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.

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.

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.

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.

Fourteen patients with 22 solitary aneurysms of the iliac artery were operated in a 16-year period (1983 to 1999). Patients were divided into two groups. The non-ruptured group consisted of 6 patients who underwent surgical intervention before aneurysm rupture, and their mean age was 78.5 years. The ruptured group consisted of 8 patients who underwent surgical intervention for aneurysm rupture, with a mean age of 68.5 years. Although seven patients underwent emergency surgery for aneurysm rupture, less than half of them were operated upon within 24hr after the onset of aneurysm rupture. The average size of aneurysms was similar in the two groups (common iliac artery aneurysms: non-ruptured 47mm vs. ruptured 44mm in diameter, internal iliac artery aneurysms: non-ruptured 55mm vs. ruptured 55mm). Two patients died in the ruptured group, in which the operative mortality rate was 25%. Six patients (75%) of the ruptured group had hypovolemic shock, and two of them died during surgical repair. Of the patients with shock, two patients had intestinal ischemia after operation. Intestinal ischemia was one of the serious complications of ruptured iliac aneurysms. These results suggest that in patients with shock from ruptured iliac artery aneurysms, strategy for treatment is an important determinant of the outcome.

A 51-year-old man underwent arch replacement for a thoracic aortic succular aneurysm in December 1996. The pathological examination indicated aortitis to be the cause of the aneurysm. At that time we did not surgically treat the abdominal aortic aneurysm (AAA) which was only 32mm in diameter. Sixteen months after the first operation, he complained of a pulsatile tumor in his left leg. Angiography revealed an aneurysm of the left superficial femoral artery. The artery distal to the aneurysm was occluded, and the left popliteal artery received collateral blood flow from the deep femoral artery. The size of the AAA increased to 48mm, an indication of repair. Aneurysmectomy of the left superficial femoral artery and replacement of the abdominal aorta were performed simultaneously. The operative findings showed that the aneurysm of the left superficial femoral artery had been ruptured and formed a pseudoaneurysm. The pathological findings demonstrated both aneurysm aortitis. After the second operation, he was given steroid therapy to control the inflammatory reaction and he has been well for one year.

A 49-year-old man who had no history of cardiac disease or intravenous drug abuse was referred to our hospital complaining of fever despite antibiotic chemotherapy. Blood culture was positive for Streptococcus agalactiae, and transesophageal echocardiography revealed vegetation attached to the tricuspid valve and moderate tricuspid regurgitation. Two-thirds of the anterior leaflet and a part of the posterior leaflet of the tricuspid valve were excised with the vegetation, and the remaining anterior leaflet was sutured to the posterior leaflet after annular plication. DeVega's annuloplasty was added to a diameter of two fingers. Following this procedure tricuspid regurgitation was minimal.

We report a relatively rare case of syphilitic aortic aneurysm that was treated by reconstruction with interposition of a prosthesis. The patient was a 72-year-old woman who presented with an abnormal shadow on chest radiograph and an abdominal pulsatile tumor. Aortography revealed double aneurysms in the descending thoracic and infrarenal abdominal regions, combined with a left common iliac artery aneurysm. Microscopic examination revealed an inflammatory infiltrate within the adventitia and destruction of the elastic fibers in the media, classical features of syphilitic aortitis. The incidence of double aortic aneurysm is expected to increase in the future, and one of the many problems involved in the management of this disorder is the correct timing for safe surgery. We prefer simultaneous surgery to secondary surgery, since this rules out the possibility of rupture of the remaining aneurysm. In order to perform this operation safely, it is necessary to treat the patient's general condition with regard to the surgical procedure and possible adjevant therapy.

High economic growth since the late 1950's has brought about a severe labour shortage in Japan. Japanese industry sought migrant workers as one reliable source of labour. As seasonal and unskilled workers, they were employed in a wide variety of trades ; for example, construction, manufacturing, forestry and transportation. However, some of the migrant work was becoming a principal and nonseasonal occupation, and specialized. Migrant forestry and tunnel-construction work are two examples of such specialized work.
To identify health problems among them, we examined the factors affecting workers' entry into migrant forestry and tunnel-construction work, working conditions, and health care services at the workplace by interviewing 65 migrant wokers identified at Hayama Village in Kochi Prefecture, one of the areas well known for providing migrant wokers. Moreover, we carried out health examinations for vibration disease and pneumoconiosis. In this report, we show the results of analysis on 35 migrant forestry workers.
The main factors affecting their entry into migrant forestry work were unstable and poor socioeconomic conditions in the area and the strong demand for a workforce during the rapid economic growth from the late 1950's in Japan. Most of the wage configuration was for piece and contracted work, which promoted long working hours and above-average consecutive work days. They engaged in cutting down, collecting and transporting trees, using vibrating tools such as chain saws, bush cutters, collecting machines and so on. High levels of vibration-exposure quite exceeded the limit of the Ministry of Labour and lasted continuously over 17 years. A difference in labor conditions and working situations was observed between migrant workers who devoted themselves to migrant forestry work and those who did not. Health care administration including health examinations was inadequate. There had been no case of vibration disease identified at the workplace. However, 68 percent among 25 examinees were diagnosed as suffering from vibration disease. Moreover, 40 percent of the subjects experienced absences of more than 4 days due to occupational accidents.