Effectiveness and Safety of Cabozantinib Treatment in Patients with Advanced Renal Cell Carcinoma in Spanish and Portuguese Real-world Practice: The SOGUG-SPRWEC Study
- PMID: 40830022
- DOI: 10.1016/j.clgc.2025.102402
Effectiveness and Safety of Cabozantinib Treatment in Patients with Advanced Renal Cell Carcinoma in Spanish and Portuguese Real-world Practice: The SOGUG-SPRWEC Study
Abstract
Background: The SPRWEC study investigated cabozantinib effectiveness and safety in patients with advanced renal cell carcinoma (RCC) in real-world Spanish and Portuguese settings.
Patients and methods: Observational, ambispective, multicenter study including adult patients with advanced RCC receiving cabozantinib between October 2016 and May 2020 as second or subsequent treatment line. Primary endpoint was progression-free survival (PFS).
Results: About 258 patients (mean [SD] age 62.5 [11.0] years, 75.6% male) were included, 55.8% with prior immunotherapy. Median follow-up was 34.3 months. Median PFS was 7.63 months (95% CI, 6.64-8.72). Median overall survival (OS) was 15.36 months (95% CI, 11.58-19.11); objective response rate (ORR), 29.5% (95% CI, 24.0-35.4); median time to first response, 3.27 months (95% CI, 3.03-3.68); median duration of response, 9.77 months (95% CI, 7.24-12.63); median time to discontinuation, 6.97 months (95% CI, 5.79-8.42). Prior immunotherapy increased ORR (OR 2.132) and decreased OS (HR 1.529). ECOG 0-1 and dose reductions were associated with increased PFS (HR 0.470 and 0.558); poor and intermediate MSKCC (HR 3.861 and 1.681) and IMDC risks (HR 2.558 and 1.537) with decreased PFS. Most common AEs were diarrhea (41.9%), asthenia (34.9%), and anorexia (18.2%).
Conclusion: Cabozantinib's effectiveness and safety as second or subsequent treatment line for advanced RCC in real-world settings are similar to those observed in clinical trials. This treatment after prior immunotherapy, the front-line standard of care, resulted in increased ORR and decreased OS, without changes in PFS.
Keywords: Immunotherapy; Multicenter study; Prospective study; Real world practice; Retrospective study.
Copyright © 2025. Published by Elsevier Inc.
Conflict of interest statement
Disclosure CS reports a consultant or advisory role for BMS, Pfizer, Ipsen, MSD, EUSA Pharma, and Eisai, received research funding from Ipsen, BMS, Pfizer, and MSD, honoraria as a speaker for Ipsen, Eisai, Astellas, and MSD, and travel and accommodation expenses from Ipsen, Merck, and Bayer. ORT reports receiving honoraria from BMS, Ipsen, and Pfizer, a consulting or advisor role for Eisai, participating in speakers’ bureau for Bayer, BMS, Ipsen, Janssen-Cilag, Pfizer, and Sanofi, and receiving funding for travel and accommodation expenses from Ipsen. RMB reports advisory roles for MSD, Pfizer, Merck, Janssen, and Astellas Pharma, and receiving honoraria or travel expenses from Roche, Sanofi Aventis, Astellas, Janssen, MSD, Bayer, Merck, and Pfizer. GAP received honoraria as consultant or advisory board member from Merck, grants for attending meetings/conferences from Ipsen, Merck, BMS, MSD, and Janssen, and participated in sponsored speakers bureau for Ipsen, BMS, Merck, Astellas, and Janssen. AMBM received honoraria as consultant/speaker from Amgen, Astellas, AstraZeneca, Bayer, B. Braun, BMS, Janssen, Merck Serono, Merck Sharp & Dohme, Novartis, OMPharma, Pfizer, Pierre Fabre, Roche, and Servier. NFN reports an advisory/consultant role for Pfizer, receiving honoraria as a speaker from Pfizer, Ipsen, Roche, BMS, and Bayer, and travel and accommodation expenses from Pfizer, Ipsen, Roche, BMS, Bayer, AstraZeneca, MSD, and Lilly. MJMV received travel grants from Astellas, BMS, Roche, Pfizer, Merck, and Ipsen and honoraria for speaker engagements, advisory boards, and continuous medical education from Astellas, Sanofi, Bayer, Roche, Ipsen, BMS, MSD, Pfizer, EUSA Pharma, Eisai, Novartis, AAA, and AstraZeneca. IGC received honoraria as a speaker from Ipsen, and honoraria for travel and accommodation expenses from Ipsen. OFC reports a consultant or advisory role for Astellas Pharma, Pfizer, BMS, Ipsen, Merck, and Eisai and received honoraria as a speaker for Novartis, BMS, Ipsen, Roche, Astellas Pharma, and Bayer, and travel and accommodation expenses from BMS, Ipsen, and Astellas. RGS reported advisory roles for BMS, Roche, AstraZeneca, Pfizer, Ipsen, MSD, Merck, Novocure, and Novartis, and received honoraria for travel, accommodation, and conference expenses from BMS, Roche, Pfizer, AstraZeneca, Janssen, Astellas, MSD, Merck, Ipsen, and Bayer. GCH received honoraria as consultant or advisory board member from BMS, and grants for attending meetings/conferences from Ipsen, BMS, and MSD, and participated in sponsored speakers bureau or educational activities for Ipsen, BMS, and MSD. JAA reports consultant/speaking/advisory roles for AstraZeneca, Pfizer, BMS, MSD, Roche, Ipsen, Sanofi, and Novartis, received grant or travel support from MSD, Pfizer, Sanofi, BMS, Takeda, and Roche, and participated as researcher in clinical trials from Pfizer, AstraZeneca, Janssen, BMS, Roche, Ipsen, and Astellas. MJJF reports advisory roles and participation in medical meetings for Ipsen, Novartis, Astellas, BMS, Johnson & Johnson, Sanofi, Pierre-Fabre, AstraZeneca, Bayer, and MSD and received honoraria as a speaker and advisor from BMS, Johnson and Johnson, Roche, Ipsen, Novartis, and Pierre-Fabre. JGP reports a consulting or advisory role for Sanofi/Aventis, Kite/Gilead, and Bayer Hispania, received (the institution) research funding from Roche/Genentech, Amgen, Pierre Fabre, Ipsen, and Vifor Pharma, received funding (the institution) for immunotherapy and institutional courses from Roche, Merck, Sanofi, Pfizer, BMS, MSD, Ipsen, Clovis Oncology, Amgen, Janssen, EUSA Pharma, Lilly, Novartis, Gilead, Astellas, AstraZeneca, and Bayer, and honoraria for travel and accommodation expenses from Sanofi/Aventis and MSD. MLQ reports advisory/consultant roles for MSD, AstraZeneca, BMS, Boehringer Ingelheim, Roche, Ipsen, EUSA Pharma, Eisai, and Pfizer, participated in speakers’ bureau for Roche, Boehringer Ingelheim, Janssen-Cilag, Ipsen, MSD, Novartis, AstraZeneca, Lilly, Pfizer, and Astellas Pharma, and received honoraria for travel and accommodation expenses from MSD, BMS, AstraZeneca, Pfizer, Roche, and Lilly. ARV reports serving in an advisory role for MSD, Pfizer, BMS, Astellas, Janssen, Bayer, Clovis and Roche; receiving honoraria or travel expenses from Pfizer, MSD, Astellas, BMS, Janssen, Astra Zeneca, Roche, Bayer, and Sanofi Aventis; and receiving research funding from Takeda, Pfizer, and Merck. AMC received honoraria from AstraZeneca, Janssen-Cilag, BMS, Merck, Novartis, Ipsen, and MSD, and travel grants from MSD, Merck, BMS, Astellas Pharma, and EUSA Pharma. CGdE reported speaker roles for BMS, Janssen, Pfizer, Roche, AstraZeneca, and Merck, and participated in advisory boards for Astellas, Pfizer, Bayer, and Janssen. EMO reports advisory/consultant roles for Pfizer and Merck, speaker roles for Rocher, Servier, Astellas, BMS, Bayer, and Merck, and received grants from Roche, Ipsen, and Pfizer. EG received grants or research support from Bayer, Ipsen, Pfizer, Roche, BMS, MSD, Merck, Recordati, and Advanced Accelerator Applications, honoraria as consultant or advisory board member from Bayer, Ipsen, Pfizer, Roche, BMS, MSD, Merck, Recordati, Eisai, Novartis, and Advanced Accelerator Applications, and grants for attending meetings/conferences from Bayer, Ipsen, Pfizer, Roche, BMS, MSD, and Eisai, and participated in sponsored speakers bureau or educational activities for Bayer, Ipsen, Pfizer, Roche, BMS, MSD, Merck, Recordati, and Advanced Accelerator Applications. ARS, CHP, RCM, and CMP report no conflict of interests.
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