新型EPOC研究将可手术治疗或可考虑手术治疗的结直肠癌肝转移患者随机分配进行围手术期化疗，联用或不联用西妥昔单抗。试验招聘结束于2012年11月，因为西妥昔单抗组无进展生存期显著恶化（20.5：14.1个月，HR 1.48 95％CI为1.04-2.12，P = 0.03）。基于这一意料之外的研究结果，开始着手收集整理疾病进展的数据。
研究方法
共有257例KRAS野生型患者随机接受单纯化疗（A组）或化疗加西妥昔单抗（B组）的治疗。使用2012年11月数据截止时110例进展期KRAS野生型患者（A组48例，B组62例）病例报告表获取有关疾病进展部位及治疗的数据。使用Kaplan-Meier法计算进展后生存期（PPS）。
研究结果
肝脏是进展最频繁的部位（A组46％（22/48），B组53％（33/62）），仅肝脏疾病就占进展事件的大多数（A组91％20/22，B组79％26/33）。但总体来讲，术前或术后疾病进展的情况各组间没有差异。64例疾病进展患者进行了进一步治疗（A组26/48;B组 38/62），其中56例进行了进一步的化疗，以伊立替康为基础的化疗最常见。14例患者接受西妥昔单抗进行进一步治疗（A组9例，B组5例）。B组PPS有较差的趋势（中位数PPS A组18.7个月; B组15.9个月，HR 1.69，P = 0.131）。25例进展后进行手术治疗的患者中，中位随访11.6个月后24例存活。
结论
进展性疾病的分配和进一步的治疗都如队列所预期，且分组均衡。尽管如此，对于那些并不适合进行修正手术而接受西妥昔单抗治疗的患者，进展后生存期仍存在一种较差趋势。
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
阅读英文摘要
Patterns of progression, treatment of progressive disease, and postprogression survival in the new EPOC study.(Abstract No:3556)
Authors: Sian Alexandra Pugh, Alexandre Ball, et al.
Session Type: General Poster Session
Background: The New EPOC study randomised patients with operable or borderline operable colorectal liver metastasis to perioperative chemotherapy with or without cetuximab. Recruitment to the trial was halted in November 2012 because the progression free survival was significantly worse in the arm receiving cetuximab (20·5 vs. 14·1 months, HR 1·48 95%CI 1·04-2·12 p=0·03). Given this unexpected trial result acquisition of progression data was undertaken.
Methods: There were 257 KRAS wild-type patients who were randomised to chemotherapy alone (arm A) or chemotherapy with cetuximab (arm B). Data regarding sites and treatment of progressive disease were obtained using case report forms for the 110 (arm A n=48, arm B n=62) KRAS wild-type patients with progressive disease at the cut-off date for analysis of November 2012. Post-progression survival (PPS) was calculated using the Kaplan-Meier method.
Results: The liver was the most frequent site of progression (arm A 46% (22/48); arm B 53% (33/62)) with liver only disease accounting for the majority of those progression events (arm A 91% 20/22; arm B 79% 26/33). Overall there was no difference between the arms in respect of the distribution of progressive disease pre- or postoperatively. Further treatment for progressive disease is known for 64 patients (arm A 26/48; arm B 38/62) of whom 56 received further chemotherapy, most frequently irinotecan based. Fourteen patients received cetuximab as a further line agent (arm A n=9, arm B n=5). There was a trend towards an inferior PPS in arm B (median PPS 18·7 months arm A; 15·9 months arm B, HR 1·69 p=0·131). Of the 25 patients in whom post-progression surgery with curative intent was undertaken, 24 were still alive at a median follow-up of 11·6 months.
Conclusions: Both the distribution of progressive disease and further treatment are as expected for such a cohort and are evenly balanced between the arms. Despite this there is a trend towards an inferior survival post progression in those receiving cetuximab for whom revisional surgery is not appropriate. Clinical trial information: 22944367.
