Durbajło Agnieszka, Świeżyński Marcin, Ziemba Beata, Starzyczny-Słota Danuta, Samborska-Plewicka Marzena, Cencelewicz-Lesikow Anna, Chrzanowska-Kapica Agata, Dobrzyńska-Rutkowska Aneta, Drab-Mazur Iwona, Kulma-Kreft Monika, Sikora-Skrabaka Magdalena, Matuszewska Elwira, Foszczyńska-Kłoda Małgorzata, Lewandowski Tomasz, Słomian Grzegorz, Ostrowska-Cichocka Krystyna, Chmielowska Ewa, Wiśniowski Rafał, Twardosz Anna, Wierzbicka Katarzyna, Rumianowski Leszek, Wyrwicz Lucjan
Oncology and Chemotherapy Clinic, Maria Sklodowska-Curie Memorial Research Institute of Oncology, Roentgena 5, 02-781 Warsaw, Poland.
Prof. Franciszek Łukaszczyk Memorial Centre of Oncology, 85-796 Bydgoszcz, Poland.
Cancers (Basel). 2024 May 24;16(11):1992. doi: 10.3390/cancers16111992.
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.
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.
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%).
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.
这是一项观察性研究，前瞻性评估了按照波兰报销标准在二线转移性结直肠癌（mCRC）中应用阿柏西普/氟尿嘧啶、亚叶酸钙、伊立替康（FOLFIRI）方案的有效性和安全性。
一线接受含奥沙利铂化疗后病情进展的连续性mCRC患者接受阿柏西普（4mg/kg静脉注射），随后每2周接受一次FOLFIRI治疗，直至病情进展或出现不可接受的毒性反应。主要终点为无进展生存期（PFS）；总生存期（OS）和安全性为次要终点。
共有93例患者在波兰的17个地点接受治疗。中位给药周期数为10个周期。在中位治疗持续时间5.3个月内，中位PFS和中位OS分别为8.4个月[95%置信区间（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。主要的≥3级不良事件为中性粒细胞减少（16%）、高血压（8%）、腹泻（4%）和口腔炎（4%）。
证实了按照波兰报销标准在先前基于奥沙利铂方案治疗失败后的二线mCRC治疗中应用阿柏西普联合FOLFIRI方案的获益/风险情况。
