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Cervical conization with endoCUT mode applying gastrointestinal endoscopic polypectomy technique
Masato Tamate,Motoki Matsuura,Tsuyoshi Saito 대한산부인과학회 2023 Obstetrics & Gynecology Science Vol.66 No.6
Objective To show how endoCUT mode can be safely managed with cervical conization. Methods Demonstration of the technique and explanation of endoCUT and soft coagulation mode with narrated video footage. Cervical conization is a therapeutic and diagnostic procedure performed for the diagnosis of cervical intraepithelial lesions and cervical cancer. Specific methods include cold scalpel, ultrasonically activated device and laser, and loop electrosurgical excision procedure (LEEP), which involves transpiration and partial excision. The endoCUT mode and soft coagulation in VIO3® (ERBE, Tübingen, Germany) were used to perform cervical conical resection safely and at low cost. The endoCUT mode was originally developed for polypectomy in gastrointestinal endoscopy, where no counter traction can be applied. Results The endoCUT mode approach to cervical conization with several key strategies to minimize blood loss and ensure safety: 1) incisions can be made in close contact; 2) resection can be performed with minimal contact with the lesion; 3) control of bleeding from the resected transection by soft coagulation; and 4) low running cost of endoCUT mode. Conclusion Conventionally, cervical conical resection has been performed by using a device capable of making a close incision (cold scalpel, ultrasonically activated device and laser, and LEEP etc.), but there have been issues with bleeding control and cost. Here, we present a new technique using the endoCUT mode and several strategies for safe and effective resection.
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
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