The prostate cancer registry: Patient characteristics, treatments and preliminary outcomes from a large observational study of metastatic castration-resistant prostate cancer (mCRPC)статья
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Дата последнего поиска статьи во внешних источниках: 6 декабря 2018 г.
Аннотация:Background: The Prostate Cancer Registry (NCT02236637) is the first prospective, international, observational study to describe routine management of mCRPC. The registry has enrolled over 3000 patients, with up to 3 years' follow-up. This analysis reports baseline characteristics, treatments and first clinical outcomes in 1374 patients.
Methods: Data collected prospectively from medical records of men with documented mCRPC initiating a new mCRPC treatment or in surveillance (no active treatment; ongoing androgen deprivation and/or bone-targeted therapy allowed). Data and analyses were descriptive.
Results: Median follow-up at database close was 14.2 months (range: 0.2-28.6). Mean age at enrolment was 72.6 years; 55% of patients had a Gleason score ≥ 8 at diagnosis. 58.5% of patients had comorbidities at enrolment, most commonly cardiovascular disorders (51.7%; 41.3% hypertension) and diabetes (15.2%). 876 patients (63.8%) were chemotherapy-naïve at enrolment. During the 12-month observation period, 1191 patients (86.7%) initiated new mCRPC treatment. Descriptive, non-comparative data on previous treatment lines and time to next therapy by first documented treatment received on study are in the table.
Chemotherapy-naïve treatment Chemotherapy-naïve treatment First chemotherapy treatment Post-chemotherapy treatment Post-chemotherapy treatment Post-chemotherapy treatment Post-chemotherapy treatment
First documented treatment received on study (treatments with n ≥ 50) Abiraterone acetate + prednisone (n = 324) Enzalutamide (n = 53) Docetaxel (n = 326) Abiraterone acetate + prednisone (n = 164) Enzalutamide (n = 111) Docetaxel (n = 58)` Cabazitaxel (n = 119)
Number of previous mCRPC treatments, n (%)
0 313 (96.6) 42 (79.2) 295 (90.5) 0 0 0 0
1 11 (3.4) 11 (20.8) 29 (8.9) 121 (73.8) 61 (55.0) 35 (60.3) 43 (36.1)
2 0 0 2 (0.6) 37 (22.6) 29 (26.1) 14 (24.1) 59 (49.6)
≥3 0 0 0 6 (3.6) 21 (18.9) 9 (15.5) 17 (14.3)
Median time to next therapy, days (95% CI)* 601 (467, NE) 503 (251, NE) 278 (259, 307) 428 (359, 514) 366 (296, NE) 322 (239, 404) 264 (240, 321)
*Kaplan–Meier estimates; patients with no next therapy were censored. Time to next therapy: time from start of 1st therapy to start of next therapy. NE, not estimable.
Conclusions: The results provide unique insights into treatment and outcomes in a large, real-world mCRPC patient population. These older patients have a high prevalence of comorbidities that are common in clinical practice but often not taken into account in the results of interventional clinical trials. Follow-up of these patients will allow assessment of treatment patterns and outcomes, and thereby contribute to optimising outcomes in subsets of mCRPC patients in clinical practice.
Clinical trial identification: ClinicalTrials.gov NCT02236637