ABSTRACT
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.
Subject(s)
Humans , Male , Antineoplastic Agents, Hormonal/therapeutic use , East Asian People , Gonadotropin-Releasing Hormone/agonists , Goserelin/therapeutic use , Prostate-Specific Antigen , Prostatic Neoplasms/drug therapy , TestosteroneABSTRACT
Objective To explore prognostic factors of renal cell carcinoma and investigate the association of neutrophil-to-lymphocyte ratio (NLR) with the prognosis of renal cell carcinoma (RCC) in patients who received nephrectomy treatment.Methods We retrospectively reviewed the records of 1325 patients with renal cell carcinoma who underwent nephrectomy between January,2008 and December,2012.We retrospectively analyzed the clinicopathologic characteristics of patients.The optimal cutoff value for NLR was determined using receiver operating characteristic curve (ROC) analysis.We defined them as high NLR group when NLR ≥ 2.7 and low NLR group when NLR ＜ 2.7.Overall survival (OS) and recurrence free survival (RFS) were estimated using the Kaplan-Meier method and compared using the logrank test.Multivariate models were used to analyze the association of NLR with clinicopathologic outcomes.Results By the end of the study, 1220 cases were followed up.The follow-up rate was 92.1％.Mean follow-up was 40 months (range 2 months to 87 months).The three-year and five-year overall survival rate were 91.3％ and 86.9％, respectively.Meanwhile the three-year and five-year recurrence free survival rate were 88.2％ and 85.8％ ,respectively.2.7 was selected as the optimal cutoff value to differentiate between low NLR and high NLR.A NLR ≥2.7 was significantly associated with worse 5-year overall survival and worse 5-year recurrence free survival than a NLR ＜2.7,91.4％ vs 87.3％ ,89.6％ vs 71.9％ (P ＜0.05).Age ＞65, presentation mode with symptom, higher tumor stage, higher Fuhrman grade,histologic subtype,neutrophil count ≥ 4.5, lymphocyte count ＜ 1.7, NLR ≥ 2.7 significantly correlated with poor OS on univariate analysis.Multivariate analysis revealed that higher tumor stage, preoperative NLR ≥ 2.7 at diagnosis were poor independent prognostic factors for OS of renal cell carcinoma.Conclusion High NLR was independent poor predictor of renal cell carcinoma.
ABSTRACT
Objective To review the clinical characteristics of paraganglioma of the urinary bladder with 5 cases reprt.Methods The clinical data of 5 patients (2 males and 3 females,age 23-68 years)with paraganglioma of the urinary bladder were reported.Two cases were diagnosed by ultrasonography during health examination,1 case was found by hematuria,1 had difficulty of voiding,and 1 presented with palpitation,chest discomfort while urination.Two cases were clinical diagnosed as bladder paraganglioma,1case urachal carcinoma,and 2 cases bladder tumor.Cystoscopy showed a protruding tumor within the bladder or bladder had compressed changes.One case of tumor located in the triangle,1 in the posterior wall,1in the top,2 in the anterior wall.Three cases of biopsy were negative.Three cases of preoperative endocrine examinations showed norepinephrine significantly higher.Results Laparoscopic partial cystectomy was performed in 3 cases,open partial cystectomy in 1 case,and transurethral resection of bladder tumor (TURBT) in 1 case.One case had the complication of stress cardiomyopathy during TURBT,3 cases found intraoperative hypertensive crisis.The bleeding volume was 20-800 ml (average 126 ml),and I case received blood transfusion.During the follow-up period for 3-48 months,the blood pressure was normal,and no recurrence was found.Conclusions Bladder paraganglioma is uncommon and easily misdiagnosed.For the patients with bladder tumor,accompanied by changes in blood pressure,palpitations during urination should be highly suspicious of bladder paraganglioma.Partial cystectomy is the main treatment method.