hamamoto Yasuo, Koizumi Wasaburo, Mizunuma Nobuyuki, Takiuchi Hiroya
Showa University School of Medicine, Japan.
Gan To Kagaku Ryoho. 2011 Apr;38(4):561-9.
FOLFOX plus Bevacizumab (BEV) is one of he current standard treatments for unresectable colorectal cancer. In Europe and the United States, XELOX is a regimen which replaced 5-FU/LV of FOLFOX with capecitabine (XEL), an oral prodrug of fluorouracil. Benefits of XELOX and FOLFOX are reported to be same in Europe and United States. XELOX + BEV is recommended as treatment option in various guidelines. However, the safety and effectiveness data were from overseas and unconfirmed in Japan. Therefore, we carried out a JO19380 study to evaluate the effectiveness and safety XELOX + BEV on Japanese patients in a domestic phase I/II clinical trial. A total of 64 patients were registered in this study. The response rate was 72%, the progression free survival was 11 months, and the median survival time was 27.4 months with XELOX + BEV. The common grade 3/4 toxicities were sensory neurotoxicity (17%) and neutropenia (16%). The effectiveness and safety equivalents of overseas reports were confirmed in Japanese patients. They suggested that XELOX + BEV has the potential to become one of the standard treatments for unresectable colorectal cancer in Japan. In the trial, long-term disease control with XEL-BEV was reported in patients who discontinued oxaliplatin because of adverse events. Continuous treatment with XEL + BEV after XELOX + BEV is considered to be significant first-line therapy for colorectal cancer based on that report.
FOLFOX联合贝伐单抗（BEV）是目前不可切除结直肠癌的标准治疗方案之一。在欧洲和美国，XELOX方案用氟尿嘧啶的口服前体药物卡培他滨（XEL）替代了FOLFOX方案中的5-氟尿嘧啶/亚叶酸（5-FU/LV）。据报道，XELOX和FOLFOX在欧洲和美国的疗效相同。各种指南均推荐XELOX + BEV作为治疗选择。然而，其安全性和有效性数据来自海外，在日本未经证实。因此，我们开展了JO19380研究，在一项国内I/II期临床试验中评估XELOX + BEV对日本患者的有效性和安全性。本研究共登记了64例患者。XELOX + BEV治疗的缓解率为72%，无进展生存期为11个月，中位生存期为27.4个月。常见的3/4级毒性反应为感觉神经毒性（17%）和中性粒细胞减少（16%）。在日本患者中证实了海外报告中的有效性和安全性等效性。他们认为XELOX + BEV有可能成为日本不可切除结直肠癌的标准治疗方案之一。在试验中，有报告称因不良事件停用奥沙利铂的患者接受XEL-BEV治疗可实现长期疾病控制。基于该报告，在XELOX + BEV之后继续使用XEL + BEV治疗被认为是结直肠癌重要的一线治疗方案。
