Effect of aflibercept plus FOLFIRI and potential efficacy biomarkers in patients with metastatic colorectal cancer: the POLAF trial.

Autor: Élez E; Department of Medical Oncology, Vall d'Hebron Hospital Campus and Institute of Oncology (VHIO), Universitat Autònoma de Barcelona, Passeig de la Vall d'Hebron, 119, 08035, Barcelona, Spain., Gómez-España MA; Department of Medical Oncology, IMIBIC, Reina Sofía Hospital, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Avenida Menéndez Pidal, S/N, 14004, Córdoba, Spain., Grávalos C; Department of Medical Oncology, H. Universitario 12 de Octubre, Instituto de Investigación i + 12, Avenida de Córdoba, S/N, 28041, Madrid, Spain., García-Alfonso P; Department of Medical Oncology, H. Gregorio Marañón, Calle del Doctor Esquerdo, 46, 28007, Madrid, Spain., Ortiz-Morales MJ; Department of Medical Oncology, IMIBIC, Reina Sofía Hospital, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Avenida Menéndez Pidal, S/N, 14004, Córdoba, Spain., Losa F; Department of Medical Oncology, H. Sant Joan Despí - Moisés Broggi, Carrer d'Oriol Martorell, 12, 08970, Sant Joan Despí, Barcelona, Spain., Díaz IA; Department of Medical Oncology, Unidad de Gestión Clínica Intercentros de Oncología Médica. Hospitales Universitarios Regional y Virgen de la Victoria. IBIMA, Campus de Teatinos, S/N, 29010, Málaga, Spain., Graña B; Department of Medical Oncology, C. H. Universitario, Lugar, Xubias de Arriba, 84, 15006, A Coruña, Spain., Toledano-Fonseca M; Department of Medical Oncology, IMIBIC, Reina Sofía Hospital, CIBERONC, Instituto de Salud Carlos III, Avenida Menéndez Pidal, S/N, 14004, Córdoba, Spain., Valladares-Ayerbes M; Department of Medical Oncology, H. Virgen del Rocío, IBIS, Av. Manuel Siurot s/n, 41013, Sevilla, Spain., Polo E; Department of Medical Oncology, H. Miguel Servet, Paseo Isabel la Católica, 1-3, 50009, Zaragoza, Spain., Salgado M; Department of Medical Oncology, C. H. Universitario de Ourense, Calle Ramón Puga Noguerol, 54, 32005, Orense, Spain., Martínez de Castro E; Department of Medical Oncology, H. Universitario Marqués de Valdecilla, IDIVAL, Avenida de Valdecilla, 25, 39008, Santander, Spain., Safont MJ; Department of Medical Oncology, H. General Universitario, CIBERONC, Avenida de les Tres Creus, 2, 46014, Valencia, Spain., Salud A; Department of Medical Oncology, H. de Lleida Arnau de Vilanova, Avenida Alcalde Rovira Roure, 80, 25198, Lérida, Spain., Ruiz-Casado A; Department of Medical Oncology, H. Puerta de Hierro Majadahonda, Calle Joaquín Rodrigo, 1, 28222, Majadahonda, Spain., Tabernero J; Department of Medical Oncology, Vall d'Hebron Hospital Campus and Institute of Oncology (VHIO), Passeig de la Vall d'Hebron, 119, 08035, Barcelona, Spain., Riesco MDC; Department of Medical Oncology, H. Universitario 12 de Octubre, Instituto de Investigación i + 12, Avenida de Córdoba, S/N, 28041, Madrid, Spain., Rodriguez-Ariza A; Department of Medical Oncology, IMIBIC, Reina Sofía Hospital, CIBERONC, Instituto de Salud Carlos III, Avenida Menéndez Pidal, S/N, 14004, Córdoba, Spain., Aranda E; Department of Medical Oncology, IMIBIC, Reina Sofía Hospital, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Avenida Menéndez Pidal, S/N, 14004, Córdoba, Spain. earandaa@seom.org.
Jazyk: angličtina
Zdroj: British journal of cancer [Br J Cancer] 2022 Apr; Vol. 126 (6), pp. 874-880. Date of Electronic Publication: 2021 Dec 22.
DOI: 10.1038/s41416-021-01638-w
Abstrakt: Background: 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).
Methods: 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.
Results: 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.
Conclusions: This study supports aflibercept plus FOLFIRI benefits, suggesting VEGF-A as a potential biomarker to predict better outcomes.
(© 2021. The Author(s), under exclusive licence to Springer Nature Limited.)
Databáze: MEDLINE
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