Gastrointestinal Cancer Center, Sano Hospital, 2-5-1, Shimizugaoka, Tarumi-ku, Kobe, 655-0031, Japan.
Cancer Center, Aichi Medical University, Aichi, Japan.
Int J Clin Oncol. 2020 Aug;25(8):1515-1522. doi: 10.1007/s10147-020-01701-1. Epub 2020 May 14.
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.
Patients that participated in this trial had a medical history of adjuvant chemotherapy, including oxaliplatin with a cumulative dose greater than 400 mg/m, 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.
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.
Reintroduction of oxaliplatin was feasible and achieved high RR or DCR in patients after more than 6 months post oxaliplatin adjuvant chemotherapy.
奥沙利铂辅助化疗后复发的结直肠癌患者的化疗存在争议。REACT 研究旨在探讨在奥沙利铂辅助化疗后复发的结直肠癌患者中重新引入改良 FOLFOX6（mFOLFOX6）或 CAPOX 联合或不联合贝伐珠单抗的疗效。
参与该试验的患者有辅助化疗病史，包括奥沙利铂累积剂量大于 400mg/m2，辅助化疗后 6 个月以上诊断为复发。主要终点为缓解率（RR）和疾病控制率（DCR），次要终点为治疗失败时间（TTF）、无进展生存期（PFS）、总生存期（OS）和安全性。
共有 31 例患者于 2012 年 10 月至 2016 年 10 月入组。29 例可评估患者中，7 例接受 mFOLFOX6，22 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）。奥沙利铂无进展间隔 6-12 个月的 RR 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。3 级或更高级别的周围感觉神经病变发生率为 6.5%。过敏反应发生率为 12.9%，其中 1 例（3.2%）为 3 级。无其他严重与治疗相关的不良事件。
奥沙利铂辅助化疗 6 个月后再次应用于患者是可行的，可获得较高的 RR 或 DCR。
