1.Durvalumab plus carboplatin/paclitaxel followed by durvalumab with or without olaparib as first-line treatment for newly diagnosed advanced or recurrent endometrial cancer: Japan subset from the phase III DUO-E trial
Shin NISHIO ; Tadaaki NISHIKAWA ; Masahiko MORI ; Shoji KAMIURA ; Toshiyuki SUMI ; Mayu YUNOKAWA ; Yuichi IMAI ; Eiji KONDO ; Kazuhiro TAKEHARA ; Hirokuni TAKANO ; Wataru KUDAKA ; Nobuhiro KADO ; Wataru YAMAGAMI ; Hidenori KATO ; Koji NISHINO ; Tomoka USAMI ; Junzo HAMANISHI ; Masahiro NII ; Itsumi TAKAYA ; Aikou OKAMOTO
Journal of Gynecologic Oncology 2025;36(4):e118-
Objective:
DUO-E/GOG-3041/ENGOT-EN10 (NCT04269200) demonstrated statistically significant and clinically meaningful progression-free survival (PFS) improvement with durvalumab plus carboplatin/paclitaxel, followed by durvalumab with or without olaparib, vs. carboplatin/paclitaxel alone (intention-to-treat [ITT] population) in patients with newly diagnosed advanced or recurrent endometrial cancer. We evaluated efficacy and safety in the Japan subset of DUO-E.
Methods:
Patients with newly diagnosed International Federation of Gynecology and Obstetrics stage III/IV or recurrent endometrial cancer were randomized 1:1:1 to control arm (carboplatin/paclitaxel + durvalumab placebo [6 cycles] followed by durvalumab placebo + olaparib placebo), durvalumab arm (carboplatin/paclitaxel + durvalumab [1,120 mg every 3 weeks] [6 cycles] followed by durvalumab [1,500 mg every 4 weeks] + olaparib placebo), or durvalumab + olaparib arm (carboplatin/paclitaxel + durvalumab [6 cycles] followed by durvalumab + olaparib [300 mg twice a day]). Dual primary endpoints were investigatorassessed PFS for durvalumab and durvalumab + olaparib arms vs. control. This prespecified exploratory analysis evaluated PFS and safety in the Japan subset.
Results:
In the Japan subset (n=88) PFS favored durvalumab (hazard ratio=0.61, 95% confidence interval [CI]=0.32–1.12) and durvalumab + olaparib (0.44, 95% CI=0.22–0.85) vs. control; median PFS was 9.9 and 15.1 vs. 9.5 months, and the 18-month PFS rate was 37.0% and 42.1% vs. 22.2%, respectively. The safety profile in the Japan subset was generally consistent with the full safety analysis set and the established profiles of the individual agents.
Conclusion
Efficacy and safety in the Japan subset were generally consistent with outcomes in the DUO-E ITT population. This Japanese subset analysis of DUO-E supports carboplatin/ paclitaxel + durvalumab followed by durvalumab with or without olaparib as new treatment options in patients with advanced or recurrent endometrial cancer and is the first to report on these regimens in Japanese patients alone.
2.Relationship between Hot Water Bathing Customs and Underlying Disease in Middle-Aged and Elderly Ambulatory Patients: Information from a Multicenter Cross-Sectional Study for the Design of Future Studies
Yasunori MORI ; Hiroharu KAMIOKA ; Katsutaro NAGATA ; Shigeaki IWANAGA ; Masahiko UZURA ; Satoru YAMAGUCHI
The Journal of The Japanese Society of Balneology, Climatology and Physical Medicine 2019;82(2):100-110
3.A Case of Local Disseminated Intravascular Coagulation Caused by DeBakey IIIb Aortic Dissection and Bilateral Iliac Aneurysm.
Kengo Nishimura ; Masahiko Ikebuchi ; Maromi Tachibana ; Teruo Maeda ; Shigetugu Ohgi ; Tohru Mori
Japanese Journal of Cardiovascular Surgery 1998;27(3):169-172
A 73-year-old man complained of sudden severe back pain and was admitted to a community hospital on February 2, 1994. DeBakey IIIb aortic dissection was diagnosed and he was treated conservatively. He noted a pulsating mass in his abdomen on June 7, 1995 and was referred to our hospital. Because of a decrease in platelet and fibrinogen and increase in FDP, local disseminated intravascular coagulation was diagnosed. Since abdominal pain continued, impending rupture was suspected. Computed tomogram showed abdominal aortic dissection and multiple iliac aneurysms. As coagulopathy did not improved by medical treatment, we performed prosthetic graft replacement of the aortio-iliac system on September 4, 1995. Before operation, the effectiveness of heparin was confirmed. After the operation local disseminated intravascular coagulation improved without drug therapy.
4.The Physical Effects of Body Movement on Axillary-to-Femoral Artery Graft.
Rie Yamamoto ; Takaaki Sugita ; Shouji Watarida ; Masahiko Onoe ; Kazuhiko Katsuyama ; Yasuhiko Nakajima ; Ryoukou Tabata ; Shuuichi Matuno ; Astushi Mori
Japanese Journal of Cardiovascular Surgery 1996;25(2):109-112
We encountered an unusual disruption of an expanded polytetrafluoroethylene (EPTFE) axillofemoral bypass graft apart from that anastomoses. We suspected the possible robe of the physical effects of body movement provoking the disruption of the axillofemoral bypass graft and therefore examined the physical effect of body movement on the axillary-to-femoral artery graft in 15 healthy men. At the lower part of the graft, the physical effect was significantly stronger. The disruption of this axillary-to-femoral artery graft was associated with the physical effect of body movement.
5.Eliminating Homologous Blood Transfusion Using a Cell Saver during Abdominal Aortic Aneurysm Repair.
Takehisa Nojima ; Tatsuo Magara ; Atsushi Katsura ; Tadao Nishikawa ; Shoji Watarida ; Masahiko Onoe ; Takaaki Sugita ; Kazuhiko Katsuyama ; Atsumi Mori ; Ryuzaburo Yasuda
Japanese Journal of Cardiovascular Surgery 1996;25(2):86-89
The purpose of this study was to determine the effect of intraoperative autologous blood salvage during elective abdominal aortic aneurysm repair with Cell Saver 4 (Heamonetics Inc.). Fifty patients prospectively received intraoperative autologous transfusion (Group CS; n=50, 1991-94) and 25 received no intraoperative autologous transfusion (Group NCS; n=25, 1983-91). Only 7 patients in Group NCS received no homologous blood (28%), while 43 in Group CS received autologous blood transfusion (86%). There was no difference between the groups with respect to postoperative platelets counts or serum concentrations of total protein, albumin, BUN and LDH. We conclude that the use of the Cell Saver 4 reduces perioperative homologous blood during elective aortic aneurysm repair.
6.Anastomotic External Iliac Artery False Aneurysm Developing 15 Years Later at the Site of Peripheral Anastomosis of a Temporary Bypass
Yasuhiko Nakajima ; Takaaki Sugita ; Shoji Watarida ; Masahiko Onoe ; Takehisa Nojima ; Kazuhiko Katsuyama ; Ryoko Tabata ; Shuichi Matsuno ; Atsumi Mori
Japanese Journal of Cardiovascular Surgery 1995;24(4):268-271
Anastomotic false aneurysm (AFA) of the aorta or iliac artery is a rare but life-threatening complication of prosthetic grafts. We report a surgical case involving AFA of the right external iliac artery which developed at the site of peripheral anastomosis of the temporary bypass procedure used during prosthetic reconstruction of the descending aorta for dissecting aneurysm (DeBakey IIIb) 15 years previously. A 60-year-old woman was hospitalized with rapidly growing right lower abdominal mass. Computed tomography and angiography revealed that the mass was an anastomotic external iliac artery false aneurysm and surgery was performed. The AFA was exposed transperitoneally and resected with a part of the intact external iliac artery without complication. Anatomical reconstruction was completed with a prosthesis. The postoperative course was uneventful. We conclude that patients with retroperitoneal grafts require lifelong routine periodic follow-up and if an AFA is discovered, it should be resected.
7.Unusual Dilatation of Gelatin-Impregnated Knitted Dacron Prostheses after Abdominal Aortic Aneurysm Surgery.
Takaaki Sugita ; Shoji Watarida ; Masahiko Onoe ; Takehisa Nojima ; Kazuhiko Katsuyama ; Yasuhiko Nakajima ; Rie Yamamoto ; Ryoko Tabata ; Shuichi Matsuno ; Atsumi Mori
Japanese Journal of Cardiovascular Surgery 1995;24(6):363-367
We experienced unusual dilatation of gelatin-impregnated knitted Dacron prostheses after abdominal aortic aneurysm surgery. Therefore, we investigated dilatation of gelatin impregnated knitted Dacron grafts compared with other types of Dacron grafts after abdominal aortic aneurysm surgery. Eighteen grafts inserted after abdominal aortic aneurysm surgery were studied for to evaluate dilatation. Enhance CT was used to determine the external diameter of the most dilated portion of the abdominal aortic grafts and high speed plain CT was used to determine the most dilated internal diameter. The gelatin-impregnated knitted Dacron grafts dilated from 25% to 43.8% (mean 31.8±7.2%), significantly more than collagen impregnated woven Dacron grafts (p=0.0003). Moreover, high fever was frequently noticed after these grafts implantation (66.7%). Therefore, caution must be used concerning these implantation in aortic lesions and careful follow-up study should be performed after implantation.
8.Serum CPK-isoform after Cardiopulmonary Bypass.
Masahiko ONOE ; Atsumi MORI ; Shoji WATARIDA ; Takaaki SUGITA ; Shoichiro SHIRAISHI ; Takehisa NOJIMA ; Ryoko TABATA ; Shuichi MATSUNO
Japanese Journal of Cardiovascular Surgery 1992;21(6):552-555
CPK-MM, one of the CPK-isozyme, is divided into the three subbands (isoform) MMa, MMb, MMc. It has reported that in acute myocardial infarction serum MMa and MMa/MMc increased earlier than other myocardial intracellular enzyme, such as CPK-MB. In this study, we measured serum CPK, CPK isozyme, and CPK isoforms during and after open heart surgery and examined whether CPK isoforms would serve as a marker for myocardial damage during open heart surgery. CPK-MB peaked at 153.3±85.1IU six hours after cardiopulmonary bypass (CPB) was taken off and subsequently decreased. On the other hand, MMa/MMc peaked at 5.6±2.2 immediately after CPB was taken off. Moreover, we found that there was a statistically significant positive correlation (Y=24.46X+16.68, r=0.63, p<0.05) between MMa/MMc immediately after CPB was taken off and CPK-MB six hours after CPB was taken off. The maximum value of CPK-MB correlates with the degree of myocardial damage. Therfore, it is reasonable to suggest that the maximum value of MMa/MMc immediately after CPB is taken off also correlates with the degree of myocardial damage. We concluded that serum CPK isoform, especially MMa/MMc served as a marker to estimates the degree of myocardial damage in open heart surgery at an early stage.
9.Spinal Cord Damage after Aorto-bifemoral Bypass Operation.
Takaaki SUGITA ; Syoji WATARIDA ; Masahiko ONOE ; Shoichiro SHIRAISHI ; Takehisa NOJIMA ; Ryoko TABATA ; Shuichi MATSUNO ; Atsumi MORI
Japanese Journal of Cardiovascular Surgery 1992;21(6):593-596
A 59-year-old man underwent an aorto-bifemoral bypass operation for aorto-iliac arteriosclerotic occlusive disease. The total aortic occlusion time was 38min. Soon after the operation, the patient was found to have motor and sensory loss between right L2 and S1, which did not improve. We considered that spinal cord damage was caused by occlusion of the lumbar artery as a result of side clamping of the atherosclerotic abdominal aorta. Therefore, side clamping of the atherosclerotic aorta should be avoided to prevent this serious complication.


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