Real-World Outcomes in First-Line Treatment of Metastatic Castration-Resistant Prostate Cancer: The Prostate Cancer Registry
Por:
Chowdhury, S, Bjartell, A, Lumen, N, Maroto, P, Paiss, T, Gomez-Veiga, F, Birtle, A, Kramer, G, Kalinka, E, Spaeth, D, Feyerabend, S, Matveev, V, Lefresne, F, Lukac, M, Wapenaarls, R, Costa, L
Publicada:
1 jun 2020
Ahead of Print:
1 jun 2020
Resumen:
Background Metastatic prostate cancer has a 30% 5-year survival rate despite recent therapeutic advances. There is a need to improve the clinical understanding and treatment of this disease, particularly in the real-world setting and among patients who are under-represented in clinical trials. Objective We aimed to evaluate the characteristics and clinical outcomes of patients who received their first treatment for metastatic castration-resistant prostate cancer (mCRPC) in routine clinical practice, independent of treatment used, including subgroups with baseline cardiac disease, diabetes mellitus, or visceral metastases. Patients and methods Prospective, noninterventional analysis of patient record data in the multicenter Prostate Cancer Registry (PCR) of men with mCRPC. The data were collected in 16 countries with the aim of recruiting more than 3000 patients between 2013 and 2016. The study end date was 9 July 2018. Data evaluated included baseline characteristics, treatment exposure, and efficacy outcomes [overall survival (OS) and time to progression (TTP)] of patients treated with abiraterone acetate plus prednisone or prednisolone (collectively, "abiraterone"), enzalutamide, or docetaxel. Descriptive outcomes are reported from the overall patient population and subgroups of patients with baseline cardiovascular disease, diabetes mellitus, or visceral metastases. The treatment effects for time to progression were compared for the overall patient population. Results The study enrollment period lasted 2.5 years, and each patient was followed for a maximum of 3 years. A total of 1874 patients in the PCR had not received previous mCRPC treatment at baseline, although they had received androgen-deprivation therapy. Prevalent co-morbidities included cardiovascular disease in 65.4% and diabetes mellitus in 17.4% of patients. Baseline characteristics suggested that patients with more advanced disease received docetaxel treatment. In the overall patient population, the median time to progression with abiraterone, enzalutamide, and docetaxel as first-line mCRPC therapy was 9.6, 10.3, and 7.6 months, respectively, and median OS was 27.1, 27.1, and 27.9 months, respectively. Outcomes in the subgroups of patients with cardiovascular disease or diabetes mellitus were similar to those of the whole population in the analysis. As expected, patients with visceral metastases had shorter TTP and OS than patients in the overall population. Conclusions This analysis shows, for the first time, the effectiveness in parallel of first-line abiraterone, enzalutamide, and docetaxel in mCRPC, including in patients with co-morbidities such as cardiovascular disease or diabetes mellitus or in patients with visceral metastases. These real-world findings from the PCR provide meaningful information to help manage mCRPC, particularly in patients under-represented in clinical studies.
Filiaciones:
Chowdhury, S:
Guys & St Thomas NHS Fdn Trust, Westminster Bridge Rd, London SE1 7EH, England
Sarah Cannon Res Inst, Westminster Bridge Rd, London SE1 7EH, England
Bjartell, A:
Skane Univ Hosp Malmo, Dept Urol, Malmo, Sweden
Lumen, N:
Ghent Univ Hosp, Dept Urol, C Heymanslaan 10, B-9000 Ghent, Belgium
Maroto, P:
Autonomous Univ Barcelona, Hosp Santa Creu & St Pau, Dept Med Oncol, Barcelona 08025, Spain
Paiss, T:
Urol Team Ulm, Ulm, Germany
Gomez-Veiga, F:
Salamanca Univ Hosp, Urol Dept, Salamanca, Spain
Salamanca Univ Hosp, Kidney Transplant Unit, Translat Res Grp Urol GITUR IBSAL, Salamanca, Spain
Birtle, A:
Royal Preston Hosp, Preston, Lancs, England
Kramer, G:
Med Univ Vienna, Dept Urol, Vienna, Austria
Kalinka, E:
Polish Mothers Mem Hosp Res Inst, Clin Oncol, Lodz, Poland
Spaeth, D:
Ctr Oncol Gentilly, Nancy, France
Feyerabend, S:
Studienpraxis Urol, Nurtingen, Germany
Matveev, V:
NN Blokhin Natl Canc Res Ctr, Moscow, Russia
Lefresne, F:
Janssen Pharmaceut NV, EMEA Oncol, Beerse, Belgium
Lukac, M:
Janssen Pharmaceut NV, Parexel Int Czech Republ Sro, Beerse, Belgium
Wapenaarls, R:
Janssen Cilag BV, Breda, Netherlands
Costa, L:
Univ Lisbon, Hosp Santa Maria, Fac Med, Inst Med Mol,Oncol Div, P-1649035 Lisbon, Portugal
Green Published, Hybrid Gold
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