1.The Emergency Operation for Ruptured Dissecting Limited Abdominal Aortic Aneurysm.
Osamu Shigemitsu ; Tetsuo Hadama ; Yoshiaki Mori ; Tatsunori Kimura ; Shinji Mjyamoto ; Hidenori Sako ; Toru Soeda ; Yuzo Uchida
Japanese Journal of Cardiovascular Surgery 1995;24(6):368-372
The diagnosis of ruptured dissecting limited abdominal aortic aneurysm was made in four cases. The sex ratio (M/F) was 1/3, and mean age was 63.5 years (from 53 to 78yr). Only one of these cases die due to intraoperative bleeding. Other three cases were discharged from our hospital. Intraluminal proximal anastomosis after fixed dissected aortic wall due to mattress suture and end to end anastomosis with reinforcement by Teflon felt were good results. The one case who was anastomosed simple intraluminal method has pseudoaneurysm in the proximal portion. It is important to diagnose preoperatively dissection and to make end to end anastomosis with Teflon felt.
2.Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer
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 NAKAMURA ; Jun SAKATA ; Tsutomu TABATA ; Kazuhiro TAKEHARA ; Munetaka TAKEKUMA ; Yoshihito YOKOYAMA ; Yoichi KASE ; Shuuji SUMINO ; Junpei SOEDA ; Ajit SURI ; Daisuke AOKI ; Toru SUGIYAMA
Journal of Gynecologic Oncology 2021;32(2):e16-
Objective:
To evaluate the efficacy and safety of niraparib in Japanese women with heavily pretreated ovarian cancer.
Methods:
This Phase 2 open-label, single-arm study enrolled Japanese women with homologous 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-day cycles until objective progressive disease, unacceptable toxicity, consent withdrawal or discontinuation. The primary endpoint, objective response rate (ORR), was assessed by the investigator using RECIST version 1.1. Safety evaluations included the incidence of treatment-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. Disease control rate in the FAS was 90.0%. The most frequently reported TEAEs (>50%) were anemia, nausea, and platelet count decreased. One patient (5.0%) had TEAEs leading to 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 was comparable to that seen in an equivalent population of non-Japanese women. No new safety signals were identified.