Price Timothy, Shen Lin, Ma Brigette, Esser Regina, Chen Wenfeng, Gibbs Peter, Lim Robert, Cheng Ann-Lii
Queen Elizabeth Hospital, Woodville, SA, Australia.
Peking University Cancer Hospital & Institute, Haidian Qu, Beijing, China.
Asia Pac J Clin Oncol. 2019 Aug;15(4):225-230. doi: 10.1111/ajco.13154. Epub 2019 May 15.
The open-label, nonrandomized, phase II APEC study enrolled 167 patients with RAS wild-type (wt) metastatic colorectal cancer (mCRC) to investigate the safety and efficacy of first-line, every-2-weeks cetuximab plus investigator's choice of FOLFIRI or FOLFOX in this patient population.
A subgroup analysis of the APEC study population by primary tumor location was performed.
A total of 130 patients (81.8%) had left-sided and 29 (18.2%) had right-sided mCRC. Median progression-free survival (PFS), overall survival (OS) and overall response rate (ORR) were 14.0 months, 30.6 months and 68.5% for patients with left-sided tumors and 8.9 months, 24.6 months and 51.7% for patients with right-sided mCRC, concurring with pivotal phase III trial results. In patients with right-sided tumors, median PFS was 15.4 months vs 8.3 months with cetuximab plus FOLFIRI vs cetuximab plus FOLFOX, respectively; median OS was 32.1 months vs 21.8 months with cetuximab plus FOLFIRI vs cetuximab plus FOLFOX, respectively.
The APEC tumor-location subgroup analysis results were largely consistent with available literature regarding the equivalent efficacy of cetuximab plus FOLFIRI/FOLFOX in patients with left-sided RAS wt mCRC. A trend toward improved efficacy with cetuximab plus FOLFIRI compared with cetuximab plus FOLFOX was observed in patients with right-sided tumors; however, a direct comparison between groups cannot be made due to the nonrandomized study design. Nevertheless, the similar ORR observed with either chemotherapy backbone in patients with right-sided RAS wt mCRC suggests a potential role for both regimens in this patient population when cytoreduction is a treatment goal.
开放性、非随机的II期APEC研究纳入了167例RAS野生型（wt）转移性结直肠癌（mCRC）患者，以研究一线每2周使用西妥昔单抗联合研究者选择的FOLFIRI或FOLFOX方案在该患者群体中的安全性和疗效。
对APEC研究人群按原发肿瘤部位进行亚组分析。
共有130例患者（81.8%）患有左侧mCRC，29例（18.2%）患有右侧mCRC。左侧肿瘤患者的中位无进展生存期（PFS）、总生存期（OS）和总缓解率（ORR）分别为14.0个月、30.6个月和68.5%，右侧mCRC患者分别为8.9个月、24.6个月和51.7%，这与关键的III期试验结果一致。在右侧肿瘤患者中，西妥昔单抗联合FOLFIRI与西妥昔单抗联合FOLFOX相比，中位PFS分别为15.4个月和8.3个月；中位OS分别为32.1个月和21.8个月。
APEC肿瘤部位亚组分析结果在很大程度上与现有文献一致，即西妥昔单抗联合FOLFIRI/FOLFOX在左侧RAS wt mCRC患者中疗效相当。在右侧肿瘤患者中，观察到西妥昔单抗联合FOLFIRI较西妥昔单抗联合FOLFOX有疗效改善的趋势；然而，由于研究设计非随机，无法在组间进行直接比较。尽管如此，在右侧RAS wt mCRC患者中，两种化疗方案观察到的ORR相似，这表明当减瘤是治疗目标时，两种方案在该患者群体中都有潜在作用。
