| Popis: |
Aim: PROXIMA is a prospective, international registry study of treatment patterns over 12 months and survival at 24 months in pts with mCRPC during or after DOC failure. Interim regional management and baseline data are presented. Methods: Men aged ≥18 yrs with mCRPC who progressed during or after a DOC-based regimen were included. Results: 906 pts (Asia 19.5%; Europe [Eur] 49.0%; Latin America [LatAm] 14.2%; other 17.2%) from 167 randomly selected sites were included. The most frequent hospital type was public in Eur (80.3%), private in LatAm (80.6%), and teaching/university in Asia (55.6%) and other countries (74.4%). The most frequent specialty was medical oncologist in Eur (90.2%) and LatAm (100%), urologist in Asia (80.6%) and radiation oncologist in other countries (48.7%). A multidisciplinary approach was predominant in all regions. Median age was 71.0 yrs (range 42–91) and median time from diagnosis to inclusion was 55.0 months (2.0–361.3). At diagnosis, median Gleason score was 8.0 and median PSA was 63.5 ng/ml. At study entry, metastatic sites were bone (90.6%), lymph node (30.5%) and visceral/soft tissue (19.5%). Pts received 1 (85.3%), 2 (12.1%) or ≥3 (2.7%) lines of DOC therapy before entry, with a similar pattern across regions. Median cumulative DOC dose was 540 mg/m2 and was similar across regions. 207 pts (22.8%) received further therapy after DOC and before inclusion, more frequently in Eur (29.5%) vs other regions (range 11.3–20.9%) (Table). Post-DOC, use of CTX (12.4%) vs hormonal therapy (11.5%) was similar, and of pts receiving CTX, taxane therapy (non-DOC) was more common in Eur (6.8%) vs elsewhere (range 0.6–3.1%). 699 pts were yet to be treated post-DOC, but will be followed to evaluate treatment patterns. Conclusions: Treatment practices for mCRPC differ between global regions. Treatment following DOC failure and effect on outcome are being evaluated. Patients, N (%) Asia n = 177 Europe n = 444 Latin America n = 129 Other n = 156 Total N = 906 Post-docetaxel treatment at baseline 20 (11.3) 131 (29.5) 27 (20.9) 29 (18.6) 207 (22.8) Chemotherapy 12 (6.8) 70 (15.8) 16 (12.4) 14 (9.0) 112 (12.4) Taxane 1 (0.6) 30 (6.8) 4 (3.1) 4 (2.6) 39 (4.3) Hormonal agent 11 (6.2) 65 (14.6) 10 (7.8) 18 (11.5) 104 (11.5) Disclosure: H. Akaza: has acted as a consultant/advisor for Takeda Pharmaceutical Company Ltd, Janssen Pharmaceutical K.K. and Astellas Pharma Inc.; G. Procopio: is a member of advisory boards for Bayer, Bristol, GSK, Novartis and Pfizer and has acted as a consultant for Astellas and Janssen; S. Hitier: is an employee of Sanofi and holds Sanofi stock; E.B. Ecstein-Fraisse: is an employee of Sanofi and holds Sanofi stock; S. Bensfia: is an employee of Sanofi and holds Sanofi stock and has had involvement in corporate-sponsored research; M. Ozguroglu: participated in advisory boards for Sanofi. All other authors have declared no conflicts of interest. |
