1.Adjuvant Pembrolizumab Versus Placebo for Renal Cell Carcinoma in the East Asian Subgroup of the Phase 3 KEYNOTE-564 Study
Se Hoon PARK ; Yen-Hwa CHANG ; Jae Lyun LEE ; Toni K. CHOUEIRI ; Go KIMURA ; Jinsoo CHUNG ; Naoya MASUMORI ; Kazuo NISHIMURA ; Minoru KATO ; Haruaki KATO ; Kazuyuki NUMAKURA ; Chao-Hsiang CHANG ; Satoshi ANAI ; Hiroyuki TSUNEMORI ; Chung-Hsin CHEN ; Jianxin LIN ; Aymen ELFIKY ; Joseph E. BURGENTS ; Hiroshi KITAMURA
Cancer Research and Treatment 2026;58(2):613-621
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.
2.Serous-lined tunnel technique in urinary reconstruction
Baojun GU ; Haruaki KATO ; Feng LIU ; Ting SHEN ; Denglong WU ; Sanbao JIN ; Yong QIAO ; Yuemin XU
Chinese Journal of Urology 2010;31(5):347-349
Objective To examine the feasibility of using the serous-lined tunnel technique for orthotopic neobladder, continent cutaneous diversion and ureteral replacement by the intestinal segment. Methods In 31 patients of orthotopic ileal neobladder, the serous-lined tunnel techniques were used for antirefluxing ureteral implantation: In 13 patients of continent ileal pouch, the techniques were adopted for continent-valve construction and for uretersl implantation: In 3 patients (with lower ureteric cancer), the same techniques were applied for constructing the ileal ureters with a proximal antirefluxing mechanism. Results With a mean follow-up of 27 mon( 12-132 mon), 88 ureters implanted into ileal neobladders or continent pouches functioned well with neither obstruction nor reflux: 12 in 13 continent valves functioned well with no incontinence. 3 patients with ileal ureters showed no ileo-ureteric reflux and had reduced hydronephrosis comparing to that of before surgery.Conclusions Ureteral reimplantation and continent valve formation achieved by adopting the serouslined tunnel technique provide satisfactory results. The versatility of the technique is obvious in the present experience and the creative application of the serous-lined tunnel technique should be possible in urinary reconstruction.

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