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RISS 인기검색어
- 검색키워드
- 저자 : ( Junzo Hamanishi ) (검색결과 10 건)
- 무료
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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 Y 대한부인종양학회 2021 Journal of Gynecologic Oncology Vol.32 No.2
Objective: The primary objective of this study was to evaluate the safety of niraparib 300 mg/dayin Japanese patients with platinum-sensitive, relapsed ovarian cancer in a maintenance setting. Methods: Phase 2, multicenter, open-label, single-arm study enrolled Japanese patients withplatinum-sensitive, relapsed ovarian cancer who had received ≥2 platinum-based regimens. The primary endpoint (incidence of grade 3 or 4 thrombocytopenia-related events within 30days after initial niraparib administration) was justified by the incidences of a global pivotalphase 3 study and its post-hoc safety analysis on thrombocytopenia, the major hematologicaladverse event of niraparib. The overall safety analysis examined other treatment-emergentadverse 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 niraparib300 mg/day but this decreased in subsequent cycles (mean±standard deviation doseintensity, 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. Noprogression-free or overall survival events occurred; only 1 of 4 response-evaluable patientshad a post-baseline tumor assessment (stable disease). Conclusion: The incidence of grade 3 or 4 thrombocytopenia-related events in Japaneseovarian 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 previousexperience with niraparib. Trial Registration: ClinicalTrials.gov Identifier: NCT03759587
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Muneaki Shimada,Kosuke Yoshihara,Terumi Tanigawa,Hiroyuki Nomura,Junzo Hamanishi,Satoe Fujiwara,Hiroshi Tanabe,Hiroaki Kajiyama,Masaki Mandai,Daisuke Aoki,Takayuki Enomoto,Aikou Okamoto 대한부인종양학회 2023 Journal of Gynecologic Oncology Vol.34 No.3
The development of new treatments for gynecological malignancies has been conducted mainly through collaborative international phase III trials led by the United States and Europe. The survival outcomes of many gynecological malignancies have greatly improved as a result. Recent large-scale genome-wide association studies have revealed that drug efficacy and adverse event profiles are not always uniform. Thus, it is important to validate new treatment options in each country to safely and efficiently provide newly developed treatment options to patients with gynecological malignancies. The Japanese Gynecologic Oncology Group (JGOG) is conducting 5 cohort studies (JGOG 3026, 3027, 3028, 3030, and 3031) to establish real-world data (RWD) of poly(ADP-ribose) polymerase (PARP) inhibitor use in patients with advanced or recurrent epithelial ovarian cancer. The RWD constructed will be used to provide newly developed PARP inhibitors for women with advanced or recurrent ovarian cancer in a safer and more efficient manner as well as to develop further treatment options. In 2022, The JGOG, Korean Gynecologic Oncology Group, Chinese Gynecologic Cancer Society, and Taiwanese Gynecologic Oncology Group established the East Asian Gynecologic Oncology Trial Group to collaborate with East Asian countries in clinical research on gynecologic malignancies and disseminate new knowledge on gynecologic malignancies from Asia. The JGOG will conduct a collaborative integrated analysis of the RWD generated from Asian countries and disseminate real-world clinical knowledge regarding new treatment options that have been clinically implemented.
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Ikuo Konishi,Kaoru Abiko,Takuma Hayashi,Koji Yamanoi,Ryusuke Murakami,Ken Yamaguchi,Junzo Hamanishi,Tsukasa Baba,Noriomi Matsumura,Masaki Mandai,Kyoto Study Group for Ovarian Cancer Research 대한부인종양학회 2022 Journal of Gynecologic Oncology Vol.33 No.5
Epithelial ovarian cancer remains the lethal gynecological malignancy in women. The representative histotype is high-grade serous carcinoma (HGSC), and most patients with HGSC present at advanced stages with peritoneal dissemination. Since the peritoneal dissemination is the most important factor for poor prognosis of the patients, complete exploration for its molecular mechanisms is mandatory. In this narrative review, being based on the clinical, pathologic, and genomic findings of HGSC, chromosomal instability and epigenetic dynamics have been discussed as the potential drivers for cancer development in the fallopian tube, acquisition of cancer stem cell (CSC)-like properties, and peritoneal metastasis of HGSC. The natural history of carcinogenesis with clonal evolution, and adaptation to microenvironment of peritoneal dissemination of HGSC should be targeted in the novel development of strategies for prevention, early detection, and precision treatment for patients with HGSC.
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Ayami Inoue,Ken Yamaguchi,Yasuhisa Kurata,Ryusuke Murakami,Kaoru Abiko,Junzo Hamanishi,Eiji Kondoh,Tsukasa Baba,Aki Kido,Ikuo Konishi,Noriomi Matsumura 대한부인종양학회 2017 Journal of Gynecologic Oncology Vol.28 No.5
Objective: Carcinosarcoma of the uterine corpus has a poor prognosis. Although pathologicalnecrosis is a prognostic factor of endometrial cancer, the clinicopathological influences of anunenhanced region observed on magnetic resonance imaging (MRI) are inconclusive. The aimof our study was to determine the clinicobiological impact of the presence of an unenhancedregion on MRI, which can represent necrosis, in uterine carcinosarcoma. Methods: The clinicopathological factors of 29 patients diagnosed with uterinecarcinosarcoma were assessed retrospectively. The percentage of the tumor that wasunenhanced on MRI was determined. The clinicopathological factors related to theunenhanced regions were evaluated. The prognostic significance was assessed using theKaplan-Meier method and Cox regression model. Results: Although the presence of pathological necrosis was not a poor prognosticfactor (p=0.704), unenhanced regions on MRI correlated with poor prognosis when theunenhanced regions in the tumor accounted for more than 10% of the total tumor (p=0.019). The percentage of unenhanced regions was positively correlated with stage (p=0.028;r=0.4691) and related to tumor size (p=0.086; r=0.3749). The Cox regression analysisindicated that the presence of lymph node (LN) metastasis and more than 10% of the tumorbeing unenhanced on MRI were prognostic factors of overall survival in the univariateanalyses (p=0.018 and p=0.047, respectively). Conclusion: The unenhanced region on MRI, which represents pathological necrosis, reflectstumor progression, and semi-quantification of the region is useful to predict the prognosis inpatients with uterine carcinosarcoma.
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Makiko So,Taito Miyamoto,Ryusuke Murakami,Kaoru Abiko,Junzo Hamanishi,Tsukasa Baba,Masaki Mandai 대한부인종양학회 2019 Journal of Gynecologic Oncology Vol.30 No.6
Objective: In patients with recurrent ovarian cancer (ROC) in whom surgery is likely torender them disease-free, it is unclear whether secondary cytoreductive surgery (SCS)combined with chemotherapy is superior to chemotherapy alone. The aim of this study wasto evaluate the 2 treatment options in Tian-model low-risk patients. Methods: We retrospectively reviewed 118 ROC cases treated in our hospital between2004 and 2016. Of these, 52 platinum-sensitive cases were classified as low-risk (completeresection anticipated) using the Tian model. Prognostic factors were assessed with univariateand multivariate analysis using Cox's regression model. Progression-free survival (PFS)and overall survival (OS) were compared in patients treated with SCS plus chemotherapy(SCS group) and those treated with chemotherapy alone (chemotherapy group), using apropensity-score-based matching method. Results: By multivariate analysis, the only factor associated with better OS was SCS. PFS and OSwere significantly longer in the SCS group compared to the chemotherapy group in the matchedcohort (median PFS: 21.7 vs. 15.1 months, p=0.027 and median OS: 91.4 vs. 33.4 months,p=0.008, respectively). In cases with multiple-site recurrence, the SCS group also showedsignificantly longer OS than the chemotherapy group (median 91.4 vs. 34.8 months, p=0.022). In almost all SCS cases, cooperation was required from other departments, and operation timewas lengthy (median 323 minutes); however, no serious complications occurred. Conclusion: SCS combined with chemotherapy results in better PFS and OS than chemotherapyalone in first platinum-sensitive ROC patients categorized as low-risk by Tian's model.
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Groin lymph node detection and sentinel lymph node biopsy in vulvar cancer
Chieko Sakae,Ken Yamaguchi,Noriomi Matsumura,Hidekatsu Nakai,Yumiko Yoshioka,Eiji Kondoh,Junzo Hamanishi,Kaoru Abiko,Masafumi Koshiyama,Tsukasa Baba,Aki Kido,Masaki Mandai,Ikuo Konishi 대한부인종양학회 2016 Journal of Gynecologic Oncology Vol.27 No.6
Objective: To identify suitable diagnostic tools and evaluate the efficacy of sentinel lymphnode (SLN) biopsy for inguinal lymph node metastasis in vulvar cancer. Methods: Data from 41 patients with vulvar cancer were evaluated retrospectively, includingmagnetic resonance imaging (MRI) measurements, SLN biopsy status, groin lymph nodemetastasis, and prognosis. Results: SLN biopsy was conducted in 12 patients who had stage I to III disease. Groinlymphadenectomy was omitted in five of the nine patients with negative SLNs. All SLNnegativepatients who did not undergo groin lymphadenectomy showed no evidence ofdisease after treatment. On MRI, the long and short diameters of the inguinal node weresignificantly longer in metastasis-positive cases, compared with negative cases, in 25 patientswhose nodes were evaluated pathologically (long diameter, 12.8 mm vs. 8.8 mm, p=0.025;short diameter, 9.2 mm vs. 6.7 mm, p=0.041). The threshold of >10.0 mm for the longaxis gave a sensitivity, specificity, positive predictive value, and negative predictive value of87.5%, 70.6%, 58.3%, and 92.3%, respectively, using a binary classification test. Decisiontree analysis revealed a sensitivity, specificity, and accuracy of 87.5%, 70.6%, and 76.0%,respectively, with the threshold of >10.0 mm for the long axis on MRI. The criteria of >10.0mm for the long axis on MRI predicted an advanced stage and poorer prognosis using avalidation set of 15 cases (p=0.028). Conclusion: Minimally invasive surgery after preoperative evaluation on MRI and SLN biopsyis a feasible strategy for patients with vulvar cancer.
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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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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: To evaluate the long-term efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer. Methods: This was the follow-up analysis of a phase 2, multicenter, open-label, single-arm study in Japanese women with homologous recombination-deficient, platinum-sensitive, relapsed, high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who had completed 3–4 lines of chemotherapy and were poly(ADP-ribose) polymerase inhibitor naïve. Participants received niraparib (starting dose, 300 mg) once daily in continuous 28-day cycles until objective disease progression, unacceptable toxicity, or consent withdrawal. The primary endpoint was confirmed objective response rate (ORR), as assessed using Response Evaluation Criteria in Solid Tumors version 1.1. Safety evaluations included treatment-emergent adverse events (TEAEs). Results: 20 patients were enrolled in the study and included in both efficacy and safety analyses. Median total study duration was 759.5 days. Median dose intensity was 201.3 mg/day. Confirmed ORR was 60.0% (90% confidence interval [CI]=39.4–78.3); 2 patients had complete response and 10 patients had partial response. Median duration of response was 9.9 months (95% CI=3.9–26.9) and the disease control rate was 90.0% (95% CI=68.3–98.8). The most common TEAEs were anemia (n=15), nausea (n=12), and decreased platelet count (n=11). TEAEs leading to study drug dose reduction, interruption, or discontinuation were reported in 16 (80.0%), 15 (75.0%), and 2 patients (10.0%), respectively. Conclusion: The long-term efficacy and safety profile of niraparib was consistent with previous findings in the equivalent population in non-Japanese patients. No new safety signals were identified. Trial Registration: ClinicalTrials.gov Identifier: NCT03759600
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