Hofheinz Ralf-Dieter, Anchisi Sandro, Grünberger Birgit, Derigs Hans G, Zahn Mark-Oliver, Geffriaud-Ricouard Christine, Gueldner Max, Windemuth-Kieselbach Christine, Pederiva Stefanie, Bohanes Pierre, Scholten Felicitas, Piringer Gudrun, Thaler Josef, von Moos Roger
Department of Oncology, University Hospital Mannheim, Theodor-Kutzer-Ufer 1, 68167 Mannheim, Germany.
Department of Oncology, Valais Romand Hospital Center, Valais Hospital, Av. Grand-Champsec 86, 1951 Sion, Switzerland.
Cancers (Basel). 2022 Jul 20;14(14):3522. doi: 10.3390/cancers14143522.
Aflibercept plus FOLFIRI prolongs overall survival (OS) in patients with metastatic colorectal cancer after the failure of oxaliplatin-containing therapy. QoLiTrap prospectively evaluated the quality of life (QoL) and effectiveness of this regimen in daily clinical practice, according to RAS status, sex, and prior targeted therapy, especially epidermal growth factor receptor inhibitors (EGFR-I). The primary endpoint was the percentage of patients whose EORTC QLQ-C30 global health status (GHS) improved or reduced by <5% from baseline during the first 12 weeks of therapy. Secondary endpoints included objective response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. One thousand two hundred and seventy-seven patients were treated with aflibercept plus FOLFIRI and 872 were evaluable for QoL. GHS improved or decreased by <5% in 40.3% of cases. The ORR was 20.8%, the median PFS was 7.8 months (95% confidence interval (CI), 7.3−8.3), and the median OS was 14.4 months (95% CI, 13.1−18.1). After prior EGFR-I, the ORR was 23.7%, median PFS was 9.4 months (95% CI, 6.5−12.9), and median OS was 17.4 months (95% CI, 10.5−33.7). The safety profile was consistent with previously reported data. Aflibercept plus FOLFIRI given in daily practice maintained QoL in mCRC patients, was associated with a high objective tumor response, and retained its activity regardless of sex, RAS status, and prior EGFR-I therapy.
在含奥沙利铂的治疗失败后，阿柏西普联合FOLFIRI方案可延长转移性结直肠癌患者的总生存期（OS）。QoLiTrap研究前瞻性评估了该方案在日常临床实践中根据RAS状态、性别和既往靶向治疗（尤其是表皮生长因子受体抑制剂（EGFR-I））的生活质量（QoL）和疗效。主要终点是在治疗的前12周内，欧洲癌症研究与治疗组织核心生活质量问卷（EORTC QLQ-C30）全球健康状况（GHS）较基线改善或降低幅度<5%的患者百分比。次要终点包括客观缓解率（ORR）、无进展生存期（PFS）、总生存期（OS）和安全性。1277例患者接受了阿柏西普联合FOLFIRI治疗，其中872例可进行生活质量评估。40.3%的病例中GHS改善或降低幅度<5%。ORR为20.8%，中位PFS为7.8个月（95%置信区间（CI），7.3 - 8.3），中位OS为14.4个月（95%CI，13.1 - 18.1）。既往接受过EGFR-I治疗后，ORR为23.7%，中位PFS为9.4个月（95%CI，6.5 - 12.9），中位OS为17.4个月（95%CI，10.5 - 33.7）。安全性概况与先前报告的数据一致。在日常实践中给予阿柏西普联合FOLFIRI可维持转移性结直肠癌患者的生活质量，与较高的客观肿瘤缓解相关，且无论性别、RAS状态和既往EGFR-I治疗情况如何均保持其活性。
