Clinical Research Papers:
Combined abiraterone acetate plus prednisone, salvage prostate bed radiotherapy and LH-RH agonists (CARLHA-GEP12) in biochemically-relapsing prostate cancer patients following prostatectomy: A phase I study of the GETUG/GEP
Metrics: PDF 1149 views | HTML 2179 views | ?
Stéphane Supiot1, Loic Campion1, Pascal Pommier2, Mélanie Dore1, Clément Palpacuer1, Séverine Racadot2, Emmanuel Rio1, Gérard A. Milano3, Céline Mahier - Ait Oukhatar4 and Christian Carrie2
1Departments of Radiation Oncology and Biostatistics, Institut de Cancérologie de l'Ouest, Nantes, France
2Department of Radiation Oncology, Centre Léon Berard, Lyon, France
3Laboratoire d’Oncopharmacologie, Centre Antoine-Lacassagne, Nice, France
4Groupe des Essais Précoces, Unicancer, Paris, France
Stéphane Supiot, email: [email protected]
Keywords: abiraterone; prostate cancer; prostate bed radiotherapy; salvage radiotherapy; rising PSA
Received: March 24, 2018 Accepted: April 04, 2018 Published: April 24, 2018
Background: To establish the maximum tolerated dose of abiraterone acetate plus prednisone (AA) combined with salvage radiotherapy (SRT) and goserelin in a phase 1 study in men with rising PSA following radical prostatectomy.
Methods: AA was given during one month before SRT at 1000 mg PO once daily, then 750 mg (Dose Level 1, DL1) or 1000 mg (DL2) during 5 months combined with 6-months goserelin by injection on the first day of irradiation (scheme NEO) or one month before starting SRT (scheme CONCO).
Results: In scheme NEO at DL1, 2/9 patients did not achieve castration levels of testosterone. 4/9 patients (44%) presented with grade 3 liver enzyme elevation. In scheme CONCO testosterone dropped to undetectable levels. At DL1, 6 patients were recruited, with no dose limiting toxicities. At DL2, 2/3 patients presented with grade 3 liver enzyme elevation occurring during SRT.
Conclusions: When AA was administered without goserilin, only 78% achieved castration levels. AA combined with SRT and goserilin did not increase pelvic toxicity, but lead to an unsuspected high frequency of grade 3 liver toxicity. The phase II recommended dose of AA combined to goserelin and SRT is 750 mg.
All site content, except where otherwise noted, is licensed under a Creative Commons Attribution 4.0 License.