Background: This was an observational study prospectively evaluating the effectiveness and safety of aflibercept/FOLFIRI administered in second-line mCRC per the reimbursement criteria in Poland. Methods: Consecutive mCRC patients who progressed with first-line oxaliplatin-based chemotherapy received aflibercept (4 mg/kg IV) followed by FOLFIRI every 2 weeks until progression or unacceptable toxicity. The primary endpoint was progression-free survival (PFS); overall survival (OS) and safety were the secondary endpoints. Results: A total of 93 patients were treated at 17 Polish sites. A median of 10 cycles was administered. Over a median treatment duration of 5.3 months, median PFS and median OS were 8.4 months [95% CI, 6.9–9.9] and 27.0 months [95% CI, 23.9–30.1], respectively. There was no significant impact of primary tumor location, metastatic site, or KRAS status on PFS and OS. Main grade ≥ 3 adverse events were neutropenia (16%), hypertension (8%), diarrhea (4%), and stomatitis (4%). Conclusions: The benefits/risks of Aflibercept plus FOLFIRI administered per the Polish reimbursement criteria in second-line treatment of mCRC after failure of a prior oxaliplatin-based regimen is confirmed.
背景：本研究为一项观察性研究，前瞻性评估了根据波兰报销标准在二线治疗转移性结直肠癌（mCRC）中应用阿柏西普联合FOLFIRI方案的有效性和安全性。方法：连续入组经一线奥沙利铂为基础化疗后进展的mCRC患者，接受阿柏西普（4 mg/kg静脉注射）序贯FOLFIRI方案治疗，每2周一次，直至疾病进展或出现不可耐受毒性。主要终点为无进展生存期（PFS）；次要终点包括总生存期（OS）和安全性。结果：共93例患者在波兰17个中心接受治疗，中位治疗周期数为10个。中位治疗持续时间为5.3个月，中位PFS和中位OS分别为8.4个月[95% CI, 6.9–9.9]和27.0个月[95% CI, 23.9–30.1]。原发肿瘤部位、转移部位或KRAS状态对PFS和OS均无显著影响。主要≥3级不良事件包括中性粒细胞减少（16%）、高血压（8%）、腹泻（4%）和口腔炎（4%）。结论：本研究证实，对于一线奥沙利铂为基础方案治疗失败的mCRC患者，按照波兰报销标准在二线治疗中使用阿柏西普联合FOLFIRI方案具有积极的获益/风险比。
肿瘤(癌症)患者之家