Prospective, Observational Study of Aflibercept Use in Combination with FOLFIRI in Patients with Metastatic Colorectal Cancer: A Real-World Effectiveness Study

• Published in: Cancers 2024-05, Vol.16 (11), p.1992
• Main 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, Rumianowski, Leszek, Wyrwicz, Lucjan
• Format: Article
• Language: English
• Subjects: Angiogenesis; Cancer therapies; Chemotherapy; Chemotherapy, Combination; Clinical medicine; Colorectal cancer; Colorectal carcinoma; Development and progression; Diagnosis; Diarrhea; Dosage and administration; Drug therapy; Medical prognosis; Metastases; Metastasis; Mortality; Neutropenia; Observational studies; Oxaliplatin; Patient outcomes; Patients; Placenta growth factor; Response rates; Safety; Stomatitis; Survival; Testing; Toxicity; Tumors; Vascular endothelial growth factor
• ISSN: 2072-6694; 2072-6694
• 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.