Purpose: Adjuvant pembrolizumab improved disease-free survival (DFS) and overall survival (OS) versus placebo in participants with renal cell carcinoma (RCC) at increased risk of recurrence after nephrectomy in the global phase 3 KEYNOTE-564 study. This post hoc subgroup analysis evaluated the efficacy and safety of adjuvant pembrolizumab in East Asian (Japan, South Korea, and Taiwan) participants enrolled in KEYNOTE-564. Materials and Methods: Eligible participants were randomly assigned 1:1 to receive adjuvant pembrolizumab 200 mg or placebo intravenously every 3 weeks for ≤ 17 cycles. The primary endpoint was DFS by investigator assessment. OS was a key secondary endpoint. Safety was a secondary endpoint. Results: The East Asian subgroup included 126 participants (pembrolizumab, n=58; placebo, n=68). Median follow-up was 62.1 months (range, 49.6 to 73.0 months). Hazard ratio for DFS with pembrolizumab versus placebo was 0.70 (95% confidence interval 0.41 to 1.20). Median DFS was not reached with pembrolizumab versus 58.8 months with placebo; estimated 48-month rate was 61.3% versus 51.2%. Hazard ratio for OS was 0.47 (95% confidence interval, 0.15 to 1.49). Median OS was not reached with pembrolizumab and placebo; estimated 48-month rate was 94.8% versus 91.2%. Treatment-related adverse events occurred in 70.7% of participants (29.3% grade 3 or 4) receiving pembrolizumab and 36.8% of participants (0.0% grade 3 or 4) receiving placebo. No pembrolizumab-related deaths occurred. Conclusion In the KEYNOTE-564 East Asian subgroup, adjuvant pembrolizumab provided DFS and OS benefits versus placebo and had a safety profile consistent with the global results. These results further support pembrolizumab as adjuvant treatment for East Asian patients with RCC at increased risk of recurrence after nephrectomy.

The da Vinci S surgical system (Intuitive Surgical) was approved as a medical device in 2009 by the Japanese Ministry of Health, Labour and Welfare. Robotic surgery has since been used in gastrointestinal, thoracic, gynecological, and urological surgeries. In April 2012, robotic-assisted laparoscopic radical prostatectomy (RALP) was first approved for insurance coverage. Since then, RALP has been increasingly used, with more than 3,000 RALP procedures performed by March 2013. By July 2014, 183 institutions in Japan had installed the da Vinci surgical system. Other types of robotic surgeries are not widespread because they are not covered by public health insurance. Clinical trials using robotic partial nephrectomy and robotic gastrectomy for renal and gastric cancers, respectively, have recently begun as advanced medical treatments to evaluate health insurance coverage. These procedures must be evaluated for efficacy and safety before being covered by public health insurance. Other types of robotic surgery are being evaluated in clinical studies. There are several challenges in robotic surgery, including accreditation, training, efficacy, and cost. The largest issue is the cost-benefit balance. In this review, the current situation and a prospective view of robotic surgery in Japan are discussed.
Cost-Benefit Analysis ; Esophageal Neoplasms/surgery ; Gastrectomy/*methods ; Gynecologic Surgical Procedures/methods ; Humans ; Japan ; Laparoscopy/*methods ; Nephrectomy/*methods ; Otolaryngology/methods ; Prospective Studies ; Prostatectomy/*methods ; Rectal Neoplasms/surgery ; Robotic Surgical Procedures/education/*trends ; Stomach Neoplasms/surgery ; Thymectomy/methods ; Thyroid Diseases/surgery