1.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.
2.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.
3.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.
4.Physical Signs and Clinical Features of Cervical Myelopathy in Elderly Patients, Especially 80 Years or Older: Comparison of 100 Consecutive Operative Cases across Three Age Groups
Takahiko HAMASAKI ; Toshio NAKAMAE ; Naosuke KAMEI ; Yasushi FUJIWARA ; John M. RHEE ; Nobuhiro TANAKA ; Yoshinori FUJIMOTO ; Nobuo ADACHI ; Shoji SHIMOSE
Asian Spine Journal 2023;17(5):916-921
Methods:
We evaluated 100 consecutive surgical patients with CM and divided them into the following groups: 80s (34 patients; mean age, 83.9 years), 70s (33 patients; mean age, 73.9 years), and 69 or younger (33 patients; mean age, 60.9 years). The clinical symptoms and physical signs were evaluated and recorded.
Results:
Although the recovery rate decreased with increasing age, all groups demonstrated a significant improvement in clinical symptoms relative to preoperative values. The Hoffman sign and hyperreflexia of the triceps tendon were, respectively, present in 82% and 88% of patients in the 80s group, 74% and 64% of those in the 70s group, and 69% and 82% of those in the 69 or younger group, with no significant difference among the groups. In contrast, the rates of hyperreflexia of the patellar and Achilles tendons were, respectively, 59% and 32% in the 80s group, 85% and 48% in the 70s group, and 91% and 70% in the 69 or younger group, with significant differences.
Conclusions
The positivity rate of the lower extremity hyperreflexia decreased significantly with increasing age in patients with CM. The absence of hyperreflexia, particularly lower extremity, is not uncommon in elderly patients with suspected CM.
5.Dynamic Chest X-Ray Using a Flat-Panel Detector System: Technique and Applications
Akinori HATA ; Yoshitake YAMADA ; Rie TANAKA ; Mizuki NISHINO ; Tomoyuki HIDA ; Takuya HINO ; Masako UEYAMA ; Masahiro YANAGAWA ; Takeshi KAMITANI ; Atsuko KUROSAKI ; Shigeru SANADA ; Masahiro JINZAKI ; Kousei ISHIGAMI ; Noriyuki TOMIYAMA ; Hiroshi HONDA ; Shoji KUDOH ; Hiroto HATABU
Korean Journal of Radiology 2021;22(4):634-651
Dynamic X-ray (DXR) is a functional imaging technique that uses sequential images obtained by a flat-panel detector (FPD).This article aims to describe the mechanism of DXR and the analysis methods used as well as review the clinical evidence for its use. DXR analyzes dynamic changes on the basis of X-ray translucency and can be used for analysis of diaphragmatic kinetics, ventilation, and lung perfusion. It offers many advantages such as a high temporal resolution and flexibility in body positioning. Many clinical studies have reported the feasibility of DXR and its characteristic findings in pulmonary diseases. DXR may serve as an alternative to pulmonary function tests in patients requiring contact inhibition, including patients with suspected or confirmed coronavirus disease 2019 or other infectious diseases. Thus, DXR has a great potential to play an important role in the clinical setting. Further investigations are needed to utilize DXR more effectively and to establish it as a valuable diagnostic tool.
6.Phase 2 single-arm study on the safety of maintenance niraparib in Japanese patients with platinum-sensitive relapsed ovarian cancer
Kazuhiro TAKEHARA ; Takashi MATSUMOTO ; Junzo HAMANISHI ; Kosei HASEGAWA ; Motoki MATSUURA ; Kiyonori MIURA ; Shoji NAGAO ; Hidekatsu NAKAI ; Naotake TANAKA ; Hideki TOKUNAGA ; Kimio USHIJIMA ; Hidemichi WATARI ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Ajit SURI ; Hiroaki ITAMOCHI ; Nobuhiro TAKESHIMA
Journal of Gynecologic Oncology 2021;32(2):e21-
Objective:
The primary objective of this study was to evaluate the safety of niraparib 300 mg/day in Japanese patients with platinum-sensitive, relapsed ovarian cancer in a maintenance setting.
Methods:
Phase 2, multicenter, open-label, single-arm study enrolled Japanese patients with platinum-sensitive, relapsed ovarian cancer who had received ≥2 platinum-based regimens.The primary endpoint (incidence of grade 3 or 4 thrombocytopenia-related events within 30 days after initial niraparib administration) was justified by the incidences of a global pivotal phase 3 study and its post-hoc safety analysis on thrombocytopenia, the major hematological adverse event of niraparib. The overall safety analysis examined other treatment-emergent adverse events (TEAEs).
Results:
Enrolled patients (n=19) had a median (min, max) body weight of 53.9 (40.8–79.1) kg; all but one patient weighed <77 kg. Most (94.7%) patients initially received niraparib 300 mg/day but this decreased in subsequent cycles (mean±standard deviation dose intensity, 191.6±65.7 mg/day). In total, 6/19 (31.6%) patients experienced grade 3 or 4 thrombocytopenia-related events within 30 days of initial niraparib administration.Other common TEAEs included nausea, and decreased platelet or neutrophil counts. No progression-free or overall survival events occurred; only 1 of 4 response-evaluable patients had a post-baseline tumor assessment (stable disease).
Conclusion
The incidence of grade 3 or 4 thrombocytopenia-related events in Japanese ovarian cancer patients was similar to that in the corresponding non-Japanese study. Overall, the safety profile was acceptable and consistent with the known safety profile and previous experience with niraparib.
7.Dynamic Chest X-Ray Using a Flat-Panel Detector System: Technique and Applications
Akinori HATA ; Yoshitake YAMADA ; Rie TANAKA ; Mizuki NISHINO ; Tomoyuki HIDA ; Takuya HINO ; Masako UEYAMA ; Masahiro YANAGAWA ; Takeshi KAMITANI ; Atsuko KUROSAKI ; Shigeru SANADA ; Masahiro JINZAKI ; Kousei ISHIGAMI ; Noriyuki TOMIYAMA ; Hiroshi HONDA ; Shoji KUDOH ; Hiroto HATABU
Korean Journal of Radiology 2021;22(4):634-651
Dynamic X-ray (DXR) is a functional imaging technique that uses sequential images obtained by a flat-panel detector (FPD).This article aims to describe the mechanism of DXR and the analysis methods used as well as review the clinical evidence for its use. DXR analyzes dynamic changes on the basis of X-ray translucency and can be used for analysis of diaphragmatic kinetics, ventilation, and lung perfusion. It offers many advantages such as a high temporal resolution and flexibility in body positioning. Many clinical studies have reported the feasibility of DXR and its characteristic findings in pulmonary diseases. DXR may serve as an alternative to pulmonary function tests in patients requiring contact inhibition, including patients with suspected or confirmed coronavirus disease 2019 or other infectious diseases. Thus, DXR has a great potential to play an important role in the clinical setting. Further investigations are needed to utilize DXR more effectively and to establish it as a valuable diagnostic tool.
8.Factor Structure of the Targeted Inventory on Problems in Schizophrenia.
Shoji TANAKA ; Takanori NAGASE ; Takefumi SUZUKI ; Kensuke NOMURA ; Hiroyoshi TAKEUCHI ; Shinichiro NAKAJIMA ; Hiroyuki UCHIDA ; Gohei YAGI ; Koichiro WATANABE ; Masaru MIMURA
Clinical Psychopharmacology and Neuroscience 2013;11(1):18-23
OBJECTIVE: The aim of this study was to explore the factor structure of a novel, 10-item rating scale, the Targeted Inventory on Problems in Schizophrenia (TIP-Sz). Determining the factor structure will be useful in the brief evaluation of medication and non-medication treatment of the disease. METHODS: An exploratory factor analysis was performed on TIP-Sz scores obtained from 100 patients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for schizophrenia. RESULTS: The factor analysis extracted four factors that were deemed clinically pertinent, which we labeled: disorganization, social cooperativeness, functional capacity, and emotional state. The items exhibited cross-loadings on the first three factors (i.e., some items loaded on more than one factor). In particular, the 'behavioral dyscontrol and disorganization,' 'insight and reality testing,' and 'overall prognostic impression' items had comparable cross-loadings on all of the first three factors. The emotional state factor was distinct from the other factors in that the items loading on it did not cross-load on other factors. CONCLUSION: The TIP-Sz scale comprises factors that are associated with the psychosocial functioning and emotional state of patients, which are important outcome parameters for successful treatment of the disease.
Anomie
;
Diagnostic and Statistical Manual of Mental Disorders
;
Humans
;
Schizophrenia
9.The correlation between contamination of soil with Ascaris sp. eggs in school yards and ascariasis among primary school children in Mai Trung Commune, Northern Vietnam
Junichi Gyoten ; Nguyen T V Hoa ; Yasunori Fujimaki ; Kumi Tanaka ; Shoji Uga ; Shinichi Noda
Tropical Medicine and Health 2010;38(1):35-38
Four hundred and six soil samples collected from five schoolyards in Mai Trung Commune, Bac Giang Province, Northern Vietnam, from 2005 to 2007 were examined for helminth eggs using a sucrose centrifugal flotation method. The soils around latrines was found to be heavily contaminated with Ascaris sp. eggs. The contamination rate of Ascaris sp. eggs at each school and prevalence of ascariasis among the school children showed a positive correlation (P&It;0.05). This indicated that examination of soil from the area around latrines for Ascaris sp. eggs is a useful method to estimate the prevalence of ascariasis among school children.
10.Simultaneous Surgical Treatment for Atrial Fibrillation and Mitral Valve Disease.
Shigeo Yamauchi ; Tetsuo Asano ; Atsushi Harada ; Masatoshi Ikeshita ; Shigeo Tanaka ; Tasuku Shoji
Japanese Journal of Cardiovascular Surgery 1994;23(3):172-178
We performed surgery for atrial fibrillation and mitral valve disease on 3 patients along with atrial mapping. Macroreentrant circuits were found in 2 patients and the other patient showed a preexcitation ectopic focus in the left atrium. Right atrial excitation was chaotic in all three patients. Of the two patients with reentry circuits, one patient underwent biatrial incisions and the other patient had only a left atrial incision. In the patient with a preexcitation ectopic focus, we performed cryoablation of that focus and made a left atrial incision in order to prevent the reoccurrence of atrial fibrillation after surgery. Following surgery, one patient experienced transient atrial fibrillation, however, continuous atrial fibrillation was resolved by this procedure and all patients returned to a normal sinus rhythm.


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