1361MO - 8-month PSA strongly predicts outcomes of men with metastatic castration-sensitive prostate cancer in the PEACE-1 phase III trial

Background

Addition of abiraterone acetate plus prednisone (AAP) to androgen deprivation therapy (ADT) with or without docetaxel (D), improved overall survival (OS) in men with de novo metastatic castration sensitive prostate cancer (mCSPC) in the PEACE-1 phase 3 trial (Lancet 2022; April 8). The 8-months PSA decline to undetectable levels has been associated with improved OS and radiological progression-free survival (rPFS) in mCSPC men treated with ADT plus D or AAP. We assessed the association of 8-months PSA value with rPFS and OS in mCSPC men treated in PEACE-1 with the triplet systemic association: ADT+D+AAP.

Methods

It is a preplanned analysis of data from 1172 men receiving ADT+/- D +/- AAP. The analysis required a PSA at 8 months from ADT initiation. Data cut off was 1^st June 2021. rPFS and OS were assessed overall, and then by randomization groups. The analysis was performed for the following 8-month PSA cut-offs: 0.2 and 4 ng/ml. Median values of rPFS and OS were calculated from 8 months-PSA using the Kaplan Meier method.

Results

PSA values at 8 months after ADT initiation were available in 931 men (79%). Standard of care was ADT + D in 62% and 56% had “high volume” disease. The median follow-up was 4.4 years (95% CI [4.3-4.5]). Results are in the table. Table: 1361MO

∗p<.0001 ∗∗0.0007 NR: Not reach, CI: confidence interval.

Conclusions

8-month PSA value strongly predicts both rPFS and OS in men with mCSPC in PEACE-1. Early therapeutic intervention in men with unfavorable 8-month PSA values needs to be investigated.

Clinical trial identification

NCT01957436.

Editorial acknowledgement

Legal entity responsible for the study

UNICANCER.

Funding

Janssen Pharmaceutical NV, Ipsen, Sanofi, French Academic Institution Financial support (PHRC).

Disclosure

G. Gravis Mescam: Financial Interests, Institutional, Advisory Board: AAA, Alliance Merck-Pfizer, Astellas, BMS, Janssen, Pfizer, ipsen, alliance Merck Pfizer; Financial Interests, Institutional, Invited Speaker: AAA, Amgen, Astellas, BMS, Janssen, MSD, Pfizer, Sanofi, Ipsen, AstraZeneca, BMS; Financial Interests, Institutional, Funding: Janssen; Non-Financial Interests, Principal Investigator: Ipsen, BMS, Merck. G. Roubaud: Financial Interests, Personal, Invited Speaker: Astellas, Ipsen, Sanofi, Janssen. R.S. McDermott: Financial Interests, Personal, Advisory Board: Pfizer, Amgen, BMS, Bayer, Janssen, Clovis; Financial Interests, Personal, Invited Speaker: MSD, Ipsen, Astellas; Financial Interests, Institutional, Invited Speaker: MSD, Clovis, BMS, Regeneron, Bayer, Astellas. A. Flechon: Financial Interests, Personal, Expert Testimony: Sanofi, AstraZeneca, Astellas, Janssen, AAA, Bayer; Financial Interests, Personal, Invited Speaker: Novartis. B. Tombal: Financial Interests, Personal, Advisory Board: Astellas, Bayer, Amgen, Janssen, Sanofi, Myovant, Novartis (AAA), Pfizer, MSD, AstraZeneca; Financial Interests, Personal, Invited Speaker: Astellas, Amgen, Ferring; Financial Interests, Personal, Expert Testimony: Astellas; Non-Financial Interests, Invited Speaker, Past President: European Organisation of Research and Treatment of Cancer (EORTC); Non-Financial Interests, Invited Speaker, Education in the field of Oncology: ISSECAM. S. Supiot: Financial Interests, Personal, Invited Speaker: Bayer, Janssen, Astellas, Ipsen, Sanofi; Financial Interests, Personal, Leadership Role: Bayer; Financial Interests, Institutional, Principal Investigator: AstraZeneca, Janssen, Astellas; Financial Interests, Personal, Project Lead: AstraZeneca, Janssen, Astellas. D.R. Berthold: Financial Interests, Institutional, Invited Speaker: Astellas, Janssen; Financial Interests, Institutional, Advisory Board: MSD, Ipsen, Bayer, BMS, Roche. G. Kacso: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, Johnson & Johnson, Sanofi; Financial Interests, Personal, Invited Speaker: Novartis; Financial Interests, Personal, Officer: Amethyst; Financial Interests, Personal, Royalties: Astellas, AstraZeneca, Johnson & Johnson, Merck/ MSD, Novartis, Sanofi. F. Calabrò: Financial Interests, Personal, Advisory Board: BMS, MSD, AstraZeneca, Ipsen, Merck, Pfizer; Financial Interests, Institutional, Principal Investigator: Parexel, AstraZeneca, BMS, Syneos, MSD, PRA, IQVIA, Pfizer, J and J, Janssen, ICON, Roche, Eisai, Bayer. J.F. Berdah: Financial Interests, Personal, Invited Speaker: Janssen Cilag, Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Astellas. A. Thiery-Vuillemin: Financial Interests, Personal, Advisory Board, & public speaking: Pfizer, astrazeneca, Janssen, Ipsen, Bristol Myers Squibb; Financial Interests, Personal, Advisory Board: Sanofi, Novartis, Roche/Genentech, MSD, Astellas Pharma; Financial Interests, Institutional, Funding: Pfizer, Ipsen, Bayer; Financial Interests, Institutional, Invited Speaker: Pfizer, AstraZeneca, Sanofi, JNJ, Novartis, Ipsen, Roche, BMS, MSD, Astellas Pharma, Excelixis, UNICANCER / GETUG, Incyte; Financial Interests, Invited Speaker: AstraZeneca, Novartis, BMS; Non-Financial Interests, Member: ASCO, GETUG; Other, Travel, Accommodations: Roche, MSD, JNJ, BMS, AstraZeneca, Pfizer, Astellas Pharma, Ipsen. A. Rodriguez-Vida: Financial Interests, Personal, Invited Speaker: Roche, MSD, Pfizer, BMS, Astellas, Janssen, Bayer, Clovis, AstraZeneca, Sanofi; Financial Interests, Personal, Principal Investigator: Takeda, Pfizer, Merck. K. Fizazi: Financial Interests, Institutional, Advisory Board: Astellas, Bayer, Janssen, AAA, MSD, AstraZeneca, Novartis/AAA, Pfizer; Financial Interests, Institutional, Invited Speaker: Astellas, Bayer, Janssen, Sanofi, MSD, AstraZeneca, Novartis, Pfizer; Financial Interests, Personal, Advisory Board: Curevac, Orion; Financial Interests, Institutional, Research Grant, Trial chair: Pfizer, Bayer, AstraZeneca, Orion, MSD, BMS, Janssen; Non-Financial Interests, Principal Investigator, Chair of the 7DX phase 3 trial: BMS; Non-Financial Interests, Principal Investigator, Chair of the Docetaxel-pembrolizumab phase 3 trial: Merck; Non-Financial Interests, Principal Investigator, Chair of the Darolutamide BCR phase 3 trial: Bayer; Non-Financial Interests, Principal Investigator, Chair of the PSMAfore phase 3 trial: AAA/Novartis; Non-Financial Interests, Principal Investigator, Chair of the CYPIDES ODM-208 Phase I-II trial: Orion; Non-Financial Interests, Principal Investigator, Chair of the STESIDES ODM-209 Phase I-II trial: Orion. All other authors have declared no conflicts of interest.