Background: Immune checkpoint inhibitor-tyrosine kinase inhibitor combinations represent a standard first-line option for metastatic renal cell carcinoma (mRCC). However, patients enrolled in pivotal trials often differ from those treated in routine practice. We report real-world outcomes of pembrolizumab plus axitinib within the Campania Oncology Network. Methods: We conducted a multicenter retrospective study including consecutive treatment-naïve mRCC patients who received first-line pembrolizumab plus axitinib between January 2021 and November 2023 across eight regional centers. The primary endpoints were progression-free survival (PFS) and overall survival (OS); secondary endpoints included objective response rate (ORR) and safety. Results: A total of 117 patients were included. IMDC risk was favorable in 19.6%, intermediate/poor in 65%, and unknown in 15.4%. Median age was 59 years, and 53.8% had ECOG performance status ≥ 1. Clear-cell histology accounted for 87.2% of cases; brain metastases were present in 36%. After a median follow-up of 12.8 months, median PFS was 15.1 months (95% CI 9.6-NR), and median OS was not reached. ORR was 27.3%, with a disease control rate of 79.5%; patients with non-clear-cell histology showed an ORR of 41.7%. Disease progression was the main cause of treatment discontinuation (49%), while adverse events (AEs) led to discontinuation in 6% of cases. Grade ≥3 AEs occurred in 14% of patients. Most toxicities were grade 1-2, including diarrhea (23.9%), asthenia (18%), hypothyroidism (12.8%), and hypertension (9.4%). Grade 1-2 AEs were significantly more frequent in females compared with males (57.6% vs. 35.7%, p = 0.05). Conclusions: In this consecutive regional cohort, pembrolizumab plus axitinib showed clinically relevant disease control, although ORR was lower than in pivotal trials. Performance status emerged as a key prognostic factor. Real-world data from oncology networks may support personalized first-line treatment decisions in mRCC.
Current oncology (Toronto, Ont.). 2026 May 30*** epublish ***
Marilena Di Napoli, Elisabetta Coppola, Carmine D'Aniello, Sarah Scagliarini, Carlo Buonerba, Andrea Muto, Luigi Formisano, Francesco Sabbatino, Davide Bosso, Sabrina Rossetti, Lorenzo Lobianco, Rosa Tambaro, Fabrizio Di Costanzo, Pasquale Rescigno, Carmela Pisano, Sabrina Chiara Cecere, Anna Passarelli, Jole Ventriglia, Gabriele Calvanese, Maria Rosaria Lamia, Erica Perri, Roberto Contieri, Dario Franzese, Maria Adelina Simeoni, Caterina Mariarosaria Giorgio, Florinda Feroce, Salvatore Stilo, Giovanni Pacifico, Giuseppina Canciello, Sandro Pignata
Department of Urology and Gynecology, Istituto Nazionale Tumori di Napoli, IRCCS 'G. Pascale', 80131 Naples, Italy., Division of Medical Oncology, AORN dei Colli-Monaldi Hospital, 80131 Naples, Italy., Department of Medical Oncology, AORN "A. Cardarelli", 80131 Naples, Italy., Oncology Unit, "Andrea Tortora" Hospital, 84016 Pagani, Italy., Division of Medical Oncology, "San Giuseppe Moscati" Hospital, 83100 Avellino, Italy., Department of Clinical Medicine and Surgery, University of Naples "Federico II", 80138 Napoli, Italy., Oncology Department, University Hospital "San Giovanni di Dio e Ruggi d'Aragona", 84131 Salerno, Italy., Oncology Unit, Ospedale del Mare, 80147 Naples, Italy., Translational and Clinical Research Institute, Newcastle University Centre for Cancer, Newcastle Upon Tyne NE2 4HH, UK., Department of Urology, Istituto Nazionale Tumori di Napoli, IRCCS 'G. Pascale', 80131 Naples, Italy., Nephrology and Dialysis Unite, Department of Translation Medicine Medical Sciences, University of Campania "Luigi Vanvitelli", 80138 Naples, Italy., Dermatology Unit, Department of Mental and Physical Health and Preventive Medicine, University of Campania Luigi Vanvitelli, 81100 Naples, Italy., Department of Pathology, Istituto Nazionale Tumori di Napoli, IRCCS 'G. Pascale', 80131 Naples, Italy., Interventional Radiology Unit, Istituto Nazionale Tumori di Napoli, IRCCS 'G. Pascale', 80131 Naples, Italy.