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Proffered paper session - Genitourinary tumours, prostate

1576 - A Randomized Phase 2 Study of Cabazitaxel (CAB) vs (ABI) Abiraterone or (ENZ) Enzalutamide in Poor Prognosis Metastatic Castration-Resistant Prostate Cancer (mCRPC)


19 Oct 2018


Proffered paper session - Genitourinary tumours, prostate


Cytotoxic Therapy

Tumour Site

Prostate Cancer


Kim Chi


Annals of Oncology (2018) 29 (suppl_8): viii271-viii302. 10.1093/annonc/mdy284


K.N. Chi1, S. Taavitsainen2, N. Iqbal3, C. Ferrario4, M. Ong5, D. Wadhwa6, S.J. Hotte7, G. Lo8, B. Tran9, A. Azad10, L. Wood11, J.R. Gingerich12, S. North13, C.V. Pezaro14, D. Ruether15, S.S. Sridhar16, M. Annala17, J. Bacon2, A.W. Wyatt2

Author affiliations

  • 1 Medical Oncology, BC Cancer - Vancouver Centre, V5Z 4E6 - Vancouver/CA
  • 2 Urologic Sciences, University of British Columbia, V5Z1M9 - Vancouver/CA
  • 3 Oncology, Saskatoon Cancer Centre University of Saskatchewan, S7N 4H4 - Saskatoon/CA
  • 4 Medical Oncology, Jewish General Hospital McGill University, H3T 1E2 - Montreal/CA
  • 5 Medical Oncology, Ottawa Hospital Cancer Centre, Ottawa/CA
  • 6 Medical Oncology, BC Cancer - Kelowna Centre, Kelowna/CA
  • 7 Medical Oncology, Juravinski Cancer Centre, L8V 5C2 - Hamilton/CA
  • 8 Medical Oncology, Durham Regional Cancer Centre, Oshawa/CA
  • 9 Medical Oncology, Peter MacCallum Cancer Centre, Melbourne/AU
  • 10 Medical Oncology, Monash Health, Melbourne/AU
  • 11 Medical Oncology, QEII Health Sciences Centre, Halifax/CA
  • 12 Medical Oncology, CancerCare Manitoba, Winnipeg/CA
  • 13 Medical Oncology, University of Alberta Cross Cancer Institute, T6G 1Z2 - Edmonton/CA
  • 14 Oncology, Eastern Health, 3128 - Box Hill/AU
  • 15 Medical Oncology, Tom Baker Cancer Centre, T2N 4N2 - Calgary/CA
  • 16 Medical Oncology, Princess Margaret Hospital, M5G 2M9 - Toronto/CA
  • 17 Department Of Urologic Sciences, Vancouver Prostate Centre-Vancouver General Hospital, V6H 3Z6 - Vancouver/CA


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Abstract 1576


The optimal treatment for poor prognosis mCRPC is undefined and includes either taxane chemotherapy or androgen receptor (AR) targeted therapy, emphasizing the need for predictive biomarkers.


Patients (pts) with poor prognosis (liver metastases, early CRPC (<12 months from ADT start), and/or >3 of 6 poor prognostic criteria (Chi et al, Annals of Oncol, 2016)) were randomized to receive CAB (Arm A) or AR targeted therapy (Arm B, ABI or ENZ by investigator choice) with cross over at progression. No prior ABI or ENZ was permitted, but prior docetaxel allowed. Primary objective was to determine the clinical benefit rate (CBR) (PSA decline ≥50% (PSA50), objective response (OR), or stable disease (SD) ≥ 12 weeks). Other endpoints included time to PSA progression (TTPP), time to progression (TTP), and overall survival (OS). Serial plasma was sampled for circulating tumour DNA (ctDNA).


95 pts were randomized (Arm A: 45, Arm B: 50). Poor prognosis was based on liver mets in 18%, early CRPC in 88%, and 30% by prognostic criteria. Other baseline factors: median age 68 years, elevated LDH in 41%, elevated ALK PHOS in 52%, ECOG PS 0-1 in 94%, 52% had prior docetaxel (half for castration sensitive disease). Median duration of therapy was 5.8 months (m) for Arm A and 4.5 m for Arm B. Treatment discontinuation reasons included disease progression (A vs B: 40% vs 46%) and toxicity (11% vs 4%). Outcomes are summarized in table. In 58 pts with available results, baseline ctDNA fraction >2% correlated with TTP (median 3.4 m vs 10.8 m, p = 0.011) and OS (median 15.5 m vs not reached (NR), p = 0.002). Genomic alterations in AR, RB1, TP53, PI3K pathway, and DNA repair were present in 69%, 36%, 51%, 40%, and 15%.Table: 792O

Arm A (CAB)Arm B (ABI/ENZ)HR (95% CI)P
CBR (%)82860.16
PSA50 (%)56600.68
OR (%)1112>0.90
SD > 12 weeks (%)62460.15
Median TTPP (m) (0.42-1.29)0.28
Median TTP (m) (.53-1.40)0.56
Median OS (m)NR15.50.56 (0.25-1.22)0.14


Treatment with CAB vs ABI/ENZA resulted in similar outcomes. There was a trend in favour of CAB for survival. Genomic correlations will be presented.

Clinical trial identification


Legal entity responsible for the study

Kim N. Chi and BC Cancer.


Sanofi Genzyme, Prostate Cancer Canada Movember Disxcovery Grant, Canadian Institutes of Health Research Project Grant, Terry Fox Research Institute Program Project Grant.

Editorial Acknowledgement


K.N. Chi: Honorarium, grant support: Sanofi Genzyme. N. Iqbal: Honorarium: Janssen, Astellas. M. Ong: Honorarium: Sanofi Genzyme, Janssen, Astellas. S.J. Hotte: Honorarium, advisory board, grant support: Janssen, Astellas. B. Tran: Consulting, honorarium, research grant support: Sanofi Genzyme, Janssen, Astellas. A. Azad: Honorarium: Sanofi, Janssen, Astellas; Grant: Astellas. S. North: Honorarium: Sanofi Genzyme, Janssen, Astellas. C.V. Pezaro: Honoraria, education support: Janssen, Astellas. S.S. Sridhar: Honorarium, grant support: Sanofi Genzyme, Janssen, Astellas. All other authors have declared no conflicts of interest.

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