Carlo Buonerba1, Matteo Ferro2, Pasquale Dolce3, Felice Crocetto4, Antonio Verde5, Giuseppe Lucarelli6, Luca Scafuri5, Sergio Facchini4, Angelo Vaia5, Alfredo Marinelli5, Daniela Terracciano7, Liliana Montella8, Nicola Longo4, Ciro Imbimbo4, Vincenzo Mirone4, Giuseppe Di Lorenzo9, Sabino De Placido5, Guru Sonpavde10. 1. Regional Reference Center for Rare Tumors, Department of Oncology and Hematology, AOU Federico II of Naples, 80131 Naples, Italy; National Reference Center for Environmental Health, Zoo-prophylactic Institute of Southern Italy, 80055 Portici, Italy. Electronic address: carlo.buonerba@izsmportici.it. 2. Division of Urology, European Institute of Oncology-IRCCS, Milan, Italy. 3. Department of Public Health, Federico II University of Naples, 80131 Naples, Italy. 4. Department of Neurosciences, Human Reproduction and Odontostomatology, University of Naples Federico II, Naples, Italy. 5. Department of Clinical Medicine and Surgery, University Federico II of Naples, Via Pansini 5, 80131 Naples, Italy. 6. Department of Emergency and Organ Transplantation, Urology, Andrology and Kidney Transplantation Unit, University of Bari, Bari, Italy. 7. Department of Translational Medical Sciences, University Federico II, Napoli, Italy. 8. Medical Oncology Unit, S.Maria delle Grazie Hospital, Pozzuoli, Italy. 9. Department of Oncology, Hospital "Andrea Tortora", ASL Salerno, 84016 Pagani, Italy. 10. Genitourinary Oncology Section, Dana Farber Cancer Institute, Boston, MA, USA.
Abstract
BACKGROUND: Both docetaxel and androgen-receptor-axis-targeted (ARAT) agents are approved in metastatic castration-sensitive prostate cancer (mCSPC) patients. Predictive factors of therapy efficacy are lacking. METHODS: We included articles reporting data about randomized-controlled clinical trials (RCTs) testing an ARAT agent plus ADT vs. ADT. We aimed to obtain pooled estimates of efficacy outcomes and assess differences in pooled estimates of efficacy outcomes between sub-groups. RESULTS: A total of 5427 mCSPC patients enrolled in five RCTs were evaluable for OS (Overall Survival) and PFS (Progression-free survival). Pooled OS-HR (Hazard Ratio) was 0.66 (95 % CI: 0.60-0.74), while pooled PFS-HR was 0.46 (95 % CI: 0.40-0.53). Combined treatment with docetaxel was associated with differential OS outcomes, while tumor volume according to the CHAARTED criteria and visceral metastasis were associated with differential PFS outcomes. CONCLUSION: Our results add evidence that ARAT agents improve OS in mCSPC and discourage their combined use with docetaxel in this setting.
BACKGROUND: Both docetaxel and androgen-receptor-axis-targeted (ARAT) agents are approved in metastatic castration-sensitive prostate cancer (mCSPC) patients. Predictive factors of therapy efficacy are lacking. METHODS: We included articles reporting data about randomized-controlled clinical trials (RCTs) testing an ARAT agent plus ADT vs. ADT. We aimed to obtain pooled estimates of efficacy outcomes and assess differences in pooled estimates of efficacy outcomes between sub-groups. RESULTS: A total of 5427 mCSPC patients enrolled in five RCTs were evaluable for OS (Overall Survival) and PFS (Progression-free survival). Pooled OS-HR (Hazard Ratio) was 0.66 (95 % CI: 0.60-0.74), while pooled PFS-HR was 0.46 (95 % CI: 0.40-0.53). Combined treatment with docetaxel was associated with differential OS outcomes, while tumor volume according to the CHAARTED criteria and visceral metastasis were associated with differential PFS outcomes. CONCLUSION: Our results add evidence that ARAT agents improve OS in mCSPC and discourage their combined use with docetaxel in this setting.
Authors: Maria Lucia Iacovino; Chiara Carmen Miceli; Marco De Felice; Biagio Barone; Luca Pompella; Francesco Chiancone; Erika Di Zazzo; Giuseppe Tirino; Carminia Maria Della Corte; Ciro Imbimbo; Ferdinando De Vita; Felice Crocetto Journal: Int J Mol Sci Date: 2022-01-20 Impact factor: 5.923