First results from a randomized phase II study of cabazitaxel (CBZ) versus an androgen receptor targeted agent (ARTA) in patients with poor-prognosis castration-resistant prostate cancer (mCRPC).

Authors

null

Kim van der Zande

Netherlands Cancer Insitute, Amsterdam, Netherlands

Kim van der Zande , Vincent van der Noort , Milou Busard , Paul Hamberg , Suzan Ras - van Spijk , Jeantine De Feijter , Vincent O. Dezentjé , Metin Tascilar , Danny Houtsma , Aart Beeker , H Pieter van den Berg , Diederik ten Oever , Irma M. Oving , Wilbert Zwart , Andre M. Bergman

Organizations

Netherlands Cancer Insitute, Amsterdam, Netherlands, Netherlands Cancer Institute, Amsterdam, Netherlands, Franciscus Gasthuis & Vlietland, Rotterdam, Netherlands, Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Amsterdam, Netherlands, Isala Clinics, Zwolle, Netherlands, HAGA Hospital, Den Haag, Netherlands, Spaarne Gasthuis, Hoofddorp, Netherlands, Tergooi Medical Hospital, Hilversum, Netherlands, Noordwest Ziekenhuisgroep, Alkmaar, Netherlands, Ziekenhuisgroep Twente, Almelo, Netherlands

Research Funding

Pharmaceutical/Biotech Company
Sanofi

Background: In the OSTRICh trial, poor-prognosis mCRPC patients were randomized between CBZ and ARTA, following progression on docetaxel (DOC) treatment. Methods: The OSTRICh trial is an open label, multicenter, phase IIb study. Patients with poor-prognosis mCRPC (visceral metastases AND/OR < 12 months responsive to androgen deprivation AND/OR progressing during or within 6 months after DOC completion), were randomized 1:1 between CBZ (25 mg/m2 IV Q3W and prednisone 2 d 5 mg PO) and ARTA (daily abiraterone 1000 mg and prednisone 2 d 5 mg PO OR enzalutamide 160 mg PO). Life prolonging therapy between DOC and randomization was not allowed. Primary endpoint was to establish the Clinical Benefit Rate (no radiotherapy, no ECOG PS increase ≥2, no change of therapy AND no radiological progression) at 12 weeks (CBR) in the study arms, while formal comparison of the CBR was a secondary endpoint. A Fisher Exact test was used to assess differences in rates and a log rank test to assess differences in progression free and overall survival. All time to event endpoints were estimated with the Kaplan-Meier method and censored at last follow-up. Results: A total of 106 patients were randomized, 53 in each arm. Baseline median age was 70 (IQR 67-75) years and PSA 79.4 (IQR 29.0 - 160) ng/ml. ECOG PS score was 0/1 in 99 (93%) and 2 in 7 (7%) patients. Al patients fulfilled the criteria for poor-prognosis disease. Thirty-six (34%) patients received DOC in the metastatic hormone sensitive stage, while 41 (39%) previously received ARTA. Twenty-six of 43 evaluable patients in the CBZ arm had clinical benefit at 12 weeks (CBR: 60%, 95% CI: 44%-75%) and 20 of 39 (CBR: 51%, 95% CI: 35%-68%) in the ARTA arm (p = 0.50). At 12 weeks, 30 of 34 (88%, 95% CI: 73% - 97%) patients in the CBZ arm and 24 of 36 (67%, 95% CI: 49% - 81%) patients in the ARTA arm had no radiological progression (p = 0.046). After a median follow-up of 16.4 months (95% CI: 13.6–27.8), a serum PSA decrease ≥50% from baseline was established in 12 (23%, 95% CI: 12% - 36%) and 26 (49%, 95% CI: 35% - 63%)(p = 0.008) patients treated with CBZ and ARTA, respectively. Median radiological progression free survival (rPFS) was 6.0 months (95%CI: 4.11-14.5) in the CBZ arm and 5.8 months (95% CI: 5.22-10.2) months in the ARTA arm (p = 0.5), while median overall survival (OS) was 15.3 months (95%CI 9.49-22.4) and 13.8 months (95%CI 11.7-16.4) in CBZ and ARTA treated patients, respectively (p = 0.8). Grade ≥3 adverse events (AEs) occurred in 15 (29%) and 8 (15%) of patients treated with CBZ and ARTA, respectively. Conclusions: No significant difference in CBR was established between CBZ and ARTA treated patients. However, at 12 weeks significantly more CBZ treated patients had no radiological progression, while ≥50% PSA response rates were higher in ARTA treated patients. Clinical trial information: NCT03295565

Disclaimer

This material on this page is ©2024 American Society of Clinical Oncology, all rights reserved. Licensing available upon request. For more information, please contact licensing@asco.org

Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Genitourinary Cancer—Prostate, Testicular, and Penile

Track

Genitourinary Cancer—Prostate, Testicular, and Penile

Sub Track

Prostate Cancer– Advanced/Castrate-Resistant

Clinical Trial Registration Number

NCT03295565

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 5059)

DOI

10.1200/JCO.2021.39.15_suppl.5059

Abstract #

5059

Poster Bd #

Online Only

Abstract Disclosures