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RISS 인기검색어
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- 저자 : Kensuke Kondo (검색결과 4 건)
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Kensuke Hori,Shin Nishio,Kimio Ushijima,Yuka Kasamatsu,Eiji Kondo,Kazuhiro Takehara,Kimihiko Ito 대한부인종양학회 2021 Journal of Gynecologic Oncology Vol.32 No.4
Objective: To determine the safety and efficacy of dose-dense (dd) paclitaxel (PTX) and carboplatin (CBDCA) in treating advanced or recurrent endometrial cancer. Methods: Women aged 20–75 years with histologically confirmed endometrial cancer, the International Federation of Gynecology and Obstetrics (FIGO) stage III disease with some residual tumor, FIGO stage IV disease, recurrence after front-line curative treatment, or recurrence after second-line chemotherapy or radiotherapy were enrolled in this study. PTX (80 mg/m2) was administered intravenously (IV) to every participant on days 1, 8, and 15, and CBDCA (area under the curve of 5) was administered IV on day 1 once every 3 weeks until the disease progressed, unacceptable adverse events occurred, or consent was withdrawn. The primary endpoint was the response rate (RR), while the secondary endpoints were progression-free survival, overall survival, and adverse effects. Results: Forty-eight participants were enrolled, and 46 were eligible to receive treatment. The patients' median age was 61 years (range, 43–76 years). Twenty-two participants had experienced recurrence, and the remaining patients had primary advanced endometrial cancer. There were 10 cases of serous carcinoma, 3 cases of endometrioid carcinoma G3, 2 cases of carcinosarcoma, and 2 cases of clear-cell carcinoma according to histology. Twenty- nine participants (63.0%) received ≥6 cycles of chemotherapy. The RR (complete, 13 cases; partial, 20 cases) was 71.3% (95% confidence interval: 59.0%–84.5%). Conclusion: The dd PTX with CBDCA is feasible and available as a treatment option for advanced or recurrent endometrial cancer. Trial Registration: UMIN Clinical Trials Registry Identifier: UMIN000017138
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Aikou Okamoto,Eiji Kondo,Toshiaki Nakamura,Satoshi Yanagida,Junzo Hamanishi,Kenichi Harano,Kosei Hasegawa,Takeshi Hirasawa,Kensuke Hori,Shinichi Komiyama,Motoki Matsuura,Hidekatsu Nakai,Hiroko Nakamur 대한부인종양학회 2021 Journal of Gynecologic Oncology Vol.32 No.2
Objective: To evaluate the efficacy and safety of niraparib in Japanese women with heavilypretreated ovarian cancer. Methods: This Phase 2 open-label, single-arm study enrolled Japanese women withhomologous recombination deficiency-positive relapsed, high-grade serous ovarian,fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of therapy. The starting dose of niraparib was 300 mg administered once daily in continuous 28-daycycles until objective progressive disease, unacceptable toxicity, consent withdrawal ordiscontinuation. The primary endpoint, objective response rate (ORR), was assessed bythe investigator using RECIST version 1.1. Safety evaluations included the incidence oftreatment-emergent adverse events (TEAEs), including serious TEAEs. Results: Twenty women were enrolled and the confirmed ORR in the full analysis set (FAS)was 35.0% (7/20), consisting of 1 complete response and 6 partial responses. Diseasecontrol rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) wereanemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leadingto discontinuation of niraparib whereas reductions or interruptions were reported in 14(70.0%) and 15 (75.0%) patients, respectively. The median dose intensity (202.9 mg daily)corresponded to a relative dose intensity of 67.6%. Conclusion: Efficacy and safety of niraparib in heavily pretreated Japanese women wascomparable to that seen in an equivalent population of non-Japanese women. No new safetysignals were identified.Trial Registration: ClinicalTrials.gov Identifier: NCT03759600
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Daisuke Aoki,Aikou Okamoto,Tsutomu Tabata,Satoshi Yanagida,Toshiaki Nakamura,Eiji Kondo,Junzo Hamanishi,Kenichi Harano,Kosei Hasegawa,Takeshi Hirasawa,Kensuke Hori 대한부인종양학회 2024 Journal of Gynecologic Oncology Vol.35 No.5
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. Trial Registration: ClinicalTrials.gov Identifier: NCT03759587
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