Abstract 260MO
Background
The treatment landscape of mCSPC has been evolving in the last decade with androgen receptor signaling inhibitors being the preferred life prolonging therapeutic choice. We examined the impact of the starting therapy on clinical outcomes in mCSPC in real-world clinical practice in Japan.
Methods
This retrospective cohort study evaluated treatment patterns and outcomes in adult patients with mCSPC using the Medical Data Vision hospital-based dataset in Japan. All patients with newly diagnosed mCSPC from 1 Jan 2018 to 30 Sept 2022 were enrolled and followed up until 31 Mar 2023. Time to event analyses used Kaplan Meier methods. Risks of death and onset of castration resistance (CR) was estimated using a Cox proportional hazard model adjusted for potential confounding factors (age, BMI, co-morbidities).
Results
16,454 patients with mCSPC were enrolled; 600 (3.6%) started on apalutamide (APA) + androgen-deprivation therapy (ADT), 607 (3.7%) on enzalutamide (ENZ) + (ADT), 945 (5.7%) on abiraterone acetate + prednisone (ABI) +ADT, 253 (1.5%) on docetaxel (DOC) +ADT, 9115 (55.3%) on combined androgen blockade (CAB), 1174 (7.1%) on ADT alone, and 3097 (18.8 %) had radiation therapy. Overall survival and CR-free survival were significantly longer in patients starting with APA + ADT compared to other treatment regimens (p<0.001 for both). In patients with regular PSA assessment available, a higher % of patients starting with APA+ADT achieved PSA50 (p<0.001) and undetectable PSA (≤ 0.2 ng/ml) at 3 months (p<0.001) compared with other treatments after adjusting for age, BMI and CCI. Table: 260MO
Features and clinical outcomes of patients with mCSPC*
| APA+ADT | ENZ+ADT | ABI+ADT | DOC+ADT | CAB | ADT alone | |
| N=600 | N=607 | N=945 | N=253 | N=9115 | N=1174 | |
| Age, median (range) | 74 (69,79) | 75 (70,81) | 73 (69,79) | 71 (67,76) | 78 (72,83) | 78 (72,83) |
| OS at 24 m, % | 94 | 87 | 90 | 82 | 88 | 89 |
| CR-free survival at 24 m, % | 73 | 62 | 56 | 39 | 56 | 46 |
| PSA 50 at 3m % | 76 | 56 | 63 | 26 | 49 | 54 |
| PSA90 at 3 m % | 49 | 36 | 49 | 10 | 33 | 41 |
| PSA ≤0.2 ng/ml at 3m % | 40 | 26 | 26 | 23 | 12 | 12 |
m, months. P-value <0.001 for age difference between APA, ENZA, ABI and DOC vs CAB or ADT alone
Conclusions
ADT/CAB continue to be used widely despite availability of newer life prolonging therapies. This analysis demonstrated that Use of APA + ADT as a starting treatment of mCSPC was associated with significantly better clinical outcomes versus any other life prolonging therapy or traditional CAB in real-world clinical practice in Japan.
Clinical trial identification
Editorial acknowledgement
Writing assistance was provided by Joanne Wolter MBBS, PhD (independent) on behalf of Janssen Global Services LLC.
Legal entity responsible for the study
Janssen Global Services, LLC.
Funding
Janssen Global Services, LLC.
Disclosure
M. Shiota: Financial Interests, Personal, Financially compensated role: Janssen Pharmaceutical, AstraZeneca, Astellas Pharma, Sanofi and Bayer Yakuhin; Financial Interests, Personal, Research Funding: Daiichi Sankyo. Yanfang Liu, Suneel Mundle, Xiayi Wang, Mehregan Nematian-Samani. S.D. Mundle, Y. Liu: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson LLC; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson LLC. M. Nematian-Samani, J. Hwang, X. Wang: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson LLC.
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