Cited by 73Prostate Cancer Treatment and ResearchBone health and treatmentsProstate Cancer Diagnosis and Treatment

Cabazitaxel versus abiraterone or enzalutamide in poor prognosis metastatic castration-resistant prostate cancer: a multicentre, randomised, open-label, phase II trial

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Annala, M., Fu, S., Bacon, J.V.W., Sipola, J., Iqbal, N., Ferrario, C., Ong, M., Wadhwa, D. +20 more·2021·Annals of Oncology

Abstract

Background Treatment of poor prognosis metastatic castration-resistant prostate cancer (mCRPC) includes taxane chemotherapy and androgen receptor pathway inhibitors (ARPI). We sought to determine optimal treatment in this setting. Patients and methods This multicentre, randomised, open-label, phase II trial recruited patients with ARPI-naive mCRPC and poor prognosis features (presence of liver metastases, progression to mCRPC after <12 months of androgen deprivation therapy, or ≥4 of 6 clinical criteria). Patients were randomly assigned 1 : 1 to receive cabazitaxel plus prednisone (group A) or physician's choice of enzalutamide or abiraterone plus prednisone (group B) at standard doses. Patients could cross over at progression. The primary endpoint was clinical benefit rate for first-line treatment (defined as prostate-specific antigen response ≥50%, radiographic response, or stable disease ≥12 weeks). Results Ninety-five patients were accrued (median follow-up 21.9 months). First-line clinical benefit rate was greater in group A versus group B (80% versus 62%, P = 0.039). Overall survival was not different between groups A and B (median 37.0 versus 15.5 months, hazard ratio (HR) = 0.58, P = 0.073) nor was time to progression (median 5.3 versus 2.8 months, HR = 0.87, P = 0.52). The most common first-line treatment-related grade ≥3 adverse events were neutropenia (cabazitaxel 32% versus ARPI 0%), diarrhoea (9% versus 0%), infection (9% versus 0%), and fatigue (7% versus 5%). Baseline circulating tumour DNA (ctDNA) fraction above the cohort median and on-treatment ctDNA increase were associated with shorter time to progression (HR = 2.38, P < 0.001; HR = 4.03, P < 0.001). Patients with >30% ctDNA fraction at baseline had markedly shorter overall survival than those with undetectable ctDNA (HR = 38.22, P < 0.001). Conclusions Cabazitaxel was associated with a higher clinical benefit rate in patients with ARPI-naive poor prognosis mCRPC. ctDNA abundance was prognostic independent of clinical features, and holds promise as a stratification biomarker.

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Crossref · 10.1016/j.annonc.2021.03.205

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  • A phase 2 trial (NCT02254785) including patients with ARPI-naïve mCRPC and poor prognostic features (including liver metastases) demonstrated a higher clinical benefit rate with cabazitaxel versus physician's choice of enzalutamide or abiraterone.

    “A phase 2 trial (NCT02254785) including patients with ARPI-naïve mCRPC and poor prognostic features (including liver metastases) demonstrated a higher clinical benefit rate with cabazitaxel vs physician’s choice of enzalutamide or abiraterone [45].”

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Authors
Annala, M., Fu, S., Bacon, J. V. W., Sipola, J., Iqbal, N., Ferrario, C., Ong, M., Wadhwa, D., Hotte, S. J., Lo, G., Tran, B., Wood, L. A., Gingerich, J. R., North, S. A., Pezaro, C. J., Ruether, J. D., Sridhar, S. S., Kallio, H. M. L., Khalaf, D. J., Wong, A., Beja, K., Schönlau, E., Taavitsainen, S., Nykter, M., Vandekerkhove, G., Azad, A. A., Wyatt, A. W., & Chi, K. N.
Affiliations
  • University of British Columbia (CA)
  • BC Cancer Agency (CA)
  • Tampere University (FI)
  • University of Saskatchewan (CA)
  • Jewish General Hospital (CA)
  • University of Ottawa (CA)
  • BC Cancer – Kelowna (CA)
  • Juravinski Cancer Centre (CA)
  • Lakeridge Health (CA)
  • Peter MacCallum Cancer Centre (AU)
  • Queen Elizabeth II Health Sciences Centre (CA)
  • CancerCare Manitoba (CA)
  • University of Alberta (CA)
  • Eastern Health (AU)
  • Princess Margaret Cancer Centre (CA)
Corresponding author
  • Wyatt, A.W.
  • Chi, K.N.
Venue
Annals of Oncology
Publisher
Elsevier BV
Published
2021-07
Volume
32
Issue
7
Pages
896-905
ISSN
0923-7534 (ISSN-L)
OpenAlex
W3143844999
Cited by
73
References
42
Citations by year
2026: 7 · 2025: 9 · 2024: 15 · 2023: 18 · 2022: 11 · 2021: 13
FWCI
9.33
Type
journal article
Language
en
Open access
Locations
  • Annals of Oncology (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • Movember Foundation
  • Prostate Cancer Foundation
  • Prostate Cancer Canada
  • Terry Fox Research Institute
Topics
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
  • Health Sciences › Medicine › Oncology › Bone health and treatments
  • Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
Keywords
metastatic castration-resistant prostate cancer, cabazitaxel, enzalutamide, abiraterone, androgen receptor pathway inhibitors, taxane-based chemotherapy, first-line therapy, clinical benefit rate, circulating tumor DNA, time to progression, overall survival, neutropenia, liver metastasis, androgen deprivation therapy, prognostic factors, treatment-related adverse events
MeSH terms
Androgen Antagonists, Androstenes, Antineoplastic Combined Chemotherapy Protocols, Benzamides, Humans, Male, Nitriles, Phenylthiohydantoin, Prednisone, Prognosis, Treatment Outcome, Taxoids, Prostatic Neoplasms, Castration-Resistant

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