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- Title
Effect of aflibercept plus FOLFIRI and potential efficacy biomarkers in patients with metastatic colorectal cancer: the POLAF trial.
- Authors
Élez, Elena; Gómez-España, María Auxiliadora; Grávalos, Cristina; García-Alfonso, Pilar; Ortiz-Morales, María José; Losa, Ferrán; Díaz, Inmaculada Alés; Graña, Begoña; Toledano-Fonseca, Marta; Valladares-Ayerbes, Manuel; Polo, Eduardo; Salgado, Mercedes; Martínez de Castro, Eva; Safont, María José; Salud, Antonieta; Ruiz-Casado, Ana; Tabernero, Josep; Riesco, María del Carmen; Rodriguez-Ariza, Antonio; Aranda, Enrique
- Abstract
<bold>Background: </bold>Aflibercept is an antiangiogenic drug against metastatic colorectal cancer (mCRC) combined with 5-fluorouracil/leucovorin/irinotecan (FOLFIRI); however, no antiangiogenic biomarker has yet been validated. We assessed aflibercept plus FOLFIRI, investigating the biomarker role of baseline vascular endothelial growth factor A (VEGF-A) and angiotensin-converting enzyme (ACE).<bold>Methods: </bold>Phase II trial in oxaliplatin-treated mCRC patients who received aflibercept plus FOLFIRI. The reported 135 ng/mL ACE cut-off was used and ROC analysis was performed to assess the optimal VEGF-A cut-off for progression-free survival (PFS). Overall survival (OS), time to progression (TTP), time to treatment failure (TTF), overall response rate (ORR) and disease control rate (DCR) were also assessed.<bold>Results: </bold>In total, 101 patients were followed for a median of 12 (6-17) months. The 1941 pg/mL VEGF-A was an optimal cut-off, with a longer median PFS when VEGF-A was <1941 versus ≥1941 pg/mL (9 versus 4 months). Patients with VEGF-A < 1941 pg/mL showed longer median OS (19 versus 8 months), TTP (9 versus 4 months) and TTF (8 versus 4 months), along with higher ORR (26% versus 9%) and DCR (81% versus 55%). No differences were identified according to ACE levels.<bold>Conclusions: </bold>This study supports aflibercept plus FOLFIRI benefits, suggesting VEGF-A as a potential biomarker to predict better outcomes.
- Subjects
THERAPEUTIC use of antineoplastic agents; FOLINIC acid; CLINICAL trials; CAMPTOTHECIN; CELL receptors; COLORECTAL cancer; FLUOROURACIL; PSYCHOLOGICAL tests; VASCULAR endothelial growth factors; RECOMBINANT proteins
- Publication
British Journal of Cancer, 2022, Vol 126, Issue 6, p874
- ISSN
0007-0920
- Publication type
journal article
- DOI
10.1038/s41416-021-01638-w