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.
Humans ; Male ; Antineoplastic Agents, Hormonal/therapeutic use* ; East Asian People ; Gonadotropin-Releasing Hormone/agonists* ; Goserelin/therapeutic use* ; Prostate-Specific Antigen ; Prostatic Neoplasms/drug therapy* ; Testosterone

Objective:To investigate the current perceptions, treatment patterns and unmet needs of androgen deprivation therapy (ADT) on treating prostate cancer (PCa) by gonadotropin-releasing hormone agonist (GnRH-a) in Chinese urologists.Methods:The survey was conducted between July 2020 and August 2020. Questionnaires were designed to investigate the urologists employed by 163 grade A tertiary hospitals from 7 districts (North, Northeast, East, South, Central, Southwest, Northwest) across China. The inclusion criteria were urologists who had the title of attending physician or above, had experience of prescribing GnRH-a, and agreed to participate in the survey. An electronic self-administered structured questionnaire was used for data collection, with a target sample size of 300, covering treatment patterns, experience of GnRH-a prescription, and unmet needs of GnRH-a.Results:There were 13 886 questionnaires had been distributed, among which 410 questionnaires had met the inclusion criteria. After excluding 110 incomplete questionnaires, 300 valid questionnaires were included in the analysis. The average number of PCa patients administered castration treatment per urologist per month was 12±8. Monthly GnRH-a injection was more often used than quarterly GnRH-a injection[(62.0±24.7)% vs. (38.0±24.7)%]. The main follow-up frequency for patients receiving GnRH-a was once a month as reported by 49.3% (148/300) of urologists. GnRH-a injection frequency (31.3%, 94/300), prostate-specific antigen (PSA) testing frequency (27.7%, 83/300) and clinical effectiveness (26.0%, 78/300) were reported as top factors determining the follow-up frequency. Only 46.0% (138/300) urologists believed that over 70.0% of the patients were completely adherent to the prescribed treatment. When deciding which GnRH-a product to be prescribed, the top 4 factors considered by urologists were effectiveness (92.0%, 276/300), adverse events (85.7%, 257/300), economic burden (76.7%, 230/300), and frequency of injection (61.3%, 184/300). The urgency of improvement for each aspect of GnRH-a therapy was evaluated with a 5-point Likert scale (from 1 (not urgent) to 5 (extremely urgent)). The top 4 aspects needing further improvement were effectiveness (4.04±0.93), economic burden (3.93±0.84), adverse events (3.90±0.90), and frequency of injection (3.60±0.93). A 5-point Likert scale (from 1 (not influential) to 5 (extremely influential)) was also applied to evaluate factors influencing patients’ quality of life and the top 4 factors were pain (4.09±0.94), psychological stress (3.61±0.90), adverse events (3.46±0.89), and discomfort caused by frequent GnRH-a injection (3.34±0.91).Conclusions:Most urologists in China hoped that GnRH-a therapy could have reduced injection frequency, improved effectiveness, reduced economic burden and decreased adverse events in order to increase patient’s adherence and to improve the effectiveness of PCa treatment as well.

Objective:To explore the effect of intravenous thrombolysis in patients with acute ST segment elevation myocardial infarction (STEAMI) caused by acute occlusion of venous bridging vessels.Methods:The clinical data of a patient with acute STEMI caused by acute occlusion of venous bridge in the North China University of Science and Technology Affiliated Hospital in 2019 was retrospectively analyzed.A 58-year-old male patient underwent coronary artery bypass grafting (CABG) 12 years ago.He was re-admitted to the hospital due to acute inferior ST-segment elevation myocardial infarction for 4 hours.He was given Immediately aspirin 0.3 g chewed, ticagrelor 180 mg orally, heparin 4000 U intravenous injection.Next, he was given 50 mg of recombinant prourokinase intravenous thrombolysis.The successful thrombolysis was judged by observing the relief of chest pain symptoms, the ST segment of ECG falling down and the moving of myocardial enzyme peak.Coronary angiography was performed to observe the pathological changes of coronary artery and Bridge in situ, and further treatment strategies were formulated.Cardiac ultrasound examination was performed to understand the structure and function of the heart.The patients were followed up for 1 year to observe whether there were angina pectoris and cardiovascular events.Results:Thrombolytic therapy was successful at 1 hour.Coronary angiography was performed on the 8th day after acute inferior STEMI.The culprit vessel was ascending aorta great saphenous vein right coronary artery.The whole course was diffuse lesions with a large number of thrombus shadows.In situ, the left main coronary artery was diffuse 60% stenosis, the ostia of anterior descending branch and right coronary artery were completely occluded, and the proximal part of circumflex artery was completely occluded.The patients were given intensive antithrombotic therapy for 14 days, and he got better and was discharged.On the 41st day after acute STEMI, coronary angiography was reexamined.Thrombus shadow in aorta great saphenous vein right coronary artery disappeared.Echocardiography showed that left ventricular diastolic diameter was 53 mm and ejection fraction was 55%.The patient was given improved lifestyle and intensive drug treatment.One year after myocardial infarction, the patient had no angina pectoris and was competent for daily work and life.Conclusion:For patients more than 10 years after CABG, with chronic occlusion of coronary artery in situ, when acute STEMI caused by venous bridge occlusion, intravenous thrombolytic therapy is in line with the principle of early reperfusion treatment and has a good prognosis.

Background and purpose:It has been demonstrated that radical prostatectomy for patients with oligometastatic prostate cancer may contribute to improving local control of prostate cancer and overall survival by several retrospective studies. Perioperative complications play an important role in determining whether radical prostatectomy is appropriate for patients with oligometastatic prostate cancer. This study aimed to discuss the recurrence rate and the sever-ity of perioperative complications, and the primary curative effect of radical prostatectomy on oligometastatic prostate can-cer patients.Methods:A total number of 247 patients who received radical prostatectomy were recruited in the study from Jul. 2015 to Jan. 2016, including 25 patients with oligometastatic prostate cancer and 222 patients with localized prostate cancer. Patients with perioperative complications in both groups were graded with the Clavien-Dindo grading system. The proportion of PSA decline and the rates and severity of perioperative complications were analyzed in both groups.Results:The cases of prostate specific antigen (PSA) decline in the oligometastatic group were 21 (84.0%), lower than the localized group with 212 cases (95.5%). There were 6 cases (24.0%) with postoperative complications in the oligometastatic group, including serious complications (Ⅲ or above) 1 case (4.0%), and 49 cases (22.1%) with postoperative complications in the localized group, including serious complications (Ⅲ or above) 7 cases (3.2%). The differences between the groups reached no statistical significance (P>0.05).Conclusion:Radical prostatectomy for patients with oligometastatic prostate cancer could be safe, effective, and appropriate, the risk of perioperative complications should not be one of the limiting factors.

Background and purpose:Laparoscopic retroperitoneal adrenalectomy makes access to the adrenal glands easier and less invasive than open surgery. The aim of this study was to evaluate the clinical efifcacy of laparoscopic retroperitoneal adrenalectomy.Methods:A total of 130 patients who underwent retroperitoneal adrenalectomy for adrenal mass from Jan. 2007 to Dec. 2012 in Fudan University Shanghai Cancer Center were retrospectively assessed. Their clinicopathological factors, perioperative complications and short-term prognostic data were retrieved from the medical records.Results:One hundred and twenty-seven of 130 patients underwent retroperitoneal adrenalectomy successfully, and 3 patients were converted to open surgery due to severe bleeding. Among 130 patients, 63 were male and 67 were female, with the mean age 50.0 years. The pathological results of the 130 patients indicated adrenocortical adenoma in 68, pheochromocytoma in 15, medullary lipoma in 13, adrenal cysts in 10 , ganglioneuroma in 7, metastatic cancer in 5, adrenal hyperplasia in 4, schwannoma in 3, lymphangioma in 2, adrenal hematoma in 1, adrenal cortical carcinoma in 1, adrenal angiosarcoma in 1 and the deputy spleen in 1 (one patient suffering from both pheochromocytoma and ganglioneuroma). The maximum diameters were ranging from 0.5 to 9.0 cm, and mean diameter was 3.48 cm. The average blood loss in surgery was 62.73 mL. Mean length of stay in hospital was 7 d. GradeⅠ complications occurred in 5 patients, including 2 of fever, 1 of food allergy, 1 of drug allergy and 1 of hypokalemia.Conclusion: Retroperitoneal adrenalectomy should be considered as the procedure of choice for the resection of most adrenal tumors in skilled centers with the advantages of minimal invasion, increased safety and faster recovery.

OBJECTIVETo evaluate the alterations in renal function after radical nephrectomy (RN) and partial nephrectomy (PN) for renal cell carcinoma (RCC) and to determine the risk factors for the onset of postoperative renal function impairment.

METHODSWe assessed the renal function of 429 T1a RCC patients by investigating the time-dependent changes of the estimated glomerular filtration rate (eGFR) after surgery from August 2003 to August 2010. Univariate and multivariate regression models were used to determine the risk factors for the onset of an eGFR < 60 ml · min⁻¹ · 1.73 m⁻² function, and to evaluate the prognosis for the two groups.

RESULTSThe mean eGFR values (ml · min⁻¹ · 1.73 m⁻²) at postoperative 1, 7 days, 1, 3, 6, 12 and 24 months were 51.4 ± 12.6, 52.1 ± 17.8, 53.2 ± 19.5, 54.6 ± 20.2, 53.8 ± 16.6, 52.7 ± 22.3 and 51.5 ± 18.4 in the RN group and 69.6 ± 18.3, 70.3 ± 19.5, 71.5 ± 21.4, 76.2 ± 22.8, 75.4 ± 19.7, 74.3 ± 16.3 and 73.1 ± 23.2 in the PN group, respectively. The eGFR of the radical nephrectomy group was significantly lower than that of the partial nephrectomy group (P < 0.05). Multivariable analysis revealed that radical nephrectomy and age were risk factors for the onset of postoperative chronic renal dysfunction.

CONCLUSIONSRenal function recovered partially after partial and radical nephrectomy and is maintained constantly after 3 months. Surgical mode and age are risk factors for the onset of postoperative eGFR < 60 ml · min⁻¹ · 1.73 m⁻² impairment. Compared with radical nephrectomy, partial nephrectomy can preserve renal function and reduce the incidence of postoperative chronic renal dysfunction.

Age Factors ; Carcinoma, Renal Cell ; pathology ; physiopathology ; surgery ; Glomerular Filtration Rate ; Humans ; Kidney Neoplasms ; pathology ; physiopathology ; surgery ; Nephrectomy ; adverse effects ; methods ; Postoperative Complications ; physiopathology ; Postoperative Period ; Renal Insufficiency, Chronic ; etiology ; physiopathology ; Risk Factors

OBJECTIVETo evaluate clinical factors affecting Gleason score upgrade in patients receiving radical prostatectomy (RP).

METHODSA total of 322 patients with prostate cancer who received RP from January 2012 to December 2013 at Department of Urology at Fudan University Shanghai Cancer Center were included, and their data of age, body mass index (BMI), prostate-specific antigen (PSA), prostate volume, percentage core, clinical staging, pathological characteristics, biopsy Gleason score and RP Gleason score were analyzed. Differences in categorical variables and continuous variables were compared using χ² tests and Student's t-test, respectively. Unconditional multiple logistic regression was used to estimate OR and 95% CI of the association of Gleason score upgrade with clinical factors.

RESULTSGleason score upgrade occurred in 107 of 322 (33.3%) patients. There was no difference in age, BMI and clinical staging between the two groups. Compared with patients without Gleason score upgrade, higher levels of PSA (χ² =6.740, P=0.034), smaller prostate volume (t=3.481, P=0.002) and elevated percentage core (t=-2.097, P=0.037) were observed in patients with Gleason score upgrade. In addition, lymph node metastasis (χ² =4.193, P=0.041) and extracapsular extension (χ² =4.747, P=0.029) were more common in patients with Gleason score upgrade. After adjusting for potential confounders, PSA levels (OR=2.451, 95% CI: 1.290-4.660), prostate volume (OR=0.982, 95% CI: 0.969-0.995) and percentage core (OR=2.756, 95% CI: 1.033-7.357) were independent predictors for Gleason score upgrade.

CONCLUSIONGleason score upgrade happens at a relatively high rate. PSA levels, prostate volume and percentage core are important factors affecting Gleason score upgrade.

Biopsy ; Body Mass Index ; China ; Humans ; Logistic Models ; Male ; Multivariate Analysis ; Neoplasm Grading ; Prostate-Specific Antigen ; blood ; Prostatectomy ; Prostatic Neoplasms ; diagnosis ; surgery

Objective To evaluate the alterations in renal function after radical nephrectomy ( RN) and partial nephrectomy ( PN) for renal cell carcinoma ( RCC) and to determine the risk factors for the onset of postoperative renal function impairment. Methods We assessed the renal function of 429 T1a RCC patients by investigating the time?dependent changes of the estimated glomerular filtration rate ( eGFR) after surgery from August 2003 to August 2010. Univariate and multivariate regression models were used to determine the risk factors for the onset of an eGFR<60 ml·min-1 ·1.73 m-2 function, and to evaluate the prognosis for the two groups. Results The mean eGFR values ( ml·min-1 ·1.73 m-2 ) at postoperative 1, 7 days, 1, 3, 6, 12 and 24 months were 51. 4 ± 12. 6, 52. 1 ± 17. 8, 53. 2 ± 19. 5, 54. 6 ± 20. 2, 53. 8 ± 16. 6, 52.7±22.3 and 51.5±18.4 in the RN group and 69.6±18.3, 70.3±19.5, 71.5±21.4, 76.2±22.8, 75.4± 19.7, 74.3±16.3 and 73.1±23.2 in the PN group, respectively. The eGFR of the radical nephrectomy group was significantly lower than that of the partial nephrectomy group ( P<0.05) . Multivariable analysis revealed that radical nephrectomy and age were risk factors for the onset of postoperative chronic renal dysfunction. Conclusions Renal function recovered partially after partial and radical nephrectomy and is maintained constantly after 3 months. Surgical mode and age are risk factors for the onset of postoperative eGFR<60 ml· min-1 ·1.73 m-2 impairment. Compared with radical nephrectomy, partial nephrectomy can preserve renal function and reduce the incidence of postoperative chronic renal dysfunction.

Objective To evaluate the alterations in renal function after radical nephrectomy ( RN) and partial nephrectomy ( PN) for renal cell carcinoma ( RCC) and to determine the risk factors for the onset of postoperative renal function impairment. Methods We assessed the renal function of 429 T1a RCC patients by investigating the time?dependent changes of the estimated glomerular filtration rate ( eGFR) after surgery from August 2003 to August 2010. Univariate and multivariate regression models were used to determine the risk factors for the onset of an eGFR<60 ml·min-1 ·1.73 m-2 function, and to evaluate the prognosis for the two groups. Results The mean eGFR values ( ml·min-1 ·1.73 m-2 ) at postoperative 1, 7 days, 1, 3, 6, 12 and 24 months were 51. 4 ± 12. 6, 52. 1 ± 17. 8, 53. 2 ± 19. 5, 54. 6 ± 20. 2, 53. 8 ± 16. 6, 52.7±22.3 and 51.5±18.4 in the RN group and 69.6±18.3, 70.3±19.5, 71.5±21.4, 76.2±22.8, 75.4± 19.7, 74.3±16.3 and 73.1±23.2 in the PN group, respectively. The eGFR of the radical nephrectomy group was significantly lower than that of the partial nephrectomy group ( P<0.05) . Multivariable analysis revealed that radical nephrectomy and age were risk factors for the onset of postoperative chronic renal dysfunction. Conclusions Renal function recovered partially after partial and radical nephrectomy and is maintained constantly after 3 months. Surgical mode and age are risk factors for the onset of postoperative eGFR<60 ml· min-1 ·1.73 m-2 impairment. Compared with radical nephrectomy, partial nephrectomy can preserve renal function and reduce the incidence of postoperative chronic renal dysfunction.

OBJECTIVETo investigate the impact of androgen receptor splice variant 7 (AR-V7) expression on overall survival for patients with metastatic prostate cancer.

METHODSThe data of 113 diagnosed metastatic prostate cancer patients from January 2002 to June 2010 were collected retrospectively, including patient's age at diagnosis, prostate-specific antigen (PSA) level at diagnosis,Gleason score, clinical stage, PSA nadir during hormonal therapy, the time to PSA nadir, vital status, survival time and cause of death. The expression of AR-V7 in prostate cancer tissue was detected by using immunohistochemical staining. The correlation of AR-V7 expression and patient clinicopathological characteristics in all patients were analysed using Student t-test or Chi-square test. Cox proportional hazards regression models were used to evaluate the predictive role of AR-V7 expression and patient characteristics for overall survival.

RESULTSThe median PSA nadir was 0.7 µg/L (ranged from 0.0 to 143.0 µg/L). The median time to PSA nadir was 8.1 months (ranged from 0.9 to 71.0 months). The follow-up was performed until March 12, 2014. During the follow-up period, 67 of 113 metastatic prostate cancer patients (59.3%) died and the median overall survival was 96 months (ranged from 5 to 135 months). The AR-V7 detection rate was 20.4% (23/113). The serum PSA level in patients with positively expression of AR-V7 was significantly higher than that without AR-V7 expression (t = 2.521, P = 0.013). Multivariate Cox regression analysis indicated that the expression of AR-V7 (HR = 2.421, P = 0.002) and time to PSA nadir (HR = 1.019, P = 0.022) were independent prognostic factors of overall survival for metastatic prostate cancer patients.

CONCLUSIONSThe expression of AR-V7 in prostate cancer tissues and time to PSA nadir during hormonal therapy are independent prognostic factors of overall survival for metastatic prostate cancer patients. Therapy targeting AR-V7 may improve prognosis of metastatic prostate cancer patients.

Adult ; Aged ; Aged, 80 and over ; Humans ; Male ; Middle Aged ; Neoplasm Metastasis ; Prognosis ; Proportional Hazards Models ; Prostate-Specific Antigen ; blood ; Prostatic Neoplasms ; diagnosis ; metabolism ; pathology ; Protein Isoforms ; metabolism ; Receptors, Androgen ; metabolism ; Retrospective Studies