Strickler John H, Cubillo Antonio, Liang Jin-Tung, Matrana Marc, Kozloff Mark, Lowe Thomas, Blaney Martha, Sahtout Mohammad, Naumovski Louie, Wainberg Zev A
Duke University School of Medicine, Durham, NC 27710, USA.
Centro Integral Oncológico Clara Campal HM CIOCC, Madrid, Spain & Universidad Camilo José Cela, Madrid, 28050, Spain.
Future Oncol. 2022 Sep;18(27):3011-3020. doi: 10.2217/fon-2021-1603. Epub 2022 Aug 3.
This phase II study investigated safety and efficacy of dilpacimab or bevacizumab plus FOLFIRI in patients with previously treated metastatic colorectal cancer (mCRC). Overall, 66 patients were treated (n = 34 dilpacimab + FOLFIRI; n = 32 bevacizumab + FOLFIRI). Progression-free survival, overall survival, response rates and tolerability were assessed. Median progression-free survival for dilpacimab + FOLFIRI compared with bevacizumab + FOLFIRI was 3.78 months (95% CI: 2.07-7.20) versus 7.36 months (95% CI: 5.68-10.55) (hazard ratio: 3.57; 95% CI: 1.57-8.11; stratified). Median overall survival: 7.95 months for dilpacimab + FOLFIRI; not reached for bevacizumab + FOLFIRI. Objective response rates: 5.6% for dilpacimab + FOLFIRI and 14.7% for bevacizumab + FOLFIRI. Patients treated with dilpacimab + FOLFIRI experienced serious treatment-related adverse events (n = 4; 11.8%), including one case of intestinal perforation leading to death; none were reported for bevacizumab + FOLFIRI. Treatment with dilpacimab + FOLFIRI was not well tolerated and did not provide clinical benefit to patients with mCRC compared with bevacizumab + FOLFIRI. : NCT03368859 (Clinicaltrials.gov).
这项II期研究调查了地尔帕西单抗或贝伐单抗联合FOLFIRI方案治疗既往接受过治疗的转移性结直肠癌（mCRC）患者的安全性和疗效。总体而言，66例患者接受了治疗（n = 34例接受地尔帕西单抗+FOLFIRI方案；n = 32例接受贝伐单抗+FOLFIRI方案）。评估了无进展生存期、总生存期、缓解率和耐受性。地尔帕西单抗+FOLFIRI方案与贝伐单抗+FOLFIRI方案相比，中位无进展生存期分别为3.78个月（95%CI：2.07 - 7.20）和7.36个月（95%CI：5.68 - 10.55）（风险比：3.57；95%CI：1.57 - 8.11；分层）。中位总生存期：地尔帕西单抗+FOLFIRI方案为7.95个月；贝伐单抗+FOLFIRI方案未达到。客观缓解率：地尔帕西单抗+FOLFIRI方案为5.6%，贝伐单抗+FOLFIRI方案为14.7%。接受地尔帕西单抗+FOLFIRI方案治疗的患者发生了严重的治疗相关不良事件（n = 4；11.8%），包括1例肠穿孔导致死亡；贝伐单抗+FOLFIRI方案未报告此类事件。与贝伐单抗+FOLFIRI方案相比，地尔帕西单抗+FOLFIRI方案耐受性不佳，对mCRC患者未提供临床获益。试验编号：NCT03368859（Clinicaltrials.gov）
