1.Effect of screw loosening on health-related quality of life following single-level posterior lumbar interbody fusion: a retrospective study in Japan
Hiroki USHIROZAKO ; Tomohiko HASEGAWA ; Shigeto EBATA ; Tetsuro OHBA ; Hiroki OBA ; Keijiro MUKAIYAMA ; Yu YAMATO ; Go YOSHIDA ; Tomohiro BANNO ; Hideyuki ARIMA ; Shin OE ; Koichiro IDE ; Tomohiro YAMADA ; Kenta KUROSU ; Toshiyuki OJIMA ; Jun TAKAHASHI ; Hirotaka HARO ; Yukihiro MATSUYAMA
Asian Spine Journal 2026;20(2):244-254
Methods:
This study included 138 patients who underwent PLIF, with a mean age of 67 years and a follow-up period of 12 months. At 12 months postoperatively, lumbar computed tomography (CT) was performed to assess SL, and patients were categorized into SL and nonloosening (NL) groups accordingly. A propensity score-matched model was used to adjust for age, sex, and body mass index (BMI). Propensity score matching was performed to compare outcomes between the SL and NL groups.
Results:
Among the 138 patients, 29 (21%) developed SL following PLIF. Preliminary analysis revealed that the patients in the SL group were older and exhibited decreased femoral neck bone mineral density, preoperative pelvic retroversion, poor whole spine alignment, and lesser improvement in HRQOL compared with the NL group. Using propensity score matching, 22 patients were selected from each group (mean age, 72 years) (C-statistic=0.78). The propensity score-matched analysis demonstrated significant differences in the preoperative pelvic tilt (25.9° vs. 17.8°, p=0.010) between the matched SL and NL groups. Furthermore, the Oswestry Disability Index scores indicated poorer improvements in the matched SL group than in the matched NL group at 9 months postoperatively (p=0.025).
Conclusions
After matching, pre- and postoperative pelvic retroversion were significantly associated with SL. Patients with SL experienced significantly poorer improvement in HRQOL at 9 months postoperatively. Therefore, implementing strategies for preventing SL may enhance early postoperative HRQOL.
2.Pembrolizumab plus chemotherapy with or without bevacizumab in East Asian participants with persistent, recurrent, or metastatic cervical cancer: results from KEYNOTE-826final analysis
Yong-Man KIM ; Shin NISHIO ; Se Ik KIM ; Kosei HASEGAWA ; Coraline DUBOT ; M. Valeria CÁCERES ; Krishnansu S. TEWARI ; Domenica LORUSSO ; Jeong-Won LEE ; Wen-Shiung LIOU ; Kan LI ; Cumhur TEKIN ; Nicoletta COLOMBO ; Bradley J. MONK
Journal of Gynecologic Oncology 2025;36(4):e110-
Objective:
In the phase 3 KEYNOTE-826 study (NCT03635567), pembrolizumab plus chemotherapy with or without bevacizumab significantly improved progression-free survival (PFS) and overall survival (OS) in participants with persistent, recurrent, or metastatic cervical cancer. We report an exploratory analysis of outcomes for participants enrolled in East Asia based on the final analysis of KEYNOTE-826.
Methods:
Participants were randomized 1:1 to receive pembrolizumab 200 mg or placebo every 3 weeks for up to 35 cycles. All participants received chemotherapy with paclitaxel and cisplatin or carboplatin for up to 6 cycles, and optionally received bevacizumab at the investigator’s discretion. PFS and OS were dual primary endpoints.
Results:
Ninety-seven participants from East Asia were enrolled in the intention-to-treat population. At data cutoff (October 3, 2022), in the intention-to-treat population, median PFS in the pembrolizumab plus chemotherapy and placebo plus chemotherapy groups was 18.0 and 10.4 months, respectively (hazard ratio [HR]=0.42; 95% confidence interval [CI]=0.23−0.77); median OS was not reached and 20.4 months, respectively (HR=0.53;95% CI=0.28−0.99). In the programmed cell death ligand 1 combined positive score (CPS) ≥1 population, median PFS was 29.3 and 10.9 months, respectively (HR=0.36; 95% CI=0.19−0.68); median OS was not reached and 17.4 months, respectively (HR=0.43; 95% CI=0.22−0.86). The most common adverse events with pembrolizumab plus chemotherapy versus placebo plus chemotherapy were alopecia (75% vs. 68%) and anemia (67% vs. 65%).
Conclusion
These data support the use of pembrolizumab plus chemotherapy with or without bevacizumab for the treatment of persistent, recurrent, or metastatic cervical cancer in East Asian patients.
3.A prospective study on age-specific normative values of the prognostic nutritional index and the effects of malnutrition on spinal alignment using health checkup data of elderly residents
Shin OE ; Yu YAMATO ; Koichiro IDE ; Tomohiko HASEGAWA ; Go YOSHIDA ; Tomohiro BANNO ; Hideyuki ARIMA ; Tomohiro YAMADA ; Kenta KUROSU ; Yukihiro MATSUYAMA
Asian Spine Journal 2025;19(6):987-1000
Methods:
We included 237 participants from a 2-yearly resident health checkup conducted in Toei, Aichi, Japan. Participants underwent blood tests and whole-spine standing radiography, and were stratified based on age (60s, 70s, and 80s) and sex to determine age-specific normative PNI values. Additionally, participants were categorized into a lower PNI (PNI <50) or higher PNI (PNI ≥50) group to compare spinal alignment.
Results:
The average PNI values for different age groups were: 60s: males (n=13): 50.7, females (n=31): 50.9; 70s: males (n=55): 50.3, females (n=57): 50.1; 80s: males (n=28): 49.1, females (n=53): 48.3. For females, the radiographic spinal alignment parameters were comparable between the lower and higher PNI groups; however, in males, significant differences were noted for pelvic tilt (20° vs. 16°, p=0.020), lumbar lordosis (35° vs. 44°, p<0.001), and pelvic incidence minus lumbar lordosis (10° vs. 4°, p=0.013).
Conclusions
Malnutrition in males negatively impacts their lumbar-pelvic alignment. While the normative PNI value decreases with age, the two variables show a very weak correlation.
4.Adjacent segment degeneration at a minimum 2-year follow-up after posterior lumbar interbody fusion: the impact of sagittal spinal proportion: a retrospective case series
Xuepeng WEI ; Yu YAMATO ; Tomohiko HASEGAWA ; Go YOSHIDA ; Tomohiro BANNO ; Shin OE ; Hideyuki ARIMA ; Koichiro IDE ; Tomohiro YAMADA ; Kenta KUROSU ; Yukihiro MATSUYAMA
Asian Spine Journal 2024;18(5):681-689
Methods:
Radiological parameters were extracted from the whole lateral radiographs. Patients were divided into two groups: the ASD group (segmental kyphosis of ≥10º, and/or a ≥50% loss of disc height, and/or ≥3 mm of anteroposterior translation) and the non-ASD group.
Results:
All 112 included patients underwent PLIF for lumbar degenerative diseases. The minimum follow-up period was 2 years, with an average follow-up time of 63.6 months. Fifty-two patients (46.4%) were classified into the ASD group and of these, 13 required reoperation due to failure of conservative treatment. Patients with ASD exhibited significantly more caudal and posterior inflection vertebrae (IV), while the lumbar apical vertebra was significantly more caudal immediately after surgery. The IV position was identified as a significant risk factor for ASD, and the ASD incidence was significantly higher in the group where IV ≤5 (L1 vertebral body) than in the group where IV ≥5.5 (T12–L1 disc) (69.0% vs. 38.6%).
Conclusions
The IV position is a significant risk factor for ASD development. Although it is difficult to control intraoperative IV levels, we note a high risk of ASD in patients with IV lower than T12–L1.
5.Implications of the diagnosis of locomotive syndrome stage 3 for long-term care
Koichiro IDE ; Yu YAMATO ; Tomohiko HASEGAWA ; Go YOSHIDA ; Mitsuru HANADA ; Tomohiro BANNO ; Hideyuki ARIMA ; Shin OE ; Tomohiro YAMADA ; Yuh WATANABE ; Kenta KUROSU ; Hironobu HOSHINO ; Haruo NIWA ; Daisuke TOGAWA ; Yukihiro MATSUYAMA
Osteoporosis and Sarcopenia 2024;10(2):89-94
Objectives:
Locomotive syndrome stage 3 (LS3), which has been established recently, may imply a greater need for care than LS stage 0 (LS0), LS stage 1 (LS1), and LS stage 2 (LS2). The relationship between LS3 and long-term care in Japan is unclear. Therefore, this study aimed to examine this relationship.
Methods:
A total of 531 patients (314 women and 217 men; mean age, 75 years) who were not classified as requiring long-term care and underwent musculoskeletal examinations in 2012 were grouped according to their LS stage. Group L comprised patients with LS3 and Group N comprised those with LS0, LS1, and LS2. We compared these groups according to their epidemiology results and long-term care requirements from 2013 to 2018.
Results:
Fifty-nine patients (11.1%) were diagnosed with LS3. Group L comprised more patients (50.8%) who required long-term care than Group N (17.8%) (P < 0.001). Group L also comprised more patients with vertebral fractures and knee osteoarthritis than Group N (33.9% vs 19.5% [P = 0.011] and 78% vs 56.4% [P < 0.001], respectively). A Cox proportional hazards model and Kaplan–Meier analysis revealed a significant difference in the need for nursing care between Groups L and N (log-rank test, P < 0.001; hazard ratio, 2.236; 95% confidence interval, 1.451–3.447).
Conclusions
Between 2012 and 2018, 50% of patients with LS3 required nursing care. Therefore, LS3 is a highrisk condition that necessitates interventions. Approaches to vertebral fractures and osteoarthritis of the knee could be key.
6.Niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer: final results of a multicenter phase 2 study
Hiroaki ITAMOCHI ; Nobuhiro TAKESHIMA ; Junzo HAMANISHI ; Kosei HASEGAWA ; Motoki MATSUURA ; Kiyonori MIURA ; Shoji NAGAO ; Hidekatsu NAKAI ; Naotake TANAKA ; Hideki TOKUNAGA ; Shin NISHIO ; Hidemichi WATARI ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Ai KATO ; Ajit SURI ; Toshiaki YASUOKA ; Kazuhiro TAKEHARA
Journal of Gynecologic Oncology 2024;35(5):e115-
Objective:
This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer.
Methods:
This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms “thrombocytopenia” and “platelet count decreased”) occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival.
Results:
Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56–1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6–26.7) months.
Conclusion
Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients.
7.Niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer: final results of a multicenter phase 2 study
Hiroaki ITAMOCHI ; Nobuhiro TAKESHIMA ; Junzo HAMANISHI ; Kosei HASEGAWA ; Motoki MATSUURA ; Kiyonori MIURA ; Shoji NAGAO ; Hidekatsu NAKAI ; Naotake TANAKA ; Hideki TOKUNAGA ; Shin NISHIO ; Hidemichi WATARI ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Ai KATO ; Ajit SURI ; Toshiaki YASUOKA ; Kazuhiro TAKEHARA
Journal of Gynecologic Oncology 2024;35(5):e115-
Objective:
This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer.
Methods:
This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms “thrombocytopenia” and “platelet count decreased”) occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival.
Results:
Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56–1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6–26.7) months.
Conclusion
Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients.
8.5-1. Education on Diversity, Inclusion, and Co-Production in the Faculty of Medicine, the University of Tokyo
Yoshihiro SATOMURA ; Akiko KANEHARA ; Suzuka OKUBO ; Tatsuya SUGIMOTO ; Tomoe KATAOKA ; Yuka KONISHI ; Sakurako KIKKAWA ; Ryo KINOSHITA ; Mahiro SUEMATSU ; Yusuke TAKAHASHI ; Yousuke KUMAKURA ; Chie HASEGAWA ; Rie SASAKI ; Sosei YAMAGUCHI ; Utako SAWADA ; Yuki MIYAMOTO ; Norihito OSHIMA ; Shin-Ichiro KUMAGAYA ; Kiyoto KASAI
Medical Education 2024;55(2):121-127
The University of Tokyo Disability Services Office and the University of Tokyo Hospital have striven to advance the inclusion of individuals with disabilities and to encourage the co-production of research as well as mental health services with peer support workers. In convergence with these endeavors, the Center for Diversity in Medical Education and Research (CDMER) was founded in 2021. The Center aims to establish an environment and culture that facilitates the participation and success of medical professionals with disabilities. For this purpose, it is essential to integrate the perspective of the social model of disability into medical education and promote co-production in the medical field, which is among the most challenging areas that can realize co-production. The Center is involved in various educational and research activities, including managing educational programs for medical students and supporting student-led research.
9.Niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer: final results of a multicenter phase 2 study
Hiroaki ITAMOCHI ; Nobuhiro TAKESHIMA ; Junzo HAMANISHI ; Kosei HASEGAWA ; Motoki MATSUURA ; Kiyonori MIURA ; Shoji NAGAO ; Hidekatsu NAKAI ; Naotake TANAKA ; Hideki TOKUNAGA ; Shin NISHIO ; Hidemichi WATARI ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Ai KATO ; Ajit SURI ; Toshiaki YASUOKA ; Kazuhiro TAKEHARA
Journal of Gynecologic Oncology 2024;35(5):e115-
Objective:
This study evaluated the long-term safety and efficacy of niraparib in Japanese patients with platinum-sensitive recurrent ovarian cancer.
Methods:
This was a follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with platinum-sensitive, relapsed ovarian cancer. Participants received niraparib (starting dose 300 mg) once daily in continuous 28-day cycles. The primary endpoint was the incidence of Grade 3 or 4 thrombocytopenia-related events (defined as the overall incidence of the MedDRA Preferred Terms “thrombocytopenia” and “platelet count decreased”) occurring in the 30 days after initial administration of niraparib, and secondary endpoints included evaluation of treatment-emergent adverse events and progression-free survival.
Results:
Nineteen patients (median age, 62 years; median body weight, 53.9 kg) were enrolled. As previously reported, the incidence of Grade 3 or 4 thrombocytopenia-related events during the first 30 days of treatment was 31.6%. At data cutoff, median (range) treatment exposure was 504.0 (56–1,054) days and mean ± standard deviation dose intensity was 154.4±77.5 mg/day. The most common treatment-emergent adverse events were nausea (n=14, 73.7%), decreased platelet count (n=12, 63.2%), decreased neutrophil count (n=11, 57.9%), anemia, vomiting, and decreased appetite (all n=9, 47.4%). One patient was diagnosed with treatment-related leukemia, which resulted in death. Median (95% confidence interval) progression-free survival was 18.0 (5.6–26.7) months.
Conclusion
Overall, the safety profile of niraparib was considered manageable in this study population of Japanese patients with platinum-sensitive, relapsed ovarian cancer and was consistent with that observed in studies of non-Japanese patients.
10.Change in Line of Sight after Corrective Surgery of Adult Spinal Deformity Patients: A 2-Year Follow-up
Ken Jeffrey MAGCALAS ; Shin OE ; Yu YAMATO ; Tomohiko HASEGAWA ; Go YOSHIDA ; Tomohiro BANNO ; Hideyuki ARIMA ; Yuki MIHARA ; Hiroki USHIROZAKO ; Tomohiro YAMADA ; Koichiro IDE ; Yuh WATANABE ; Yukihiro MATSUYAMA
Asian Spine Journal 2023;17(2):272-284
Methods:
This retrospective study includes 295 corrective surgery patients with ASD. Subjects were divided into two groups after propensity age matching analysis: cranial malalignment (McGS <−8 or >13) and normal cranial alignment (−8≤ McGS ≤13). Lumbar lordosis (LL), pelvic tilt (PT), TK, cervical lordosis (CL), and sagittal vertical axis (SVA) were evaluated between the two groups.
Results:
SVA (95–56 mm) and PT (34°–25°) decreased and LL (19°–41°) increased 2 years after surgery (p <0.05), but McGS (−1.1° to −0.5°) and CL (21°–19°) did not change. Conversely, in the group with cranial malalignment, SVA (120–64 mm), PT (35°–26°), and LL (12°–41°) showed similar results to the normal cranial parameter group 2 years after surgery, but in contrast, McGS (−13° to −2°) and CL (24°–18°) improved significantly.
Conclusions
Severe ASD adversely affects to maintain horizontal gaze but can be improved by spinal corrective surgery.


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