584P - Health-related quality of life (HRQoL) in ACIS: A phase III trial of apalutamide with abiraterone acetate and prednisone (APA + AAP) vs AAP in metastatic castration-resistant prostate cancer (mCRPC)

Background

In the updated analysis of radiographic progression-free survival (rPFS) in ACIS, median rPFS (primary end point) was extended by 7.4 mo with APA + AAP vs AAP with ongoing androgen deprivation therapy (p < 0.0001) in chemo-naive mCRPC patients (pts), with no significant new safety signals identified (Rathkopf ASCO GU 2021). Here we evaluate pt HRQoL.

Methods

982 mCRPC pts were randomized 1:1 to APA (240 mg QD) + AA (1000 mg QD) + P (5 mg BID) or placebo + AAP. HRQoL: assessed by Functional Assessment of Cancer Therapy-Prostate (FACT-P) at cycle (C)1 (baseline [BL]) to C6, then every 3C to 12 mo after end of treatment (EOT); and Brief Pain Inventory-Short Form (BPI-SF) for 7 consecutive days each C to EOT. Descriptive statistics and mean changes from BL using mixed model for repeated measures (LSM-MMRM) are reported.

Results

Completion rates: FACT-P, 67-75% (BL-C39); BPI-SF, 60-98% (BL-C43). There were no clinically meaningful differences between groups in LSM-MMRM for FACT-P total. BPI worst pain intensity and pain interference increased over time in both groups, with no clinically meaningful differences (threshold: ± 2 points). Median time to deterioration did not differ between groups for FACT-P total (HR 1.16, 95% CI 0.94-1.42), worst pain intensity (HR 1.11, 95% CI 0.92-1.34), and pain interference (HR 1.19, 95% CI 0.95-1.47). Most pts (90-96%) were “not at all” or “a little bit” bothered by side effects; most (70-79%) responded to “I have lack of energy” with “not at all” or “a little bit” (BL-C39). Side effect bother and fatigue were stable over time and comparable between groups. PRO scores were similar in both groups prior to radiographic progression of disease (rPD) and at last observation (Table). Table: 584P

^aPRO score prior to rPD ^b257 (APA + AAP) and 330 (AAP) pts had rPD ^cLast PRO score ^dHigher PRO score: more favorable HRQoL ^eHigher BPI score: worse pain-related outcome SE, standard error

Conclusions

Relative to AAP, treatment intensification with APA + AAP maintained HRQoL prior to rPD. The addition of APA to AAP significantly improved rPFS without compromising HRQoL in pts with mCRPC.

Clinical trial identification

NCT02257736.

Editorial acknowledgement

Ann Tighe, PhD, of Parexel International provided editorial assistance for this abstract.

Legal entity responsible for the study

Janssen.

Funding

Janssen.

Disclosure

S.M. Oudard: Financial Interests, Personal, Advisory Role: Pfizer, Bayer, Bristol-Meyers Squibb, Novartis, Eisai, Sanofi, Janssen, Astellas Pharma, MSD Oncology, Roche, Boehringer Ingelheim, Ipsen; Financial Interests, Personal, Other, Honoraria: Pfizer, Bayer, Merck, Bristol-Meyers Squibb, Novartis, Eisai, Sanofi, Astellas Pharma, Janssen, MSD, Ipsen, Roche/Genentech; Financial Interests, Personal, Funding, Research: Ipsen, Sanofi; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Pfizer, Bayer, Merck, Bristol-Myers Squibb, Novartis, Eisai, MSD oncology, Roche, Boehinger Ingelheim. K.B. Bevans: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. G. Attard: Financial Interests, Personal, Advisory Role: Janssen-Cilag, Veridex, Ventana Medical Systems, Astellas Pharma, Medivation, Novartis, Millennium, Abbott Laboratories, Essa, Bayer, Pfizer, AstraZeneca, Ferring; Financial Interests, Personal, Speaker’s Bureau: Janssen, Astellas Pharma, Takeda, Sanofi, Ventana Medical Systems, Ipsen, AstraZeneca, Ferring; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Janssen, Astellas Pharma, Medivation, Ventana Medical Systems, Abbott Laboratories, Bayer, ESSA, Pfizer Ferring; Financial Interests, Personal, Royalties: I am on The ICR rewards to inventors list of abiraterone acetate, Institute of Cancer Research; Financial Interests, Personal, Other, Honoraria: Janssen, Astellas Pharm; Financial Interests, Personal, Research Grant: Janssen, Arno Therapeutics, Innocrin Pharma. E. Efstathiou: Financial Interests, Personal, Other, Honoraria: Janssen-Cilag; Financial Interests, Personal, Advisory Board: Janssen-Cilag, AstraZeneca, Sanofi, Merck; Financial Interests, Personal, Speaker’s Bureau: Janssen Biotech, Sanofi Pasteur, AstraZeneca. T.W. Flaig: Financial Interests, Personal, Advisory Role: Seattle Genetics, Janssen Oncology; Financial Interests, Personal, Leadership Role: Aurora Oncology; Financial Interests, Personal, Royalties: The University of Colorado has filed 2 patents related in which I am an inventor. These are related to early-stage bladder cancer treatment and detection. Neither is commercialized or licensed at this time; Financial Interests, Personal, Stocks/Shares: Norvartis, Bavarian Nordic, Dendreon, GTx, Janssen Oncology, Medivation, Sanofi, Pfizer, Bristol-Myers Squibb, Roche/Genentech, Exelixis, Aragon Pharmaceuticals, Sotio, Tokai Pharmaceuticals, AstraZeneca/Medimmune, Lilly, Astellas Pharma, Agensys, Seattle. O.B. Goodman Jr: Financial Interests, Personal, Advisory Role: Janssen Oncology, Bayer; Financial Interests, Personal, Stocks/Shares: Bristol-Myers Squibb, Abbvie. U. De Giorgi: Financial Interests, Personal, Advisory Board: Astellas, Bayer, BMS, Ipsen, Janssen, Merck, Pfizer, Sanofi; Financial Interests, Personal, Other, Travel: BMS, Ipsen, Janssen, Pfizer; Financial Interests, Personal, Funding, Research: AstraZeneca, Roche, Sanofi. C.M. Pieczonka: Financial Interests, Personal, Advisory Role: Pfizer/Astellas, Bayer, Janssen Oncology, Tolmar, Sun Pharma, Dendreon, AstraZeneca, Merck, Bristol-Myers Squibb; Financial Interests, Personal, Leadership Role: Associated Medical Professionals of New York; Financial Interests, Personal, Speaker’s Bureau: Bayer, Dendreon, Pfizer, Astellas Pharma, Merck, Sun Pharma, Myovant Sciences, Tolmar, Janssen Oncology; Financial Interests, Personal, Stocks/Shares: US Urology Partners; Financial Interests, Personal, Other, Honoraria: Janssen, Dendreon, Pfizer/Astellas, Bayer, Sun Pharma, Tolmar, Myovant Sciences, Merck, AstraZeneca, Bristol-Myers Squibb; Financial Interests, Personal, Funding, Research: Bayer, Innocrin Pharma, Pfizer, Astellas Pharma, Merck, AstraZeneca, Advantagene, Dendreon, Janssen Oncology; Financial Interests, Personal, Full or part-time Employment: Associated Medical Professionals of New York. K. Yeruva: Financial Interests, Personal, Full or part-time Employment: Janssen Research & Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. P. De Porre: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. S.D. Brookman-May: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. S. Dibaj: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. D. Wu: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. S.D. Mundle: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. S. McCarthy: Financial Interests, Personal, Full or part-time Employment: Janssen Research and Development; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. T. Steuber: Financial Interests, Personal, Other, Honoraria: Janssen, LLC; Financial Interests, Personal, Advisory Board: Janssen, LLC; Financial Interests, Personal, Speaker’s Bureau: Janssen, LLC; Financial Interests, Personal, Other, Travel, Accommodations, Expenses: Janssen, LLC. H. Suzuki: Financial Interests, Personal, Other, Honoraria: Takeda, Astellas Pharma, Janssen, Bayer, Sanofi, AstraZeneca, Nippon Shinyaku, Pfizer; Financial Interests, Personal, Advisory Board: Takeda, Ono Pharmaceutical, AstraZeneca, Lilly, Janssen, MSD, Roche, Bayer, Sanofi, Astellas Pharma, Sumitomo Group; Financial Interests, Personal, Other, Research Funding: Takeda, Astellas Pharma, Nippon Shinyaku, Kissei Pharmaceutical, Taiho Oncology, Sanofi, Bayer, Daiichi Sankyo. D.E. Rathkopf: Financial Interests, Personal, Advisory Board: Janssen, Genentech, AstraZeneca, Bayer, Myovant Sciences; Financial Interests, Personal, Funding: Janssen Oncology, Medivation, Celgene, Takeda, millennium, Ferring, Novartis, taiho Pharmaceutical, AstraZeneca, Genentech/Roche, TRACON Pharma, Bayer, Phosplatin Therapeutics. F. Saad: Financial Interests, Personal, Other, Honoraria: AbbVie, Amgen, Astellas, AstraZeneca/MedImmune, Bayer, Janssen, Sanofi; Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca/MedImmune, Bayer, Janssen, Sanofi; Financial Interests, Personal, Research Grant: Astellas, AstraZeneca/MedImmune, Bayer, Bristol-Myers Squibb, Janssen, Pfizer, Sanofi. All other authors have declared no conflicts of interest.