Early Experiences with Nivolumab in Patients with Metastatic Renal Cell Carcinoma and Failed Target Therapy

PURPOSE: The efficacy of nivolumab in metastatic renal cell carcinoma (mRCC) has been proven. However, the nivolumab experience in Korean patients with mRCC is still poorly reported. We report initial experiences with the efficacy and safety of nivolumab in patients with mRCC. MATERIALS AND METHODS: We retrospectively reviewed records for 25 patients with mRCC who had failed targeted therapy and were treated by nivolumab (2 mg/kg, every 2 weeks) at a single institution. The primary endpoint was objective response rate (ORR), and secondary endpoints were progression-free survival (PFS), safety profiles, and ORR in a programmed cell death receptor ligand 1 (PD-L1) expression subgroup. RESULTS: The median age was 60 years and 16 patients (64%) were male. Objective responses were achieved in 8 patients (32.0%) (complete response, 1; partial response, 7). Median PFS was 3.0 months (95% confidence interval, 1.46–4.53). Treatment-related adverse events (AEs) of any grade were observed in 19 patients (76.0%) with 6 (24.0%) experiencing grade 3 to 4 treatment-related AEs. In subgroups by PD-L1 expression levels classified as 1% or greater and less than 1%, ORR was 50% and 0%, respectively. CONCLUSIONS: This study showed the efficacy and safety of initial experiences with nivolumab in Korean patients with mRCC who had failed targeted therapy. Our results were comparable to recent clinical trials on nivolumab in mRCC.

Comparison of 5-Year Outcomes of Robot-Assisted Laparoscopic and Laparoscopic Partial Nephrectomy in Patients With Localized Renal Cell Carcinoma

PURPOSE: To compare the 5-year oncologic and functional outcomes of robot-assisted laparoscopic partial nephrectomy (RALPN) and laparoscopic partial nephrectomy (LPN) as treatment for localized renal cell carcinoma (RCC). MATERIALS AND METHODS: We analyzed the records of 181 patients with localized RCC who underwent RALPN (n=97) or LPN (n=84) between 2007 and 2011. Demographic and preoperative data with estimated glomerular filtration rate (eGFR), intraoperative data including warm ischemic time (WIT) and complications, oncologic outcomes (recurrence, metastasis), and rate of eGFR preservation at most recent follow-up were examined. RESULTS: WIT was shorter in the RALPN group (27±9.1 minutes) than the LPN group (31±10 minutes, p=0.019). Intraoperative complication rates were also lower in RALPN patients than LPN patients (4.1% vs. 14.3%). The eGFR preservation rate was higher in the RALPN group (84.6%) than in the LPN group (81.5%, p=0.049). Particularly, a relatively high difference in the eGFR preservation rate was observed in the RALPN group compared with the LPN group according to R.E.N.A.L. score 7–10 values (RALPN, 86.5±12.9 vs. LPN, 76.7±16.0; p=0.003). During the follow-up period, there was no local recurrence in either group and distant metastases only occurred in one patient in the RALPN group and in 2 patients in the LPN group. CONCLUSIONS: RALPN and LPN showed similar 5-year oncologic outcomes, but RALPN was superior to LPN in terms of WIT, intraoperative complications, and long-term eGFR preservation rate, especially in complex cases.

High-Intensity Focused Ultrasound as Salvage Therapy for Patients With Recurrent Prostate Cancer After Radiotherapy

PURPOSE: To evaluate the oncologic outcomes and postoperative complications of high-intensity focused ultrasound (HIFU) as a salvage therapy after external-beam radiotherapy (EBRT) failure in patients with prostate cancer. MATERIALS AND METHODS: Between February 2002 and August 2010, we retrospectively reviewed the medical records of all patients who underwent salvage HIFU for transrectal ultrasound-guided, biopsy-proven locally recurred prostate cancer after EBRT failure (by ASTRO definition: prostate-specific antigen [PSA] failure after three consecutive PSA increases after a nadir, with the date of failure as the point halfway between the nadir date and the first increase or any increase great enough to provoke initiation of therapy). All patients underwent prostate magnetic resonance imaging and bone scintigraphy and had no evidence of distant metastasis. Biochemical recurrence (BCR) was defined according to the Stuttgart definition (PSA nadir plus 1.2 ng/mL). RESULTS: A total of 13 patients with a median age of 68 years (range, 60-76 years) were included. The median pre-EBRT PSA was 21.12 ng/mL, the pre-HIFU PSA was 4.63 ng/mL, and the period of salvage HIFU after EBRT was 32.7 months. The median follow-up after salvage HIFU was 44.5 months. The overall BCR-free rate was 53.8%. In the univariate analysis, predictive factors for BCR after salvage HIFU were higher pre-EBRT PSA (p=0.037), pre-HIFU PSA (p=0.015), and short time to nadir (p=0.036). In the multivariate analysis, there were no significant predictive factors for BCR. The complication rate requiring intervention was 38.5%. CONCLUSIONS: Salvage HIFU for prostate cancer provides effective oncologic outcomes for local recurrence after EBRT failure. However, salvage HIFU had a relatively high rate of complications.