Abiraterone Plus Leuprolide Offers Edge in M0 Hormone-Naive Prostate Cancer
Abiraterone plus leuprolide compared with leuprolide decreased the risk of biochemical recurrence by 38%.
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Eight months of treatment with abiraterone (AA) plus leuprolide for biochemically recurrent non-metastatic hormone-naive prostate cancer (M0HNPC) improves PSA-free survival compared with the use of leuprolide alone, with no delay in testosterone recovery or significant safety concerns, according to data presented at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois, on Monday, June 4.1
Eleni Efstathiou, MD, and colleagues at The University of Texas MD Anderson Cancer Center in Houston, studied 197 patients with M0HNPC randomly assigned to receive AA plus leuprolide (99 men) for 8 months or leuprolide alone (98 men). Patients had a median age of 65 years (range 42-85 years). With regard to patients' definitive prostate cancer treatment, 186 (94%) patients had undergone radical prostatectomy (RP) and the remaining 11 (6%) received external beam radiation therapy (EBRT).
The median PSA-free survival time was 28.3 months (range 24.2–35.4 months) for the AA plus leuprolide recipients compared with 21.1 months (range 19.1–27.2 months) for the leuprolide-only group, Dr Efstathiou's team reported. Treatment with AA plus leuprolide was associated with a significant 38% decreased risk of biochemical recurrence compared with leuprolide alone (95% CI: 0.44–0.88; P = .007).
Dr Efstathiou and colleagues defined biochemical recurrence among RP patients as a rising PSA of 0.2 ng/mL confirmed by subsequent PSA value greater than 0.2 ng/mL. They defined biochemical recurrence in EBRT patients as nadir PSA plus 2 ng/mL.
The median time to testosterone recovery was 13.1 months for AA plus leuprolide and 12.9 months for leuprolide alone. AA plus leuprolide improved biochemical recurrence-free survival relative to leuprolide alone regardless of pretreatment PSA level, Gleason score, pathology, time to relapse from treatment, and definitive treatment type.
According to the investigators, no grade 4 adverse events or new safety concerns were reported. The most common AEs were grade 1 hot flashes (71%) and fatigue (51%), with no difference between treatment arms, the investigators noted.
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- Efstathiou E Wang X, Zurita AJ, et al. A randomized study of finite abiraterone acetate (AA) plus leuprolide (LHRHa) versus LHRHa in biochemically recurrent non metastatic prostate cancer (M0HNPC). J Clin Oncol. 2018: 36, (suppl; abstr 5002). Presented at 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL.