Evaluation of FOLFOX or CAPOX reintroduction with or without bevacizumab in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy (REACT study)
Evaluation of FOLFOX or CAPOX reintroduction with or without bevacizumab in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy (REACT study)
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DOI：
10.1007/s10147-020-01701-1
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发表时间：
2020-05-14
影响因子：
3.3
通讯作者：
Tomita, Naohiro
中科院分区：
文献类型：
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作者：
Kotaka, Masahito;Iwamoto, Shigeyoshi;Tomita, Naohiro
背景：奥沙利铂作为辅助化疗用于复发性结直肠癌患者的化疗仍存在争议。REACT研究旨在研究奥沙利铂辅助化疗后复发性结直肠癌患者重新引入改良FOLFOX 6（mFOLFOX 6）或CAPOX联合或不联合贝伐珠单抗的疗效。方法参与本试验的患者有辅助化疗病史，包括累积剂量大于400 mg/m2的奥沙利铂，并且在辅助化疗后6个月以上被诊断为复发。主要终点为缓解率（RR）和疾病控制率（DCR），而关键次要终点为至治疗失败时间（TTF）、无进展生存期（PFS）、总生存期（OS）和安全性。结果2012年10月至2016年10月，共入组31例患者。在29例合格患者中，7例接受mFOLFOX 6，22例接受CAPOX。RR为62.1%（95%置信区间42.3-79.3），DCR为82.8%（95%置信区间64.2-94.2）。无奥沙利铂间期的RR在6-12个月为100.0%，12个月后为56.0%。中位TTF、PFS和OS分别为6.3、10.8和28.7个月。6.5%的患者发生3级或更严重的外周感觉神经病变。12.9%的患者发生过敏反应，其中1例（3.2%）为3级发作。未发生其他重度治疗相关不良事件。结论奥沙利铂辅助化疗后6个月以上再次使用奥沙利铂是可行的，并可获得较高的RR或DCR。
Background Chemotherapy in relapsed colorectal cancer patients treated with oxaliplatin as adjuvant chemotherapy is under debate. REACT study aimed to investigate the efficacy of reintroducing modified FOLFOX6 (mFOLFOX6) or CAPOX with or without bevacizumab in recurrent colorectal cancer patients after oxaliplatin adjuvant chemotherapy. Methods Patients that participated in this trial had a medical history of adjuvant chemotherapy, including oxaliplatin with a cumulative dose greater than 400 mg/m(2), and recurrence that was diagnosed more six months post adjuvant chemotherapy. Primary endpoints were response rate (RR) and disease control rate (DCR), while key secondary endpoints were time to treatment failure (TTF), progression-free survival (PFS), overall survival (OS), and safety. Results A total of 31 patients were enrolled between October 2012 and October 2016. Of the 29 eligible patients, 7 received mFOLFOX6 and 22 received CAPOX. The RR was 62.1% (95% confidence interval 42.3-79.3) and the DCR was 82.8% (95% confidence interval 64.2-94.2). The RR for oxaliplatin-free interval was 100.0% in months 6-12 and 56.0% after 12 months. Median TTF, PFS, and OS were 6.3, 10.8, and 28.7 months, respectively. Grade 3 or worse peripheral sensory neuropathy developed in 6.5%. Allergic reactions occurred in 12.9% of the patients, with one (3.2%) grade 3 episode. There were no other severe treatment-related adverse events. Conclusion Reintroduction of oxaliplatin was feasible and achieved high RR or DCR in patients after more than 6 months post oxaliplatin adjuvant chemotherapy.