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Health-related quality of life (HRQL) in a randomized phase 3 trial of enzalutamide with standard first line therapy for metastatic, hormone-sensitive prostate cancer (mHSPC): ENZAMET (ANZUP 1304), an ANZUP-led, international, co-operative group trial

Date

29 Sep 2019

Session

Poster Discussion – Genitourinary tumours, prostate

Presenters

Martin Stockler

Citation

Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Authors

M.R. Stockler1, A.J. Martin1, H. Dhillon2, I.D. Davis3, K.N. Chi4, S. Chowdhury5, L.G. Horvath6, N.J. Lawrence7, G.M. Marx8, J. Mc Caffrey9, R. McDermott10, S.A. North11, F. Parnis12, D.W. Pook13, M.N. Reaume14, S.K. Sandhu15, T.H. Tan16, A. Thomson17, R. Zielinski18, C.J. Sweeney19

Author affiliations

  • 1 Nhmrc Clinical Trials Centre, University of Sydney, 2050 - Sydney/AU
  • 2 Quality Of Life Subcommittee, Australian and New Zealand Urogenital and Prostate Cancer Trials Group, 2050 - Camperdown/AU
  • 3 Eastern Health Clinical School, Monash University, 3128 - Box Hill/AU
  • 4 Medical Oncology, BC Cancer Agency - Vancouver, V5Z 4E6 - Vancouver/CA
  • 5 Medical Oncology, Guy’s, King’s and St. Thomas’ Hospitals, and Sarah Cannon Research Institute, SE1 9RT - London/GB
  • 6 Medical Oncology, Chris O'Brien Lifehouse RPA, 2050 - Sydney/AU
  • 7 Medical Oncology, Auckland City Hospital, Auckland/NZ
  • 8 Sydney Adventist Hospital, University of Sydney, NSW 2076 - Wahroonga/AU
  • 9 Cancer Trials Ireland, Mater Misericordiae University Hospital University College Dublin, 7 - Dublin/IE
  • 10 Medical Oncology, Adelaide and Meath Hospital, Dublin 24 - Tallaght/IE
  • 11 Cross Cancer Institute, University of Alberta, Edmonton/CA
  • 12 Medical Oncology, Adelaide Cancer Centre, 5037 - Adelaide/AU
  • 13 Oncology, Monash Health, 3165 - Bentleigh/AU
  • 14 Medical Oncology, The Ottawa Hospital Regional Cancer Centre, K1H 8L6 - Ottawa/CA
  • 15 Division Of Medical Oncology, Peter MacCallum Cancer Centre, Melbourne/AU
  • 16 Medical Oncology, Royal Adelaide Hospital RAH Cancer Centre, 5000 - Adelaide/AU
  • 17 Oncology, Royal Cornwall Hospital, TR1 3LJ - Truro/GB
  • 18 Medical Oncology, Central West Cancer Services, Orange/AU
  • 19 Medical Oncology, Dana Farber Cancer Institute, 02115 - Boston/US
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Resources

Background

We previously reported that treatment with enzalutamide (ENZA) rather than an older non-steroidal anti-androgen (NSAA: bicalutamide, nilutamide, or flutamide), resulted in longer overall survival when added to standard first-line treatment, with or without concurrent early docetaxel, in mHSPC (hazard ratio 0.67, 95% CI 0.52 to 0.86, p = 0.002, NEJM 2019). Here we report effects on HRQL.

Methods

HRQL was measured with the EORTC QLQ-C30 and PR25 at weeks 0, 4, 12, and then 12-weekly until clinical progression. We used mixed models for repeated measures to calculate the least squares mean difference (LSMD), 95% CI, and p-value for comparisons of the randomly assigned groups for all assessments from week 4 to 156. For each analysis of deterioration-free survival, the endpoint was defined a-priori as the earliest of death, clinical progression, cessation of study treatment, or a 10-point worsening from baseline (minimum clinically important difference on scales scored from 0 to 100) in the pertinent HRQL sub-scale: physical functioning (PF), global health and quality of life (GHQL), cognitive functioning (CF), and fatigue; p-values were based on the log-rank test.

Results

Completion of HRQL forms in 1016 men with a baseline assessment of HRQL (1125 randomised) ranged from 94% at week 12 to 78% at week 156. Random assignment to ENZA v NSAA was associated with modest impairments (LSMD, 95% CI) from week 4 to 156 in fatigue (5.0, 3.3 to 6.7, p < 0.0001), CF (3.9, 2.4 to 5.4, p < 0.0001), and PF (2.5, 1.2 to 3.8, p = 0.0002), but not GHQL (1.1, -0.4 to 2.6, p = 0.16). Deterioration-free survival rates at 3 years favoured ENZA over NSAA for GHQL (32% v 18%, p < 0.0001), CF (33% v 21%, p = 0.0003), and PF (31% v 22%, p = 0.001), but not fatigue (26% v 18%, p = 0.1). The effects of ENZA on HRQL were relatively stable over time and unaffected by treatment with concurrent early docetaxel.

Conclusions

The addition of ENZA maintained GHQL and improved deterioration-free survival because early impairments in specific aspects of HRQL were insufficient to outweigh the subsequent benefits of delayed clinical progression.

Clinical trial identification

ACTRN12614000110684, NCT02446405; EUCTR2014-003190-42-IE.

Editorial acknowledgement

Legal entity responsible for the study

ANZUP Cancer Trials Group and the NHMRC Clinical Trials Centre, University of Sydney.

Funding

Astellas Pharma.

Disclosure

M.R. Stockler: Research grant / Funding (institution): Astellas; Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Research grant / Funding (institution): Medivation; Research grant / Funding (institution): Bayer. A.J. Martin: Research grant / Funding (institution): Astellas. I.D. Davis: Research grant / Funding (institution): Astellas. K.N. Chi: Research grant / Funding (institution): Astellas. S. Chowdhury: Research grant / Funding (institution): Astellas. L.G. Horvath: Research grant / Funding (institution): Astellas. N.J. Lawrence: Research grant / Funding (institution): Astellas. G.M. Marx: Research grant / Funding (institution): Astellas. J. Mc Caffrey: Research grant / Funding (institution): Astellas. R. McDermott: Research grant / Funding (institution): Astellas. S.A. North: Research grant / Funding (institution): Astellas. F. Parnis: Research grant / Funding (institution): Astellas. D.W. Pook: Research grant / Funding (institution): Astellas. M.N. Reaume: Research grant / Funding (institution): Astellas. S.K. Sandhu: Research grant / Funding (institution): Astellas. T.H. Tan: Research grant / Funding (institution): Astellas. A. Thomson: Research grant / Funding (institution): Astellas. R. Zielinski: Research grant / Funding (institution): Astellas. C.J. Sweeney: Research grant / Funding (institution): Astellas. All other authors have declared no conflicts of interest.

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