We report two cases in which insomnia successfully treated with sansoninto alone or in combination and the effectiveness could be objectively evaluated with the portable sleep test. Case 1 was 40-year-old man who had suffered from arousal during sleep and daytime fatigue for several years. After taking sansoninto with ninjinto, his symptoms improved. Case 2 was 60-year-old woman who had suffered from a lack of deep sleep and daytime sleepiness. After taking sansoninto, she could get a deep sleep and could have less daytime sleepiness. In this report, we present that portable sleep test conducted before and after treatment confirmed that sleep quality improved. Sansoninto is one of the curative medicines for insomnia, but we believe this is the first report showing objective therapeutic effects using portable sleep test.

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.

Methods: We observed 141 patients (61 men, 80 women; average age, 65.8 years) who had undergone PLIF and checked for the presence of L5/S interbody fusion. We investigated factors such as age, gender, the presence of diffuse idiopathic skeletal hyperostosis (DISH), fusion level, and grade 2 osteotomy, as well as pre-, post-, and post−preoperative L5/S disk height and angle, lumbar lordosis, Visual Analog Scale (VAS) score, Japanese Orthopaedic Association (JOA) score, and pelvic incidence (PI), comparing those with and without L5/S interbody fusion. In addition, we analyzed the patients classified into short-level (n=111) and multi-level fusion groups (n=30). Results: Overall, the L5/S interbody fusion rate was 70% (short-level, 78%; multi-level, 40%). Age and pre- and post−preoperative L5/S disk angle were significantly different in each fusion level group. DISH presence, grade 2 osteotomy, and postoperative VAS and JOA scores were significantly different in the short-level fusion group, whereas PI was significantly different in the multi-level fusion group. Conclusions Incomplete union after L5/S PLIF correlates with advanced age, many fusion levels, and a large value of preoperative and a small value of post−preoperative L5/S disk angles.

Methods: A total of 400 patients (175 men, 225 women) who underwent PLIF were observed for >1 year. Factors investigated included the frequency of cage retropulsion and surgical revision. In addition, physical (age, sex, disease), surgical (fusion and PLIF levels, cage number, grade 2 osteotomy), and comorbid (DISH, existing vertebral fracture) factors were compared between patients with and without cage retropulsion. Factors related to surgical revision during the observation period were also considered. Results: Cage retropulsion occurred in 15 patients and surgical revision was performed in 11. Revisions included the replacement of pedicle screws (PSs) with larger screws in all patients and supplementary implants in 10. Among the patients with cage retropulsion, the average PLIF level was 2.7, with DISH present in nine patients and existing vertebral fractures in six. Factors affecting cage retropulsion were diagnoses of osteoporotic vertebral fracture, multilevel fusion, single-cage insertion, grade 2 osteotomy, presence of DISH, and existing vertebral fracture. Multivariable analysis indicated that retropulsion of a fusion cage occurred significantly more frequently in patients with DISH and multilevel PLIF. Conclusions DISH and multilevel PLIF were significant risk factors affecting cage retropulsion. Revision surgery for cage retropulsion revealed PS loosening, suggesting that implant replacement was necessary to prevent repeat cage retropulsion after revision.

Objective: We investigated the efficacy and toxicity of tailored-dose chemotherapy with gemcitabine and irinotecan for platinum-refractory/resistant ovarian or primary peritoneal cancer. Methods: We enrolled patients with ovarian or primary peritoneal cancer who received ≥2 previous chemotherapeutic regimens but developed progressive disease during platinumbased chemotherapy or within 6 months post-treatment. All patients received gemcitabine (500 mg/m 2 ) and irinotecan (50 mg/m 2 ) on days 1 and 8 every 21 days at the starting dose. The dose was increased or decreased by 4 levels in subsequent cycles based on hematological or non-hematological toxicities observed. The primary endpoint was progression-free survival (PFS), and secondary endpoints were disease control rate (DCR), overall survival (OS), and adverse events. Results: We investigated 25 patients who received 267 cycles (median 8 cycles/patient) between October 2008 and May 2011. Tailored-dose gemcitabine was administered up to the 5th cycle as follows: 1,000 mg/m 2 in 1 (4%), 750 mg/m 2 in 16 (64%), 500 mg/m 2 in 6 (24%), and 250 mg/m 2 in 2 patients (8%). The median PFS and OS were 6.2 months (95% confidence interval [CI]=2.7–10.7) and 16.8 months (95% CI=9.4–30.7), respectively. The DCR was 76%, and PFS was >6 months in 12 of 25 patients (48%). Grade 3 hematological toxicities included leukopenia (9.4%), neutropenia (11.2%), anemia (9.8%), and thrombocytopenia (1.1%).Grade 3/4 non-hematological toxicities did not occur except for fatigue in one patient. Conclusions Tailored-dose chemotherapy with gemcitabine and irinotecan was effective and well tolerated in patients with platinum-refractory/resistant ovarian or primary peritoneal cancer.

Anastomotic Leak ; Certification ; Cytoreduction Surgical Procedures ; Diaphragm ; Gynecology ; Humans ; Incidence ; Learning ; Obstetrics ; Ovarian Neoplasms ; Pancreatectomy ; Pancreatic Fistula ; Pleural Effusion ; Pneumothorax ; Postoperative Complications ; Splenectomy

Objective: This study aimed to evaluate the presence of pathological residual tumor (pRT) in each initial disseminated site after neoadjuvant chemotherapy (NACT) to assess the appropriate surgical margins during interval debulking surgery (IDS) for a favorable prognosis. Methods: This prospective descriptive study included patients with stage IIIC–IV epithelial ovarian, fallopian tubal, and peritoneal cancer. One hundred eleven patients underwent diagnostic exploratory laparotomy, and their initial intra-abdominal dissemination statuses were recorded. Any tumor >1 cm in diameter found during the exploratory laparotomy was resected during IDS even if it was macroscopically invisible after NACT. The pRT rate after NACT and negative predictive value (NPV; probability that sites with macroscopically invisible tumors have no pRT) during IDS were assessed in each disseminated site. Results: A median of 5 NACT cycles were performed. Sites with a high incidence of pRT and low NPV included the rectosigmoid colon (71.4%, 38.6%), transverse mesentery (70.3%, 50.0%), greater omentum (68.3%, 51.7%), right diaphragm (61.9%, 48.1%), paracolic gutters (61.1%, 50.0%), and vesicouterine pouch (56.6%, 50.0%). Organs/tissues with a high incidence of pRT featured a low NPV. The median progression-free survival and overall survival in this cohort were 27.7 and 71.9 months, respectively. Conclusion Even if a disseminated site >1 cm in diameter before NACT is invisible during IDS, microscopic disease remains present within it. The appropriate surgical margins for IDS with a favorable prognosis could be secured by resecting a lesion of >1 cm before NACT even if it is invisible during IDS.