A Proposal for Standardization of Early Outcomes Following Robot-Assisted Radical Cystectomy (RARC): RARC Tetrafecta.

BACKGROUND: Currently, there is no dedicated tool to record the early outcomes of robot-assisted radical cystectomy (RARC), and existing criteria for longer-term outcomes require a minimum of 3 months for assessment. However, early evaluation is essential to prevent future morbidity and mortality, especially in surgeries with a high risk of complications in the short term. We propose a comprehensive approach to report early RARC outcomes and investigate the influence of surgeon experience on these results. PATIENTS AND METHODS: We retrospectively analyzed the outcomes of patients who underwent RARC for bladder cancer between April 2009 and April 2020. The cohort was divided chronologically into three groups: patients 1-60 in group 1, 61-120 in group 2, and 121-192 in group 3. Patients with yields of ≥ 16 lymph nodes (LN), negative soft tissue surgical margins, absence of transfusion, and absence of major complications at 30 days were regarded as attaining the RARC tetrafecta. RESULTS: Of the 192 included patients, 93 (48.4%) achieved RARC tetrafecta, with the proportion increasing with surgical experience from 41.7% in group 1 to 55.6% in group 3. Age [odds ratio (OR) 0.947; 95% confidence interval (CI) 0.924-0.970; P = 0.021], LN yield (OR 1.432; 95% CI 1.139-1.867; P = 0.001), and greater surgical experience with RARC (> 120 patients; OR 2.740; 95% CI 1.231-6.100; P = 0.014) were significantly associated with the achievement of RARC tetrafecta. CONCLUSIONS: RARC tetrafecta could be a comprehensive method for reporting early outcomes in patients undergoing RARC, with improvements aligned with the surgeon's experience.

Sextant Systematic Biopsy Versus Extended 12-Core Systematic Biopsy in Combined Biopsy for Prostate Cancer.

BACKGROUND: This study assessed the comparative effectiveness of sextant and extended 12-core systematic biopsy within combined biopsy for the detection of prostate cancer. METHODS: Patients who underwent combined biopsy targeting lesions with a Prostate Imaging Reporting and Data System (PI-RADS) score of 3-5 were assessed. Two specialists performed all combined cognitive biopsies. Both specialists performed target biopsies with five or more cores. One performed sextant systematic biopsies, and the other performed extended 12-core systematic biopsies. A total of 550 patients were analyzed. RESULTS: Cases requiring systematic biopsy in combined biopsy exhibited a significant association with age ≥ 65 years (odds ratio [OR], 2.32; 95% confidence interval [CI], 1.25-4.32; P = 0.008), PI-RADS score (OR, 2.32; 95% CI, 1.25-4.32; P = 0.008), and the number of systematic biopsy cores (OR, 3.69; 95% CI, 2.11-6.44; P < 0.001). In patients with an index lesion of PI-RADS 4, an extended 12-core systematic biopsy was required (target-negative/systematic-positive or a greater Gleason score in the systematic biopsy than in the targeted biopsy) (P < 0.001). CONCLUSION: During combined biopsy for prostate cancer in patients with PI-RADS 3 or 5, sextant systematic biopsy should be recommended over extended 12-core systematic biopsy when an effective targeted biopsy is performed.

Fat Loss in Patients with Metastatic Clear Cell Renal Cell Carcinoma Treated with Immune Checkpoint Inhibitors.

The purpose of this study was to determine the prognostic impact of fat loss after immune checkpoint inhibitor (ICI) treatment in patients with metastatic clear cell renal cell carcinoma (ccRCC). Data from 60 patients treated with ICI therapy for metastatic ccRCC were retrospectively analyzed. Changes in cross-sectional areas of subcutaneous fat (SF) between the pre-treatment and post-treatment abdominal computed tomography (CT) images were expressed as percentages and were divided by the interval between the CT scans to calculate ΔSF (%/month). SF loss was defined as ΔSF < -5%/month. Survival analyses for overall survival (OS) and progression-free survival (PFS) were performed. Patients with SF loss had shorter OS (median, 9.5 months vs. not reached; p < 0.001) and PFS (median, 2.6 months vs. 33.5 months; p < 0.001) than patients without SF loss. ΔSF was independently associated with OS (adjusted hazard ratio (HR), 1.49; 95% confidence interval (CI), 1.07-2.07; p = 0.020) and PFS (adjusted HR, 1.57; 95% CI, 1.17-2.12; p = 0.003), with a 5%/month decrease in SF increasing the risk of death and progression by 49% and 57%, respectively. In conclusion, Loss of SF after treatment initiation is a significant and independent poor prognostic factor for OS and PFS in patients with metastatic ccRCC who receive ICI therapy.

A prospective phase-II trial of biweekly docetaxel plus androgen deprivation therapy in patients with previously-untreated metastatic castration-naïve prostate cancer.

INTRODUCTION: The aim of this prospective phase II study was to evaluate the efficacy and safety of biweekly docetaxel plus androgen-deprivation therapy (ADT) in patients with metastatic castration-naïve prostate cancer (mCNPC). PATIENTS AND METHODS: Patients with histologically-proven, previously-untreated mCNPC received ADT plus docetaxel, 40 mg/m2. Docetaxel was repeated every 2 weeks, up to 12 cycles. Endpoints included castration-resistant prostate cancer (CRPC)-free survival, prostate-specific antigen (PSA) response, and safety. RESULTS: A total of 42 patients were registered and analyzed for final outcomes. Of the 42 patients, 36 (86%) completed the 12 planned cycles of docetaxel plus ADT. During a median follow up of 25 months, all but two patients (95%) achieved a PSA response with a nadir PSA level of 0.42 ng/ml (range 0.01-1280.87). The median CRPC-free survival was 26.4 months (95% confidence interval [CI] 20.9-32.0) with a one-year CRPC-free rate of 79% (33 patients, 95% CI 66-91). Multivariable analysis revealed that the performance status of the Eastern Cooperative Oncology Group 0 was independently associated with longer CRPC-free survival (hazard ratio [HR] 0.27, 95% CI 0.07-0.99). The most common adverse events of any grade were anemia (95%), followed by nail changes (33%), fatigue (29%), and oral mucositis (26%). Severe (grade 3 or higher) adverse events were infrequent: pneumonitis (n = 2), diarrhea (n = 1), and neutropenia (n = 1). CONCLUSION: Our results suggest that biweekly docetaxel plus ADT is feasible, and clinical efficacy does not seem to be compromised compared to a standard triweekly docetaxel 75 mg/m2 plus ADT regimen.

Strategy for Prostate Cancer Patients with Low Prostate Specific Antigen Level (2.5 to 4.0 ng/mL).

BACKGROUND: To evaluate the strategy for detection of prostate cancer (PCa) with low prostate specific antigen (PSA) level (2.5-4.0 ng/mL), prostate biopsy patients with low PSA were assessed. We evaluated the risk of low PSA PCa and the strategy for screening low-PSA patients. METHODS: We retrospectively analyzed the patients who underwent prostate biopsy with low PSA level. Baseline characteristics, PSA level before prostate biopsy, prostate volume, prostate specific antigen density (PSAD), and pathological data were assessed. RESULTS: Among the 1986 patients, 24.97% were diagnosed with PCa. The PSAD was 0.12 ± 0.04 ng/mL² in the PCa-diagnosed group and 0.10 ± 0.04 ng/mL² in non-cancer-diagnosed group (P < 0.001). Of the 496 patients diagnosed with PCa, 302 (60.89%) were in the intermediate- or high-risk group. PSAD was 0.13 ± 0.04 ng/mL² in the intermediate- or high-risk group and 0.11 ± 0.03 ng/mL² in the very low- and low-risk group (P < 0.001). Of 330 patients who underwent radical prostatectomy, 85.15% were diagnosed as having significant cancer. There was significant correlation between PSAD and PCa (r = 0.294, P < 0.001). PSAD with a specificity of 80.00% of a clinically significant cancer diagnosis was assessed at 0.1226 ng/mL². CONCLUSION: The PCa detection rate in the low-PSA group was not lower than that of previous studies of patients with PSA from 4.0 to 10.0 ng/mL. Further, it may be helpful to define a strategy for PCa detection using PSAD in the low-PSA group.

A randomized, double-blind, placebo-controlled trial to evaluate the role of curcumin in prostate cancer patients with intermittent androgen deprivation.

BACKGROUND: The anti-cancer activities of curcumin are well-documented from preclinical studies using prostate cancer models. Our objective was to evaluate the anti-cancer activity of oral curcumin in patients with prostate cancer. METHODS: This randomized, double-blind, placebo-controlled trial was performed on patients with prostate cancer who received intermittent androgen deprivation (IAD). Participants who finished the first on-treatment period of IAD were randomized into a curcumin or placebo group. The patients took oral curcumin (1440 mg/day) or placebo for six months and were followed up until the beginning of the second on-treatment. The primary end-point was duration of the first off-treatment. The secondary end-points were change in PSA and testosterone levels during 6 months, PSA progression rate, and health-related quality of life (HRQOL) scores at 6 months. Safety assessments included adverse event, adverse drug reaction, and serious adverse event. RESULTS: A total of 97 participants were randomized 1:1 to curcumin (n = 49) and placebo (n = 48) groups. Among them, 82 patients (84.5%) were evaluable for the analysis (39 and 43 patients in the curcumin and placebo groups, respectively). The median off-treatment duration was 16.3 months (95% confidence interval [CI] 12.3-20.3 months) and 18.5 months (95% CI 12.5-23.0 months) in the curcumin and placebo groups, respectively. There was no significant difference in the curve of off-treatment duration between the two groups (P = 0.4816). The proportion of patients with PSA progression during the active curcumin treatment period (6 months) was significantly lower in the curcumin group than the placebo group (10.3% vs 30.2%, P = 0.0259). The change of PSA, testosterone levels during 6 months, and HRQOL scores at 6 months were not different between curcumin and placebo groups. Adverse events were higher in the placebo group (16 of 46 vs 7 of 45 patients, P = 0.0349). No significant differences in the adverse drug reaction were found between the two groups. CONCLUSIONS: Six months' intake of oral curcumin did not significantly affect the overall off-treatment duration of IAD. However, PSA elevation was suppressed with curcumin intake during the curcumin administration period. Curcumin at this dose was well tolerated and safe.

Combination of multiparametric magnetic resonance imaging and transrectal ultrasound-guided prostate biopsies is not enough for identifying patients eligible for hemiablative focal therapy for prostate cancer.

PURPOSE: To evaluate focal therapy (hemiablation) eligibility in men undergoing prostate biopsy and multiparametric magnetic resonance imaging (mpMRI) with reference to histopathology from radical prostatectomy (RP) specimens. METHODS: Subjects were selected among 810 men who underwent prostate biopsy, mpMRI, and RP from January 2016 to December 2017. Hemiablation eligibility criteria were biopsy-proven unilateral cancer, prostate-specific antigen ≤ 15 ng/ml, and Gleason score (GS) ≤ 3 + 4. Evidence of non-organ-confined disease or Prostate Imaging Reporting and Data System score ≥ 4 on the contralateral lobe on mpMRI was classified as ineligible for hemiablation. Of the 810, data for 185 who met the screening criteria were compared to final pathology findings. Significant cancer at RP was defined as any of the following: (1) GS 6 with tumor volume ≥ 0.5 ml; (2) GS ≥ 3 + 4; or (3) the presence of advanced stage (≥ pT3). RESULTS: Among the 185 candidates for hemiablation, 62 (33.5%) had unilateral cancer on final RP histopathology. Among the 123 bilateral cancers, 50 (27%) were organ confined and had GS ≤ 3 + 4 = 7 and bilateral multifocal tumor in which the index tumor was confined to one lobe and the secondary tumor in the contralateral lobe had tumor volume < 0.5 ml and GS ≤ 6. A total of 112 (60.5%) patients in this series were considered suitable for hemiablation. Significant cancer on biopsy and mpMRI-negative lobes were found in 72 (38.9%) of 185 lobes, including 1 (0.5%) with advanced stage. CONCLUSIONS: The combination of standard prostate biopsy and mpMRI did not accurately identify lobes that could be considered as non-treated regions.

A retrospective feasibility study of biweekly docetaxel in patients with high-risk metastatic castration-naïve prostate cancer.

BACKGROUND: Results from randomized phase III trials have shown that thrice-weekly docetaxel added to androgen-deprivation therapy (ADT) has a significant impact on the survival of patients with metastatic castration-naïve prostate cancer (mCNPC) and established early chemotherapy as part of the standard of care for high-risk disease. Controversy remains, however, because some patients experience critical toxicities related to docetaxel. The purpose of the current study was to evaluate the feasibility and adverse events of biweekly-administered docetaxel in patients with previously-untreated, high-risk mCNPC. METHODS: The study included 35 consecutive patients with high-risk mCNPC who received ADT plus docetaxel 40 mg/m2. Oral prednisone 5 mg twice daily was also given. Treatment was repeated every two weeks for up to 12 cycles or until disease progression or unacceptable toxicity occurred. High-risk was defined as bone metastases beyond axial skeleton and/or visceral disease. RESULTS: The included patients' median age was 68 years (range: 31-86 years) and 17 (49%) had visceral metastases. Biweekly docetaxel was generally well-tolerated; the most commonly observed adverse events, considering those of all grades, included alopecia (74%), nail changes (42%), and constipation (31%). Hematologic adverse events were infrequent, and no patient received hematopoietic growth factors. One patient died after the fourth cycle due to respiratory failure, which occurred as a complication of pneumonia. Among the 35 patients, 28 completed the planned 12 cycles of biweekly docetaxel. Prostate-specific antigen response (> 50% decrease from baseline) was recorded in 33 patients (94%), and the radiologic response rate was 49%. Median progression-free survival was 13.6 months (95% confidence interval: 6.7-20.4). CONCLUSION: ADT plus biweekly-administered docetaxel appeared to be tolerated and effective in patients with high-risk mCNPC.

Cancer Location in Upgrading and Detection after Transperineal Template-Guided Mapping Biopsy for Patients in Active Surveillance and Negative Transrectal Ultrasonography-Guided Prostate Biopsy.

OBJECTIVES: We investigated the efficacy of transperineal template-guided mapping biopsy (TTMB) for patients on active surveillance (AS) or those with previous negative transrectal ultrasound-guided biopsy (TRUS-Bx). METHODS: We retrospectively analyzed 99 patients on AS and 60 patients with previous negative TRUS-Bx, which is a total of 159 patients who underwent TTMB from May 2017 to January 2019. Cancer location was analyzed with focus on the anterior and apex lesions of the prostate after TTMB. Multiparametric magnetic resonance imaging was performed before TTMB. Cancer location after TTMB in 138 patients, excluding 21 patients who were not eligible for analysis (4 patients on AS and 17 patients with previous negative TRUS-Bx) was compared with Prostate Imaging-Reporting and Data System version 2 (PI-RADSTM v2) score. Factors that may affect detecting cancer after TTMB with previous negative TRUS-Bx was analyzed using a logistic regression model. RESULTS: In AS patients, 29 patients (29.3%) exhibited an upgrade in Gleason score (GS) after TTMB. Among them, 22 patients (75.9%) showed at the anterior or apex lesions. In patients with previous negative TRUS-Bx, 18 patients (30.0%) were diagnosed with prostate cancer. Among them, 13 patients (72.2%) exhibited cancer at the anterior or apex lesion. Among the 25 AS patients with PI-RADSTM score 1-2, 5 patients (20.0%) showed an upgrade in GS. Among the 26 patients with previous negative TRUS-Bx and PI-RADSTM score 1-2, 6 patients (23.1%) had cancer. In multivariate regression model, prostate volume (OR 0.951) was identified as the predictor for a positive biopsy result after TTMB with previous negative TRUS-Bx. CONCLUSIONS: TTMB is efficient for patients on AS in the detection of upgraded cancer located in anterior or apex or those with previous negative TRUS-Bx in the detection of anterior or apex cancer. In PI-RADSTM score 1-2, a substantial proportion of patients after experienced upgrade in GS on AS patients or cancer detection on previous negative TRUS-Bx. Moreover, we identified prostate volume is the independent predictor for a positive biopsy result after TTMB with previous negative TRUS-Bx.

Changeable Conditional Survival Rates and Associated Prognosticators in Patients with Metastatic Renal Cell Carcinoma Receiving First Line Targeted Therapy.

PURPOSE: In this study we evaluated conditional survival probabilities in patients with metastatic renal cell carcinoma who underwent first line tyrosine kinase inhibitor therapy. We also identified predictors of conditional survival with time. MATERIALS AND METHODS: We retrospectively reviewed clinical data on 1,659 individuals with metastatic renal cell carcinoma in the Korean Renal Cancer Study Group database, of whom the records of 1,131 were finally analyzed. The primary end point was conditional overall survival. Kaplan-Meier survival analysis was used to calculate conditional overall survival probabilities using the formula, conditional survival (α│ß) = S(α + ß)/S(ß), indicating the likelihood of additional α years survivorship in person who has already survived for ß years after initial therapy. S(χ) represents the actual survival rate. Multivariate Cox regression model was used to identify predictors of conditional survival with time. RESULTS: Six, 12, 18, 24 and 36-month conditional overall survival gradually increased in patients at all additional survival times after initial treatment compared to patient baseline survival estimations. While the actual overall survival rate decreased with time, the 36-month conditional overall survival rate was calculated as 7.3% higher in patients who had already survived 36 months compared to baseline estimations at the time of initial tyrosine kinase inhibitor treatment. Furthermore, predictors of conditional overall survival changed with time. Only previous metastasectomy remained a key prognosticator of conditional overall survival until 36 months of survival following initial tyrosine kinase inhibitor treatment. CONCLUSIONS: Conditional survival improved with time after initial tyrosine kinase inhibitor treatment in patients with metastatic renal cell carcinoma. Our study offers valuable information for practical survival estimations and relevant prognosticators in patients with metastatic renal cell carcinoma who receive first line tyrosine kinase inhibitor.

RFA versus robotic partial nephrectomy for T1a renal cell carcinoma: a propensity score-matched comparison of mid-term outcome.

OBJECTIVE: To compare oncological and functional mid-term outcomes following robotic partial nephrectomy (RPN) and radiofrequency ablation (RFA) for treating T1a renal cell carcinoma (RCC) using propensity score-matching. METHODS: Between December 2008-April 2016, 63 patients from each treatment group were propensity score-matched for age, sex, American Society of Anesthesiologists score, tumour size, tumour laterality, tumour histology, R.E.N.A.L. nephrometry score and preoperative estimated glomerular filtration rate (eGFR). Post-treatment follow-up periods for RPN and RFA ranged from 1-90 months (median, 24.6) and 1-65 months (21), respectively. Tumour location, percentage of eGFR preservation and 2-year recurrence-free survival rate were compared between groups. RESULTS: Exophytic and endophytic RCC occurred in 73.0 % (46/63) and 27.0 % (17/63) of the RPN group, and 52.4 % (33/63) and 47.6 % (30/63) of the RFA group, respectively (p=0.017). There was 91.7 % preservation of eGFR in the RPN group and 86.8 % in the RFA group (p=0.088). Two-year recurrence-free survival rate was 100 % in the RPN and 95.2 % in the RFA group (p=0.029). CONCLUSIONS: RPN provides a higher recurrence-free survival rate than RFA. However, RFA is a better treatment option for an endophytic or recurrent RCC that is difficult to treat with RPN. KEY POINTS: • RPN provides a higher recurrence-free survival rate than RFA. • Unlike RPN, repeat RFA is easy to perform for recurrent RCC. • Endophytic RCC could be better treated with RFA.

Prognostic impact of the pretreatment aspartate transaminase/alanine transaminase ratio in patients treated with first-line systemic tyrosine kinase inhibitor therapy for metastatic renal cell carcinoma.

OBJECTIVES: To examine the prognostic role of the pretreatment aspartate transaminase/alanine transaminase or De Ritis ratio in patients with metastatic renal cell carcinoma receiving first-line systemic tyrosine kinase inhibitor therapy. METHODS: We retrospectively searched the medical records of 579 patients with metastatic renal cell carcinoma who visited Samsung Medical Center, Seoul, Korea, from January 2001 through August 2016. After excluding 210 patients, we analyzed 360 patients who received first-line tyrosine kinase inhibitor therapy. Cancer-specific survival and overall survival were defined as the primary and secondary end-points, respectively. A multivariate Cox proportional hazards regression model was used to identify independent prognosticators of survival outcomes. RESULTS: The overall population was divided into two groups according to the pretreatment De Ritis ratio as an optimal cut-off value of 1.2, which was determined by a time-dependent receiver operating characteristic curve analysis. Patients with a higher pretreatment De Ritis ratio (≥1.2) had worse cancer-specific survival and overall survival outcomes, compared with those with a lower De Ritis ratio (<1.2). Notably, a higher De Ritis ratio (≥1.2) was found to be an independent predictor of both cancer-specific survival (hazard ratio 1.61, 95% confidence interval 1.13-2.30) and overall survival outcomes (hazard ratio 1.69, 95% confidence interval 1.19-2.39), along with male sex, multiple metastasis (≥2), non-clear cell histology, advanced pT stage (≥3), previous metastasectomy and the Memorial Sloan Kettering Cancer Center risk classification. CONCLUSION: Our findings show that the pretreatment De Ritis ratio can provide valuable information about the survival outcomes of metastatic renal cell carcinoma patients receiving first-line tyrosine kinase inhibitor therapy.

Prognostic Significance of Pre- to Postoperative Dynamics of the Prognostic Nutritional Index for Patients with Renal Cell Carcinoma Who Underwent Radical Nephrectomy.

BACKGROUND: This study aimed to examine the prognostic role of Prognostic Nutritional Index (PNI) dynamics in the pre- and postoperative periods for patients with renal cell carcinoma (RCC) who undergo radical nephrectomy (RN). METHODS: The study analyzed 324 patients with RCC who underwent RN. The overall population was classified into four groups according to four types of pre- to postoperative PNI dynamics as follows: group 1 (low â†’ low PNI), group 2 (low â†’ high PNI), group 3 (high â†’ low PNI), and group 4 (high â†’ high PNI). The level of PNI was calculated using the following formula: 10 × serum albumin level (g/dL) + 0.005 × absolute lymphocyte counts in blood (/mm3). The primary end point was cancer-specific survival (CSS), and the secondary end point was overall survival (OS). RESULTS: The patients with higher pre- and postoperative PNI (>45) had better survival outcomes than those with lower pre- and postoperative PNI (≤45). Notably, the patients in group 4 showed the best CSS and OS rates, whereas the patients in group 1 had the worst survival outcomes. Furthermore, PNI dynamics were identified as an independent predictor of CSS and OS outcomes, in addition to pre- and postoperative PNI, tumor size, and pathologic T (pT) stage. The patients with localized RCC (≤pT2) showed significant differences in both CSS and OS estimates, whereas the patients with advanced pT stage (≥pT3) demonstrated a difference only in OS outcomes, according to PNI dynamics. CONCLUSIONS: This study is the first to provide the independent prognostic importance of dynamics of nutritional status for patients with RCC.

Accuracy of preoperative multiparametric magnetic resonance imaging for prediction of unfavorable pathology in patients with localized prostate cancer undergoing radical prostatectomy.

INTRODUCTION: We investigated the accuracy of multiparametric MRI (mpMRI) for preoperative staging and its influence on the determination of neurovascular bundle sparing and disease prognosis in patients with localized prostate cancer. METHODS: We reviewed 1045 patients who underwent radical prostatectomy with preoperative mpMRI at a single institution. Clinical local stages determined from mpMRI were correlated with preoperative and postoperative pathological outcomes. RESULTS: The sensitivity and specificity to diagnose seminal vesicle invasion (SVI) on mpMRI were 43.8 and 95.4 %, respectively. The negative predictive value was 78.9 %. The sensitivity and specificity to diagnose extracapsular extension (ECE) were 54.5 and 80.5 %, respectively. The overall sensitivity and specificity of diagnosing pathological T3 or higher were 52.6 and 82.1 %, respectively. Non-organ-confined disease determined by mpMRI was significantly associated with positive surgical margin and pathological T3 disease on multivariate analysis. Preoperative adverse findings on mpMRI were significantly associated with performance of the non-nerve-sparing technique. CONCLUSION: mpMRI did not show outstanding diagnostic accuracy relative to our expectations in predicting SVI or ECE preoperatively. However, adverse findings on preoperative mpMRI were significantly related to worse postoperative pathological outcomes as well as postoperative biochemical recurrence.

A retrospective feasibility study of biweekly, reduced-dose docetaxel in Asian patients with castrate-resistant, metastatic prostate cancer.

BACKGROUND: The aim of this retrospective study was to evaluate the clinical outcomes of reduced dose, biweekly docetaxel chemotherapy for Korean patients with castrate-resistant prostate cancer (CRPC). METHODS: We retrospectively reviewed the medical records of 48 patients with metastatic CRPC who were treated with a biweekly regimen (intravenous docetaxel 40 mg/m2 on day 1 plus prednisolone 5 mg twice daily) between 2012 and 2015 at Samsung Medical Center (Seoul, Korea). Prior to the adoption of a biweekly regimen in Oct 2013, our institutional standard chemotherapy was docetaxel 75 mg/m2 every 3 weeks for patients with CRPC (n = 24). After Oct 2013, all chemotherapy-naïve patients with CRPC received a 40 mg/m2 biweekly regimen (n = 24). The primary end point was a PSA response, defined as a greater than 50% decline in PSA level from baseline. RESULTS: The baseline characteristics of the patients in the two treatment groups were similar. The most common cause of treatment discontinuation was disease progression, which was exhibited by 17 patients (71%) in the 3-weekly group and 20 (75%) in the biweekly group. PSA responses were observed in 12 (50%) and 11 (46%) patients in the 3-weekly and biweekly groups, respectively (p = 0.683). Time to treatment failure (TTTF, 4.5 vs 3.9 months) and time-to-progression (TTP, 5.0 vs 4.2 months) were not significantly different between the 3-weekly and biweekly groups. CONCLUSIONS: Within the limitations of a retrospective study, the biweekly reduced dose docetaxel regimen was active and well-tolerated in Korean patients with metastatic CRPC.

Surgical treatment of renal cell carcinoma: Can morphological features of inferior vena cava tumor thrombus on computed tomography or magnetic resonance imaging be a prognostic factor?

OBJECTIVES: To evaluate the impact of morphological features of inferior vena cava thrombus on the overall survival and cancer-specific survival (cancer-specific survival of patients with renal cell carcinoma). METHODS: We retrospectively analyzed the records of 156 renal cell carcinoma patients with inferior vena cava thrombus who underwent radical nephrectomy and thrombectomy from 1998 to 2013 at five tertiary centers. Inferior vena cava thrombi were classified as spherical (type I) and spiculated (type II) according to morphological features on computed tomography or magnetic resonance imaging. Multivariate cox regression models were used to quantify the impact of prognostic factors on overall survival and cancer-specific survival. RESULTS: Type I was found in 29 patients (18.6%), and type II in 127 patients (81.4%). Median follow up was 38.2 months (interquartile range 12-57). Demographic characteristics were not significantly different, except for the cranial thrombus height (P = 0.003). On multivariate analysis, Eastern Cooperative Oncology Group performance score, clinical tumor size, distant metastasis, histologic subtype, thrombus morphology and remnant venous thrombus significantly affected overall survival in pNany Many patients (all P < 0.05). Among the pNO /X MO patients, clinical tumor size, histologic subtype, thrombus morphology and remnant venous thrombus significantly affected overall survival (all P < 0.05). In terms of cancer-specific survival, Eastern Cooperative Oncology Group performance score, clinical tumor size, distant metastasis, histologic subtype and thrombus morphology significantly affected cancer-specific survival in pNany Many patients (all P < 0.05). In patients with pNO /X MO , body mass index, clinical tumor size, histological subtype, thrombus morphology and remnant venous thrombus significantly affected cancer-specific survival (all P < 0.05). CONCLUSION: Clinical tumor size, histological subtype, and thrombus morphology are independent predictors of overall survival and cancer-specific survival in renal cell carcinoma patients with inferior vena cava thrombus. These factors might be helpful for the surgeon's determination to improve therapeutic efficacy.

Percutaneous Kidney Biopsy for a Small Renal Mass: A Critical Appraisal of Results.

PURPOSE: We report the diagnostic accuracy of renal mass biopsy for a small renal mass (4 cm or less) and identify predictors of successful renal mass biopsy in a contemporary cohort of patients from 2 large tertiary referral centers. MATERIALS AND METHODS: A total of 442 biopsies of renal tumors 4 cm or less at 2 tertiary centers between 2008 and 2015 were included in study. Biopsy outcomes (malignant, benign or nondiagnostic) and concordance rates between renal mass biopsy and final surgical pathology were determined. Univariate and multivariate logistic regression analyses were performed to identify factors indicative of nondiagnostic biopsy. RESULTS: The initial biopsy was diagnostic in 393 cases (88.9%) and nondiagnostic in 49 (11.1%). Of diagnostic biopsies 76% revealed renal cell carcinoma and 24% were benign. Renal cell carcinoma histological subtyping and grading was possible in 90.2% and 31.3% of cases, respectively. A second biopsy was performed in 11 of the 49 nondiagnostic cases and a diagnosis was possible in 100%, including renal cell carcinoma in 10 and oncocytoma in 1. Small tumor size, cystic nature of tumors and biopsy during the initial years of the study were independent predictors of nondiagnostic biopsy. The rates of accuracy in identifying malignancies, histiotyping and 2-tier grading between renal mass biopsy and surgical pathology were 97.1%, 95.1% and 68.8%, respectively. CONCLUSIONS: Renal mass biopsy for a small renal mass can be performed accurately. Nondiagnostic renal mass biopsy was common for smaller masses and cystic masses, and during the initial years of the study. A second biopsy should be considered in nondiagnostic biopsy cases.

Preoperative Prognostic Nutritional Index is a Significant Predictor of Survival in Renal Cell Carcinoma Patients Undergoing Nephrectomy.

BACKGROUND: Preoperative assessment of patients' immunologic and nutritional conditions is required to predict the outcome of patients with malignant tumors. The aim of the current study was to clarify the significance of the prognostic nutritional index (PNI), which simply accounts for immunological and nutritional conditions, in patients with renal cell carcinoma (RCC). METHODS: We included 1437 patients who underwent nephrectomy for RCC between 1994 and 2008. PNI was calculated using the following formula: 10 × serum albumin concentration (g/dL) + 0.005 × lymphocyte counts (number/mm(2)) in peripheral blood. We examined the correlation of the preoperative PNI value with clinicopathological features. A Cox regression model and the Harrell concordance index with variables only or combined PNI data were used to evaluate the prognostic significance in the T1-4NallMall and T1-4N0M0 groups. RESULTS: The mean preoperative PNI value was 52.7 ± 6.3 (range 27.7-85.3). The mean PNI values were significantly lower in patients with more advanced tumor T stage, regional lymph node metastasis, distant metastases, higher Fuhrman grade, and sarcomatoid differentiation than in patients without such factors (p < 0.001). Patients with low PNI (<51) had poor survival rates compared to those with high PNI in univariate analysis (>51, p < 0.001). Multivariate analysis showed that low PNI was significantly associated with cancer-specific survival (p = 0.026 and p = 0.009) and overall survival (p = 0.013 and p = 0.011) in the T1-4NallMall and T1-4N0M0 groups, respectively, after correcting for other clinicopathological factors. CONCLUSIONS: PNI is an independent prognostic factor for predicting survival after nephrectomy in patients with RCC.

Volumetric measurement of compensatory hypertrophy in the contralateral normal kidney by the tumor growth.

PURPOSE: We evaluated the association between tumor size and preoperative volumetric kidney parameters measured with CT in patients with renal cell carcinoma (RCC). METHODS: We prospectively identified 1118 patients who underwent radical or partial nephrectomy for RCC between 2011 and 2014. Contrast-enhanced CT was performed within three months before surgery. Kidney volume was measured using a tissue segmentation tool program from CT images. We classified patients into three groups depending on tumor size (A: ≤4 cm, B: 4-7 cm, C: >7 cm). The preoperative volumetric kidney parameters were compared and multivariable linear regression was used to analyze potential factors associated with compensatory hypertrophy of the contralateral normal kidney before surgery. RESULTS: Patients in group C had a significantly larger contralateral normal kidney volume than patients in A and B (A: 170.0 mL, B: 171.7 mL, C: 187.2 mL, p < 0.001). The contralateral kidney volume was not significantly different between groups A and B (p > 0.05). However, tumor-side real kidney volume in group C was significantly smaller than that of groups A and B (A: 168.8 mL, B: 164.9 mL, C: 150.9 mL, p < 0.001). On multivariable analysis, increased contralateral kidney volume was positively associated with male gender, higher BMI, DM, higher preoperative GFR, and tumor size (>7 cm), and negatively associated with older age (p < 0.05). Tumor size had the strongest positive association with contralateral kidney volume (>7 cm, partial regression coefficient = 30.2). CONCLUSIONS: Tumor size (>7 cm) is the strongest factor associated with compensatory hypertrophy in the contralateral normal kidney before surgery.

The impact of three-dimensional tumor volume on cancer-specific survival for patients with pT1 clear-cell renal cell carcinoma.

PURPOSE: To evaluate the impact of three-dimensional tumor volume on cancer-specific survival for patients with pT1 clear-cell renal cell carcinoma (ccRCC). MATERIALS AND METHODS: We reviewed a prospectively maintained database of 917 patients who underwent radical nephrectomy or nephron-sparing surgery for unilateral, pT1 ccRCC, including 654 pT1a and 263 pT1b patients, between April 1997 and December 2010. Three-dimensional tumor volume was measured using specialized volumetric software on cross-sectional computed tomography images of a preoperative venous phase. Kaplan-Meier and Cox regression analyses were carried out. RESULTS: The median age was 54 years with a follow-up of 60.8 months. Median tumor size and volume were 3.2 cm and 17.4 cm(3), respectively. Of 917 patients, 54 (5.9 %) had died, including 32 patients with ccRCC (9 patients in pT1a and 23 patients in pT1b). On multivariate analysis, tumor size >3.2 cm and tumor volume >17.4 cm(3) were associated with cancer-specific death in pT1 ccRCC patients. When stratified by pT1a/pT1b status and analyzed on median splits, tumor size >2.5 cm was associated with cancer-specific death but not tumor volume >9.5 cm(3) in pT1a patients. However, in pT1b patients, tumor volume >62.1 cm(3) (P = 0.036, HR 2.91, 95 % CI 1.02-7.77) was highly associated with cancer-specific death but not tumor size >5.0 cm (P = 0.159, HR 1.91, 95 % CI 0.78-4.70). CONCLUSIONS: In addition to tumor size, tumor volume is associated with cancer-specific death in pT1 ccRCC patients, particularly in pT1b ccRCC but not in pT1a ccRCC.