Bicalutamide 50mg tablets

Background and objectiveIn patients with prostate cancer treated with antiandrogen monotherapy, gynecomastia and breast pain are relatively common. In the setting of androgen receptor pathway inhibitors (ARPIs), the incidence of these adverse events (AEs) remains unclear. In addition, the effect of prophylactic treatment on gynecomastia remains uncertain. We aimed to evaluate the incidence of gynecomastia and breast pain in prostate cancer patients treated with ARPIs compared with androgen deprivation therapy (ADT) and the effect of prophylactic treatment for these AEs due to antiandrogen therapy.MethodsIn June 2024, we queried four databases-PubMed, Scopus, Web of Science, and Embase-for randomized controlled trials (RCTs) investigating prostate cancer treatments involving antiandrogen therapy. The endpoints of interest were the incidence of these AEs due to ARPIs and the effect of prophylactic treatment for these.Key findings and limitationsEighteen RCTs, comprising 5036 patients, were included in the systematic review and meta-analysis. ARPIs included enzalutamide, darolutamide, and apalutamide. The results indicated that patients who received ARPI monotherapy had a significantly higher incidence of gynecomastia than those who received ADT monotherapy (risk ratio [RR]: 5.19, 95% confidence interval [CI]: 3.58-7.51, p p = 0.2). Prophylactic tamoxifen or radiotherapy reduced significantly the incidence of gynecomastia and breast pain caused by bicalutamide monotherapy.Conclusions and clinical implicationsWe found that ARPI monotherapy increases the incidence of these AEs significantly compared with ADT. In contrast, ARPI plus ADT therapy did not result in a higher incidence of AEs. The use of either tamoxifen or radiotherapy was effective in reducing the incidence of these AEs due to bicalutamide monotherapy. These prophylactic treatments could reduce the incidence of AEs due to ARPI monotherapy. However, further studies are needed to clarify their efficacy.Patient summaryAlthough androgen deprivation therapy (ADT) improves overall survival in patients with prostate cancer, it is associated with several complications. Androgen receptor pathway inhibitor (ARPI) monotherapy has emerged as a promising strategy for improving oncological outcomes in these patients. However, ARPI monotherapy increases gynecomastia and breast pain in prostate cancer patients compared with ADT, while ARPI plus ADT did not result in a higher incidence of adverse events.

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BackgroundAntiandrogenic drugs are often used to treat female pattern hair loss (FPHL) despite limited evidence supporting their use. There is growing interest in bicalutamide for this purpose, but its efficacy in treating FPHL has not been evaluated in clinical trials.ObjectivesTo assess the efficacy of 25 mg/d bicalutamide combined with 1 mg/d minoxidil compared to 1 mg/d minoxidil monotherapy over 24 weeks for FPHL treatment.MethodsA randomized, controlled, double-blind clinical trial enrolled 74 participants into 2 groups: bicalutamide 25 mg/d plus minoxidil 1 mg/d or placebo plus minoxidil 1 mg/d for 24 weeks. The primary outcome was the change in total hair density in the target area.ResultSixty-four (86.5%) participants completed the study (32 per group). There was a mean increase of 18.1 hairs/cm2 in the bicalutamide-minoxidil group and 21.5 hairs/cm2 in the minoxidil group (P = .86). According to the global consensus analysis of clinical photographs, there was no difference in clinical improvement between the groups (P = .78).LimitationsSingle-center study and short follow-up period (24 weeks).ConclusionBicalutamide 25 mg/d combined with minoxidil 1 mg/d did not provide additional improvement in FPHL treatment compared to minoxidil alone after 24 weeks.

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Background and objectiveFor patients with detectable prostate-specific antigen (PSA) after radical prostatectomy, 6 mo of a GNRH agonist with salvage radiotherapy (sRT) is a standard treatment option.MethodsFORMULA-509 (NCT03141671) enrolled 345 patients with PSA ≥0.1 ng/ml and high-risk features from November 24, 2017 to March 25, 2020. Patients received sRT plus 6 mo of a GNRH agonist and randomization to bicalutamide (50 mg) or abiraterone acetate + prednisone (AAP; 1000 mg/5 mg) + apalutamide (240 mg) QD. The primary endpoint was PSA progression-free survival (PFS). A secondary endpoint was metastasis-free survival (MFS) on conventional imaging. Stratification was by PSA (>0.5 vs ≤0.5 ng/ml) and pN status (pN0 vs pN1).Key findings and limitationsMedian follow-up was 34 mo. AAP + apalutamide did not reach the prespecified significance level for PFS benefit in comparison to bicalutamide (hazard ratio [HR] 0.71. 90% confidence interval [CI] 0.49-1.03; stratified one-sided log-rank p = 0.063), with 3-yr PFS rates of 68.5% with bicalutamide versus 74.9% with AAP + apalutamide. The HR for MFS was 0.57 (90% CI 0.33-1.01; stratified one-sided p = 0.050) and the 3-yr MFS rates were 87.2% with bicalutamide versus 90.6% with AAP + apalutamide. A preplanned analysis by stratification factors revealed that for patients with PSA >0.5 ng/ml, AAP + apalutamide was associated with superior PFS (HR 0.50, 95% CI 0.27-0.95; 2-sided p = 0.030; 3-yr PFS 46.8% with bicalutamide vs 67.2% with AAP + apalutamide) and MFS (HR 0.32, 95% CI 0.13-0.84; 2-sided p = 0.014; 3-yr MFS 66.1% with bicalutamide vs 84.3% with AAP + apalutamide). Adverse events were consistent with the known safety profiles of the study agents, with more frequent rash and hypertension in the AAP + apalutamide arm.Conclusions and clinical implicationsThis study did not reveal a benefit for the overall population, but addition of AAP + apalutamide (vs bicalutamide) to sRT and ADT improved PFS and MFS in the prespecified subgroup with PSA >0.5 ng/ml.

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