A phase II randomised trial of abiraterone acetate plus prednisone in combination with docetaxel or docetaxel plus prednisone after disease progression to abiraterone acetate plus prednisone in patients with metastatic castration-resistant prostate cancer: The ABIDO-SOGUG trial.

BACKGROUND

We aimed to compare the efficacy and safety of maintaining or withdrawing abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer who had experienced cancer progression to this treatment and were beginning a docetaxel-based therapy.

PATIENTS AND METHODS

Phase II, randomised, open-label study conducted in patients with metastatic castration-resistant prostate cancer who were asymptomatic or mildly symptomatic. After open-label treatment with AAP, patients who had experienced cancer progression to AAP were randomised to 75 mg/m

RESULTS

A total of 148 patients were included in open-label treatment with AAP, and of them, 94 patients were randomised to receive either docetaxel plus AAP (intervention group; n = 47) or docetaxel plus prednisone (control group; n = 47). The 12-month radiographic progression-free survival rates did not differ between the intervention group (34.9%; 95% CI 20.7-49.2) and the control group (33.9%; 95% CI 19.5-48.3). There were no significant differences in the time to radiographic progression and the overall survival between the intervention and control groups. Grade 3-5 neutropenia with the combination of docetaxel plus prednisone and AA was more frequent than with docetaxel plus prednisone (59.6% versus 27.7%).

CONCLUSION

Our results indicate that the therapeutic strategy of maintaining AAP added to docetaxel in chemotherapy-naïve patients who have experienced cancer progression to AAP treatment should not be further evaluated and should be avoided in clinical practice.

CLINICAL TRIALS

NCT02036060 https://clinicaltrials.gov/ct2/show/NCT02036060.

Informations de copyright

Copyright © 2022 Elsevier Ltd. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest statement The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: M-AC: advisory role from BMS, MSD, Bayer, EUSA, Pfizer, Merck, Roche, Janssen, Ipsen, Astellas, Astra Zeneca; has received honoraria from Ipsen, Astella, Janssen, BMS, MSD, Pfizer, Merck, Roche, EUSA, AstraZeneca. AF: research grants from Astra-Zeneca, Pierre-Fabre; consulting honorarium from Astellas; advisory honorarium from Janssen, Eusa, Astellas, Sanofi, Roche, Astra-Zeneca; and travel grants from Roche, Sanofi, Astellas. ID: Astellas, Invited Speaker, Personal, I have participated in compensated educational activities for this company in the last two years. ASTELLAS, Advisory Board, Personal, I have participated in different compensated advisory boards over the last two years. Bristol Myers Squibb, Advisory Board, Personal, I have served as an advisor for this company in the last two years. Bristol Myers Squibb, Invited Speaker, Personal, I have participated in different compensated educational activities sponsored by this company over the last two years. EUSA PHARMA, Invited Speaker, Personal, I have participated in educational activities sponsored by this company in the last two years. Immunomedics, Inc., Advisory Board, Personal, I have collaborated as an advisor for this company over the last two years. IPSEN, Invited Speaker, Personal, I have participated in different compensated educational activities sponsored by this company over the last two years. Ipsen, Advisory Board, Personal, I have collaborated as an advisor in different occasions over the last two years. Jansen, Invited Speaker, Personal, I have participated in different compensated educational activities sponsored by Jansen over the last two years. Merck, Advisory Board, Personal, I have collaborated as an advisor for this company in the last two year. MSD, Advisory Board, Personal, I have served as an advisor for this company in the last two years. MSD, Invited Speaker, Personal, I have participated in educational activities sponsored by this company in the last two years. Novartis, Invited Speaker, Personal, I have participated in educational activities sponsored by Novartis in the last 2 years. PFIZER, Invited Speaker, Personal, I have participated in different compensated educational activities sponsored by Pfizer over the last two years. Roche Genentech, Advisory Board, Personal, I have served as an advisor for this company in the last two years. Astra Zeneca, Research Grant, Personal and Institutional, Financial interest, AZ has funded research conducted in my institution related to a project where I am the PI. Immunomedics, Inc., Steering Committee Member, Personal, Financial interest, I serve as a member of a SC for a trial sponsored by this company. ROCHE GENENTECH, Research Grant, Personal and Institutional, Financial interest, Roche has funded research in my institution to projects under my coordination. Non-Financial Interests ASEICA, Member of Board of Directors, I belong as a external advisor to the board of directors of the Spanish Association of cancer research since 2021. GO NORTE, Leadership Role, I am the president of an independent cooperative group of GU Oncologist from the north of Spain. JP: Honoraria for speaker engagements, advisory roles or continuous medical education: Astellas, Astra Zeneca, Janssen, MSD, Bayer, Pfizer, Eisai, Ipsen, Sanofi, Roche, BMS, Pierre Fabre, Merck; Research Funding: Astellas, Pfizer; Consultant: Astellas, Roche. MJM-V: Invited speaker from Janssen-Cilag, Bayer healthcare, Sanofi Aventis, Astellas Medivation, Roche, Ipsen, Novartis, Pfizer, MSD; Advisory role from Janssen-Cilag, Bayer healthcare, Sanofi Aventis, Astellas Medivation, Roche, Ipsen, EISAI, Novartis, Pfizer, MSD; Travel support from Roche, Ipsen. JAAA: Advisory board: Janssen, Merck, MSD, BMS, Pfizer, Astellas; Speaker Honoraria: Merck, Pfizer, BMS; Travel accommodation: Merck, MSD, Janssen, Astellas. AG-D-A: has received research funding from Astellas, travel grants from Astellas, Jansen, Sanofi, BMS, Roche, Pfizer and Ipsen and honoraria for speaker engagements, advisory boards and continuous medical education from Janssen, Astellas, Sanofi, Bayer, Roche, Ipsen, BMS, MSD, Pfizer, Eusa Pharma, Eisai and Astra Zeneca. AS-H: Honoraria from BMS, MSD, AstraZeneca, Roche, Janssen, Sanofi, Pfizer, Lilly and Novartis; Consulting or advisory accommodations and expenses from BMS, MSD, AstraZeneca, Roche, Janssen, Sanofi, Pfizer, Lilly and Novartis; Speakers’ bureau from BMS, MSD, AstraZeneca, Roche, Janssen, Sanofi, Pfizer, Lilly and Novartis. MJJF: Advisory member from Janssen, BMS; Speaker honorarium from Janssen, Sanofi, BMS, GPPharm, Pierre-Fabre; Advisory honorarium from Novartis, Janssen, BMS. TA-G: Scientific Consultancy Role (speaker and advisory role) and travel grant: IPSEN, Pfizer, Roche, Bayer, Sanofi, Janssen, Astellas, Eisai, Adacap, Lilly, Novartis, BMS; Research grants: Roche, Pfizer, IPSEN. BMG: Speakers’ Bureau: Roche, Sanofi, Janssen, Astellas, Pfizer, Novartis, Bristol-Myers Squibb and Ipsen; Research Funding: Roche, Bayer and Janssen. PM: Research grant from Roche, Bayer; Speaker honorarium from Janssen; Advisory honorarium from Janssen, Bayer, Astellas, Pfizer, BMS. ML-Q: Consultant or Advisory Role: BMS, MSD, Takeda, Roche, Pfizer, Roche, Ipsen, Astra-Zéneca, Boehringer, Pierre-Fabré, Bayer; Speaking: Roche, Ipsen, Lilly, Astellas, Janssen, Novartis, Boehringer, BMS; Grant or travel support: MSD, Ipsen, Roche, Janssen, Pfizer, Astellas, Pierre-Fabré; Participation in clinical trials: Merck, Astellas, Pfizer, Ipsen, Roche, Mirati. JC-E: Advisory board member for ASTELLAS, JANSSEN, ASTRAZÉNECA, BRISTOL-MYERS, MSD; Speaker honorarium from ASTELLAS, JANSSEN, ASTRAZÉNECA, BRISTOL-MYERS, MSD IPSEN, PFIZER. BP-V: Consultancy from Astellas Parma; honoraria from Pierre Fabre; travel/accommodations expenses covered or reimbursed from Janssen-Cilag and Pfizer. CG: Speaker honorarium from Janssen, Pfizer, BMS, Astellas, Bayer; Consulting honorarium from Janssen, Pfizer, BMS, Astellas, Bayer; Advisory honorarium from Janssen, Astellas, Bayer, Sanofi, Roche; Travel grants from Pfizer, Roche. DC: ASTELLAS, Advisory Board, Personal; ASTRA ZENECA, Advisory Board, Personal; BMS, Advisory Board, Personal; GSK, Advisory Board, Personal; IPSEN, Advisory Board, Personal; JANSSEN, Advisory Board, Personal; MSD, Advisory Board, Personal; NOVARTIS, Advisory Board, Personal; Pfizer, Advisory Board, Personal; ROCHE, Advisory Board, Personal. ASTELLAS, Local PI, Institutional, No financial interest; ASTRA ZENECA, Local PI, institutional, No financial interest; BAYER, Local PI, Institutional, No financial interest; BMS, Local PI, Institutional, No financial interest; CLOVIS, Local PI, Institutional, No financial interest; EISAI, Local PI, Institutional, No financial interest; EXELISIS, Local PI, Institutional, No financial interest; GSK, Local PI, Institutional, No financial interest; IPSEN, Local PI, Institutional, No financial interest; JANSSEN, Local PI, Institutional, No financial interest. LILLY, Local PI, Institutional, No financial interest; MSD, Local PI, Institutional, No financial interest; PFIZER, Local PI, Institutional, No financial interest; QED Therapeutics, Local PI, Institutional, No financial interest; ROCHE, Local PI, Institutional, No financial interest. MIS, CSL and EE report no conflict of interest.