Real-world experience of abiraterone acetate plus prednisone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: long-term results of the prospective ABItude study

ESMO Open - Tập 7 - Trang 100431 - 2022
G. Procopio1, V.E. Chiuri2, M. Giordano3, A.R. Alitto4, R. Maisano5, R. Bordonaro6, S. Cinieri7, S. Rossetti8, S. De Placido9, M. Airoldi10, L. Galli11, D. Gasparro12, G.M. Ludovico13, P.F. Guglielmini14, C. Carella15, P. Nova16, M. Aglietta17, L. Schips18, P. Beccaglia19, A. Sciarra20
1Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy
2Medical Oncology Department, Ospedale Vito Fazzi, Lecce, Italy
3Medical Oncology Division, ASST-Lariana, Como, Italy
4Department of Diagnostic Imaging, Radiation Oncology and Hematology, Fondazione Policlinico Universitario ‘A. Gemelli’ IRCCS, Rome, Italy
5Department of Oncology, A.O. Bianchi-Melacrino-Morelli, Reggio Calabria, Italy
6Medical Oncology Unit, Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione, Garibaldi Catania, Catania, Italy
7Medical Oncology Unit, Antonio Perrino Hospital, Brindisi, Italy
8Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy
9Department of Clinical Medicine and Surgery, University of Naples “Federico II”, Naples, Italy
10Oncology Unit 2, Città della Salute e della Scienza di Torino, Turin, Italy
11Department of Medical Oncology, A.O.U. Pisana, Pisa, Italy
12Medical Oncology Unit, Department of General & Specialistic Medicine, University Hospital of Parma, Parma, Italy
13Department of Urology, Ospedale F. Miulli, Acquaviva delle Fonti, Bari, Italy
14Oncology Unit, SS Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy
15Medical Oncology Unit, IRCCS Istituto Tumori Giovanni Paolo II, Bari, Italy
16Department of Medical Oncology, ASST Brianza, Presidio Vimercate, Vimercate, Italy
17Candiolo Cancer Institute - FPO, IRCCS, Candiolo, Italy
18Department of Medical, Oral and Biotechnological Sciences, G. D’Annunzio University of Chieti, Urology Unit, SS Annunziata Hospital, Chieti, Italy
19Janssen-Cilag SpA, Cologno Monzese, Italy
20Department of Urology, Sapienza Rome University, Policlinico Umberto I, Rome, Italy

Tài liệu tham khảo

Bray, 2018, Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries, CA Cancer J Clin, 68, 394, 10.3322/caac.21492 Miller, 2019, Cancer treatment and survivorship statistics, 2019, CA Cancer J Clin, 69, 363, 10.3322/caac.21565 Nuhn, 2019, Update on systemic prostate cancer therapies: management of metastatic castration-resistant prostate Ccncer in the era of precision oncology, Eur Urol, 75, 88, 10.1016/j.eururo.2018.03.028 Ritch, 2016, Advances in the management of castration resistant prostate cancer, BMJ, 355, i4405, 10.1136/bmj.i4405 Karantanos, 2015, Understanding the mechanisms of androgen deprivation resistance in prostate cancer at the molecular level, Eur Urol, 67, 470, 10.1016/j.eururo.2014.09.049 Sartor, 2018, Metastatic prostate cancer, N Engl J Med, 378, 645, 10.1056/NEJMra1701695 Potter, 1995, Novel steroidal inhibitors of human cytochrome P45017 alpha (17 alpha-hydroxylase-C17,20-lyase): potential agents for the treatment of prostatic cancer, J Med Chem, 38, 2463, 10.1021/jm00013a022 de Bono, 2011, Abiraterone and increased survival in metastatic prostate cancer, N Engl J Med, 364, 1995, 10.1056/NEJMoa1014618 Fizazi, 2012, Abiraterone acetate for treatment of metastatic castration-resistant prostate cancer: final overall survival analysis of the COU-AA-301 randomised, double-blind, placebo-controlled phase 3 study, Lancet Oncol, 13, 983, 10.1016/S1470-2045(12)70379-0 Ryan, 2013, Abiraterone in metastatic prostate cancer without previous chemotherapy, N Engl J Med, 368, 138, 10.1056/NEJMoa1209096 Rathkopf, 2014, Updated interim efficacy analysis and long-term safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients without prior chemotherapy (COU-AA-302), Eur Urol, 66, 815, 10.1016/j.eururo.2014.02.056 Ryan, 2015, Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study, Lancet Oncol, 16, 152, 10.1016/S1470-2045(14)71205-7 Basch, 2013, Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial, Lancet Oncol, 14, 1193, 10.1016/S1470-2045(13)70424-8 Marchioni, 2018, Abiraterone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: a systematic review of ‘real-life’ studies, Ther Adv Urol, 10, 305, 10.1177/1756287218786160 Chowdhury, 2020, Real-world outcomes in first-line treatment of metastatic castration-resistant prostate cancer: the Prostate Cancer Registry, Target Oncol, 15, 301, 10.1007/s11523-020-00720-2 Procopio, 2020, Effectiveness of abiraterone acetate plus prednisone in chemotherapy-naive patients with metastatic castration-resistant prostate cancer in a large prospective real-world cohort: the ABItude study, Ther Adv Med Oncol, 12, 10.1177/1758835920968725 Cleeland, 1994, Pain assessment: global use of the Brief Pain Inventory, Ann Acad Med Singap, 23, 129 Esper, 1997, Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument, Urology, 50, 920, 10.1016/S0090-4295(97)00459-7 1990, EuroQol—a new facility for the measurement of health-related quality of life, Health Policy, 16, 199, 10.1016/0168-8510(90)90421-9 Scalone, 2013, Italian population-based values of EQ-5D health states, Value Health, 16, 814, 10.1016/j.jval.2013.04.008 Morisky, 2008, Predictive validity of a medication adherence measure in an outpatient setting, J Clin Hypertens (Greenwich), 10, 348, 10.1111/j.1751-7176.2008.07572.x Berlowitz, 2017, Effect of intensive blood-pressure treatment on patient-reported outcomes, N Engl J Med, 377, 733, 10.1056/NEJMoa1611179 Morisky, 2011, Improving the measurement of self-reported medication nonadherence: response to authors, J Clin Epidemiol, 64, 255, 10.1016/j.jclinepi.2010.09.002 Fabbrini, 2013, Adherence to anti-Parkinson drug therapy in the “REASON” sample of Italian patients with Parkinson’s disease: the linguistic validation of the Italian version of the “Morisky Medical Adherence Scale-8 items”, Neurol Sci, 34, 2015, 10.1007/s10072-013-1438-1 von Elm, 2007, The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies, Ann Intern Med, 147, 573, 10.7326/0003-4819-147-8-200710160-00010 Chan, 2020, Real-world outcome with abiraterone acetate plus prednisone in Asian men with metastatic castrate-resistant prostate cancer: the Singapore experience, Asia Pac J Clin Oncol, 16, 75, 10.1111/ajco.13241 Koninckx, 2019, Effectiveness, safety and cost of abiraterone acetate in patients with metastatic castration-resistant prostate cancer: a real-world data analysis, Clin Transl Oncol, 21, 314, 10.1007/s12094-018-1921-5 Cavo, 2018, Abiraterone acetate and prednisone in the pre- and post-docetaxel setting for metastatic castration-resistant prostate cancer: a mono-institutional experience focused on cardiovascular events and their impact on clinical outcomes, Ther Adv Med Oncol, 10, 10.1177/1758834017745819 Cindolo, 2017, Safety and efficacy of abiraterone acetate in chemotherapy-naive patients with metastatic castration-resistant prostate cancer: an Italian multicenter “real life” study, BMC Cancer, 17, 753, 10.1186/s12885-017-3755-x Miyake, 2017, Comparative assessment of clinical outcomes between abiraterone acetate and enzalutamide in patients with docetaxel-naive metastatic castration-resistant prostate cancer: experience in real-world clinical practice in Japan, Clin Genitourin Cancer, 15, 313, 10.1016/j.clgc.2016.06.010 Halabi, 2008, Pain predicts overall survival in men with metastatic castration-refractory prostate cancer, J Clin Oncol, 26, 2544, 10.1200/JCO.2007.15.0367 Scher, 2016, Trial design and objectives for castration-resistant prostate cancer: updated recommendations from the Prostate Cancer Clinical Trials Working Group 3, J Clin Oncol, 34, 1402, 10.1200/JCO.2015.64.2702 Harland, 2013, Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy, Eur J Cancer, 49, 3648, 10.1016/j.ejca.2013.07.144 Gotto, 2020, Real-world evidence in patient-reported outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate + prednisone (AA+P) across Canada: final results of COSMiC, Can Urol Assoc J, 14, E616, 10.5489/cuaj.6388 Kretschmer, 2021, Health-related quality of life in patients with advanced prostate cancer: a systematic review, Eur Urol Focus, 7, 742, 10.1016/j.euf.2020.01.017 Thiery-Vuillemin, 2020, Impact of abiraterone acetate plus prednisone or enzalutamide on patient-reported outcomes in patients with metastatic castration-resistant prostate cancer: final 12-mo analysis from the observational AQUARiUS study, Eur Urol, 77, 380, 10.1016/j.eururo.2019.09.019 Khalaf, 2019, Health-related quality of life for abiraterone plus prednisone versus enzalutamide in patients with metastatic castration-resistant prostate cancer: results from a phase II randomized trial, Eur Urol, 75, 940, 10.1016/j.eururo.2018.12.015 Salem, 2017, Impact of abiraterone acetate and enzalutamide on symptom burden of patients with chemotherapy-naive metastatic castration-resistant prostate cancer, Clin Oncol (R Coll Radiol), 29, 601, 10.1016/j.clon.2017.03.010 Lafeuille, 2014, Adherence patterns for abiraterone acetate and concomitant prednisone use in patients with prostate cancer, J Manag Care Spec Pharm, 20, 477 Behl, 2017, Medication adherence, treatment patterns, and dose reduction in patients with metastatic castration-resistant prostate cancer receiving abiraterone acetate or enzalutamide, Am Health Drug Benefits, 10, 296 Fallara, 2020, Observational study on time on treatment with abiraterone and enzalutamide, PLoS One, 15, 10.1371/journal.pone.0244462 Grundmark, 2012, Anti-androgen prescribing patterns, patient treatment adherence and influencing factors; results from the nationwide PCBaSe Sweden, Eur J Clin Pharmacol, 68, 1619, 10.1007/s00228-012-1290-x Zhu, 2018, Toxicity profile characteristics of novel androgen-deprivation therapy agents in patients with prostate cancer: a meta-analysis, Expert Rev Anticancer Ther, 18, 193, 10.1080/14737140.2018.1419871 Prati, 2018, Cardiovascular safety of abiraterone acetate in metastatic castration-resistant prostate cancer patients: a prospective evaluation, Future Oncol, 14, 443, 10.2217/fon-2017-0385 Verzoni, 2016, Safety of long-term exposure to abiraterone acetate in patients with castration-resistant prostate cancer and concomitant cardiovascular risk factors, Ther Adv Med Oncol, 8, 323, 10.1177/1758834016656493 Procopio, 2015, Safety of abiraterone acetate in castration-resistant prostate cancer patients with concomitant cardiovascular risk factors, Am J Clin Oncol, 38, 479, 10.1097/COC.0b013e3182a790ce Sciarra, 2013, Multidisciplinary management of prostate cancer: how and why, Am J Clin Exp Urol, 1, 12 Cornford, 2017, EAU-ESTRO-SIOG guidelines on prostate cancer. Part II: treatment of relapsing, metastatic, and castration-resistant prostate cancer, Eur Urol, 71, 630, 10.1016/j.eururo.2016.08.002 Saad, 2021, 2021 Canadian Urological Association (CUA)-Canadian Uro Oncology Group (CUOG) guideline: management of castration-resistant prostate cancer (CRPC), Can Urol Assoc J, 15, E81, 10.5489/cuaj.7074 Parker, 2020, Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up, Ann Oncol, 31, 1119, 10.1016/j.annonc.2020.06.011 Atwell, 2019, Referral rates to multidisciplinary team meetings: is there disparity between tumour streams?, J Med Imaging Radiat Oncol, 63, 378, 10.1111/1754-9485.12851 Magnani, 2012, The 6-year attendance of a multidisciplinary prostate cancer clinic in Italy: incidence of management changes, BJU Int, 110, 998, 10.1111/j.1464-410X.2012.10970.x Fizazi, 2017, Abiraterone plus prednisone in metastatic, castration-sensitive prostate cancer, N Engl J Med, 377, 352, 10.1056/NEJMoa1704174 James, 2017, Abiraterone for prostate cancer not previously treated with hormone therapy, N Engl J Med, 377, 338, 10.1056/NEJMoa1702900