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Genitourinary tumours, prostate

1623 - Benefits of Abiraterone Acetate Plus Prednisone (AA+P) When Added to Androgen Deprivation Therapy (ADT) in LATITUDE on Patient (Pt) Reported Outcomes (PRO)

Date

08 Sep 2017

Session

Genitourinary tumours, prostate

Topics

Cytotoxic Therapy;  Prostate Cancer

Presenters

Kim Chi

Citation

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

Authors

K. Chi1, A. Protheroe2, A. Rodriguez Antolin3, G. Facchini4, H. Suttmann5, N. Matsubara6, Z. Ye7, B. Keam8, T. Li9, K. McQuarrie10, B. Jia11, P. De Porre12, J. Martin13, M.B. Todd9, K. Fizazi14

Author affiliations

  • 1 Medical Oncology, BC Cancer Agency - Vancouver Centre, V5Z 4E6 - Vancouver/CA
  • 2 Oncology, The Churchill Hospital Oxford University Hospitals NHS Trust, Oxford/GB
  • 3 Urology, Hospital Universitario 12 de Octubre, Madrid/ES
  • 4 Uro-gynecological, Istituto Nazionale Tumori – I.R.C.C.S. - Fondazione Pascale, 80131 - Naples/IT
  • 5 Urology, Urologikum Hamburg, Hamburg/DE
  • 6 Breast And Medical Oncology, National Cancer Center Hospital East, Chiba/JP
  • 7 Urology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology, Wuhan/CN
  • 8 Genitourinary, Seoul National University Hospital, Seoul/KR
  • 9 Oncology, Janssen Global Services, Raritan/US
  • 10 Patient Reported Outcome Group, Janssen Research & Development, Horsham/US
  • 11 Biostatistics, Janssen Research & Development, Shanghai/CN
  • 12 Clinical Oncology, Janssen Research & Development BE, Beerse/BE
  • 13 Clinical Oncology, Janssen Research & Development, Buckinghamshire/GB
  • 14 Cancer Medicine, Institut Gustave Roussy, University of Paris Sud, Villejuif/FR
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Abstract 1623

Background

In the LATITUDE study, treatment with ADT+AA+P significantly improved overall survival and delayed disease progression in pts with newly diagnosed, high-risk, metastatic castration-naïve prostate cancer (mCNPC). In this analysis we evaluated the impact of ADT+AA+P on PROs, including symptom and health-related quality of life (HRQoL) measures.

Methods

1199 mCNPC pts were randomized 1:1 to ADT + AA+P or ADT + placebos (PBOs). Brief Pain Inventory-Short Form (BPI-SF), Brief Fatigue Inventory (BFI), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and EQ-5D-5L questionnaires were administered at baseline (BL), Day 1 of Cycles (C) 2-13, then every 2 months until treatment discontinuation (TD). EQ-5D-5L were performed every 4 months until 12 months after TD. Time to event and repeated measures analyses on changes from baseline were conducted.

Results

Questionnaire compliance rate was high at ≥ 90%. Compared to ADT+PBOs, the ADT+AA+P arm had significant delayed time to pain and fatigue intensity and interference progression (Table). FACT-P assessments demonstrated significant delay in degradation for the total score and symptom subscales for the ADT+AA+P arm (Table). Repeated measures analyses showed maintenance or improvement from BL for the ADT+AA+P arm compared to the ADT+PBOs arm, with significant differences emerging as early as C2. Significant improvement from BL in EQ-5D VAS for general health status and health utility scores occurred as early as C5 and was maintained throughout the study.

Conclusions

Compared with ADT+PBOs, treatment with ADT+AA+P consistently demonstrated improvement across multiple PRO measures, with statistically significant improvement in HRQoL and delays in progression of pain fatigue intensity and interference, and functional decline. Results for PROs were consistent with improvements in clinical outcomes.

Clinical trial identification

EudraCT: 2012-002940-26 NCT01715285

Legal entity responsible for the study

Janssen Research & Development

Funding

Janssen Research & Development

Disclosure

K. Chi: Consulting/Advisory Role: Janssen Research Funding: Janssen A. Protheroe: Consulting/Advisory Role: IPSEN, Bayer, Roche, BMS Research Funding: Merck Travel, Accommodations, Expenses: BMS A. Rodriguez Antolin: Consulting/Advisory Role: Astellas, Janssen, Bayer Speaker's Bureau: Astellas, Janssen Travel, Accommodations, Expenses: Astellas, IPSEN Pharma H. Suttmann: Honoraria, Consulting/Advisory Role, Research Funding: Astellas, Bayer Health Care, Bristol-Myers-Squibb, Ipsen, Janssen-Cilag, Medac, Santorin-Aventis N. Matsubara: Consulting/Adisory Role: MSD, AstraZeneca, Eisai, Ono, Kissei, Sanofi, Taiho, Takeda, Chugai, Novartis, Bayer, Yakuhin, Pfizer Japan, Merck, Serono, Janssen - Research Funding: Shionogi, Bayer, Yakuhin, Janssen, Chugai, Eli Lilly Japan, Eisai, MSD Z-Q. Ye: Consulting/Adisory Role: MSD, AstraZeneca, Eisai, Ono, Kissei, Sanofi, Taiho, Takeda, Chugai, Novartis, Bayer, Yakuhin, Pfizer Japan, Merck, Serono, Janssen - Research Funding: Shionogi, Bayer, Yakuhin, Janssen, Chugai, Eli Lilly Japan, Eisai, MSD T. Li, P. De Porre, J. Martin: Employment at Janssen Research and Development Stock Ownership of Johnson & Johnson K. McQuarrie, B. Jia, M.B. Todd: Employment at Janssen Research and Development Stock Ownership of Johnson & Johnson K. Fizazi: Honoraria, Consulting/Advisory Role: Astellas, Bayer, Clovis, Curevac, Genentech, Janssen, Orion, Sanofi All other authors have declared no conflicts of interest.

Disclosure

K. Chi: Consulting/Advisory Role: Janssen Research Funding: Janssen A. Protheroe: Consulting/Advisory Role: IPSEN, Bayer, Roche, BMS Research Funding: Merck Travel, Accommodations, Expenses: BMS A. Rodriguez Antolin: Consulting/Advisory Role: Astellas, Janssen, Bayer Speaker\'s Bureau: Astellas, Janssen Travel, Accommodations, Expenses: Astellas, IPSEN Pharma H. Suttmann: Honoraria, Consulting/Advisory Role, Research Funding: Astellas, Bayer Health Care, Bristol-Myers-Squibb, Ipsen, Janssen-Cilag, Medac, Santorin-Aventis N. Matsubara: Consulting/Adisory Role: MSD, AstraZeneca, Eisai, Ono, Kissei, Sanofi, Taiho, Takeda, Chugai, Novartis, Bayer, Yakuhin, Pfizer Japan, Merck, Serono, Janssen - Research Funding: Shionogi, Bayer, Yakuhin, Janssen, Chugai, Eli Lilly Japan, Eisai, MSD Z-Q. Ye: Consulting/Adisory Role: MSD, AstraZeneca, Eisai, Ono, Kissei, Sanofi, Taiho, Takeda, Chugai, Novartis, Bayer, Yakuhin, Pfizer Japan, Merck, Serono, Janssen - Research Funding: Shionogi, Bayer, Yakuhin, Janssen, Chugai, Eli Lilly Japan, Eisai, MSD T. Li, P. De Porre, J. Martin: Employment at Janssen Research and Development Stock Ownership of Johnson & Johnson K. McQuarrie, B. Jia, M.B. Todd: Employment at Janssen Research and Development Stock Ownership of Johnson & Johnson 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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