Bumsik Hong

A Double-Blind Crossover Study Evaluating the Efficacy of Korean Red Ginseng in Patients With Erectile Dysfunction: A Preliminary Report

PURPOSE We investigated the efficacy of Korean red ginseng for erectile dysfunction using the International Index of Erectile Function, RigiScan (UroHealth Systems, Laguna Niguel, California), hormonal levels and penile duplex ultrasonography with audiovisual sexual stimulation. MATERIALS AND METHODS A total of 45 patients with clinically diagnosed erectile dysfunction were enrolled in a double-blind, placebo controlled, crossover study (8 weeks on treatment, 2 weeks of washout and 8 weeks on treatment) in which the effects of Korean red ginseng and a vehicle placebo were compared using multiple variables. The ginseng dose was 900 mg. 3 times daily. RESULTS Mean International Index of Erectile Function scores were significantly higher in patients treated with Korean red ginseng than in those who received placebo (baseline 28.0 +/- 16.7 and 38.1 +/- 16.6 versus 30.9 +/- 15.7, p <0.01). Scores on questions 3 (penetration) and 4 (maintenance) were significantly higher in the ginseng than in the placebo group (p <0.01). In response to the global efficacy question 60% of the patients answered that Korean red ginseng improved erection (p <0.01). Among other variables penile tip rigidity on RigiScan showed significant improvement for ginseng versus placebo. CONCLUSIONS Our data show that Korean red ginseng can be as effective alternative for treating male erectile dysfunction.

The Efficacy and Safety of Sunitinib in Korean Patients with Advanced Renal Cell Carcinoma: High Incidence of Toxicity Leads to Frequent Dose Reduction

OBJECTIVE The effects of sunitinib in a broad patient population, especially those of Asian ethnicity, have been rarely investigated. Here, we assessed the efficacy and safety of sunitinib in Korean patients with advanced renal cell carcinoma. METHODS Between April 2006 and August 2008, 77 Korean patients with advanced renal cell carcinoma were treated with sunitinib. We performed retrospective analysis for efficacy in terms of survival outcomes and response rate. Toxicity profiles were also assessed. RESULTS A total of 65 patients, including 39 (60%) patients without previous cytotoxic or immunotherapy, were eligible for the analysis. In 53 patients with measurable lesions, the objective response rate was 43% and disease control was achieved in 46 (86%) patients. The median time to treatment failure, time to progression and overall survival were 7.0, 11.8 and 22.8 months, respectively, with a median follow-up of 26.8 months in surviving patients. The most common treatment-related adverse events were fatigue (81%) and stomatitis (60%). The most common Grade 3 or 4 adverse events were hand-foot syndrome (16%), thrombocytopenia (16%) and stomatitis (10%). Dose reduction was required in 46% of patients. CONCLUSIONS The efficacy was similar to a previous Phase III trial and a safety profile of sunitinib was manageable in Korean patients with advanced renal cell carcinoma, although the incidence of dose reduction and Grade 3 or 4 adverse events were higher than those of western reports. Future studies should investigate the ethnic differences in toxicity profiles of sunitinib.

The Protective Role of Renal Parenchyma as a Barrier to Local Tumor Spread of Upper Tract Transitional Cell Carcinoma and its Impact on Patient Survival

PURPOSE We investigated whether tumor location has independent prognostic significance in upper tract transitional cell carcinoma cases and which factor determines it. MATERIALS AND METHODS We reviewed data on 122 renal pelvis and 102 ureteral tumor cases, including the recurrence pattern. Tumor location and other clinicopathological variables were evaluated regarding cancer specific and recurrence-free survival. Stage pT3 tumors were stratified into those invading renal parenchyma or peripelvic/periureteral fat. RESULTS Overall 5-year cancer specific survival and recurrence-free survival rates were 77.0% and 71.6%, respectively, at a mean followup of 60.7 months. Of the clinicopathological parameters T stage was the most significant prognosticator of the survival rate, while nodal involvement, high grade and ureteral tumor location were also significant for lower survival rates. Stratification analysis for matching pathological stage revealed that, while survival rates were similar in the renal pelvis and ureteral tumor groups at stage pT2 or less, renal pelvic tumors were associated with significantly higher survival rates than ureteral tumors for stage pT3. Specifically renal pelvic tumors invading the renal parenchyma were associated with a lower local failure rate, and higher cancer specific and recurrence-free survival rates than tumors invading peripelvic or periureteral fat, ie 77.5% vs 49.7% 5-year cancer specific survival and 75.6% vs 32.0% 5-year recurrence-free survival (p = 0.014 and 0.003, respectively). CONCLUSIONS Tumor location is an independent prognostic factor for pT3 upper tract transitional cell carcinoma. The overall better prognosis of renal pelvic tumors was mainly attributable to pT3 tumor outcomes, specifically lesions invading the renal parenchyma. These findings may be due to the protective role of thick renal parenchyma against local tumor spread.

Differential Diagnosis of Complex Cystic Renal Mass Using Multiphase Computerized Tomography

PURPOSE We evaluated the additional usefulness of multiphase computerized tomography for improving the differential diagnosis of cystic renal masses by the Bosniak classification. MATERIALS AND METHODS We reviewed the records of 104 patients with Bosniak class II (29 or 27.8%), III (38 or 36.5%) and IV (37 or 35.7%) cystic renal masses managed surgically between 1997 and 2007. On preoperative multiphase computerized tomography enhancement differences in HU between the precontrast and corticomedullary phases were measured at the highest enhancement area to correlate with pathological findings. RESULTS Renal cell carcinoma was diagnosed in 56 patients (53.8%). Of the tumors 35 (62.5%) showed clear cell histology. According to Bosniak class 3 (11.5%), 21 (55.2%) and 32 (86.4%) class II to IV lesions, respectively, were diagnosed as renal cell carcinoma. For renal cell carcinoma and benign cysts mean HU at the precontrast phase was similar (31.5 and 32.4 HU, respectively), while renal cell carcinoma showed a significantly higher measurement at the corticomedullary phase (112.9 vs 59.8 HU, p <0.0001). To differentiate renal cell carcinoma a corticomedullary phase minus precontrast phase value of greater than 42 HU was predictive with 97.1% sensitivity and 85.7% specificity (area under the ROC curve 0.966). In a multiple regression model the corticomedullary phase minus precontrast phase value and the Bosniak classification independently determined malignant pathological findings (corticomedullary phase minus precontrast phase greater than 42 HU HR 31.541, 95% CI 8.320-119.563 and Bosniak class HR 5.545, 95% CI 2.153-14.279, each p <0.0001). CONCLUSIONS In cases of complex cystic renal masses diagnostic accuracy can be improved to differentiate renal cell carcinoma by combining Bosniak class and enhancement differences measured on multiphase computerized tomography between precontrast and maximal enhancement phases. This would help determine the need for and the method of surgical treatment.

Predictive Characteristics of Malignant Pheochromocytoma

Purpose The prognosis of patients with malignant pheochromocytoma is poor, but the predictive factors are not well understood. We aimed to identify the clinical characteristics predictive of malignancy after initial surgical removal in patients with pheochromocytoma. Materials and Methods We retrospectively reviewed the records of 152 patients diagnosed with pheochromocytoma, including 5 (3.3%) with metastasis at the time of the initial surgical excision and 12 (7.9%) who developed metastasis during follow-up. To determine the factors predictive of malignancy, we compared clinical, radiographical, and urinary chemical findings between patients with benign and malignant disease. Mean follow-up was 41.5 months (range, 0.9-298 months) after surgery. Results Malignant tumors were significantly larger than benign tumors (11.1±4.0 cm vs. 6.2±3.4 cm, p<0.001), and postoperative persistence of arterial hypertension was more frequent after removal of malignant than benign tumors (p=0.001). Among the 147 patients without metastatic disease at diagnosis, those who developed metastasis had significantly lower concentrations of urinary catecholamine metabolites per unit of tumor, including vanillylmandelic acid (1.2 vs. 3.7 mg/day/cm, p=0.049), epinephrine (4.5 vs. 168.9 µg/day/cm, p=0.008), and norepinephrine (13.1 vs. 121.8 mg/day/cm, p<0.001). The overall 5-year metastasis-free survival rate was 84.4% and was significantly higher in patients with smaller tumors (≤5.5 vs. >5.5 cm; 90.6% vs. 81.2%, p=0.025) and higher 24-hour secretion of vanillylmandelic acid (>2.1 vs. ≤2.1 mg/day/cm; 94.9% vs. 70.9%, p=0.019). Conclusions Large tumor size (>5.5 cm) and minimally elevated 24-hour urinary vanillylmandelic acid (≤2.1 mg/day/cm) were significantly associated with a higher probability of a malignant pheochromocytoma portending a lower metastasis-free survival and mandating more rigorous follow-up after surgery.

Value of immediate second resection of the tumor bed to improve the effectiveness of transurethral resection of bladder tumor.

BACKGROUND AND PURPOSE Current guidelines recommend routine second transurethral resection (TUR) for accurate diagnosis and to prevent understaging of muscle-invasive bladder cancer. We evaluated the diagnostic accuracy of immediate second resection of the tumor bed during initial TUR and its prognostic significance. PATIENTS AND METHODS Patients (n=126) undergoing TUR were prospectively randomized to undergo (n=63) or not undergo (n=63) immediate second resection of the tumor bed after complete TUR. Second resection was repeated until muscularis propria (MP) was identified in the specimen and the depth of tumor invasion was inspected. The results of second resection were compared with final pathology results for diagnostic accuracy. Recurrence and progression rates were compared in the two groups, and factors affecting recurrence were evaluated. RESULTS Patient age, sex distribution, number of tumors, pathologic T stage and grade were similar in the groups. MP was included in all TUR specimens in the immediate second resection group, compared with 41 of 63 (65.1%) in the nonsecond resection group. The concordance rate of second resection with final pathology was r=0.810 (P<0.01). The sensitivity and specificity of second resection for T(2) disease were 90.9% and 98.0%, respectively, and the positive and negative predictive values of second resection for T(2) disease were 90.0% and 96.2%, respectively. Among the 94 patients followed up, those in the second resection group had significantly higher 2-year recurrence-free survival rate (77.0% vs 45.8%, P=0.025), but there was no difference in progression-free survival rate. CONCLUSIONS Immediate second resection of the tumor bed after complete TUR improves the effectiveness of resection by immediately confirming the presence of MP in the specimen and accurately differentiating muscle-invasive disease. The advantages of immediate second resection were precise prediction of final pathology results and reduced early recurrence.

Analysis of pre-operative variables for identifying patients who might benefit from upfront cytoreductive nephrectomy for metastatic renal cell carcinoma in the targeted therapy era

OBJECTIVE The aim of the study is to identify pre-operative variables for selection of patients who would benefit from upfront cytoreductive nephrectomy for metastatic renal cell carcinoma. METHODS We reviewed the medical records of 171 patients who were presented with synchronous metastatic renal cell carcinoma and who had received no systemic therapy before enrollment. Of these, 96 underwent cytoreductive nephrectomy followed by targeted therapy (cytoreductive nephrectomy group) and 75 treated with targeted therapy alone (non-cytoreductive nephrectomy group). A Cox proportional hazards regression model was used to estimate the prognostic significance of pre-operative characteristics predicting overall survival in the cytoreductive nephrectomy group. The significant variables were designated as pre-operative factors to identify patients who would benefit from cytoreductive nephrectomy. RESULTS The median overall survival was 19.9 and 11.7 months in the cytoreductive nephrectomy and non-cytoreductive nephrectomy groups (P < 0.001). Karnofsky performance status (<80; hazard ratio 9.497, P < 0.001), hemoglobin (less than lower limit of normal; hazard ratio 1.913, P = 0.025), neutrophils (greater than upper limit of normal; hazard ratio 6.533, P < 0.001) and clinical N stage (N2; HR 2.714, P = 0.001) were independent pre-operative risk factors of mortality. Only those patients with risk factor <2 who had undergone upfront cytoreductive nephrectomy had a better median overall survival than patients who received targeted therapy alone (28.2 vs. 18.4 months, P = 0.018). CONCLUSIONS Four pre-operative risk factors (Karnofsky performance status, hemoglobin, neutrophils and clinical N stage) were identified as suitable for selection of patients who would not benefit from undergoing cytoreductive nephrectomy.

Smoking and survival after radical cystectomy for bladder cancer.

OBJECTIVE To present our long-term follow-up data to investigate whether cigarette smoking is associated with the prognosis of bladder cancer after radical cystectomy. Despite the close link between cigarette smoking and the development of bladder cancer, little is known about the influence of cigarette smoking on the bladder cancer prognosis after radical cystectomy. MATERIALS AND METHODS The cigarette smoking status of 602 patients who had undergone radical cystectomy for bladder cancer was determined using questionnaires completed before surgery. The effect of cigarette smoking on recurrence-free survival, cancer-specific survival, and overall survival was determined. RESULTS Of the 340 patients with a smoking history, 159 were current smokers. The smokers were younger (P = .001) and more likely to be male (P = .001) than were the nonsmokers. The 5-year recurrence-free survival rate of the smokers and nonsmokers was 62.1% and 56.8% (P = .182), the 5-year cancer-specific survival rate was 67.3%, 63.9% (P = .436), and the 5-year overall survival rate was 63.0% and 58.8% (P = .309), respectively. Multivariate analysis revealed that smoking was not an independent predictor of recurrence-free survival or cancer-specific survival. After adjusting for other prognostic variables, cigarette smoking status (non-, ex-, or current smoker), cumulative exposure, and years from smoking cessation were not associated with cancer-specific survival (P = .378, P = .827, and P = .876, respectively). CONCLUSION The results of the present study found no association between cigarette smoking and the prognosis of bladder cancer after radical cystectomy.

Obesity and prognosis in muscle-invasive bladder cancer: The continuing controversy

To investigate the association between body mass index and clinicopathological features of bladder cancer, and to assess the prognostic value of body mass index in patients undergoing radical cystectomy for bladder cancer.

Efficacy and safety of docetaxel plus prednisolone chemotherapy for metastatic hormone-refractory prostate adenocarcinoma: single institutional study in Korea.

PURPOSE To assess the efficacy and safety of treating Korean patients with metastatic hormone-refractory prostate cancer (HRPC) using docetaxel plus prednisolone chemotherapy. MATERIALS AND METHODS This was a retrospective cohort study performed in 98 patients with metastatic HRPC between October 2003 and April 2008. After screening, 72 patients fit the eligibility criteria for inclusion in this study. Treatment consisted of 5 mg prednisolone twice daily and 75 mg/m² docetaxel once every 3 weeks. RESULTS Patient demographic characteristics included: median age 67 years (range, 51~86), median ECOG performance status 1 (0~2), Gleason score ≥8 in 61 patients (86%), and median serum PSA 45.5 ng/mL (range, 3.7~2,420.0). A total of 405 cycles of treatment were administered with a median 6 cycles (range, 1~20) per patient. The median docetaxel dose-intensity was 24.4 mg/m(2)/week (range, 17.5~25.6). A PSA response was seen in 51% of 63 evaluable patients at 12 weeks and maximal PSA decline ≥50% in 59% of 70 evaluable patients. Tumor response was evaluated in 13 patients, 4 patients achieved PR, and 5 patients had SD with a response rate of 31%. With a median follow-up duration of 23.1 months (95%CI, 16.7~29.5), the median time to PSA progression was 5.1 months (95%CI, 4.5~5.8) and median overall survival was 22.8 months (95%CI, 16.6~29.1). Nine (13%) patients experienced grade 3 or higher febrile neutropenia. CONCLUSION This chemotherapy regimen (docetaxel every 3 weeks plus prednisolone daily) demonstrated a strong response in Korean patients with metastatic HRPC, while the toxicity profile was manageable and similar to that observed in Western patients.