1627P - Long survivors after androgen deprivation therapy (ADT) with or without docetaxel for metastatic castration-sensitive prostate cancer (mCSPC): Long-term follow-up of GETUG-15

Background

During the last decade, systemic treatment intensification (doublets or triplets) has become standard for men with mCSPC based on results from phase 3 trials and GETUG 15 (NCT00104715) was the very first trial that established progression-free survival improvement using ADT+docetaxel in these patients (Gravis G, Lancet Oncol 2013). Data on long-term mCSPC survivors are currently scarce and questions arise regarding the risk/benefit balance of continuous systemic treatments, as well as that of local treatments.

Methods

Twelve centers comprising a restricted population of 280 patients enrolled in GETUG 15 between 2004 and 2008, agreed on collecting clinical and biological data of patients known as being still alive at the time of the final trial analysis in April 2015.

Results

Baseline characteristics of the restricted population were comparable to those of the overall GETUG-15 population. Overall, 89 patients (32%) were still alive in April 2015 and represent the long-term survivors population. The current median follow-up time for these men is 13 years (range: 6.4-19 years). Among these men, 44 developed castration-resistance (mostly before April 2015) while the remaining 45 patients (16% of the restricted population) still had castration-sensitive disease at last follow-up. ADT was discontinued in 25 patients (28.1% of the long-term survivors population) mainly due to continuous remission, after a median time of treatment of 6.3 years (range: 1.6-15.5 years). The median duration of treatment discontinuation was 5.6 years, with 15 patients never resuming ADT. A recovery of serum testosterone > 0.5 ng/mL was achieved in 10/25 patients (40%) following discontinuation. In this restricted population, ADT+docetaxel improved overall survival in high-volume patients (HR of 0.689 [0.486-0.977], p = 0.035).

Conclusions

To our knowledge, this study is the first to report very long-term data over 10 years of follow-up with modern management for men with mCSPC. ADT was most frequently continued in men with long-term remission in GETUG-15 and this provides a contemporaneous benchmark for ongoing studies testing early systemic treatment discontinuation.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Institut Gustave Roussy.

Funding

Has not received any funding.

Disclosure

K. Fizazi: Financial Interests, Institutional, Advisory Board: Astellas, Bayer, Janssen, AAA, MSD, AstraZeneca, Novartis/AAA, Pfizer, Daiichi Sankyo; Financial Interests, Institutional, Invited Speaker: Astellas, Bayer, Janssen, Sanofi, MSD, AstraZeneca, Novartis, Pfizer; Financial Interests, Personal, Advisory Board: Curevac, Orion; Financial Interests, Personal, Advisory Board, February 2022: Arvinas; Financial Interests, Personal, Advisory Board, April 2022: Macrogenics; 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; Non-Financial Interests, Principal Investigator, Chair of the CAPITELLO 281 phase 3 trial: AstraZeneca; Non-Financial Interests, Principal Investigator, Chair of the TALAPRO-2 and TALAPRO-3 phase 3 trials: Pfizer; Non-Financial Interests, Principal Investigator, Chair of the RADIANT phase 3 trial: Bayer; Non-Financial Interests, Principal Investigator, Chair of the TRITON-3 phase 3 trial: Clovis. S. Oudard: Financial Interests, Personal, Advisory Board, consultancy, advisory role: Sanofi; Financial Interests, Personal, Invited Speaker, public speaking and advisory role: Janssen; Financial Interests, Personal, Advisory Board, advisory role and public speaking: AstraZeneca, MSD, Merck, Astellas, Ipsen, Pfizer, Roche, Genentech; Financial Interests, Personal, Advisory Board, Advisory board and public speaking: BMS, Bayer, Novartis. G. Gravis: Financial Interests, Institutional, Invited Speaker: AAA, Amgen, Astellas, BMS, Janssen, MSD, Pfizer, Ipsen, AstraZeneca, alliance Merck Pfizer, Bayer, Eisai; Financial Interests, Institutional, Advisory Board: Alliance Merck-Pfizer, BMS, Janssen, Pfizer, Ipsen, Bayer, EISAI; Financial Interests, Institutional, Funding: Janssen; Financial Interests, Institutional, Coordinating PI: BMS; Non-Financial Interests, Principal Investigator: Ipsen, BMS, Merck. D. Borchiellini: Financial Interests, Personal, Advisory Board: Astellas, AstraZeneca, Bristol Myer Squibb, Ipsen, Janssen, Merck, Pfizer; Financial Interests, Institutional, Advisory Board: Bayer, MSD; Financial Interests, Personal, Invited Speaker: Accord HealthCare; Financial Interests, Institutional, Local PI, Clinical Research: Astellas, AstraZeneca, Bayer, Bristol Myer Squibb, Exelixis, Infinity, Janssen, MSD, Roche, Taiho Oncology; Financial Interests, Institutional, Local PI: Aveo, Gilead, Seagen. S. Foulon: Financial Interests, Institutional, Advisory Board, Participation to the advisory board (statistical advice) of an epidemiological study performed by Gilead on real world data (medico-administrative data): Review and validation of the study protocol, validation of the study population, as well as the review and validation of the results and of the study report: Gilead. P. Beuzeboc: Financial Interests, Invited Speaker: Astellas, Zeneca, Bayer. L. Mourey: Financial Interests, Personal, Advisory Board: Astellas, Janssen, MSD, BMS, Ipsen, AstraZeneca, Pfizer, AAA. B. Laguerre: Financial Interests, Personal, Other, ASCO GU symposium 2023 (travel and registration): Pfizer; Financial Interests, Personal, Other, honoraria: Astellas, Janssen, Pfizer, Eisai, Bayer; Financial Interests, Personal, Other, registration ASCO virtual meeting 2022: BMS; Financial Interests, Personal, Other, registration ASCO GU symposium 2022 (virtual): MSD; Financial Interests, Personal, Other, registration and travel for ASCO meeting 2023: AstraZeneca; Financial Interests, Personal, Other, registration and travel meeting ASCO GU 2024: Ipsen; Financial Interests, Personal, Other, registration virtual meeting EMOS 2023: MSD. D. Tosi: Financial Interests, Institutional, Advisory Board: Mabqi, Vertical; Financial Interests, Institutional, Coordinating PI, preclinical research grant: Ipsen, Bayer; Financial Interests, Institutional, Local PI, Compensations for local PI role in clinical trials: Several pharmaceutical companies; Non-Financial Interests, Leadership Role: Fondazione Gianni Bonadonna; Non-Financial Interests, Advisory Role: CyteaBio, Phost'in, Revolution Medicines, Brenus Pharma, Italian Ministry of health, Cancéropôle PACA, Qu Biologics; Non-Financial Interests, Institutional, Product Samples, drug for research purposes: Ipsen, Bayer; Non-Financial Interests, Personal, Other, support for participation to scientific meetings: Several pharmaceuticals companies. F. Priou: Financial Interests, Advisory Board: Daiichi Sankyo; Financial Interests, Sponsor/Funding, congres and travels: Novartis. V. Massard: Financial Interests, Personal, Advisory Board: AstraZeneca, Novartis, Eli Lilly, Pfizer, Bayer; Financial Interests, Personal, Invited Speaker: Gilead Sciences, Astellas Pharma, Janssen Pharmaceuticals, Laboratoires Pierre Fabre. All other authors have declared no conflicts of interest.