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2016ESMO世界胃肠肿瘤大会（GI）于6月29日至7月2日在西班牙巴塞罗那召开。ESMO GI涉及胃肠道的各个部分，涵盖了众多常见和不常见肿瘤的筛查、诊断和治疗进展，是胃肠恶性肿瘤领域的世界级盛会。
第18届 ESMO GI大会最新突破性研究（Late Breaking Abstracts）之一LBA05是由我国研究者完成，也是LBA系列中唯一一个中国研究。TAILOR研究由南京八一医院副院长秦叔逵教授和上海天佑医院副院长李进教授作为PI领衔，比较RAS野生型（RASwt）转移性结直肠癌（mCRC）中一线[FOLFOX-4+西妥昔单抗]vs[FOLFOX-4]的疗效。
对于RASwt的mCRC患者，西妥昔单抗联合化疗（FOLFIRI或FOLFOX）是标准一线方案。之前的CRYSTAL Ⅲ期研究和OPUS Ⅱ期研究结果均表明西妥昔单抗+一线FOLFIRI或FOLFOX-4可以改善此类患者结局。TAILOR研究是一项开放标签、多中心随机Ⅲ期研究，在中国人中验证这一方案的有效性和安全性。巴塞罗那当地时间7月2日，上海中山医院的刘天舒教授口头报告了这项研究。
主要研究内容
基于改良意向治疗（mITT）人群（393名RASwt mCRC患者）评价两种治疗方案的有效性。其中193名随机进入［FOLFOX-4+西妥昔单抗］治疗组，200名进入[FOLFOX-4]组，两组的基线数据得到了较好的均衡。
◆治疗持续直到疾病进展或不能耐受毒性。
◆主要终点是无进展生存（PFS）期，关键的次要终点包括总生存（OS）期、完全缓解率（ORR）、安全性和耐受性。上述数据均由独立数据监测委员会（IRC）根据RECIST 1.0标准确定。
主要结果
与［FOLFOX-4］相比，[FOLFOX-4+西妥昔单抗]组有更高的累积化疗剂量，可能是PFS时间更长从而给药时间长。
◆根据IRC的监测数据，[FOLFOX-4+西妥昔单抗]组患者在主要终点PFS方面显著优于［FOLFOX-4］组，分别为9.2个月 vs 7.4个月（HR=0.69）。
◆两方案在关键的次要终点ORR和OS也有显著差异，ORR为61.1% vs 39.5%；中位OS为20.7个月vs 17.8个月。
安全性方面并未看到有特殊的意外事件发生。
结论
一线FOLFOX+西妥昔单抗显著改善了中国RASwt转移性结直肠癌患者的PFS、OS和ORR，这与之前的重要研究结果一致。TAILOR研究证实了西妥昔单抗联合化疗作为RASwt mCRC患者标准一线治疗的地位，为铂类联合西妥昔单抗提供了详细的临床数据。
摘要阅读
LBA—05
First-lineFOLFOX-4 ± cetuximab in patients with RAS wild-type (wt) metastatic colorectalcancer (mCRC): the open-label, randomized phase 3 TAILOR trial
Background: Cetuximab incombination with chemotherapy (either FOLFIRI or FOLFOX) is a standard-of-carefirst-line treatment for patients with RAS wt mCRC. The addition of cetuximabto first-line FOLFIRI or FOLFOX-4 has previously been shown to improve survivaloutcomes in patients with RAS wt mCRC in the randomized phase 3 CRYSTAL trialand the randomized phase 2 OPUS trial. The purpose of the randomized phase 3TAILOR trial is to confirm the efficacy and safety of FOLFOX-4 plus cetuximabvs FOLFOX-4 in the first-line treatment of Chinese patients with RAS wt mCRC.
Methods: TAILOR (EMR62202-057;NCT01228734) is an open-label, randomized, multicenter phase 3 trial. Theefficacy analyses are based on a modified intention-to-treat (mITT) populationof 393 Chinese patients with RAS wt mCRC treated with FOLFOX-4 ± cetuximab.Study treatment continues until disease progression or unacceptable toxicity(ie, not for a fixed number of courses). The primary endpoint of TAILOR isprogression-free survival (PFS) time as assessed by an independent reviewcommittee (IRC) according to RECIST 1.0; key secondary endpoints includeoverall survival (OS) time, overall response rate (ORR), and safety/tolerability.
Results: Within the mITTpopulation, 193 patients with RAS wt mCRC were randomized to FOLFOX-4 pluscetuximab and 200 patients to FOLFOX-4. Baseline characteristics were reasonablybalanced between treatment arms. Higher cumulative chemotherapy doses in theFOLFOX-4 plus cetuximab arm vs FOLFOX-4 arm likely reflect longer dosing due toa longer PFS time. Indeed, adding cetuximab to FOLFOX-4 demonstrated astatistically significant difference between treatment arms for the primaryendpoint of PFS by IRC with an HR [95% CI] of 0.69 [0.54-0.89] ( p = .004;median PFS time: 9.2 vs 7.4 months). The key secondary endpoints of ORR (61.1%vs 39.5%; odds ratio [95% CI] = 2.41 [1.61-3.61]; p < .001) and current assessmentof OS (with an HR [95% CI] = 0.76 [0.61-0.96]; p = .020; median OS: 20.7 vs17.8 months) also confirmed clinical benefit from the addition of cetuximab to FOLFOX-4.There were no new or unexpected safety findings.
Conclusions: The addition ofcetuximab to first-line FOLFOX chemotherapy statistically significantlyimproved PFS, OS, and ORR in Chinese patients with RAS wt mCRC, an observationthat is consistent with previous pivotal studies. The TAILOR study met its primaryendpoint and confirms cetuximab in combination with chemotherapy as astandard-of-care first-line treatment regimen for patients with RAS wt mCRC.
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文献：S. Qin.et al. AnnOncol (2016) 27 (suppl 2): ii141.
