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Multicenter Study
. 2022 Dec:177:33-44.
doi: 10.1016/j.ejca.2022.09.032. Epub 2022 Oct 6.

CABA-V7: a prospective biomarker selected trial of cabazitaxel treatment in AR-V7 positive prostate cancer patients

Khrystany T Isebia  1 , Bianca Mostert  1 , Bodine P S Belderbos  1 , Stefan A J Buck  1 , Jean C A Helmijr  1 , Jaco Kraan  1 , Corine M Beaufort  1 , Mai N Van  1 , Esther Oomen-de Hoop  1 , Anieta M Sieuwerts  1 , Wilfred F J van IJcken  2 , Mirjam C G N van den Hout-van Vroonhoven  2 , Rutger W W Brouwer  2 , Edwin Oole  2 , Paul Hamberg  3 , Brigitte C M Haberkorn  4 , Helgi H Helgason  5 , Ronald de Wit  1 , Stefan Sleijfer  1 , Ron H J Mathijssen  1 , John W M Martens  1 , Maurice P H M Jansen  1 , Job van Riet  1 , Martijn P Lolkema  6
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Free article
Multicenter Study

CABA-V7: a prospective biomarker selected trial of cabazitaxel treatment in AR-V7 positive prostate cancer patients

Khrystany T Isebia et al. Eur J Cancer. 2022 Dec.
Free article

Abstract

Background: Metastatic castration-resistant prostate cancer (mCRPC) patients with positive AR-V7 expression in their circulating tumour cells (CTCs) rarely derive benefit from abiraterone and enzalutamide.

Design: We performed a prospective, multicenter, single arm phase II clinical trial (CABA-V7) in mCRPC patients previously treated with docetaxel and androgen deprivation therapy.

Objective: In this trial, we investigated whether cabazitaxel treatment resulted in clinically meaningful PSA response rates in patients with positive CTC-based AR-V7 expression and collected liquid biopsies for genomic profiling.

Results: Cabazitaxel was found to be modestly effective, with only 12% of these patients obtaining a PSA response. Genomic profiling revealed that CTC-based AR-V7 expression was not associated with other known mCRPC-associated alterations. CTC-based AR-V7 status and dichotomised CTC counts were observed as independent prognostic markers at baseline.

Conclusions: AR-V7 positivity predicted poor overall survival (OS). However, cabazitaxel-treated AR-V7 positive patients and those lacking AR-V7 positivity, who received cabazitaxel as standard of care, appeared to have similar OS. Therefore, despite the low response rate, cabazitaxel may still be an effective treatment in this poor prognosis, AR-V7 positive patient population.

Keywords: Androgen receptor; CTC; Cabazitaxel; Metastasis; NGS; Prostate cancer.

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Conflict of interest statement

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Ronald de Wit has acted in a consulting or advisory role for Sanofi, Merck, Astellas, Bayer, Orion; and has received research funding from Bayer, Sanofi, Travel support from Sanofi, Bayer. Stefan Sleijfer has acted in a consulting or advisory role for the Center for Personalized Cancer Treatment (chair), Dutch Science Agenda Personalized Medicine (chair) and Supervisory board of SkylineDx; and holds an interest in patent #10555926 (Use of cabazitaxel in the treatment of prostate cancer) held by Erasmus University Medical Center Rotterdam. Martijn P. Lolkema has acted in a consulting or advisory role for Sanofi, Johnson & Johnson, Merck, Astellas, Incyte, Amgen, Janssen Cilag, Bayer, Servier and Pfizer. John. W. M. Martens has acted in a consulting or advisory role for Novartis. Paul Hamberg has acted in a consulting or advisory role for Astellas, MSD, Pfizer AstraZeneca, BMS, Ipsen. Bianca Mostert has acted in consulting or advisory role for Servier, BMS and Lilly; and has received research funding from Sanofi, BMS. Ron H.J. Mathijssen acted in a consulting or advisory role Servier; and has received research funding for Sanofi, Pamgene, Astellas, ISI, Bayer, Servier, Roche, Novartis, Cristal Therapeutics, and Pfizer. All remaining authors have declared no conflicts of interest.

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