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- Title
Prospective, Observational Study of Aflibercept Use in Combination with FOLFIRI in Patients with Metastatic Colorectal Cancer: A Real-World Effectiveness Study.
- Authors
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
- Abstract
Simple Summary: The VELOUR randomized phase III trial established aflibercept (an anti-angiogenic targeting VEGF-A, VEGF-B, and placenta growth factor) combined with FOLFIRI as an effective treatment in patients with metastatic colorectal cancer (mCRC) failing a prior oxaliplatin-based regimen. This real-world study mandated by Polish Health Authorities aimed at assessing the benefits/risks of aflibercept plus FOLFIRI prescribed to Polish patients with mCRC according to reimbursement criteria. The activity of aflibercept plus FOLFIRI in such patients was confirmed, and no new safety signal was reported. 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.
- Subjects
POLAND; THERAPEUTIC use of antineoplastic agents; VASCULAR endothelial growth factor antagonists; IRINOTECAN; HEALTH insurance reimbursement; SURVIVAL rate; RESEARCH funding; ANTINEOPLASTIC agents; STATISTICAL sampling; COLORECTAL cancer; CANCER patients; DESCRIPTIVE statistics; MANN Whitney U Test; RANDOMIZED controlled trials; METASTASIS; LONGITUDINAL method; KAPLAN-Meier estimator; DRUG efficacy; OXALIPLATIN; FOLINIC acid; TREATMENT failure; FLUOROURACIL; CONFIDENCE intervals; PROGRESSION-free survival; OVERALL survival
- Publication
Cancers, 2024, Vol 16, Issue 11, p1992
- ISSN
2072-6694
- Publication type
Article
- DOI
10.3390/cancers16111992