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Melania Dovizio,1 Daniela Castelletti,2 Paolo Luraghi,2 Serena Losi,2 Andrea Gervasi,2 Matteo Risi,2 Melania Leogrande,1 Luca Degli Esposti,1 Giuseppe Procopio3 1CliCon S.r.l. Benefit Society, Health, Economics & Outcomes Research, Bologna, Italy; 2AstraZeneca SpA, Milan, Italy; 3Prostate Genitourinary Medical Oncology Program, Fondazione IRCCS Istituto Nazionale Tumori Milano, Milan, ItalyCorrespondence: Luca Degli Esposti, CliCon S.r.l. Società Benefit - Health, Economics & Outcomes Research, Via Murri 9, 40137, Bologna, Italy, Tel +39 0544 38393, Fax +39 0544 212699, Email luca.degliesposti@clicon.itPurpose: This real-world analysis described the characteristics and therapeutic management of patients with metastatic castration-resistant prostate cancer (mCRPC) in Italy before and after 2015, when androgen receptor signalling inhibitors (ARPI) entered clinical practice.Patients and Methods: An observational retrospective analysis was conducted using administrative healthcare databases from a pool of Italian Local Health Units, covering ~6.2 million residents. Adult men with ≥ 1 prescription of androgen deprivation therapy (ADT) from January 2011 to June 2022 were identified. mCRPC was proxied by treatment patterns—addition of docetaxel/cabazitaxel or ARPI to ADT—and confirmed by hospital discharge for metastasis. Patients were stratified according to their inclusion (date of the last inclusion criterion met): pre-2015 (2011– 2014) and post-2015 (2015– 2020).Results: Among 1890 mCRPC patients identified, 551 (29%) received ≥ 2 treatment lines. Chemotherapy (CHT) was the predominant first-line (1L) therapy in both cohorts [97.2% vs 82.9%], followed by ARPI [2.8% vs 17.1%]. In a 2020 sensitivity analysis (n=406), 1L therapy was ARPI in 76% and CHT in 24%. Among pre- and post-2015 patients, 29.4% and 31.6% received second-line (2L) therapy, mostly ARPI. Median OS from ADT initiation was 46.4 months (pre-2015) and 53.9 months (post-2015). In post-2015 patients, median OS from mCRPC index-date—reflecting the proxy-based diagnosis—was 14.2 months.Conclusion: In Italian clinical practice, CHT remains the most common 1L therapy though ARPI use has increased since 2015. While OS from ADT initiation has improved, survival from mCRPC diagnosis—based on proxies in administrative data—remains poor, underscoring an unmet clinical need. Differences in OS estimates depending on the starting point (ADT initiation vs mCRPC diagnosis) should be considered when interpreting results.Keywords: chemotherapy, new hormone therapy, oncological drugs, real-world evidence, therapeutic sequences |