Clinical Factors Associated With Long-Term Benefit in Patients With Metastatic Renal Cell Carcinoma Treated With Axitinib: Real-World AXILONG Study.

Axitinib monotherapy obtained approval in pre-treated mRCC patients and recently in combination with pembrolizumab or avelumab in the first-line setting. However, patient profiles that may obtain increased benefit from this drug and its combinations still need to be identified.

Retrospective multicentre analysis describing clinical characteristics associated with axitinib long-responder (LR) population by comparing two extreme-response sub-groups (progression-free survival [PFS] ≥9 months vs. disease progression/refractory patients [RP]). A multivariate logistic-regression model was used to analyse clinical factors. Efficacy and safety were also analysed.

In total, 157 patients who received axitinib in second or subsequent line were evaluated (91 LR and 66 RP). Older age at start of axitinib and haemoglobin levels > LLN were independent predictive factors for LR in multivariate analyses. In LR patients, median (m) PFS was 18.1 months, median overall survival was 36.0 months and objective response rate (ORR) was 45.5%. In 59 LR patients receiving axitinib in second-line, mPFS was 18.7 months, mOS was 44.8 months and ORR was 43.9%. mOS was significantly longer in second line compared to subsequent lines (44.8 vs. 26.5 months; P = .009). In LR vs. RP, mPFS with sunitinib in first-line was correlated with mPFS with axitinib in second-line (27.2 vs. 10.9 months P < .001). The safety profile was manageable and consistent with known data.

This study confirms the long-term benefits of axitinib in a selected population, helping clinicians to select the best sequential approach and patients who could obtain a greater benefit from axitinib.

Clinical genitourinary cancer. 2021 Oct 20 [Epub ahead of print]

Álvaro Pinto, Oscar Reig, Clara Iglesias, Enrique Gallardo, Xavier García-Del Muro, Teresa Alonso, Georgia Anguera, Cristina Suárez, José Muñoz-Langa, Laura Villalobos-León, Ángel Rodríguez-Sánchez, Nuria Lainez, Esther Martínez-Ortega, Marc Campayo, Alejandro Velastegui, Alejo Rodriguez-Vida, José C Villa-Guzmán, Maria J Méndez-Vidal, Gustavo Rubio, Iciar García, Laia Capdevila, Julio Lambea, Sergio Vázquez, Ovidio Fernández, Susana Hernando-Polo, Sara Cerezo, Carmen Santander, Rosa García-Marrero, Francisco Zambrana, Aranzazu González-Del Alba, Martin Lazaro-Quintela, Daniel Castellano, Isabel Chirivella, Urbano Anido, Antonio Viana, Arancha García, Miguel Sotelo, María Garrido Arévalo, Jesús García-Donas, Carolina Hernández, M Victoria Bolós, Julia Llinares, Miguel A Climent

Medical Oncology Department, Hospital Universitario La Paz, Paseo de la Castellana, 261, 28046 Madrid, Spain. 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Gral. del Rosario, 145, 38010 Santa Cruz de Tenerife, Spain., Pfizer S.L.U. Avenida de Europa, 20, 28108, Madrid, Spain., Medical Oncology Department, Instituto Valenciano De Oncología, Carrer del Professor Beltrán Báguena, 8, 46009 Valencia, Spain.