在一项III期CAIRO3研究的最终结果和亚组分析中，对于转移性结
研究方法：
之前未经治疗病情稳定或者在接受CAPOX-B方案6个周期治疗后病情好转的转移性结直肠癌患者被随机分配到观察组（组A）或者卡培他滨625mg/m2每日两次，每日连续+贝伐珠单抗7.5mg/kg，静脉注射，三周一次（组B）。出现第一次进展（PFS1），两组的患者都要接受CAPOX-B治疗直到第二次进展（PFS2，主要终点）。次要终点是总生存期（OS）和第二次进展时间（TTP2，其中TTP2定义为第一次进展后接受任何治疗再次进展的时间），以及生活质量（QoL）。在该项研究也开展预先计划的子集分析。
研究结果：
一共有558例患者参与随机分配。出现第一次进展，61%的组A患者和47%的组B患者再次引入CAPOX-B方案。该项研究支持PFS1时接受维持治疗。中位TT2PD和PFS2分别为8.5个月 vs 11.7个月（HR 0.67，P＜0.0001）。多变量分析显示治疗与OS间有明显的相互作用。亚组分析表明，同步转移瘤切除的原发肿瘤患者（n=180）接受治疗的相互作用：中位OS：18.0个月（组A） vs 25.0个月（组B）（P＜0.0001），以及对于在随机分配前接受诱导治疗的完全/部分缓解患者，其中位OS是18.8个月（组A） vs 24.1个月（组B；P＜0.0001）。在维持治疗期间，生活质量得以保证，而且与观察组的生活质量相比较，临床上并不逊色。
研究结论：
CAIRO3研究最终结果确定了，转移性结直肠癌患者接受一线诱导治疗后从卡培他滨+贝伐珠单抗的维持治疗中获益。多变量分析显示，治疗与总生存期有明显的相互作用。同时该研究发现，维持治疗在生存期上的积极效果，在同步转移瘤切除的原发肿瘤患者中最为明显，以及对完全/部分缓解患者给予诱导治疗应该予以确认。
医脉通整理报道，转载请注明出处。
会议专题》》》2014年ASCO年会专题报道
阅读原文摘要
Final results and subgroup analyses of the phase 3 CAIRO3 study: Maintenance treatment with capecitabine + bevacizumab versus observation after induction treatment with chemotherapy + bevacizumab in metastatic colorectal cancer (mCRC).（Abstract3504）
Authors: Miriam Koopman, Lieke Simkens, Anne Maria May, et al.
Session Type: General Poster Session
Background: We investigated the efficacy of maintenance treatment with capecitabine (cap) + bev versus observation in mCRC patients (pts) not progressing during induction treatment with cap, oxaliplatin and bev (CAPOX-B).
Methods：Previously untreated mCRC pts with stable disease or better after 6 cycles of CAPOX-B were randomized between observation (arm A) or maintenance treatment with cap 625 mg/m2 bid daily continuously + bev 7.5 mg/kg iv q 3 weeks (arm B). Upon first progression (PFS1), pts in both arms were to be treated with CAPOX-B until 2nd progression (PFS2, primary endpoint). Secondary endpoints were overall survival (OS) and time to 2nd progression (TTP2), which was defined as the time to progression on any treatment following PFS1, and quality of life (QoL). Preplanned subset analyses were performed.
Results: A total of 558 pts were randomized. Upon PFS1, CAPOX-B was reintroduced in 61% of pts in arm A and 47% in arm B. There was a significant benefit for maintenance treatment for PFS1, TT2PD and PFS2 with a median of 8.5 m vs 11.7 m, respectively (HR 0.67, p < .0001). Multivariable analysis showed a significant interaction for treatment with OS. Subgroup analysis showed a significant interaction for treatment in pts with synchronous metastases with resected primary tumor (n=180): median OS 18.0 m (A) vs 25.0 m (B) (p <0.0001), and for pts with complete/ partial response to induction treatment before randomization (n=366) with median OS of 18.8 m (A) and 24.1 m (B; p < .0001). QoL was maintained during maintenance treatment, and was clinically not inferior compared to QoL in the observation arm.
Conclusions: Final CAIRO3 results establish the benefit of maintenance treatment with cap + bev after first-line induction treatment in pts with mCRC. Multivariable analysis shows a significant interaction of treatment with OS. Our finding that the positive effect on survival for maintenance treatment is most pronounced in pts with synchronous disease and resected primary tumor and with PR/CR to induction treatment should be confirmed.
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