Efficacy and safety of LY01005 versus goserelin implant in Chinese patients with prostate cancer: A multicenter, randomized, open-label, phase III, non-inferiority trial / 中华医学杂志(英文版)

BACKGROUND@#LY01005 (Goserelin acetate sustained-release microsphere injection) is a modified gonadotropin-releasing hormone (GnRH) agonist injected monthly. This phase III trial study aimed to evaluated the efficacy and safety of LY01005 in Chinese patients with prostate cancer.@*METHODS@#We conducted a randomized controlled, open-label, non-inferiority trial across 49 sites in China. This study included 290 patients with prostate cancer who received either LY01005 or goserelin implants every 28 days for three injections. The primary efficacy endpoints were the percentage of patients with testosterone suppression ≤50 ng/dL at day 29 and the cumulative probability of testosterone ≤50 ng/dL from day 29 to 85. Non-inferiority was prespecified at a margin of -10%. Secondary endpoints included significant castration (≤20 ng/dL), testosterone surge within 72 h following repeated dosing, and changes in luteinizing hormone, follicle-stimulating hormone, and prostate specific antigen levels.@*RESULTS@#On day 29, in the LY01005 and goserelin implant groups, testosterone concentrations fell below medical-castration levels in 99.3% (142/143) and 100% (140/140) of patients, respectively, with a difference of -0.7% (95% confidence interval [CI], -3.9% to 2.0%) between the two groups. The cumulative probabilities of maintaining castration from days 29 to 85 were 99.3% and 97.8%, respectively, with a between-group difference of 1.5% (95% CI, -1.3% to 4.4%). Both results met the criterion for non-inferiority. Secondary endpoints were similar between groups. Both treatments were well-tolerated. LY01005 was associated with fewer injection-site reactions than the goserelin implant (0% vs . 1.4% [2/145]).@*CONCLUSION@#LY01005 is as effective as goserelin implants in reducing testosterone to castration levels, with a similar safety profile.@*TRIAL REGISTRATION@#ClinicalTrials.gov, NCT04563936.

Expression of Bmi-1 and p16 gene in transitional cell carcinoma of bladder / 中国医师进修杂志

Objective To detect the expression of Bmi-1 and p16 gene in transitional cell carcinoma of bladder(TCC) tissue and explore its clinical significance.Methods The expression of Bmi-1 and p16 gene were detected by real-time quantitative polymerase chain reaction in 61 cases of TCC tissue and 12 cases of normal bladder tissue.Results The expression of Bmi-1 gene in TCC tissue was significantly higher than that in normal bladder tissue (0.242 ± 0.129 vs.0.031 ± 0.011),and the expression of p16 gene was significantly lower than that in normal bladder tissue (0.059 ± 0.021 vs.0.165 ± 0.029),there was significant difference (P ＜ 0.05).The expression of Bmi-1 and p16 gene were highly correlated with pathological grades,clinical stages and tumor recurrence (P ＜ 0.05 or ＜ 0.01).But there were not correlated with age and gender (P ＞ 0.05).There was a negative correlation between the expression of Bmi-1 gene and p16 gene in TCC tissue(rs =-0.714,P＜ 0.05).Conclusions Bmi-1 gene high expression and p16 gene low expression may be involved in the occurrence and development process of TCC.Bmi-1 may decrease the expression of p 16 gene in some ways,and then lead to the occurrence and development of TCC.