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. Electronic address: ., Medical Oncology Department, Hospital Clinic i Provincial, Carrer de Villarroel, 170, 08036 Barcelona, Spain., Medical Oncology Department, Hospital Universitario Central de Asturias, Avenida Roma, s/n, 33011 Oviedo, Spain., Medical Oncology Department, Hospital Universitario Parc Taulí de Sabadell, Parc Taulí, 1, 08208 Sabadell, Barcelona, Spain., Medical Oncology Department, Institut Català d'Oncologia Hospitalet, IDIBELL Institute of Researh, University of Barcelona, 1, Avinguda de la Granvia de l'Hospitalet, 199-203, 08908 L'Hospitalet de Llobregat, Barcelona, Spain., Medical Oncology Department, Hospital Universitario Ramón y Cajal, M-607, km. 9, 100, 28034 Madrid, Spain., Medical Oncology Department, Nou Hospital De La Santa Creu i Sant Pau, Carrer de Sant Quintí, 89, 08041 Barcelona, Spain., Medical Oncology Department, Hospital Universitario Vall de Hebrón, Passeig de la Vall d'Hebron, 119, 08035 Barcelona, Spain., Medical Oncology Department, Hospital Universitario La Fe, Avinguda de Fernando Abril Martorell, 106, 46026, Valencia, Spain., Medical Oncology Department, Hospital Universitario Príncipe de Asturias, Carretera de Alcalá, s/n, 28805 Meco, Madrid, Spain., Medical Oncology Department, Hospital Universitario de León, Calle Altos de Nava, s/n, 24071 León, Spain., Medical Oncology Department, Complejo Hospitalario de Navarra, Calle de Irunlarrea, 3, 31008 Pamplona, Spain., Medical Oncology Department , Complejo Hospitalario de Jaén, Avenida del Ejército Español, 10, 23007 Jaén, Spain., Medical Oncology Department, Hospital Universitario MútuaTerrassa, Plaza del Doctor Robert, 5, 08221, Terrassa, Barcelona, Spain., Medical Oncology Department, Hospital Universitario Rey Juan Carlos, Calle Gladiolo, s/n, 28933 Móstoles, Madrid, Spain., Medical Oncology Department, Hospital del Mar, Passeig Marítim 25-29, 08001, Barcelona, Spain., Medical Oncology Department, Hospital General Universitario de Ciudad Real General, Calle Obispo Rafael Torija, s/n, 13005 Ciudad Real, Spain., Medical Oncology Department, Hospital Universitario Reina Sofía, Avenida Menendez Pidal, 14004, Córdoba, Spain., Medical Oncology Department, Hospital Universitario Fundación Jiménez Díaz, Avenida Reyes Católicos, 2, 28040, Madrid, Spain., Medical Oncology Department, Hospital Virgen de la Salud, Av. de Barber, 30, 45004 Toledo, Spain., Medical Oncology Department, Hospital San Pablo y Santa Tecla, Rambla Vella, 14, 43003 Tarragona, Spain., Medical Oncology Department, Hospital Clínico Universitario Lozano Blesa, Avda, Calle de San Juan Bosco, 15, 50009 Zaragoza, Spain., Medical Oncology Department, Hospital Universitario Lucus Augusti, Rúa Dr. Ulises Romero, 1, 27003 Lugo, Spain., Medical Oncology Department, Complexo Hospitalario Universitario de Ourense, Calle Ramon Puga Noguerol, 54, 32005 Ourense, Spain., Medical Oncology Department, Hospital Universitario Fundación Alcorcón, Calle Budapest, 1, 28922, Alcorcón, Madrid, Spain., Medical Oncology Department, Hospital General La Mancha Centro, Av. Constitución, 3, 13600 Alcázar de San Juan, Ciudad Real, Spain., Medical Oncology Department, Hospital Universitario Miguel Servet, Paseo Isabel la Católica, 1-3, 50009 Zaragoza, Spain., Medical Oncology Department, Hospital Universitario de Canarias, Carretera Ofra S/N, 38320 San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain., Medical Oncology Department, Hospital Universitario Infanta Sofía, Paseo de Europa, 34, 28703 San Sebastián de los Reyes, Madrid, Spain., Medical Oncology Department, Hospital Universitari Son Espases, Carretera de Valldemossa, 79, 07120 Palma, Spain., Medical Oncology Department, Hospital Álvaro Cunqueiro, Estrada de Clara Campoamor, 341, 36213 Vigo, Spain., Medical Oncology Department, Hospital Universitario 12 de Octubre, Av. de Córdoba, s/n, 28041 Madrid, Spain., Medical Oncology Department, Hospital Clínico Universitario de Valencia, Av. de Blasco Ibáñez, 17, 46010 Valencia, Spain., Medical Oncology Department, Hospital Clínico Universitario de Santiago de Compostela, Rúa da Choupana, s/n, 15706 Santiago de Compostela, A Coruña, Spain., Medical Oncology Department, Hospital Nuestra Señora del Prado, Carretera de Madrid Km. 114, 45600 Talavera de la Reina, Toledo, Spain., TFS Trial Form Support S.L., Passeig de Gràcia, 11, 08007 Barcelona, Spain., Medical Oncology Department, Hospital Universitario Infanta Cristina, Av. 9 de Junio, 2, 28981 Parla, Madrid, Spain., Medical Oncology Department, Hospital Universitario Severo Ochoa, Av. de Orellana, s/n, 28911 Leganés, Madrid, Spain., Medical Oncology Department, Hospital Universitario Clara Campal, Calle de Oña, 10, 28050 Madrid, Spain., Medical Oncology Department, Hospital Universitario Nuestra Señora de la Candelaria, Ctra. 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.