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Mini oral session: Genitourinary tumours

260MO - Impact of starting treatment choice in metastatic castration-sensitive prostate cancer (mCSPC)

Date

01 Dec 2023

Session

Mini oral session: Genitourinary tumours

Topics

Tumour Site

Prostate Cancer

Presenters

masaki Shiota

Citation

Annals of Oncology (2023) 34 (suppl_4): S1572-S1583. 10.1016/annonc/annonc1382

Authors

M. Shiota1, S.D. Mundle2, M. Nematian-Samani3, J. Hwang4, X. Wang5, Y. Liu6

Author affiliations

  • 1 Graduate School Of Medical Sciences, Kyushu University - Faculty of Medical Sciences, 812-8582 - Fukuoka/JP
  • 2 Global Medical Affairs, Janssen Research & Development, 08869 - Raritan/US
  • 3 Oncology - Medical Affairs Solid Tumors, Janssen-Cilag GmbH Germany, 41470 - Neuss/DE
  • 4 Solid Tumor Grp., Medical Affairs Dept, Janssen Pharmaceutical Kabushiki Kaisha, Tokyo/JP
  • 5 Department Of Data Science, Janssen Pharmaceuticals, Titusville/US
  • 6 Department Of Global Real World Evidence, Janssen Pharmaceuticals, LLC, 08869 - Raritan/US

Resources

This content is available to ESMO members and event participants.

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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