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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.
الموضوعات
Humans , Male , Antineoplastic Agents, Hormonal/therapeutic use , East Asian People , Gonadotropin-Releasing Hormone/agonists , Goserelin/therapeutic use , Prostate-Specific Antigen , Prostatic Neoplasms/drug therapy , Testosteroneالملخص
Conclusion:Patients with OlimHSPC who are not sensitive to traditional CAB treatment, ADT combined with abiraterone acetate neoadjuvant therapy and postoperative adjuvant therapy can be attempted.
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To explore roles of expressions of EHD2 and E-cadherin in clear cell renal cell carcinoma (ccRCC). Methods: Four couples of fresh ccRCC tissues and adjacent non-cancerous tissues were collected to evaluate the expression of EHD2 and E-cadherin protein by Western blotting. A total of 65 paraffin-embedded renal ccRCC tissues were collected, and immunohistochemical assay was used to detect the expression of EHD2 and E-cadherin in the samples. The correlation between their expression and clinical and pathological indicators of ccRCC was analyzed, and the relationship between EHD2 and E-cadherin proteins and prognosis for patients with ccRCC was also explored. Results: The results of Western blotting showed that the expression levels of EHD2 and E-cadherin were low in 4 ccRCC tissues compared with the adjacent noncancerous tissues. Immunohistochemical results revealed that the expressions of EHD2 and E-cadherin were higher in the localized ccRCC tissues than those in the metastatic ccRCC tissues; the expression levels of EHD2 and E-cadherin were decreased, while the TNM staging and Fuhrman grade were increased (P<0.05 or P<0.01). There was positive correlation between the expressions of EHD2 and E-cadherin in ccRCC (r=0.390, P<0.01). The progression-free survival in ccRCC patients with lower expression of both EHD2 and E-cadherin was better than that in ccRCC patients with higher expressions of EHD2 and E-cadherin (P<0.05). Conclusion: The low expressions of EHD2 and E-cadherin are the potential indicators for the ccRCC patients with poor prognosis.
الموضوعات
Humans , Cadherins , Carcinoma, Renal Cell , Carrier Proteins , Kidney Neoplasms , Neoplasm Staging , Prognosisالملخص
Objective To investigate the clinical effect of five-step sequential method for hemorrhagic radiation cystitis.Methods From April 2015 to April 2018,512 cases of hemorrhagic radiation cystitis patients in 6 provincial tumor hospital were retrospectively analyzed.12 cases were male patients,and 497 cases were female.Patients'average age was (60.1 ± 8.2) years (53-71 years).Hematuria appeared in 2.9 years on average after radiotherapy(ranged 0.5 to 13 years).According to the severity of hematuria,480 patients were classified as mild and 32 patients as severe.The step 1 was drug conservative symptomatic treatment.Thrombin solution or sodium hyaluronate was used for bladder perfusion in step 2.The step 3 was transurethral electrocoagulation.The step 4 was interventional embolization.The step 5 was hyperbaric oxygen therapy.Mild patients were treated from the first step,and the severe patients were treated rom step 3,and combined with step 1.Overactive bladder symptom score (OABSS) was used to assess the improvement of patients'symptoms.Results No obvious complications occurred in step 1,2,3,5.Mild hip pain occurred at step 4.Recurrent hemorrhage rate were 6.7% (2/30) in mild patients group and 10.5% (2/19) in severe respectively in step 4.The total effective rate of step 1 in mild patients group was 65.2% (313/480),step 1 + 2 was 84.2% (404/480),step 1 + 2 + 3 was 95.6% (459/480),step 1 + 2 + 3 + 4 was 98.3% (472/480),and step 1 +2 +3 +4 +5 was 100% (480/480).The effective rate of step 3 + 1 treatment was 59.4% (19/32) in severe patients group,step 3 + 1 + 4 was 68.8% (22/32),and step 3 + 1 +4 +5 was 100% (32/32).The OABSS scores of mild and severe patients decreased after treatment (P<0.01).Condusion Five-step sequential therapy could be an effective method for the treatment of hemorrhagic radiation cystitis.
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Objective To study whether SGK1 is involved in the phenotypic transformation in adventitial fibroblasts (AF).Methods Vascular AF were separated from the thoracic aortas of SD rats.The AF not stimulated with TGF-β1 were divided into blank group,control group 1 and control group 2.The AF induced with 2.5,5.0,10.0 and 15.0 ng/ml TGF-β1 were divided into groups A-D.The AF pretreated with 50 μmol/1 EMD638683 and SB203580 were divided into inhibitor group 1 and inhibitor group 2.The AF stimulated with 5 ng/ml TGF-β1 were divided into stimulation group 1 and stimulation group 2.The expression of SGK1,α-SMA and collagen Ⅰ was detected by Western blot.Results The expression of SGK1 was significantly higher in groups AC than in blank group.The expression of α-SMA was significantly higher in groups B-D than in controlgroup (P<0.05).The α-SMA and collage Ⅰ expression levels were significantly higher in stimulation group 1 than in control group 1,and were significantly lower in inhibitor group 1 than in stimulation group 1 (P<0.05).The SGK1 expression level was significantly higher in stimulation group 2 than in control group 2 and was significantly lower in inhibitor group 2 than in stimulation group 2 (P<0.05).Conclusion SGK1 participates in TGF-β1-induced phenotypic transformation via p38 MAPK and is thus involved in vascular remodeling.
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Objective To investigate the expression of survivin/Human leukocyte antigen class I ( HLA-Ⅰ) proteins and its physiological significance in clear cell renal cell carcinoma ( CCRCC ) . Methods Immunohistochemistry was used to analyze survivin/HLA-Ⅰ protein expression in 90 cases of CCRCC and 10 normal tissues to study relationships with clinical symptoms and disease prognosis . Resutl s The level of survivin protein expression was found to be significantly higher in CCRCC tissues 82.2%( 74/90) than in normal tissues( 0/10).However, the relative amount of HLA-Ⅰprotein in colorectal cancer tis-sue was also found to be significantly lower 67.8%(61/90) than in normal tissues 90%(9/10).Survivin expression was associated with tumor grade , stage,and lymph node metastasis ( P=0.000, P=0.016, and P=0.001, respectively ) .Conversely , lost HLA-Ⅰexpression did not have any associations with clinicopath-ological data (P>0.05).Survivin negative patients (25.0%, 4/16) had a higher tumor-free survival rate than patients (52.7%, 39/74)with survivin expression (P=0.037).Patients (27.6%, 8/29) with normal HLA-Ⅰlevels had a higher tumor-free survival rate than those ( 60.7%, 37/61) with reduced HLA-Ⅰlev-els (P=0.020).The univariate and multivariate analyses indicated that expression of survivin and HLA indi -vidually and in combination were independent predictors for CCRCC patient survival . Conclusions Over-expression of survivin but reduced HLA-Ⅰ expression is associated with CCRCC development and progres-sion.
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Objective To evaluate the effects of rigorous surveillance and retroperitoneal lymph node dissection (RPLND) in the treatment of low-risk patients with clinical stage Ⅰ nonseminomatous germ cell testicular tumors (NSGCT) after radical orchiectomy.Methods The data of 71 patients with clinical stage Ⅰ NSGCT were analyzed retrospectively in Hunan Provincial Tumor Hospital,Xiangya Third Hospital of Central South University and Hunan Provincial People's Hospital between Feb,2001 and Apr,2012.Excluding lymphatic and vascular invasion,percentage of embryonal carcinoma>50% and increasing tumour markers (AFP/β-HCG) following orchiectomy,46 low-risk patients out of 71 patients with clinical stage Ⅰ NSGCT were selected and divided into rigorous surveillance group (30 cases) and RPLND group (16 cases) according to different therapeutic methods after radical orchiectomy.Univariate analysis was used to confirm variables associated with disease progression,and the disease free survival rates (DFSR) were compared by using Kaplan-Meier analysis.Results Five cases were lost,and 41 cases were followed up for an average of 61 months (range,15-147 months),with 58 months in rigorous surveillance group (range,19-147months) and 65 months in RPLND group (range,15-144 months).The survival rate was 100% in 2 groups.The DFSR was 89% (24/27) and 86% (12/14),respectively,and there was no significant difference between the 2 groups (x2 =0.08,P=0.78).The DFSR was 83% in patients with small amout of embryonal (percentage of embryonal carcinoma < 50%),and 92% in patients without embryonal carcinoma,and there was no significant difference between the 2 groups (x2=1.07,P=0.30).Also there was no significant difference between the patients less than 15 years and patients more than 15 years (x2=1.59,P =0.21).Conclusions There is no significant difference in recurrence rate and DFSR between rigorous surveillance group and RPLND group.Low-risk patients with clinical stage Ⅰ NSGCT may achieve satisfactory prognosis with surveillance after radical orchiectomy.