目前，联合化疗后最佳维持治疗策略+
研究详情：
转移性结直肠癌和符合资格标准的患者被招募至该试验。经24周的FP/Ox/Bev的诱导治疗后，无疾病进展的患者被随机分配到以下各组之一：（A）FP+Bev的标准维持治疗；（B）只接受Bev治疗；（C）不接受治疗。若一开始就进展，最初的再诱导治疗被计划加入试验。主要终点是“策略的失效时间”（TFS），包括第一次进展后维持诱导治疗。计算样本量（0.0125单侧α；80%范围）以用来得出与FP+Bev组相比较的非劣效性。次要终点包括第一次进展的时间（PFS1）和总生存期（OS）。
研究结果：
试验过程中，840名患者被招募至试验，随机分配473例参与者。中位随访期是27个月。诱导治疗后，60%的患者出现CR/PR，40%的患者表现SD。A，B，C组的中位PFS1分别为6.2个月，4.6个月，3.6个月（P＜0.0001；A vs C：HR 2.11，95% CI 1.63～2.73； A vs B：HR 1.28，95% CI 0.99～1.65；B vs C：HR 1.56，95% CI 1.22～1.99）。TFS支持A组超过C组（HR 1.31，95% CI 1.01～1.69，P=0.038），但是A组和B组之间没有差异（HR 1.04，95% CI 0.81～1.36，P=0.74）。然而，在第一次进展后，A组只有24%，B和C组一共有47%，接受再诱导治疗。来自随机分组的初步OS是23.4个月，治疗组之间没有显著差异（P=0.69）。
研究结论：
24周的诱导治疗后，给予氟尿嘧啶+贝伐珠单抗，或者单独使用贝伐珠单抗的有效维持治疗显示可以延长TFS超过不接受治疗方案。只有少数患者按照计划接受再诱导治疗。目前仅限于随访中，不同的维持治疗策略对总生存期还没产生影响。临床试验信息：NCT00973609。
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
阅读摘要原文
Maintenance strategy with fluoropyrimidines (FP) plusBevacizumab (Bev), Bev alone, or no treatment, following a standard combinationof FP, oxaliplatin (Ox), and Bev as first-line treatment for patients withmetastatic colorectal cancer (mCRC): A phase III non-inferiority trial (AIO KRK0207).（Abstract3503^）
Authors: Dirk Arnold, Ullrich Graeven, Christian A. Lerchenmuller,et al.
Session Type: Oral Abstract Session
Background: The optimal maintenance strategy following combination chemotherapy plus Bev is still controversial. AIO KRK 0207 investigates whether after a 24-week standard induction with FU/Ox/Bev, no continuation of therapy or continuation with Bev alone are non-inferior to FP plus Bev.
Methods: Pts with mCRC and‘standard’eligibility criteria were enrolled. After 24 weeks of induction treatment with FP/Ox/Bev, pts without disease progression were randomized into one of the following arms: A) standard maintenance treatment with FP plus Bev; B) Bev alone; or C) no treatment. At first progression, re-induction of the initial treatment was planned. The primary endpoint was‘time to failure of strategy’(TFS), comprising maintenance plusre-induction after first progression. Sample size was calculated (one-sided alpha of 0.0125; power of 80%) to conclude non-inferiority compared with the FP plus Bev arm. Secondary endpoints included time to first progression (PFS1) and overall survival (OS).
Results: 840 pts were enrolled, 473 randomized. Median follow-up is 27 months. After induction, 60% of pts had CR/PR, 40% SD. Median PFS1 in arms A, B, C were 6.2, 4.6 and 3.6 months (p<0.0001;A vs C: HR 2.11, 95% CI 1.63-2.73;A vs B: HR 1.28, 95% CI 0.99-1.65;B vs C: HR 1.56, 95% CI 1.22-1.99), respectively. TFS favored arm A over arm C (HR 1.31, 95% CI 1.01-1.69, p=0.038) but without difference between arms A and B (HR 1.04,95% CI 0.81-1.36, p=0.74). However, upon first progression only 24% in arm A and 47 % in both arms B and C, received re-induction. After 200 documented events, preliminary OS is 23.4 months from randomization, without significant difference between treatment arms (p=0.69).
Conclusions: Following 24 weeks of induction, active maintenance with both, FP plus Bev or Bev alone, show prolonged TFS over no treatment. Only a minority of patients received re-induction treatment as planned. With currently limited follow up, the different maintenance strategies had no impact on OS. Clinical trial information: NCT00973609.
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