Increase in creatinine levels associated with niraparib maintenance therapy in ovarian cancer.

AIM: In Japan, Niraparib maintenance therapy for primary and recurrent ovarian cancer was approved in September 2020 and is expected to improve the prognosis of ovarian cancer. However, the safety of niraparib maintenance therapy in Japanese patients has not been fully evaluated. METHODS: Patients with ovarian cancer (including fallopian tube and peritoneal cancer) treated with niraparib at Jichi Medical University Hospital from September 2020 to August 2022 were enrolled in this study. Patient background, starting dose, rates of interruption, reduction, or discontinuation, adverse events (AEs) during treatment, and estimated glomerular filtration rate (eGFR) trends were retrospectively analyzed. RESULTS: Twenty-nine patients received niraparib maintenance therapy during the study period, including 21 with primary cancer and 8 patients with recurrent cancer. Seventeen patients (58.6%) required dose interruptions and 16 patients (55.2%) required dose reductions. Only two patients (6.9%) discontinued treatment due to fatigue and nausea. The most frequent AE was creatinine increases in 18 patients (62.1%, all grades). Although eGFR levels decreased significantly after niraparib therapy compared to before niraparib therapy (59.3 vs. 50.3 mL/min/1.73 m2 , p < 0.001), the levels returned to pre-niraparib initiation levels after discontinuation of niraparib (64.6 vs. 64.6 mL/min/1.73 m2 , p = 0.96). Multivariate regression analysis showed that diabetes was independently associated with decreased eGFR (p = 0.013). CONCLUSIONS: Niraparib maintenance therapy frequently increased serum creatinine, but the change was reversible. Further studies are needed to determine the effects of niraparib on renal function in Japanese patients.

Long-term outcomes of spine surgery in dialysis patients, focusing on activities of daily living, life expectancy, and the risk factors for postoperative mortality.

BACKGROUND: Because of the high incidence of major perioperative adverse events, spine surgery in dialysis patients should be recommended carefully after consideration of its risks and benefits. However, the benefits of spine surgery in dialysis patients remain unclear because of the lack of long-term outcomes. The purpose of this study is to elucidate the long-term outcomes of spine surgery in dialysis patients, focusing on activities of daily living (ADLs), life expectancy, and risk factors for postoperative mortality. METHODS: Data for 65 dialysis patients who underwent spine surgery at our institution and were followed up for a mean duration of 6.2 years were retrospectively reviewed. ADLs, number of surgeries, and survival times were recorded. The postoperative survival rate was calculated using the Kaplan-Meier method, and risk factors for postoperative mortality were investigated using a generalized Wilcoxon test and multivariate Cox proportional-hazards model. RESULTS: Compared with preoperative ADLs, ADLs significantly improved at discharge after surgery and at the final follow-up. However, 16 of the 65 patients (24.6%) underwent multiple surgeries, and 34 (52.3%) died during the follow-up period. Kaplan-Meier analysis revealed that the survival rate after spine surgery was 95.4% at 1 year, 86.2% at 3 years, 69.6% at 5 years, 59.7% at 7 years, and 28.7% at 10 years, and the overall median survival time was 99 months. Multivariate Cox regression analysis showed that a dialysis period of ≥10 years was a significant risk factor. CONCLUSIONS: Spine surgery in dialysis patients improved and maintained ADLs in the long term and did not shorten life expectancy. However, dialysis patients undergoing spine surgery require multiple surgeries more frequently, and a dialysis period of ≥10 years is a significant risk factor for postoperative mortality.

Self-concealment is associated with brooding, but not with reflection: relationship between self-concealment and rumination among older adults.

BACKGROUND: Previous research found that self-concealment was associated with rumination in younger adults. However, no study had investigated the relationship between self-concealment and rumination in older adults. Hence, this study aimed to investigate the relationship between self-concealment and the two subfactors of rumination: brooding and reflection, in older adults. METHODS: In this study, we investigated the relationship between self-concealment and rumination in older adults. Considering that rumination has two subfactors: brooding, which reflects the more maladaptive aspects of rumination; and reflection, which reflects the more adaptive aspects of rumination, we separately investigated the relationship between self-concealment and the two subfactors of rumination. RESULTS: We found that after controlling for other potentially relevant variables and the interrelationship between these two subfactors, self-concealment was associated with brooding, but not with reflection. CONCLUSIONS: Self-concealment was only associated with the maladaptive aspect of rumination (i.e. brooding), and not with the adaptive aspects of rumination (i.e. reflection). These findings have important implications for enhancing the understanding of older adults' mental health, and imply that improving self-concealment could potentially mitigate the maladaptive aspects of rumination, which may offer valuable insights for guiding future psychogeriatrics interventions.

Bilateral ovarian vein thrombosis without underlying conditions: A case report.

Ovarian vein thrombosis (OVT) usually occurs on the right side in women with underlying conditions such as pelvic diseases and thrombophilia or during the postpartum period. Here, we present a patient with bilateral OVTs without underlying conditions. A 63-year-old woman without remarkable past or family histories complained of mild lower abdominal pain. Computed tomography revealed bilateral OVTs, with the right-sided thrombus nearly progressing into the inferior vena cava. The presence of symptoms and risk of thrombus extension/pulmonary embolism (PE) led us to administer an oral anticoagulant (rivaroxaban) promptly. Her symptom improved gradually and bilateral OVTs disappeared by 3 months without any evidence of PE. The present case suggests that OVT can occur in a woman without underlying conditions, and the use of an anticoagulant may be a treatment option in such a case.

Efficacy and toxicity of pegylated liposomal doxorubicin as therapy for recurrent ovarian cancer in relation to the number of previous chemotherapy regimens: Comparison with gemcitabine.

AIM: Pegylated liposomal doxorubicin (PLD) is one of the second-line chemotherapy regimens for platinum-resistant recurrent ovarian cancer, but in clinical practice, it is also used for third or subsequent lines of chemotherapy. There is no report on the efficacy and toxicity of PLD in relation to the number of previous chemotherapy regimens. The purpose of this study was to clarify these points and compare with the results of gemcitabine (GEM) therapy we reported previously. METHODS: We retrospectively reviewed the medical records of patients with platinum-resistant recurrent ovarian cancer who underwent two or more cycles of PLD therapy between July 2009 and March 2017 at our institution. We used our reported data of GEM for comparison analysis. RESULTS: Seventy-eight patients were enrolled in this study. The overall response rate was 19.2% and the disease control rate (DCR) was 53.8%. The DCR with 1, 2, 3, and 4 or more previous regimens was 53.8%, 48.6%, 63.6% and 66.7%, respectively. Grade 3/4 neutropenia and anemia developed in 59.0% and 12.8%, respectively. Grade 2 or higher hand -foot syndrome, stomatitis, and liver dysfunction developed in 25.6%, 25.6% and 2.6%, respectively. When the number of previous regimens was 3 or higher, the DCR of PLD was significantly higher than that of GEM (64.7% vs 30.8%, P = 0.037). CONCLUSION: The DCR did not decrease with a greater number of previous regimens. When the number of previous regimens was 3 or higher, PLD therapy had a superior DCR to GEM therapy. Toxicity was tolerable in PLD therapy.

New criteria for the omission of lymphadenectomy in endometrioid carcinoma.

OBJECTIVE: To establish new criteria for the omission of lymphadenectomy in patients with endometrioid carcinoma. METHODS: We retrospectively reviewed 185 cases of histologically confirmed endometrioid carcinoma by hysterectomy at Jichi Medical University Hospital between January 2006 and December 2011. We reviewed patient medical records to detect risk factors for lymph node metastasis to identify the optimum criteria for lymphadenectomy omission. RESULTS: Univariate analysis revealed risk factors for lymph node metastasis to be a large tumor size (volume index ≥40 cm³) (p<0.0001), tumor diameter >2 cm (p=0.0003), myometrial invasion ≥50% based on pre-operative MRI (p=0.0366), elevated serum CA125 (pre-menopausal value ≥70 U/mL, post-menopausal value ≥25 U/mL) (p=0.0004), and lymphadenopathy on pre-operative CT scans (p=0.0002). Multivariate analysis indicated that tumor volume index, tumor diameter, elevated serum CA125, and CT scans positive for lymphadenopathy were independent risk factors for lymph node metastasis. Thus, we set tumor diameter >2 cm, elevated serum CA125, and CT scans positive for lymphadenopathy as risk factors. In cases with no risk factors, the rate of lymph node metastasis was 2.1%, which rose to 8.9%, 30.4%, and 58.3% for those with one, two, and three risk factors, respectively. The rate of para-aortic lymph node metastasis rose from 0% to 2.5%, 10.9%, and 41.7% among those with zero, one, two, and three risk factors, respectively. CONCLUSIONS: We propose that lymphadenectomy can be omitted in cases of endometrioid carcinoma that do not have any of the following risk factors: tumor diameter >2 cm, elevated serum CA125, and a CT scan positive for lymphadenopathy. We believe that these new criteria will limit inter-institutional differences as they are all objective factors. Further, they are useful in predicting lymph node metastasis, including para-aortic lymph node metastasis, based on the number of risk factors present.

Liquid-based endometrial cytology using SurePath™ is not inferior to suction endometrial tissue biopsy for detecting endometrial malignancies: Midterm report of a multicentre study advocated by Japan Association of Obstetricians and Gynecologists.

OBJECTIVE: We conducted a prospective, multicentre study to compare the clinical performance of liquid-based endometrial cytology (LBEC) using SurePath™ with that of suction endometrial tissue biopsy (SETB). This study is officially advocated and reported by the Japan Association of Obstetricians and Gynecologists. By publishing our midterm data, we intend to disseminate the benefits of LBEC system, using the descriptive reporting format and algorithmic interpretational approach. METHODS: From April 2014 to December 2015, we consecutively assessed 1116 LBEC specimens and 1044 SETB specimens in our five outpatient clinics. RESULTS: The sensitivity of suction tissue biopsies was 85.2%, whereas the sensitivity of LBEC was 92.2%. The specificity of suction tissue biopsies was 98.9% and that of LBEC was 98.5%. The negative predictive value of LBEC (99.1%) was higher than that of SETB (98.1%), although the difference between these values was not significant. CONCLUSIONS: The clinical performance of LBEC for detecting endometrial malignancies was almost identical to the performance of SETB. This indicates that LBEC was not inferior to SETB for the detection of endometrial cancer. The LBEC is appropriate for various clinical situations as the first-step detecting tool. In addition, it could be used for cancer surveillance for women with signs highly suggestive of endometrial malignancies and in Lynch syndrome patients, on a larger scale.

The factors influencing long-term outcomes of stenting for malignant colorectal obstruction in elderly group in community medicine.

PURPOSE: Malignant bowel obstruction is a complication of colorectal carcinoma or metastasis from other carcinoma, and it causes significant damage on the condition of elderly patients; however, the self-expandable metallic stents (SEMSs) have been effectively used either for palliation or for bridging to the surgical procedure for this condition. The aim of this study was to investigate the factors influencing long-term outcomes of old-aged patients with SEMS for large bowel obstruction to develop the strategy for those patients in the community medicine. METHODS: We performed a retrospective review of 42 patients with a median age of 83.0 years (range, 65-99 years), who underwent SEMS placement for malignant colorectal obstruction between 2006 and 2015 in our hospital. Univariate and multivariate logistic regressions were performed on data from the patients to assess the factors affecting 6-month survival without stent dysfunction. RESULTS: The study population comprised 24 females (57.1%) and 18 males (42.9%). Of these, 38 patients (90.5%) received SEMS as palliation, whereas 4 patients (9.5%) underwent subsequent surgery. SEMSs were successfully inserted in 97.6% of patients. The median duration of follow-up was 205.0 days (range, 20-1377 days). On multivariate analysis, shorter stents (< 10 cm) yielded better outcomes than longer stents (≥ 10 cm) (P = 0.041), and the Cox proportional hazard model also indicated that shorter stents (P = 0.036) predicted longer event-free survival. CONCLUSIONS: Elderly patients with malignant bowel obstruction receiving shorter stents had longer event-free survival after stenting with better general condition.

Impact of the number of removed lymph nodes on recurrence-free survival in stage I ovarian clear cell carcinoma.

BACKGROUND: Although there have been several reports regarding the significance of staging lymphadenectomy for early stage ovarian clear cell carcinoma (CCC) patients, there have been few reports focusing on the number of removed lymph nodes. The aim of this study was to evaluate the impact of the number of removed lymph nodes on recurrence-free survival (RFS) in stage I ovarian CCC. METHODS: The subjects were patients with ovarian CCC who underwent surgery between January 1988 and December 2013. Clinicopathological variables were obtained from the medical records retrospectively. Statistical analysis using Kaplan-Meier method, log-rank test, and Cox proportional hazards model was performed. RESULTS: A total of 68 patients were entered into this study. The median number of removed lymph nodes was 56.5 (21-135). We calculated that the cutoff value of the number of removed lymph nodes for predicting recurrence was 35. RFS of the group with ≥ 35 removed lymph nodes was significantly better than that of the group with < 35 removed lymph nodes (p = 0.001). Similarly, RFS of stage IA and PS 0 or 1 was significantly better than that of stage IC (p = 0.029) and PS 2 or 3 (p = 0.001), respectively. Multivariate analysis revealed that the number of removed lymph nodes, stage, and PS was independent predictors for RFS. CONCLUSIONS: This study showed that the number of removed lymph nodes ≥ 35 was an independent predictor for improved RFS for stage I ovarian CCC. Sufficient lymphadenectomy may improve prognosis for stage I ovarian CCC.

Long-term outcomes of colorectal endoscopic submucosal dissection in elderly patients.

BACKGROUND AND AIMS: The safety and efficacy of endoscopic submucosal dissection (ESD) in elderly patients remain unclear. The aim of this study is to clarify the short- and long-term outcomes of colorectal ESD in elderly patients. PATIENTS AND METHODS: A total of 482 consecutive patients with 501 colorectal lesions treated with ESD from February 2005 to December 2013 were retrospectively reviewed. Patients were divided into two groups: an elderly group (≥ 75 years of age) and a non-elderly group (< 75 years of age). Short-term outcomes of interest were procedure time, complication rate, hospital stay, en bloc resection rate, and non-curative resection rate. Long-term outcomes of interest were disease-specific survival, and overall survival rates in the elderly group (51 patients) and non-elderly group (92 patients) were also analyzed. RESULTS: No significant differences were observed between the groups with respect to short-term outcomes. Two patients in each group required emergency surgery. Of the patients who underwent non-curative resection, 7/12 (58%) in the elderly group and 15/23 (65%) in the non-elderly group underwent additional surgery. The 5-year disease-specific survival rates in the elderly and non-elderly groups were both 100%, and the corresponding 5-year overall survival rates were 86.3 and 93.5%, respectively (p = 0.026). CONCLUSIONS: Short-term outcomes after colorectal ESD were equivalent in both groups, and all patients showed favorable long-term outcomes. Considering the benign prognosis of lesions resected with ESD, preoperative screening of comorbidities is essential to improve overall survival.

Response to and toxicity of gemcitabine for recurrent ovarian cancer according to number of previous chemotherapy regimens.

AIM: Gemcitabine is used not only as a second-line, but also as a third-line or higher regimen for taxane/platinum-resistant recurrent ovarian cancer. The purpose of this study was to clarify the response to and toxicity of gemcitabine for recurrent ovarian cancer according to the number of previous chemotherapy regimens. METHODS: The subjects were patients with taxane/platinum-resistant recurrent ovarian cancer on gemcitabine treatment at the present hospital between June 2007 and September 2013. We retrospectively reviewed the medical records. Response and adverse events were assessed using the Response Evaluation Criteria in Solid Tumors version 1.1. and the Common Terminology Criteria for Adverse Events v4.0, respectively. RESULTS: The subjects consisted of 65 patients. The median number of previous chemotherapy regimens was 3 (range, 1-7). Overall response rate was 4.6%, and disease control rate (DCR) was 40.0%. DCR versus one, two, three, and ≥four previous chemotherapy regimens was 83.3%, 45.0%, 36.4%, and 23.5%, respectively. Grade 3/4 neutropenia, anemia, and thrombocytopenia occurred in 52.3%, 9.2%, and 9.2% of patients, respectively. Prevalence of grade 3/4 neutropenia according to one, two, three, and ≥four previous chemotherapy regimens was 66.7%, 55.0%, 54.5%, and 41.2%, respectively. Prevalence of anemia, thrombocytopenia, and almost all the non-hematological toxicities also did not increase with an increase in the number of previous chemotherapy regimens. CONCLUSIONS: Although DCR decreased as the number of previous chemotherapy regimens increased, the toxicities did not increase. Gemcitabine may be relatively safe in heavily pretreated ovarian cancer patients.

Vasohibin-1 expression inhibits advancement of ovarian cancer producing various angiogenic factors.

Vasohibin-1 (VASH1) is a negative feedback regulator of angiogenesis, the first to be discovered, and was identified in vascular endothelial growth factor (VEGF)-stimulated vascular endothelial cells. Vasohibin-1 inhibits abnormal vascularization induced by various angiogenic factors including fibroblast growth factor and platelet-derived growth factor (PDGF), in addition to VEGF. By focusing on this characteristic of VASH1, we investigated the antitumor effects of VASH1 expression on ovarian cancer cells that produce different angiogenic factors. By using a high VEGF-producing ovarian cancer cell line, SHIN-3, and a high PDGF-producing ovarian cancer cell line, KOC-2S, the cells were transfected with either a VEGF antagonist, soluble VEGF receptor-1 (sVEGFR-1, or sFlt-1), or VASH1 genes to establish their respective cellular expression. The characteristics of these transfectants were compared with controls. We previously reported that the expression of sFlt-1 inhibited tumor vascularization and growth of high VEGF-producing ovarian cancer cells, reduced peritoneal dissemination and ascites development, and prolonged the survival time of the host. However, in the current study, the expression of sFlt-1 had no such effect on the high PDGF-producing ovarian cancer cells used here, whereas VASH1 expression inhibited tumor vascularization and growth, not only in high VEGF-producing cells, but also in high PDGF-producing cells, reduced their peritoneal dissemination and ascites, and prolonged the survival time of the host. These results suggest that VASH1 is an effective treatment for ovarian cancer cells that produce different angiogenic factors.

Immature ovarian teratoma with hyponatremia and low serum vasopressin level.

Hyponatremia is often caused by the syndrome of inappropriate secretion of antidiuretic hormone (SIADH). Hypersecretion of vasopressin from malignant tumors can be considered a cause of SIADH. Most of these ectopic productions of vasopressin are complications of small cell lung cancer. Cases concomitant with ovarian tumors are very rare, and a specific causative substance from the ovary is often unknown. A 16-year-old woman was diagnosed with an ovarian tumor. She developed hyponatremia that was resistant to medical treatment, but immediately improved after surgical resection of the tumor. Her diagnosis was SIADH caused by an ovarian tumor; however, her serum vasopressin level was normal. It is possible that a vasopressin-like substance causing SIADH was secreted by either nervous system tissue within an immature teratoma or small cell lung cancer. We should be cautious when SIADH is a complication of an ovarian tumor.

Prognosis of endometrial cancer patients with and without symptoms at recurrence.

AIM: During routine follow-up for postoperative endometrial cancer, we have encountered patients with and without symptoms at recurrence. In this study, we investigated whether or not there is a difference in the prognosis between patients with and without symptoms at recurrence. METHODS: We reviewed endometrial cancer patients who had been treated in our hospital between 1998 and 2007. Routine follow-up was conducted by our facility criteria. We investigated recurrence-free survival (RFS), presence or absence of symptoms at recurrence, overall survival from recurrence (OSFR), and overall survival (OS). RESULTS: The subjects were 293 patients. Recurrence was detected in 46 patients. The median RFS was 15 (1-103) months. At the time of recurrence, symptoms were present in 14 patients and absent in 32 patients. In groups with and without symptoms at recurrence, the median OSFR were 36 (2-100) and 45 (2-139) months, respectively. The median OS were 55 (6-163) and 100 (11-178) months, respectively. There were no significant differences in either parameter. Independent prognostic factors for OSFR and OS were histopathologic types other than endometrioid carcinoma (vs endometrioid carcinoma, hazard ratio = 3.102 and 3.008, respectively) and RFS of 14 months or shorter (vs 15 months or longer, hazard ratio = 2.378 and 3.739, respectively). CONCLUSION: There was no difference in the prognosis between the groups with and without symptoms at recurrence. Independent prognostic factors of recurrent patients were histopathologic types and RFS. A large-scale study should be conducted to examine the necessity of routine follow-up for detecting recurrence in the absence of symptoms.

[Hepatic Arterial Infusion Chemotherapy Using a Reservoir for Advanced Hepatocellular Carcinoma].

Administration of chemotherapy treating hepatocellular carcinoma (HCC) is divided into hepatic arterial infusion chemotherapy (HAIC) which delivers chemotherapeutic agents directly using a catheter, and systemic chemotherapy including oral treatment. Evidence for treatment with sorafenib has emerged indicating it is an effective drug for advanced HCC. HAIC can provide high anticancer efficacy, and it is often performed on patients with advanced HCC in our country. Since various HAIC regimens exist, the efficacy of HAIC using a reservoir system was tested in patients with advanced HCC. The overall response rate was 36%, with a median survival time of 11.9 months. Patients with controlled disease at 8 weeks had Child-Pugh classification A, and no increase in AFP levels when starting early stage in treatment, which were considered to be factors that influenced therapeutic efficacy. Comparison with other HAIC regimens, and consideration of combined treatments using sorafenib and HAIC will be needed.

Evaluation of endometrial cytology: cytohistological correlations in 1,441 cancer patients.

BACKGROUND: Endometrial cytology by direct intrauterine sampling is the most common test for an initial evaluation of the endometrium in Japan. However, its diagnostic value for endometrial cancer remains unknown. Here, we assess the correlation between cytopathology and histopathology to evaluate the diagnostic value of cytology for endometrial cancer. METHODS: Patients with histologically confirmed endometrial cancer and controls with a normal endometrium confirmed by hysterectomy had all undergone preoperative endometrial cytology between 2001 and 2010 at our eight institutions and were retrospectively analyzed. The cytological results were compared by clinical stage, histological type, differentiation, and sampling instrument. RESULTS: We analyzed 1,441 endometrial cancer and 1,361 control cases. Endometrial cytology detected cancer in 1,279 (916 positive and 363 suspicious) cases with a sensitivity (positive plus suspicious cases) of 88.8% and a specificity of 98.5%. The positive rate was high in advanced-stage, nonendometrioid, and undifferentiated cases, but there was no significant difference in sensitivity between these clinical conditions. CONCLUSION: Endometrial cytology shows a relatively high sensitivity and specificity for endometrial cancer, and neither statistical measure is significantly affected by clinical stage, histological type, differentiation, sample numbers, or sampling instrument. These findings form a superior dataset for evaluating the efficacy of endometrial cytology.

Successful pregnancy in a Peutz-Jeghers syndrome patient with lobular endocervical glandular hyperplasia.

Lobular endocervical glandular hyperplasia (LEGH) is histologically similar to minimal deviation adenocarcinoma (MDA), but classified as a benign disease. Although MDA often develops in Peutz-Jeghers syndrome (PJS) patients, there have been only a few reports on PJS with LEGH. We report a PJS patient who was diagnosed with LEGH by conization and delivered a baby 42 months later. She was referred to our department for multicystic lesions in the uterine cervix at 26 years old. Diagnostic conization was performed, and the histopathological diagnosis was LEGH. As the possibility of MDA could not be ruled out because of concomitant PJS, hysterectomy was considered. However, course observation was selected because the patient strongly wished to preserve fertility. She delivered a baby at 30 years old. The finding that PJS patients may be complicated by LEGH is very important. Loss of fertility by over-treatment should be avoided if patients desire its preservation.

Effect of X-ray exposure on the pharmaceutical quality of drug tablets using X-ray inspection equipment.

CONTEXT: X-ray inspection equipment is widely used to detect missing materials and defective goods in opaque containers. Its application has been expanded to the pharmaceutical industry to detect the presence of drug tablets in aluminum foil press-through packaging. However, the effect of X-rays on the pharmaceutical quality of drug tablets is not well known. OBJECTIVE: In this study, the effect of X-rays on the pharmaceutical quality of drug tablets was investigated. METHODS: Exposure of acetaminophen, loxoprofen and mefenamic acid tablets to X-ray doses of 0.34 mGy (thrice the dose by X-ray scanning) to 300 Gy (maximum dose from our X-ray equipment) was demonstrated, and the samples were evaluated by formulation tests. RESULTS: Exposure to X-rays did not affect the pharmaceutical quality of the drug content. The samples exposed to X-rays exhibited almost the same profile in formulation tests (dissolution test, disintegrating test and hardness test) as control samples (0 Gy). The combination of X-ray exposure with accelerated temperature and humidity tests (six months) also did not affect the pharmaceutical quality. The color change of light-sensitive drugs (nifedipine and furosemide tablets) after X-ray exposure was negligible (< 1.0). In contrast, tablet color was remarkably changed by light from a D65 lamp. CONCLUSION: The X-ray scanning and X-ray exposure under our experimental conditions did not affect the pharmaceutical quality of drug tablets.

Radiation therapy for chemotherapy-resistant recurrent epithelial ovarian cancer.

OBJECTIVES: While radiation therapy is administered as a palliative treatment for recurrent ovarian cancer, it remains unclear whether it improves the prognosis. METHODS: The effects and adverse events of radiation therapy for patients with recurrent epithelial ovarian cancer were investigated using medical records. RESULTS: Herein, 46 subjects comprising 33 patients whose recurrent lesions were contained within the irradiation field (therapeutic radiation group; TRG) and 13 patients with some recurrent lesions outside the irradiation field (palliative radiation group; PRG) were included. The TRG achieved a response rate (RR) of 66%, a disease control rate (DCR) of 100%, a progression-free survival (PFS) of 10 months, and an overall survival (OS) of 20 months. The PFS after radiation therapy was significantly longer than that following chemotherapy received just before radiation therapy. The PFS of patients with recurrent intrapelvic lesions was longer than that of patients with some extrapelvic recurrence. There was no significant association between PFS after radiation therapy and the duration from the previous chemotherapy or histological type. The RR, DCR, PFS, and OS of the PRG were 30 and 90% and 2 and 6 months, respectively. Serious adverse events were rare. CONCLUSIONS: Radiation therapy is a potential option for chemotherapy-resistant, localized recurrent ovarian cancer. © 2014 S. Karger AG, Basel.

Successful management of severe intrahepatic cholestasis of pregnancy: report of a first Japanese case.

BACKGROUND: Intrahepatic cholestasis of pregnancy (ICP) is a cholestasis condition caused by elevated levels of serum bile acids that mainly occurs in the third trimester of pregnancy. Maternal symptoms include pruritus; elevation of transaminases, biliary enzymes, and bilirubin levels; and abnormal liver function tests. Fetal symptoms include spontaneous preterm labor, fetal distress, and intrauterine death. It is more prevalent in the Caucasians and is rarely found in Asian countries, including Japan. The etiology of ICP has been reported as involving various factors such as, environmental factors, hormone balance, and genetic components. The genetic factors include single-nucleotide polymorphisms (SNPs) in the genes of canalicular transporters, including ABCB4 and ABCB11. It has also been reported that the combination of these SNPs induces severe cholestasis and liver dysfunction. CASE PRESENTATION: Here, we report for the first time a 24-year Japanese case of severe ICP diagnosed by typical symptoms, serum biochemical analysis, and treated with the administration of ursodeoxycholic acid which improved cholestasis and liver injury and prevented fetal death. The sequence analysis showed SNPs reported their association with ICP in the ABCB11 (rs2287622, V444A) and ABCB4 (rs1202283, N168N) loci. CONCLUSION: The risk of ICP has been reported to be population-specific, and it is rare in the Japanese population. Our case was successfully treated with ursodeoxycholic acid and the genetic sequence analysis has supported the diagnosis. Because genetic variation in ABCB4 and ABCB11 has also been reported in the Japanese population, we need to be aware of potential ICP cases in pregnant Japanese women although further studies are necessary.