2014年ESMO大会于9月26日-30日在西班牙马德里召开。转移性结直肠癌的患者可以通过多种治疗模式达到治愈目的。ESMO大会上公布的一项亚组分析旨在确定参与一线治疗试验的转移性结直肠癌患者（但不包括化疗后手术的患者）的特点和远期疗效。

研究方法

体力状态评分0-1分的KRAS野生型（密码子12和13）转移性结直肠癌患者首先应用FOLFIRI 或 mFOLFOX6方案化疗(入组时医生和患者的选择)，然后被随机分配到Cet组（首次剂量400 mg/m2, 然后每周 250 mg/m2） 或 贝伐单抗组（5 mg/kg，每2周一次）。入组时治疗的目标是医生选择的：姑息治疗或新辅助化疗（作为根治性治疗的一部分）。该治疗方案一直使用到出现疾病进展、死亡、不能耐受的毒性作用或根治性手术。允许治疗中断4周，但是患者在进行手术后一般都会退出研究。随后的治疗方案未强制性执行。自然增长的目标为1142位患者。主要评价项目是总生存期。

研究结果

在2005年11月至2012年3月之间，3058位未经选择的患者入组，2334位KRAS野生型患者进行了随机分组，最终完成试验的有1137位患者(其中333位修改前符合KRAS试验的条件, 804修改后符合条件),随访时间的中位数为32个月，年龄的中位数为59岁，其中61%为男性。化疗后一段时间，179位(15.7%)患者进行了手术，年龄的中位数为54岁，其中62%为男性。24.6%的患者是完整的原发肿瘤，36.9%的患者目的为治愈，80%的患者应用FOLFOX方案，58%的患者应用西妥昔单抗。130/179的患者术后立即无疾病征兆（其中104位(58%)患者停止协议治疗方案去进行手术治疗，20位 (11%)患者是因为不良反应；18 位(10%)患者在经过试验治疗后发生进展，然后进行了手术）。从入组到手术的时间间隔的中位数为6.8个月，从随机分组开始的总生存期的中位数为60个月，95% CI (49, 69)。无疾病征兆的患者从手术切除开始的无进展生存期的中位数为26个月; 95% CI (21, 34)。96位患者术后37个月仍存活（50位患者仍无疾病征兆）。

结论

130/1137的入组患者在化疗和手术后无疾病征兆。这些患者的总生存期的中位数为60个月，尽管许多患者复发了。我们预料到了所有的RAS状态，并计划对手术患者进行亚组分析从而找出可能的预测性特点，同时也确定是否能够解释这一事实：与应用贝伐单抗治疗的患者相比，更多的应用Cet治疗的患者进行了手术治疗。

英文原文

CALGB/SWOG 80405: ANALYSIS OF PATIENTS UNDERGOING SURGERY AS PART OF TREATMENT STRATEGY （摘要号：LBA10）

Aim: Patients with metastatic colorectal cancer may be cured with multimodality therapy. The goal of this subset analysis is to determine the characteristics and the long-term outcome of patients enrolled on this first-line treatment study for metastatic disease but who underwent surgery following chemotherapy.

Methods: Pts with KRAS wt (codons 12 and 13) MCRC and performance status 0-1 received FOLFIRI or mFOLFOX6 (MD/patient choice at enrollment) and randomized to either CET 400 mg/m2 X 1, then 250 mg/m2 qw or BV 5 mg/kg q2w. At enrollment, the goal of therapy was chosen by the MD: palliative or as neoadjuvant therapy as part of a curative treatment plan. Rx continued until progression, death, unacceptable toxicity, surgery with curative intent; treatment holidays of 4 weeks permitted but patients in general came off study if they underwent surgery. Subsequent Rx not mandated. Accrual goal was 1142 pts. 1° endpoint was overall survival (OS).

Results: Between 11/2005 and 3/2012, 3058 unselected pts enrolled, 2334 KRAS wt pts randomized; final N =1137 (333 pre-amend eligible retrospective KRAS test, 804 post-amend), median follow-up = 32 mos; Median age–59 y; 61% male. At some point after chemotherapy, 179 patients (15.7%) went to surgery, median age 54, 62% male. 24.6% with intact primary, 36.9% with curative intent, 80% FOLFOX, and 58% CET. 130 of the 179 pts were NED immediately post-surgery (104 (58%) of these pts stopped protocol treatment to pursue surgery; 20 (11%) pts due to adverse events; 18 (10%) had surgery after progressing on study treatment. ) Median time between study entry and surgery was 6.8 mos and median OS from randomization was 60 mos; 95% CI (49, 69). DFS from surgical resection among NED pts was 16.1 mos; 95%CI (10.5, 22.2) and from randomization was 26 mos; 95% CI (21, 34). 96 pts are alive post-surgery (50 remain NED) after a median of 37 mos post-surgical f/u.

Conclusions: 130 of 1137 pts enrolled on study reached NED after chemotherapy and surgery. The median OS in these patients was 60 months although many have recurred. We anticipate all-RAS status and plan on analyzing the subset of patients who underwent surgery to identify possible predictive characteristics and also to determine if there is an explanation for the fact that more patients on CET went to surgery than did pts on BV.

会议专题》》》2014年ESMO大会专题报道

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