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2016年6月3-7日，一年一度的美国临床肿瘤学会（American Society of Clinical Oncology，ASCO）年会将在芝加哥举办。6月6日上午的消化系统（非结直肠）肿瘤口头报告专场上，一项摘要号为4000的多中心随机III期试验（CRITICS研究），在可切除的胃癌患者中，将新辅助化疗序贯手术联合化疗或者手术联合化放疗进行比较，医脉通整理如下：
胃癌潜在可治愈治疗的主要方法是根治性手术切除。因为西方世界的大多数晚期患者长期存活率仍然较差，约25%，由于治疗失败的局部复发在高达80%的病例中发生。术后放化疗（CRT）和围手术期化疗（CT）证明生存获益超过单独手术。
目前这项随机III期CRITICS-研究（NCT00407186）旨在将新辅助化疗后化放疗联合适当（D2）手术与术后化疗相比较，以观察是否会带来总生存期（OS）的改善。此外，该试验对这两种治疗方案的毒性进行了探索。
研究人员将Ib-IVa期可切除的胃癌患者在确诊后进行随机分配。在这两组中被处方新辅助化疗，包括表柔比星，顺铂/奥沙利铂+卡培他滨（ECC/EOC）3个疗程。胃癌切除术后，患者接受另外3个疗程的ECC/EOC或者CRT（45Gy分25次联合每周一次顺铂+每日一次卡培他滨）。主要终点是OS；次要终点包括无疾病生存期，毒性和生活质量。
结果显示，在2007年1月到2015年4月之间，来自荷兰，瑞典和丹麦的788例患者被随机分配接受治疗（393例CT；395例CRT）。基线特征均衡，70%为男性，中位年龄61岁。84%的患者在手术前完成3次周期。CT组46%的患者，CRT组55%的患者根据协议完成治疗。在中位随访期50个月后，405例患者死亡。CT的5-年存活率是41.3，CRT的5-年存活率为40.9%（P=0.99）。对于CT和CRT来说，毒性分别以血液学（III级或更高：44% vs 34%；P=0.01）和胃肠道反应（III级或更高：37% vs 42%；P=0.14）为主。
综上所述，术后化疗组和术后化放疗组之间没有发现总生存期存在显著差异。临床试验信息：NCT00407186。
会议专题》》》2016年ASCO年会专题报道
A multicenter randomized phase III trial of neo-adjuvant chemotherapy followed by surgery and chemotherapy or by surgery and chemoradiotherapy in resectable gastric cancer: First results from the CRITICS study.（Abstract 4000）
Authors：Marcel Verheij, Edwin PM Jansen, Annemieke Cats,et al.
Session Type：Oral Abstract Session
Background: The mainstay of potentially curative treatment of gastric cancer is radical surgical resection. Because most patients in the Western world present with advanced stages long-term survival remains poor at about 25%, with local recurrences as part of treatment failure in up to 80% of cases. Postoperative chemoradiotherapy (CRT) and perioperative chemotherapy (CT) have demonstrated a survival benefit over surgery alone. The current randomized phase III CRITICS-study (NCT00407186) investigated whether chemoradiotherapy after neo-adjuvant chemotherapy and adequate (D2) surgery leads to improved overall survival (OS) in comparison with postoperative chemotherapy. Furthermore, toxicity of both treatment regimens was explored.
Methods: Patients with stage Ib-IVa resectable gastric cancer were randomized after diagnosis. Neo-adjuvant CT was prescribed in both arms and consisted of 3 courses of epirubicin, cisplatin/oxaliplatin and capecitabine (ECC/EOC). After gastric cancer resection, patients received another 3 courses of ECC/EOC or CRT (45 Gy in 25 fractions combined with weekly cisplatin and daily capecitabine). Primary endpoint is OS; secondary endpoints are: disease free survival, toxicity profile and quality of life.
Results: Between January 2007 and April 2015, 788 patients from The Netherlands, Sweden and Denmark were randomized (393 CT; 395 CRT). Baseline characteristics were well balanced with 70% males and a median age of 61 years. 84% completed 3 cycles before surgery. In the CT arm 46% and in the CRT arm 55% completed treatment according to protocol. After a median follow-up of 50 months, 405 patients have died. The 5-year survival is 41.3% for CT and 40.9% for CRT (p=0.99). Toxicity was mainly hematological (grade III or higher: 44% vs 34%; p=0.01) and gastrointestinal (grade III or higher: 37% vs 42%; p=0.14) for CT and CRT, respectively.
Conclusion: No significant difference in overall survival was found between postoperative chemotherapy and chemoradiotherapy. Clinical trial information: NCT00407186
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