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Poster display session

1622 - Indirect Comparison of Abiraterone Acetate and Docetaxel for Treatment of Metastatic “Hormone-Sensitive” Prostate Cancer

Date

10 Sep 2017

Session

Poster display session

Presenters

Susan Feyerabend

Citation

Annals of Oncology (2017) 28 (suppl_5): v269-v294. 10.1093/annonc/mdx370

Authors

S. Feyerabend1, F. Saad2, T. Li3, T. Ito4, J. Diels5, S. Van Sanden5, P. De Porre6, J. Roïz7, S. Abogunrin8, K. Fizazi9

Author affiliations

  • 1 Urologic Oncology, Studienpraxis Urologie, 72622 - Nürtingen/DE
  • 2 Surgery, Centre Hospitalier de l‘Université de Montréal/CRCHUM, Montréal/CA
  • 3 Global Market Access Oncology, Janssen Global Services, Raritan/US
  • 4 Health Economics & Market Access Emea, Janssen, High Wycombe/GB
  • 5 Health Economics & Market Access Emea, Janssen, Beerse/BE
  • 6 Clinical Oncology, Janssen Research & Development BE, Beerse/BE
  • 7 Modeling & Simulation, Evidera, London/GB
  • 8 Outcomes Research, Evidera, London/GB
  • 9 Cancer Medicine, Institut Gustave Roussy, University of Paris Sud, Villejuif/FR
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Resources

Abstract 1622

Background

Androgen deprivation therapy (ADT) with or without chemotherapy (docetaxel [DOC]) is recommended in the clinical guidelines as the mainstay of management for metastatic “hormone-sensitive” prostate cancer (mHSPC). The LATITUDE trial demonstrated the efficacy of abiraterone acetate in combination with prednisone and ADT (ADT+AA+P) vs ADT in newly diagnosed mHSPC pts with high-risk disease (NDx HRD). We performed an indirect comparison to determine the relative efficacy of AA vs DOC in mHSPC.

Methods

We conducted a systematic literature review of randomized controlled trials (RCTs) of treatments for mHSPC. To increase comparability of results across studies, the population of interest from LATITUDE and DOC studies was restricted to men with NDx HRD and/or high volume disease (NDx HVD). Two RCTs (CHAARTED, GETUG-AFU 15), both evaluating ADT vs DOC+ADT, met the inclusion criteria. Fixed effects Bayesian network meta-analyses (NMAs) were performed to estimate the relative treatment effects for ADT+AA+P vs DOC+ADT on overall survival (OS) and radiographic progression-free survival (rPFS). The HVD subgroup of LATITUDE was used in the main analysis. The LATITUDE ITT population (NDx HRD) was included as a sensitivity analysis. As STAMPEDE did not report an NDx HVD/HRD subgroup, its M1 population was included in a sensitivity analysis.

Results

The results for HRD/HVD suggested improvement with ADT+AA+P vs DOC+ADT in OS (HR 0.84) and in rPFS (HR 0.73), with Bayesian probabilities (P) for ADT+AA+P 86.8% (OS) and 99.2% (rPFS) more effective. Main results were consistent with all sensitivity analysis results (Table).Table:

803P

ADT+AA+P vs ADTADT+DOC vs ADTADT+AA+P vs ADT+DOC
LATITUDECHAARTEDGETUG- AFU 15STAMPEDE
HVD & HRDHRD (ITT)HVDHVDM1HR [95%-CrI]PAA>DOC
Main analysis
OSXXX0.84 [0.63, 1.14]86.8%
rPFSXX0.73 [0.57, 0.94]99.2%
Sensitivity analysis
OSXXX0.92 [0.69, 1.23]72.2%
OSXXXX0.79 [0.61, 1.03]96.0%
rPFSXX0.80 [0.63, 1.02]96.6%

Conclusions

Our analyses suggest that ADT+AA+P has greater reduction in risk of progression and death vs ADT+DOC. In absence of head-to-head trials, indirect comparisons based on Bayesian NMA can provide useful insights to clinicians and reimbursement decision makers on the relative efficacy of treatment options for men with mHSPC.

Clinical trial identification

NCT01715285 (LATITUDE), NCT00309985 (CHAARTED), NCT00104715 (GETUG-AFU 15)

Legal entity responsible for the study

Janssen Global Services, LLC

Funding

Janssen Global Services, LLC

Disclosure

F. Saad: Honoraria, Consulting/Advisory Role and Research Funding: Janssen, Astellas, Sanofi, Bayer T. Li, T. Ito, J. Diels, P. De Porre: Employment at Janssen Research and Development Stock Ownership of Johnson & Johnson. S. Van Sanden: Employment at Janssen Research and Development Stock Ownership of Johnson & Johnson. J. Roïz: Employment: Evidera Stock ownership: Evidera. S. Abogunrin: Employment: Evidera Research Funding: Janssen, Novartis, GSK, Shire, Sanofi, Amgen, Pfizer, Bayer, Ipsen, Clovis, AstraZeneca, Boehringer Ingelheim. K. Fizazi: Honoraria, Consulting/Advisory Role: Astellas, Bayer, Clovis, Curevac, Genentech, Janssen, Orion, Sanofi. All other authors have declared no conflicts of interest.

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