1.Review of the Expanded Clinical Trial System in the United States, Japan and Canada and its Enlightenment for China
Meiying MA ; Xiaopei ZHAO ; Lulin LI
Chinese Medical Ethics 2025;38(1):78-88
The expanded clinical trial system is designed to provide clinical trial drugs for patients suffering from serious or life-threatening diseases for which there is no effective treatment, essentially seeking a balance between the accessibility of drugs to patients and the soundness of the development of the pharmaceutical industry, as well as between the risk of expanding the use of clinical trial drugs and the need to safeguard the rights and interests of patients’ lives and health. Article 23 of China's Drug Administration Law provides only a principled description of the applicable standards and operating procedures for this system, with no implementing regulations, making it difficult for the system to function effectively in practice. The United States, Japan, and Canada have made detailed provisions on the conditions of application, applicants, review subjects and contents, and safeguards of the system through laws, regulations, and guidelines. Based on China's legislative environment and regulatory reality, and considering that the system is still in the initial stage in China, it is recommended that appropriate reference be made to the beneficial experience of foreign countries and that regulations and normative documents be promulgated as soon as possible to clarify the types of expanded clinical trials, applicants, review subjects etc., and to determine the responsibilities of all the parties involved, to promote the standardization of China’s expanded clinical trial system, to promote the availability of medicines to patients, and to effectively safeguard the rights and interests of patients’ lives and health, and the soundness and safety of the development of the pharmaceutical industry.
2.Clinical features and prognostic analysis of primary bladder adenocarcinoma
Bin YANG ; Shenmo LI ; Hongxian ZHANG ; Guoliang WANG ; Lulin MA ; Min LU ; Jianfei YE ; Shudong ZHANG
Chinese Journal of Urology 2025;46(10):745-750
Objective:To explore the clinical characteristics and prognostic factors of primary bladder adenocarcinoma(ACB).Methods:The clinical data of 33 patients with primary ACB who underwent surgical treatment in the Department of Urology of Peking University Third Hospital from July 2003 to January 2024 were retrospectively analyzed. There were 5 females and 28 males,with an average age of(61.3 ± 11.5)years. Twelve patients had comorbidities(6 hypertension,2 coronary heart disease,5 diabetes mellitus,and 3 cerebrovascular diseases)and 12 had a smoking history. The mean body mass index(BMI)was(24.8 ± 3.2)kg/m 2. The maximum tumor diameter measured by enhanced computed tomography(CT)was(29.7 ± 12.7)mm. The preoperative neutrophil-to-lymphocyte ratio(NLR)was 3.4 ± 3.2,and the systemic immune-inflammation index(SII)was(582 ± 496)× 10 9/L.Patients were divided into two groups according to the surgical approach:the radical cystectomy group( n = 23)and the bladder-sparing group( n = 10). For the radical cystectomy group,there were 19 males and 4 females,with a mean age of(59.9 ± 12.6)years. Five patients had comorbidities(3 hypertension,1 coronary heart disease,1 diabetes mellitus,and 2 cerebrovascular diseases). Eight patients had a smoking history,with a mean BMI of(25.2 ± 3.5)kg/m 2. The maximum tumor diameter was(33.6 ± 10.9)mm,the preoperative NLR was 3.5 ± 3.5,and the SII was(618 ± 558)× 10 9/L. For the bladder-sparing group,there were 9 males and 1 female,with a mean age of(64.5 ± 8.2)years. Seven patients had comorbidities(3 hypertension,1 coronary heart disease,4 diabetes mellitus,and 1 cerebrovascular diseases). Four patients had a smoking history,with a mean BMI of(23.5 ± 2.3)kg/m 2. The maximum tumor diameter was(20.7 ± 12.5)mm,the preoperative NLR was 3.1 ± 2.2,and the SII was(501 ± 323)× 10 9/L. Statistically significant differences were observed between the two groups in terms of comorbidities( P = 0.008)and maximum tumor diameter( P = 0.006),while no significant differences were found in other data( P > 0.05). The Kaplan-Meier survival curve was drawn,and Cox regression was used to analyze the prognostic factors of progression-free survival(PFS)and overall survival(OS)of patients. Results:Among the 33 patients,low-grade adenocarcinoma and high-grade adenocarcinoma accounted for 60.6% and 39.4% respectively according to the postoperative pathology,and 3 patients had positive surgical margins. There were 22 cases of muscle-invasive bladder adenocarcinoma,5 cases of lymph node metastasis,and 1 case of distant metastasis. The patients in tumor stages Ⅰ—Ⅳ were 9 cases(27.3%),8 cases(24.2%),7 cases(21.2%),and 9 cases(27.3%)respectively. Nine patients received postoperative adjuvant therapy,including 6 with adjuvant chemotherapy,2 with adjuvant chemotherapy combined with radiotherapy,and 1 with adjuvant immunotherapy. In the radical cystectomy group( n = 23),there were 13 cases of low-grade and 10 cases of high-grade pathological grading,2 cases with positive margins,19 cases of muscle-invasive bladder adenocarcinoma,5 cases of lymph node metastasis,1 case of distant metastasis,and 5 patients received adjuvant therapy(4 cases of adjuvant chemotherapy,and 1 case of adjuvant immunotherapy). In the bladder-sparing group( n = 10),there were 7 cases of low-grade,3 cases of high-grade pathological grading,1 case with positive margins,3 cases of muscle-invasive bladder adenocarcinoma,zero lymph node or distant metastasis,and 4 patients received adjuvant therapy(2 cases of adjuvant chemotherapy,and 2 cases of combined adjuvant chemotherapy and radiotherapy). A statistically significant difference was found in the proportion of muscle-invasive bladder adenocarcinoma between the two groups( P = 0.006),while no significant differences were observed in other data( P > 0.05).The median follow-up duration of the patients was 28.0 months,the median PFS was 86.0 months,and the median OS was 90.0 months. The 2-year PFS and OS were 65.4% and 73.1% respectively. The 5-year PFS and OS were 54.2% and 56.5% respectively. The Kaplan-Meier survival analysis showed that there were no significant differences in PFS( P = 0.777)and OS( P = 0.585)between the radical cystectomy group and the bladder-preserving group. Female( P = 0.011),BMI < 25 kg/m2( P = 0.038),and positive surgical margins( P < 0.01)were associated with poorer PFS. Aged ≥ 70 years( P = 0.003),lymph node metastasis( P = 0.041),and positive surgical margins( P = 0.025)were associated with poorer OS,and patients in the adjuvant therapy group had better OS( P = 0.005). Multivariate Cox regression analysis indicated that positive surgical margins(HR 10.2, P = 0.012)were an independent impact factor for PFS,and positive surgical margins(HR 39.8, P = 0.001)and adjuvant therapy(HR 0.12, P = 0.021)were independent impact factors for OS. Conclusions:Positive surgical margins and adjuvant therapy are independent impact factors for the prognosis of patients with primary ACB.
3.Clinical features and prognostic analysis of primary bladder adenocarcinoma
Bin YANG ; Shenmo LI ; Hongxian ZHANG ; Guoliang WANG ; Lulin MA ; Min LU ; Jianfei YE ; Shudong ZHANG
Chinese Journal of Urology 2025;46(10):745-750
Objective:To explore the clinical characteristics and prognostic factors of primary bladder adenocarcinoma(ACB).Methods:The clinical data of 33 patients with primary ACB who underwent surgical treatment in the Department of Urology of Peking University Third Hospital from July 2003 to January 2024 were retrospectively analyzed. There were 5 females and 28 males,with an average age of(61.3 ± 11.5)years. Twelve patients had comorbidities(6 hypertension,2 coronary heart disease,5 diabetes mellitus,and 3 cerebrovascular diseases)and 12 had a smoking history. The mean body mass index(BMI)was(24.8 ± 3.2)kg/m 2. The maximum tumor diameter measured by enhanced computed tomography(CT)was(29.7 ± 12.7)mm. The preoperative neutrophil-to-lymphocyte ratio(NLR)was 3.4 ± 3.2,and the systemic immune-inflammation index(SII)was(582 ± 496)× 10 9/L.Patients were divided into two groups according to the surgical approach:the radical cystectomy group( n = 23)and the bladder-sparing group( n = 10). For the radical cystectomy group,there were 19 males and 4 females,with a mean age of(59.9 ± 12.6)years. Five patients had comorbidities(3 hypertension,1 coronary heart disease,1 diabetes mellitus,and 2 cerebrovascular diseases). Eight patients had a smoking history,with a mean BMI of(25.2 ± 3.5)kg/m 2. The maximum tumor diameter was(33.6 ± 10.9)mm,the preoperative NLR was 3.5 ± 3.5,and the SII was(618 ± 558)× 10 9/L. For the bladder-sparing group,there were 9 males and 1 female,with a mean age of(64.5 ± 8.2)years. Seven patients had comorbidities(3 hypertension,1 coronary heart disease,4 diabetes mellitus,and 1 cerebrovascular diseases). Four patients had a smoking history,with a mean BMI of(23.5 ± 2.3)kg/m 2. The maximum tumor diameter was(20.7 ± 12.5)mm,the preoperative NLR was 3.1 ± 2.2,and the SII was(501 ± 323)× 10 9/L. Statistically significant differences were observed between the two groups in terms of comorbidities( P = 0.008)and maximum tumor diameter( P = 0.006),while no significant differences were found in other data( P > 0.05). The Kaplan-Meier survival curve was drawn,and Cox regression was used to analyze the prognostic factors of progression-free survival(PFS)and overall survival(OS)of patients. Results:Among the 33 patients,low-grade adenocarcinoma and high-grade adenocarcinoma accounted for 60.6% and 39.4% respectively according to the postoperative pathology,and 3 patients had positive surgical margins. There were 22 cases of muscle-invasive bladder adenocarcinoma,5 cases of lymph node metastasis,and 1 case of distant metastasis. The patients in tumor stages Ⅰ—Ⅳ were 9 cases(27.3%),8 cases(24.2%),7 cases(21.2%),and 9 cases(27.3%)respectively. Nine patients received postoperative adjuvant therapy,including 6 with adjuvant chemotherapy,2 with adjuvant chemotherapy combined with radiotherapy,and 1 with adjuvant immunotherapy. In the radical cystectomy group( n = 23),there were 13 cases of low-grade and 10 cases of high-grade pathological grading,2 cases with positive margins,19 cases of muscle-invasive bladder adenocarcinoma,5 cases of lymph node metastasis,1 case of distant metastasis,and 5 patients received adjuvant therapy(4 cases of adjuvant chemotherapy,and 1 case of adjuvant immunotherapy). In the bladder-sparing group( n = 10),there were 7 cases of low-grade,3 cases of high-grade pathological grading,1 case with positive margins,3 cases of muscle-invasive bladder adenocarcinoma,zero lymph node or distant metastasis,and 4 patients received adjuvant therapy(2 cases of adjuvant chemotherapy,and 2 cases of combined adjuvant chemotherapy and radiotherapy). A statistically significant difference was found in the proportion of muscle-invasive bladder adenocarcinoma between the two groups( P = 0.006),while no significant differences were observed in other data( P > 0.05).The median follow-up duration of the patients was 28.0 months,the median PFS was 86.0 months,and the median OS was 90.0 months. The 2-year PFS and OS were 65.4% and 73.1% respectively. The 5-year PFS and OS were 54.2% and 56.5% respectively. The Kaplan-Meier survival analysis showed that there were no significant differences in PFS( P = 0.777)and OS( P = 0.585)between the radical cystectomy group and the bladder-preserving group. Female( P = 0.011),BMI < 25 kg/m2( P = 0.038),and positive surgical margins( P < 0.01)were associated with poorer PFS. Aged ≥ 70 years( P = 0.003),lymph node metastasis( P = 0.041),and positive surgical margins( P = 0.025)were associated with poorer OS,and patients in the adjuvant therapy group had better OS( P = 0.005). Multivariate Cox regression analysis indicated that positive surgical margins(HR 10.2, P = 0.012)were an independent impact factor for PFS,and positive surgical margins(HR 39.8, P = 0.001)and adjuvant therapy(HR 0.12, P = 0.021)were independent impact factors for OS. Conclusions:Positive surgical margins and adjuvant therapy are independent impact factors for the prognosis of patients with primary ACB.
4.Robot-assisted laparoscopic inferior vena cava segmental resection for renal tumor with tumor thrombus invading the vascular wall
Shuai LIU ; Zhuo LIU ; Yunhe GUAN ; Guoliang WANG ; Xiaojun TIAN ; Hongxian ZHANG ; Lei LIU ; Lulin MA ; Shudong ZHANG
Journal of Peking University(Health Sciences) 2025;57(4):796-802
Objective:To evaluate the safety and oncological outcomes of robot-assisted laparoscopic inferior vena cava(IVC)segmental resection in renal tumor with IVC tumor thrombus(IVCTT).Methods:Clinical data from renal tumor patients undergoing robot-assisted laparoscopic IVC segmental resection at Peking University Third Hospital from Jan.2021 to Feb.2025 were retrospectively analyzed.Data collection included baseline demographics,tumor characteristics,perioperative parameters,and follow-up outcomes.Surgical records and pathological reports were retrieved from the electronic medical record system.Continuous variables were presented as median(P25,P75),and categorical variables as frequency(percentage).Results:Forty-four patients were enrolled.The cohort comprised 31 malesand 13 females,with a median age of 62(55,68)years.Right-sided tumors were observed in 39 cases and left-sided in 5 cases.Median tumor diameter was 8.1(6.1,10.1)cm.Mayo classifications included grade Ⅱ(n=37),Ⅲ(n=6),and Ⅳ(n=1).Neoadjuvant therapy was administered to 23 patients.Seventeen patients were complicated by IVC bland thrombus.Median operative time was 224.0(167.3,303.8)min,with intraoperative blood loss of 500.0(300.0,850.0)mL.Transfusion was administered to 19 patients,with a median blood transfusion of 800.0(400.0,1 200.0)mL.Postoperative complica-tions occurred in 25 cases(56.8%),classified as Clavien-Dindo grade Ⅰ(n=8)and grade Ⅱ(n=17).Procedure-specific complications included deep vein thrombosis(n=6),transfusion-requiring ane-mia(n=5),lower extremity edema(n=2),and pulmonary embolism(n=2),with no procedure-related mortality.Median postoperative serum creatinine was 116.0(86.5,157.5)μmnol/L.Pathological examination identified clear cell renal cell carcinoma as the predominant subtype,observed in 34 cases(77.3%).Pathological staging revealed T3b(n=12),T3c(n=29),and T4(n=3)disease,with nodal involvement(N1)in 8 cases and distant metastasis(M1)in 17.At a median follow-up of 10 months(range:1-49 months),cancer-specific mortality occurred in 3 patients,while 1 succumbed to other causes.Disease progression included pulmonary metastasis(n=5),hepatic metastasis(n=4),and local recurrence(n=4).Adjuvant therapy regimens comprised targeted-immunotherapy combina-tions(n=9)and targeted monotherapy(n=18).Conclusion:Robot-assisted laparoscopic I VC seg-mental resection achieves precise thrombus removal with confirmed short-term efficacy in renal tumor with IVCTT,though vigilance against vascular complications remains critical.
5.Clinicopathological features and survival analysis of TFE3-rearranged renal cell carcinoma with venous tumor thrombus
Zhanyi ZHANG ; Min LU ; Yuehao SUN ; Jinghan DONG ; Xiaofei HOU ; Chunlei XIAO ; Guoliang WANG ; Xiaojun TIAN ; Lulin MA ; Hongxian ZHANG ; Shudong ZHANG
Journal of Peking University(Health Sciences) 2025;57(4):650-661
Objective:To review the clinicopathological features of TFE3-rearranged renal cell carcino-ma(TFE3-RCC)with venous tumor thrombus(VT)(TFE3-VT),to explore treatment strategies and to prognostic characteristics,and to provide diagnostic and therapeutic references for TFE3-VT patients.Methods:Patients who underwent surgery at Department of Urology,Peking University Third Hospital from January 2013 to January 2024 were enrolled,including three cohorts:Pathologically confirmed TFE3-VT patients,TFE3-RCC patients without VT(TFE3-non-VT),and non-TFE3-rearranged renal cell carcinoma patients with VT(non-TFE3-VT).Clinical history,imaging data,pathological data,and follow-up records were collected.Primary and secondary endpoints were progression-free survival(PFS)and overall survival(OS),respectively.(1)Baseline characteristics were compared between the TFE3-VT and TFE3-non-VT patients.Normally distributed continuous variables were expressed as mean±SD and compared using Student's t-test;non-normally distributed variables were expressed as M(P25,P75)and analyzed with Mann-Whitney U test;categorical variables were described as frequency and percentage[n(%)]and compared by x2 test or Fisher's exact test.(2)Clinical history,radiological presenta-tions,surgical data,and histopathological features of the TFE3-VT patients were comprehensively charac-terized.(3)Survival analysis was performed for the TFE3-VT patients.Follow-up data of the TFE3-VT patients were described in detail,and their survival outcomes were compared with the TFE3-non-VT and non-TFE3-VT patients.When compared with the TFE3-non-VT counterparts,Kaplan-Meier method was used to generate PFS and OS curves among:(1)the TFE3-RCC patients across clinical stages Ⅰ-Ⅳ;(2)TFE3-VT versus TFE3-non-VT cohorts;(3)stage Ⅲ subgroups of the TFE3-VT and TFE3-non-VT patients.Intergroup survival differences were statistically evaluated using Log-rank tests.For comparisons with the non-TFE3-VT patients,a 1∶1 propensity score matching(PSM)was implemented to balance baseline characteristics between the two cohorts.Post-matching Kaplan-Meier curves were generated to compare PFS and OS between the matched groups,with Log-rank tests employed to determine statistical significance of survival disparities.All statistical analyses were conducted with R software(v 4.2.3),and two-tailed P<0.05 was considered statistically significant.Results:The study included 45 TFE3-RCC patients:13 TFE3-VT and 32 TFE3-non-VT cases.Additionally,523 non-TFE3-VT patients were enrolled.Among the 13 TFE3-VT patients,9 were female(69.2%)and 4 male(30.8%),with a mean age of(37.9±14.4)years,mean BMI of(22.2±3.5)kg/m2,median age-adjusted Charlson comorbidity index(aCCI)of 1.0(0.0,1.0),and preoperative creatinine level of(75.3±15.9)μmol/L;tumors were located in the left kidney in 7 patients(53.8%)and right kidney in 6(46.2%);preoperative distant metastasis(M1 stage)was present in 6 patients(46.2%),while 7(53.8%)showed no metastasis;VT distribution by Mayo level comprised 7 cases(53.8%)at level 0,1 case each at levels Ⅰ and Ⅳ(7.7%respectively),and 2 cases each at levels Ⅱ and Ⅲ(15.4%respectively);surgical approaches comprised open surgery(n=2,15.4%),laparoscopic surgery(n=6,46.1%),and robot-assisted laparoscopic surgery(n=5,38.5%);mean operative time was(273±79)min,and intraoperative blood loss was(722±570)mL;mean maximum tumor diameter was(10.8±2.4)cm.All the 13 patients underwent TFE3 protein immunohistochemistry(IHC)staining,with 7 confirmed by fluorescence in situ hybridization(FISH).Tumor recurrence or metastasis occurred in 11 patients(84.6%),and 9(69.2%)patients died during follow-up.Median PFS was 4 months(1 year PFS rate:31%),and median OS was 13 months(1 year OS rate:54%).Survival analysis of 45 TFE3-RCC pa-tients revealed statistically significant differences in PFS and OS across all the clinical stages(P<0.001).The TFE3-VT patients exhibited significantly worse PFS and OS than the TFE3-non-VT patients(P<0.001),with persistent significance in stage Ⅲ subgroup analysis(P<0.05).After PSM,TFE3-VT pa-tients showed significantly inferior PFS compared with non-TFE3-VT(P=0.01),though no significant difference was shown between the OS curves(P=0.11).Conclusion:TFE3-VT predominantly occurs in young females with frequent preoperative metastases.Strongly-positive staining of TFE3 protein in IHC stai-ning and red-green split signals in FISH tests are reliable diagnostic markers.TFE3-VT patients exhibit in-ferior survival compared with TFE3-non-VT patients and earlier progression than non-TFE3-VT patients.
6.Experience summary of robot-assisted laparoscopic transplant nephrectomy
Qiming ZHANG ; Zebo CHEN ; Yu TIAN ; Dameng PAN ; Lei LIU ; Hongxian ZHANG ; Lei ZHAO ; Shudong ZHANG ; Lulin MA ; Xiaofei HOU
Journal of Peking University(Health Sciences) 2025;57(4):666-669
Objective:To review and summarize the experience of robot-assisted laparoscopic trans-plant nephrectomy,share the surgical steps and technical key points,and provide a reference for clinical practice.Methods:A retrospective analysis was conducted on the perioperative data of 5 patients who underwent robot-assisted laparoscopic donor nephrectomy at Peking University Third Hospital from August 2023 to December 2024.The surgical steps and key points were summarized.The continuous variables were described by medians(ranges).Results:A total of 5 patients were included in the analysis,of whom 2 were male and 3 were female.The median age of the patients was 37(31-68)years.The me-dian time from kidney transplantation to donor nephrectomy was 10(3-22)years.The indications for donor nephrectomy included recurrent hematuria,abdominal pain,malignant tumor of the transplanted kidney,and recurrent infection with hydronephrosis of the transplanted kidney.The excised transplanted kidneys from all the 5 patients had a single renal artery and a single renal vein.The median operation time was 212(145-351)min,the median blood loss was 300(20-500)mL,and the median post-operative hospital stay was 7(4-25)days.Only 1 patient experienced intraoperative complications,who experienced an external iliac artery injury during the operation and underwent suture repair.No pa-tient died during the perioperative period.Postoperative pathological results showed that 3 patients had end-stage non-functional kidneys,1 patient had BK virus-associated urothelial carcinoma,and 1 patient had chronic pyelonephritis with renal parenchymal atrophy.Conclusion:Robot-assisted laparoscopic transplant nephrectomy as a new surgical approach is feasible and safe.Compared with traditional open transplant nephrectomy,its advantage lies in the ability to directly observe and prioritize the management of the renal pedicle of the transplanted kidney,while completely freeing and removing the transplanted kidney outside the renal capsule.With the continuous accumulation of experience,this surgical technique is expected to become a powerful alternative to traditional open transplant nephrectomy.
7.Clinical analysis of 8 cases of adrenal hemolymphangioma and literature review
Chuxiao XU ; Dameng PAN ; Huiying HE ; Lulin MA ; Shudong ZHANG
Journal of Modern Urology 2025;30(3):207-211
Objective: To investigate the clinicopathological characteristics and surgical outcomes of adrenal hemolymphangioma,so as to enhance the understanding of this disease. Methods: Clinical and pathological data of 8 patients with adrenal hemolymphangioma admitted to the Department of Urology of our hospital during Jan.2013 and Dec.2022 were retrospectively analyzed,and relevant literature was reviewed. Results: The patients included 5 males and 3 female,median age 54(25-75) years.Adrenal hemolymphangioma was detected in all patients in physical examinations without obvious symptoms.And 4 of the patients had a history of hypertension.Adrenal function test results showed no abnormalities.A total of 9 tumors were identified by imaging examination,including 1 unilateral multiple and 7 unilateral solitary tumors,with a median diameter of 3.6(1.0-5.4) cm.Posterior laparoscopic adrenal tumor resection was performed in 7 cases and robot-assisted laparoscopic adrenal tumor resection in 1 case;all of the tumors were completely removed.The median operation time was 77(53-115) min,median intraoperative blood loss 7.5(2.0-20.0) mL,and median postoperative hospital stay 4(1-7) d.Postoperative pathology showed interwoven deformed and dilated blood vessels and lymphatic vessels in the cystic tumors,with a large amount of lymphoid fluid,lymphocytes and red blood cells.Chronic lymphocyte infiltration was visible between the tube walls.The cystic cavity was partially connected,with flat endothelial cells lining.The pathological diagnosis was adrenal hemolymphangioma.During the median follow-up of 53.5(12.0-106.8) months,all patients recovered well,with stable blood pressure and no tumor recurrence or metastasis. Conclusion: Adrenal hemolymphangioma has no specific clinical symptoms.As adrenal functional tests show no obvious abnormalities,the diagnosis depends on pathological examinations.Popsterior laparoscopic or robot-assisted laparoscopic resection has good efficacy and prognosis.
8.Research progress on the relationship between vascular structure patterns and prognosis of renal cell carcinoma
Dameng PAN ; Qiming ZHANG ; Min QIU ; Lulin MA
Journal of Modern Urology 2025;30(3):261-265
Vascular structure pattern,namely the maturity,morphology and distribution of blood vessels,as one of the pathological features of renal cell carcinoma (RCC),cannot be ignored when the prognosis is concerned.The current mainstream classification of vascular structure patterns includes pseudoacini,Golgi,lacunar and dispersion patterns.Many studies have shown that the vascular structure patterns in RCC are closely related to the diagnosis and prognosis.Early features such as dendritic penetration of the endothelium contribute to the differential diagnosis of RCC,while different vascular structure patterns are not only related to tumor grade,but also affect the responsiveness of targeted therapy and prognosis.Evaluating these vascular structural patterns can help to understand the biological behaviors of tumors and guide the treatment options,but a unified assessment of vascular structural patterns is still lacking.This paper reviews the research progress on the relationship between vascular structure patterns and RCC prognosis,aiming to provide clinical reference.
9.Clinical characteristics and influencing factors of extraglandular invasion of prostatic ductal adenocarcinoma.
Xiaoyong YANG ; Fan ZHANG ; Lulin MA ; Cheng LIU
Journal of Peking University(Health Sciences) 2025;57(5):956-960
OBJECTIVE:
To explore the differences in perioperative clinical and pathological characteristics of patients with different pathological types of prostate cancer undergoing radical prostatectomy, and to analyze the influencing factors that may affect the extraglandular invasion of ductal adenocarcinoma of the prostate.
METHODS:
Retrospective collection was made of the radical prostatectomy patients who were admitted to Peking University Third Hospital from December 2011 to April 2021. The patients were screened based on inclusion criteria to obtain basic clinical features and postoperative pathological results. According to the pathological results, the patients were divided into ductal adenocarcinoma group (mixed with ductal adenocarcinoma) and acinar adenocarcinoma group, and a 1 ∶1 propensity score matching was performed to compare the differences in clinical characteristics between the two groups. Univariate and multivariate analyses of the factors related to extraglandular invasion were performed in the matched ductal adenocarcinoma groups.
RESULTS:
A total of 764 patients with prostate cancer were enrolled in this study, of which 62 patients were confirmed to have ductal adenocarcinoma components by postoperative pathology. There was a statistically significant difference in the proportion of the patients with a history of diabetes in baseline characteristics between the two groups before propensity score matching (29.5% vs. 17.7%, P=0.027). A total of 61 patients with simple acinar adenocarcinoma were successfully matched with the patients with ductal adenocarcinoma, and there was no statistically significant difference in baseline characteristics between the two groups after matching (P>0.05). The comparison of perioperative clinical and pathological features showed that International Society of Urology Pathology (ISUP) grade (P=0.003), pT stage (P=0.004), extraglandular invasion rate (P=0.018) and vascular thrombus rate (P=0.019) in ductal adenocarcinoma group were significantly higher than those in simple acinous adenocarcinoma group. Univariate analysis of the influence factors of extraglandular invasion showed that prostate-specific antigen (PSA) level, prostate volume, ISUP grade, seminal vesicle invasion and perineural invasion might be the influencing factors of extraglandular invasion (P < 0.10). Binary Logistic regression analysis showed that perineural invasion was an independent factor of extraglandular invasion (OR=11.78, 95%CI: 1.97-70.56, P=0.007).
CONCLUSION
Prostatic ductal adenocarcinoma has a worse prognosis than simple acinar adenocarcinoma. Perineural invasion is the influencing factor of extraglandular invasion of ductal adenocarcinoma.
Humans
;
Male
;
Prostatic Neoplasms/surgery*
;
Retrospective Studies
;
Prostatectomy
;
Neoplasm Invasiveness
;
Middle Aged
;
Aged
;
Carcinoma, Ductal/surgery*
;
Propensity Score
;
Adenocarcinoma/surgery*
10.Prognostic analysis of laparoscopic simultaneous radical cystectomy and nephroureterectomy.
Shenmo LI ; Dandan SU ; Jiyu LIN ; Haodong SONG ; Lulin MA ; Xiaofei HOU ; Guoliang WANG ; Hongxian ZHANG ; Jianfei YE ; Shudong ZHANG
Journal of Peking University(Health Sciences) 2025;57(5):961-966
OBJECTIVE:
To investigate the safety and prognostic factors influencing the treatment of upper urinary tract urothelial carcinoma (UTUC) combined with bladder cancer (BCa) by laparoscopic simultaneous radical cystectomy and nephroureterectomy (RCNU).
METHODS:
The clinical data of patients admitted to Peking University Third Hospital for laparoscopic RCNU surgery from January 2009 to September 2023 were analyzed retrospectively. Based on the same gender, age (±5 years), history of uroepithelial tumors, underlying diseases, T-stage, N-stage, M-stage, American Society of Anesthesiologists (ASA) score, Charlson comorbidity index, and body mass index (BMI) (±5), 34 patients with RCNU were matched 1 ∶1 with patients with bladder cancer who underwent laparoscopic radical cystectomy (RC) alone. Kaplan-Meier survival analysis was used to calculate patient survival, and Cox proportional regression risk model was used to analyze clinical factors affecting prognosis.
RESULTS:
Of the 68 patients enrolled, the follow-up rate was 100% with a median follow-up time of 27.0 (11.7, 60.2) months. Comparison of intraoperative conditions (including operation time, estimated intraoperative bleeding, intra-operative blood transfusion, etc.) between the two groups of patients showed no significant difference (P>0.05). Comparison of preoperative creatinine and postoperative creatinine between the two groups of patients showed significant differences (P < 0.05). The perioperative Clavien grade Ⅲ-Ⅳ complication rates were 2.9% (1/34) in the RC group and 5.9% (2/34) in the RCNU group. There was no significant difference in terms of perioperative complications between the two groups. Overall survival was significantly lower in the patients receiving RCNU compared with the matched group receiving RC alone (P < 0.05). Cox regression analysis suggested that two factors, high N stage and high postoperative creatinine, were independent risk factors affecting the prognosis of patients in the 2 groups (P < 0.05).
CONCLUSION
The overall survival prognosis of patients undergoing RCNU surgery was worse compared with laparoscopic RC surgery alone during the same period. There was no clinically significant difference between the two groups in terms of operation time, intraoperative bleeding, and perioperative complications, and there were clinically significant differences in preoperative renal function and post-operative renal function.
Humans
;
Laparoscopy/methods*
;
Nephroureterectomy/methods*
;
Cystectomy/methods*
;
Prognosis
;
Male
;
Retrospective Studies
;
Female
;
Urinary Bladder Neoplasms/mortality*
;
Middle Aged
;
Aged

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