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.Low-grade myofibroblastic sarcoma of the palate.
Tomohiro YAMADA ; Tomohide YOSHIMURA ; Naoya KITAMURA ; Eri SASABE ; Seiji OHNO ; Tetsuya YAMAMOTO
International Journal of Oral Science 2012;4(3):170-173
Low-grade myofibroblastic sarcoma (LGMS) is a rare, malignant tumor with myofibroblastic differentiation. Despite it being classified as a distinct entity by the World Health Organization, a few cases were reported in the oral and maxillofacial region. Here, a LGMS developed on the palate of a 73-year-old man who presented with a 1-cm tumor on the posterior border of the palate. Based on the histological and immunohistochemical features, a diagnosis of LGMS was established. The tumor was resected, and no recurrence was observed over 2 years. Although the tongue is the most preferred site for LGMS, it may occur in any region of the oral cavity.
Aged
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Humans
;
Male
;
Myofibroblasts
;
pathology
;
Osteosarcoma
;
pathology
;
surgery
;
Palatal Neoplasms
;
pathology
;
surgery
;
Palate, Hard
;
pathology
3.Developmental Signaling Disorders in Craniofacial Anomalies and Cancers
Yan Zhang ; Hua Wang ; Akihide Kamegai ; Tsuyoshi Hata ; Naoya Kitamura ; Masaru Hosoda ; Ryouji Tani ; Yasutaka Hayashido ; Shigeaki Toratani ; Tetsuji Okamoto
Oral Science International 2006;3(2):56-63
Normal human development requires the precise functioning and coordination of many complex pathways. Abnormalities in these signaling cascades often result in developmental perturbations, giving rise to congenital anomalies and cancers. There are 21,787 genes in each human nucleus, different gene subsets are expressed in different cell types, and different gene networks make different signal cascades. Among a large number of genes, in this review, we describe signaling disorders of sonic hedgehog and its receptor, patched-1; Tie2; fibroblast growth factor receptor in craniofacial anomalies and oral cancers.


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