Matteo Santoni1, Gaetano Aurilio2, Francesco Massari3, Enrique Grande4, Marc R Matrana5, Mimma Rizzo6, Ugo De Giorgi7, Lorena Incorvaia8, Angelo Martignetti9, Javier Molina-Cerrillo10, Ignacio Ortego Zabalza4, Veronica Mollica3, Alessandro Rizzo3, Nicola Battelli11, Camillo Porta12. 1. Oncology Unit, Macerata Hospital, Macerata, Italy. Electronic address: mattymo@alice.it. 2. Medical Oncology Division of Urogenital and Head and Neck Tumours, IEO, European Institute of Oncology IRCCS, Milan, Italy. 3. Medical Oncology, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna - Italia. 4. Department of Medical Oncology, MD Anderson Cancer Center Madrid, Madrid, Spain. 5. Department of Internal Medicine, Hematology/Oncology, Ochsner Medical Center, New Orleans, LA. 6. Division of Medical Oncology, Azienda Ospedaliero-Universitaria Corsorziale Policlinico di Bari, Bari, Italy. 7. Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy. 8. Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy. 9. Dipartimento Oncologico USL Sud-Est Toscana-Area Senese, Poggibonsi, Italy. 10. Medical Oncology Departmentat Hospital Ramón y Cajal, Madrid, Spain. 11. Oncology Unit, Macerata Hospital, Macerata, Italy. 12. Division of Medical Oncology, Azienda Ospedaliero-Universitaria Corsorziale Policlinico di Bari, Bari, Italy; Chair of Oncology, Department of Biomedical Sciences and Human Oncology, University of Bari "Aldo Moro", Bari, Italy.
Abstract
BACKGROUND: Tyrosine-kinase inhibitors (TKIs) still represent a first-line option for selected patients with metastatic Renal Cell Carcinoma (mRCC). We aimed to compare the real-world efficacy of nivolumab or cabozantinib as second-line therapy in specific mRCC subpopulations. PATIENTS AND METHODS: We retrospectively collected data from 11 centers from Italy, Spain and US. Overall Survival (OS) and Progression-Free Survival (PFS) were analyzed using Kaplan-Meier curves. Cox proportional models were used at univariate and multivariate analyses. RESULTS: We collected data from 343 patients with mRCC, 123 (36%) treated with cabozantinib and 220 (64%) with nivolumab. The median OS resulted longer, but not statistically significant, with nivolumab in patients aged >70 years (21.4 vs. 15.4 months, P = .746), treated with first-line pazopanib (26.8 vs. 11.6 months, P = .450), or with good (47.0 vs. 15.5 months, P = .285) or intermediate-risk criteria (14.4 vs. 11.0 months, P = .357), while it was longer, but even not statistically significant, for cabozantinib in patients who received previous sunitinib (25.7 vs. 21.7 months, P = .638) or with bone metastases (28.4 vs. 24.4 months, P = .871). The median PFS was significantly longer with cabozantinib in patients with clear cell histology (7.8 vs. 5.4 months, P = .026) and in patients with good risk features (12.3 vs. 5.7 months, P = .022). CONCLUSIONS: Nivolumab and cabozantinib resulted active in mRCC patients, showing distinct results when stratified into clinico-pathological features.
BACKGROUND: Tyrosine-kinase inhibitors (TKIs) still represent a first-line option for selected patients with metastatic Renal Cell Carcinoma (mRCC). We aimed to compare the real-world efficacy of nivolumab or cabozantinib as second-line therapy in specific mRCC subpopulations. PATIENTS AND METHODS: We retrospectively collected data from 11 centers from Italy, Spain and US. Overall Survival (OS) and Progression-Free Survival (PFS) were analyzed using Kaplan-Meier curves. Cox proportional models were used at univariate and multivariate analyses. RESULTS: We collected data from 343 patients with mRCC, 123 (36%) treated with cabozantinib and 220 (64%) with nivolumab. The median OS resulted longer, but not statistically significant, with nivolumab in patients aged >70 years (21.4 vs. 15.4 months, P = .746), treated with first-line pazopanib (26.8 vs. 11.6 months, P = .450), or with good (47.0 vs. 15.5 months, P = .285) or intermediate-risk criteria (14.4 vs. 11.0 months, P = .357), while it was longer, but even not statistically significant, for cabozantinib in patients who received previous sunitinib (25.7 vs. 21.7 months, P = .638) or with bone metastases (28.4 vs. 24.4 months, P = .871). The median PFS was significantly longer with cabozantinib in patients with clear cell histology (7.8 vs. 5.4 months, P = .026) and in patients with good risk features (12.3 vs. 5.7 months, P = .022). CONCLUSIONS: Nivolumab and cabozantinib resulted active in mRCC patients, showing distinct results when stratified into clinico-pathological features.