An analysis of the effectiveness of reflective learning through watching videos recorded with smart glasses-With multiple views (student, patient, and overall) in radiography education.

The Objective Structured Clinical Examination (OSCE) is designed to assess medical students' skills and attitude competencies before clinical practice. However, no method of reflective learning using video-based content has been used in OSCE education. This study aimed to confirm whether using smart glasses-based educational content is effective for OSCE reflective learning using multiple views (patient, student, and overall). This educational intervention study included a control group exposed to the traditional learning method and an intervention group exposed to a learning method incorporating smart glasses. Participants were 117 (72 in the control group and 45 in the intervention group) third-year radiological technology students scheduled to take the OSCE and 70 (37 in the control group and 33 in the intervention group) who met the eligibility criteria. Mock OSCEs were administered before and after the educational intervention (traditional and smart glasses-based education) to investigate changes in scores. After the educational intervention, a self-reported comprehension survey and a questionnaire were administered on the effectiveness of the video-based content from different views for student reflective learning. Unexpectedly, the OSCE evaluation score after the preliminary investigation significantly increased for the smart glasses control group (0.36±0.1) compared to the intervention group (0.06±0.1) setting up the radiographic conditions (x-ray center and detector center; p = 0.042). The intervention group's lower score in the mock OSCEs may have been due to the discomfort of wearing the smart glasses to perform the radiography procedure and their unfamiliarity with the smart glasses, which may have affected their concentration. The findings suggest that smart glasses-based education for OSCEs can be improved (e.g., being easy to handle and use and trouble-free).

Deep learning study on the mechanism of edge artifacts in point spread function reconstruction for numerical brain images.

OBJECTIVE: Non-blinded image deblurring with deep learning was performed on blurred numerical brain images without point spread function (PSF) reconstruction to obtain edge artifacts (EA)-free images. This study uses numerical simulation to investigate the mechanism of EA in PSF reconstruction based on the spatial frequency characteristics of EA-free images. METHODS: In 256 × 256 matrix brain images, the signal values of gray matter (GM), white matter, and cerebrospinal fluid were set to 1, 0.25, and 0.05, respectively. We assumed ideal projection data of a two-dimensional (2D) parallel beam with no degradation factors other than detector response blur to precisely grasp EA using the PSF reconstruction algorithm from blurred projection data. The detector response was assumed to be a shift-invariant and one-dimensional (1D) Gaussian function with 2-5 mm full width at half maximum (FWHM). Images without PSF reconstruction (non-PSF), PSF reconstruction without regularization (PSF) and with regularization of relative difference function (PSF-RD) were generated by ordered subset expectation maximization (OSEM). For non-PSF, the image deblurring with a deep image prior (DIP) was applied using a 2D Gaussian function with 2-5 mm FWHM. The 1D object-specific modulation transfer function (1D-OMTF), which is the ratio of 1D amplitude spectrum of the original and reconstructed images, was used as the index of spatial frequency characteristics. RESULTS: When the detector response was greater than 3 mm FWHM, EA in PSF was observed in GM borders and narrow GM. No remarkable EA was observed in the DIP, and the FWHM estimated from the recovery coefficient for the deblurred image of non-PSF at 5 mm FWHM was reduced to 3 mm or less. PSF of 5 mm FWHM showed higher spatial frequency characteristics than that of DIP up to around 2.2 cycles/cm but was lower than the latter after 3 cycles/cm. PSF-RD showed almost the same spatial frequency characteristics as that of DIP above 3 cycles/cm but was inferior below 3 cycles/cm. PSF-RD has a lower spatial resolution than DIP. CONCLUSIONS: Unlike DIP, PSF lacks high-frequency components around the Nyquist frequency, generating EA. PSF-RD mitigates EA while simultaneously suppressing the signal, diminishing spatial resolution.

Efficacy of Olanzapine in Addition to Standard Triplet Antiemetic Therapy for Cisplatin-Based Chemotherapy: A Secondary Analysis of the J-FORCE Randomized Clinical Trial.

Importance: It is unknown whether olanzapine combined with triplet antemetic therapy is effective for all patients undergoing highly emetogenic chemotherapy. A secondary analysis of randomized clinical trials using olanzapine may provide insight into the effectiveness of olanzapine for chemotherapy-induced nausea and vomiting (CINV), including cisplatin. Objective: To examine the add-on effect of olanzapine according to risk factors for CINV. Design, Setting, and Participants: This preplanned secondary analysis evaluated results of the J-FORCE trial, a large double-blind, placebo-controlled phase 3 randomized clinical trial conducted in Japan from February 9, 2017, to July 18, 2018. Participants were enrolled from 26 participating hospitals across Japan and included patients aged 20 to 75 years who had a malignant tumor and were cisplatin-naive. The efficacy analysis population of the J-FORCE trial was analyzed according to allocation adjustment factors (sex [male or female], age [≥55 years or <55 years], and cisplatin dose [≥70 mg/m2 or <70 mg/m2]) and patient-related risk factors (history of motion sickness, drinking habit [defined as alcoholic drinks consumption in excess of occasional drinking], and history of morning sickness during pregnancy). Statistical analysis was performed from February 18 to April 18, 2020. Interventions: Patients were randomized 1:1 to receive 5 mg of olanzapine or placebo combined with standard triplet antiemetic therapy. Main Outcomes and Measures: The primary end point was complete response (CR, defined as no vomiting and no use of rescue medication) in the delayed phase (24-120 hours after cisplatin-based chemotherapy administration). Secondary end points were CR, complete control, and total control in the acute, delayed, and overall phases for 6 CINV risk factors as well as time to treatment failure. The CR point estimates and 95% CIs of the differences between groups were calculated, and a Mantel-Haenszel test was performed. Results: Of the 705 patients (mean [SD] age, 63.0 [9.2] years; 471 males [66.8%]) included in the efficacy analysis population; 581 patients (82.4%) were 55 years or older, and 526 (74.6%) were treated with a cisplatin dose of 70 mg/m2 or more. Risk difference (RD) for a CR in the delayed phase was significantly greater in the olanzapine group than the placebo group in males (RD, 12.6% [95% CI, 5.0%-20.1%]; P = .001); in females (RD, 14.5% [95% CI, 2.2%-26.3%]; P = .02); in those 55 years or older (RD, 11.1% [95% CI, 3.9%-18.2%]; P = .003) or younger than 55 years (RD, 23.6% [95% CI, 7.3%-38.3%]; P = .005); for a cisplatin dose of 70 mg/m2 or more (RD, 13.5% [95% CI, 5.9%-21.0%]; P < .001); for those without a history of motion sickness (RD, 13.9% [95% CI, 6.9%-20.6%]; P < .001); for those with a drinking habit (RD, 14.9% [95% CI, 6.1%-23.4%]; P = .001) or without a drinking habit (RD, 12.0% [95% CI, 2.5%-21.3%]; P = .01); and for those with a history of morning sickness during pregnancy (RD, 27.2% [9.7%-42.6%]; P = .002). In other subgroups, a delayed CR was higher in the olanzapine group than the placebo group, although not significantly higher. Conclusions and Relevance: Results of this study suggest a benefit of using 5 mg of olanzapine plus triplet antiemetic therapy to counter CINV regardless of the presence or absence of risk factors. Trial Registration: University Hospital Medical Information Network Clinical Trials Registry Identifier: UMIN000024676.

Novel Strategy for the Management of Cervical Multicystic Diseases.

PURPOSE: To investigate the clinical practices of diagnosing multicystic cervical lesions as a means to develop a more appropriate diagnostic algorithm for gastric-type adenocarcinoma (GAS) and its precursors. METHODS: Clinical information for 159 surgically treated patients for multicystic disease of the uterine cervix was collected from 15 hospitals. We performed a central review of the MRI and pathological findings. The MRI findings were categorized into four types including two newly proposed imaging features based on the morphology and distribution of cysts, and the diagnosis accuracy was assessed. Among the four MRI types, types 1 and 2 were categorized as benign lesions that included LEGH; type 3 were precancerous lesions (with an assumption of atypical LEGH); and type 4 were malignant lesions. RESULTS: The central pathological review identified 56 cases of LEGH, seven with GAS, four with another form of carcinoma, and 92 with benign disease. In clinical practice, over-diagnosis of malignancy (suspicion of MDA) occurred for 12/19 cases (63.2%) and under-diagnosis of malignancy occurred for 4/11 (36%). Among the 118 patients who had a preoperative MRI and underwent a hysterectomy, type 3 or 4 MRI findings in conjunction with abnormal cytology were positively indicative of premalignancy or malignancy, with a sensitivity and specificity of 61.1% and 96.7%, respectively. CONCLUSIONS: Although the correct preoperative diagnosis of cervical cancer with a multicystic lesion is challenging, the combination of cytology and MRI findings creates a more appropriate diagnostic algorithm that significantly improves the diagnostic accuracy for differentiating benign disease from premalignancy and malignancy.

Phase II study of gemcitabine, cisplatin, and bevacizumab for first recurrent and refractory ovarian clear cell carcinoma Kansai Clinical Oncology Group-G1601.

Patients with advanced ovarian clear cell carcinoma (CCC) have a poor prognosis in the absence of an effective standard treatment. Combination therapy with gemcitabine, cisplatin, and bevacizumab (GPBev) is promising for ovarian CCC. Thus, we conducted a multi-institutional, phase II trial in Japan to examine the efficacy and safety of GPBev for CCC. This is the first study on the use of GPBev for CCC. Eighteen patients (median age, 56.5 years) with pathologically confirmed first recurrent or refractory CCC and having evaluable regions, as assessed using RECIST, were recruited between January 2017 and May 2019. Gemcitabine (1000 mg/m 2 ), cisplatin (40 mg/m 2 ), and bevacizumab (10 mg/kg) were administered intravenously on days 1 and 15, every 28 days, for 6-10 cycles, until disease progression or intolerable toxicity. The primary endpoint was overall response rate (ORR). The secondary endpoints included disease control rate (DCR) and adverse events (AEs). Fifteen patients (83.3%) completed 6-10 cycles of treatment; three patients (two with AEs and one with progressive disease) did not. The ORR was 61.1% [complete response (CR) 3 and partial response (PR) 8] and DCR was 88.9% (CR 3, PR 8, and stable disease 5). Grade 3 and 4 hematological AEs were observed in 16.7 and 5.6% of the patients, respectively. Nonhematological AEs of grades 3 and 4 were observed in 27.8 and 5.6% of the patients, respectively. GPBev is a promising therapy for CCC owing to the high ORR and acceptable toxicity for the first recurrence and refractory CCC.

Combination therapy of oral cyclophosphamide and bevacizumab for patients with recurrent ovarian and peritoneal cancer.

Chemotherapy for patients with recurrent cancer aims to obtain survival benefits, relieve symptoms, and improve quality of life. We used oral cyclophosphamide and bevacizumab (BEV) combination therapy in recurrent ovarian and peritoneal cancer cases, where standard chemotherapy was infeasible. Subsequently, we evaluated the safety and efficacy of this treatment. Between August 2014 and June 2020, patients received the following regimen: oral cyclophosphamide 50 mg daily and intravenous cyclic BEV 15 mg/kg every 3 weeks. Data from 2 facilities were retrospectively analyzed. Twenty-two patients were enrolled (20 with ovarian cancer and two with peritoneal cancer). The median follow-up period and age were 18.9 months (range, 5.0-51.5) and 60 years (range 37-81), respectively. Sixteen patients had platinum resistance. The median number of previous chemotherapy regimens was 2.5 (range 0-5). The median implementation cycle was five (range 2-14). Eighteen patients discontinued treatment due to side effects (3 patient) and disease progression (15 patient). Grade 2 toxicities included neutropenia (1 patient), proteinuria (1 patient), hypertension (2 patient), and esophagitis (1 patient). Two patients had complete response and one had a partial response. Five patients had stable disease. The response rate in platinum-sensitive recurrence was 33.3%, and 7.1% in platinum-resistant recurrence, and a clinical benefit was found in 8 (36.3%) patients. The median PFS and overall survival from cyclophosphamide and BEV initiation was 5.3 months (range, 0.8-23.5) and 9.2 months (range, 4.8-51.5), respectively. The combination of oral cyclophosphamide and BEV does not have a high response rate, but is well-tolerated and can be used safely in patients who are difficult to treat after second-line chemotherapy. Data from 2 facilities were retrospectively analyzed.

[Metastatic Tumor of the Uterine Cervical Cancer Occurred in the Infratemporal Fossa].

A 46-year-old woman presented with discomfort in her right lateral gaze, right-sided headache, and facial numbness 17 days after concurrent chemoradiotherapy(CCRT)for a Stage ⅢB cervical cancer. The initial imaging investigations, maxillofacial and otolaryngology reviews did not reveal a diagnosis. After 54 days of CCRT, her symptoms deteriorated. Magnetic resonance imaging(MRI)showed a tumor in the right infratemporal fossa and its biopsy confirmed a metastatic cervical cancer. In view of the rapid deterioration and the potential visual loss, palliative intensity-modulated radiotherapy(IMRT) was given. Although the symptoms improved temporarily, multiple metastases were subsequently found. Despite chemotherapy, the patient died 11 months after developing the symptoms of infratemporal fossa metastasis.

Use of Anti-Thrombotic Drugs and In-Hospital Mortality in Acute Aortic Dissection Patients.

Acute aortic dissection occurs due to a primary tear in the aortic intima, with blood from the aortic lumen entering the adjacent diseased media. In the clinical setting, practitioners often hesitate before the use of anti-thrombotic drugs in the acute phase of aortic dissection. Therefore, we examined the clinical course in patients who had already received antithrombotic therapies at the onset of acute aortic dissection, and who were given anti-thrombotic drugs in the acute phase during hospitalization. We retrospectively enrolled 685 consecutive patients with acute aortic dissection (type A/B: 454/231), who were transferred to Kurume University Hospital from 2004 to 2020. In types A and B, there were no significant differences between in-hospital mortality with or without antithrombotic therapies at the onset (14.3% vs. 16.4%, p = 0.66 in type A, 2.6% vs. 7.3%, p = 0.29 in type B). Patients in type A who survived more than a day and were treated with anti-thrombotic drugs during hospitalization had significantly lower in-hospital mortality compared with those who received no anti-thrombotic drugs in the acute phase (2.2% vs. 16.1%, p < 0.001), while there was no significant difference between in-hospital mortality in the two type-B groups (2.4% vs. 4.9%, p = 0.48). Although there were variations in response among patients with acute aortic dissection, anti-thrombotic drugs did not worsen in-hospital mortality for patients with acute aortic dissection, indicating that medical staff should not hesitate to administer anti-thrombotic drugs if indicated.

Metronomic chemotherapy using oral cyclophosphamide and bevacizumab for recurrent cervical cancer: A multi-institutional retrospective study.

No standard chemotherapy is available after disease progression or anaphylaxis during platinum chemotherapy among patients with recurrent cervical cancer. Here we report the efficacy and toxicities of metronomic chemotherapy consisting of 50 mg of oral cyclophosphamide (CPA) daily and intravenous 15 mg/kg of bevacizumab (BEV) repeated every 3 weeks (CPA-BEV). Treated patients were retrospectively reviewed. Adverse events and response rates were recorded according to the Common Toxicity Criteria for Adverse Events (CTCAE) ver 5.0 and Response Evaluation Criteria In Solid Tumors ver 1.1, respectively. Eleven patients had been treated with CPA-BEV between 2016 and 2021.The pathologic types were squamous cell carcinoma in seven patients, adenocarcinoma in three, and large cell neuroendocrine carcinoma in one. Nine patients had primary concurrent chemoradiotherapy (CCRT). Five patients received more than one prior chemotherapy (excluding CCRT). Six patients had progressive disease during prior platinum-based chemotherapy, four patients recurred within 6 months of the last platinum administration, and one patient had platinum anaphylaxis. Grade 3 or more hematologic toxicities and grade 2 or more non-hematological toxicities were observed in one with grade 3 neutropenia and in one with grade 2 proteinuria, respectively. The median duration of chemotherapy was 2.8 months (range 0.2-30.6 months). One patient had CR but none had PR. Median progression-free survival was 2.8 months (95 %CI: 2.1-10.7 months), and median overall survival was 13.6 months (95 %CI: 8.4-33.7 months). In conclusion, the CPA-BEV regimen showed favorable antitumor activity with minimal toxicity and is promising candidate for second-line chemotherapy.

Advanced ovarian cancer that resulted in death from intestinal perforation following tumor lysis syndrome: A case report.

INTRODUCTION AND IMPORTANCE: Tumor lysis syndrome (TLS) is an oncologic emergency, with 20 % cases occurring in solid tumors. Preventive measures are necessary depending on TLS risk. We report a case of TLS development after chemotherapy for advanced ovarian cancer which resulted in death by intestinal perforation. CASE PRESENTATION: A 76-year-old woman with multiple metastases had multi-cystic mass in the pelvic cavity. We diagnosed stage IVB ovarian cancer after exploratory laparoscopy and imaging test. Paclitaxel and carboplatin were started as neoadjuvant chemotherapy. Since day 4 of chemotherapy, vomiting, appetite loss, and diarrhea manifested; blood tests on day 9 showed electrolyte abnormality and decreased renal function. We diagnosed TLS and ileus. Her symptoms disappeared and blood chemistry improved after electrolyte correction in intensive care unit. However, vomiting and arrhythmia worsened on day 11, consciousness level lowered, and computed tomography showed intestinal perforation. She died on day 13. CLINICAL DISCUSSION: Advanced ovarian cancer is at high TLS risk due to large tumors, multiple metastases, and impaired renal function caused by urinary tract stenosis. TLS reported in ovarian cancer had large tumor volume; disease onset was often within 1 week after chemotherapy. After TLS improves, follow-up is necessary to detect serious complications. In ovarian cancer with intestinal adhesions, intestinal perforation risk should be considered, and intestinal wall invasion may be evaluated before treatment. CONCLUSION: TLS can be followed by fatal complications; many advanced ovarian cancers are at high TLS risk. Therefore, prophylactic measures and adequate information to patients and families before chemotherapy are necessary.

Adjuvant Chemotherapy for Endometrial Cancer (ACE) trial: A randomized phase II study for advanced endometrial carcinoma.

This study evaluated the feasibility and efficacy of three postoperative adjuvant chemotherapy regimens for endometrial cancer. Endometrioid cancer patients with intermediate-risk stage I and II or high-risk stage III and IV disease were randomly assigned to receive six cycles of either paclitaxel-epirubicin-carboplatin (TEC), paclitaxel-anthracycline (doxorubicin)-carboplatin (TAC), or dose-dense paclitaxel-carboplatin (ddTC). The primary end-point was the completion rate (CRate) of six cycles of treatment. The secondary end-points were progression-free survival (PFS) and overall survival (OS). One hundred and one patients were treated as follows: 33 received TEC, 33 TAC, and 35 ddTC. The CRates for TEC, TAC, and ddTC were 94%, 64%, and 69%, respectively (P = .005). The TEC CRate was significantly higher than for the other two groups. However, the PFS and OS outcomes were not statistically different between the three groups. The 2-year survival rates were 94%, 97%, and 97% for TEC, TAC, and ddTC, respectively. When compared to the current standard treatments for endometrial cancer, TEC is a promising candidate for a phase III trial based on its significantly superior CRate and equivalent PFS and OS. This study is registered with UMIN Clinical Trials Registry (UMIN000008911).

A novel few-views arrangement of the fixed X-ray tubes for tomosynthesis.

PURPOSE: Tomosynthesis is a technique that reconstructs a volume image from limited-angle projection data. In conventional tomosynthesis, the examination time is long, so it can be difficult for patients to hold their breath during certain examinations, such as chest imaging. Few-views tomosynthesis, which uses a linear arrangement of fixed X-ray tubes and enables an image to be obtained within 1 s, was found to be useful in the clinical setting in our previous study. In the present study, we attempted to develop a novel few-views tomosynthesis system that can obtain images with an improved image quality. METHODS: A novel few-views arrangement of X-ray tubes was proposed and the image reconstruction method with regularization term was applied. The linear arrangement was used for the X-ray tube arrangement in our previous few-views tomosynthesis, in contrast, a circular arrangement was proposed in this study. The validation of this system was conducted with a numerical simulation and a real data experiment. RESULTS: The wider the scan angle, the more the object shadow spreads from "in-plane", allowing for artifact suppression. In the circular arrangement, the constant scan angle of θ is used, but in the linear arrangement the scan angle is set from 0 to θ. The artifacts in "out-of-plane" were more strongly suppressed in the circular arrangement than in the linear arrangement. CONCLUSIONS: Artifacts spreading in the z-direction were more strongly suppressed using the circular arrangement than the linear arrangement. Therefore, the circular arrangement was deemed appropriate for few-views tomosynthesis.

A phase II, open-labeled, single-arm study of dose-dense paclitaxel plus carboplatin in advanced or recurrent uterine endometrial cancer treatment: a KCOG-G1303, DOENCA trial.

OBJECTIVE: To determine the safety and efficacy of dose-dense (dd) paclitaxel (PTX) and carboplatin (CBDCA) in treating advanced or recurrent endometrial cancer. METHODS: Women aged 20-75 years with histologically confirmed endometrial cancer, the International Federation of Gynecology and Obstetrics (FIGO) stage III disease with some residual tumor, FIGO stage IV disease, recurrence after front-line curative treatment, or recurrence after second-line chemotherapy or radiotherapy were enrolled in this study. PTX (80 mg/m²) was administered intravenously (IV) to every participant on days 1, 8, and 15, and CBDCA (area under the curve of 5) was administered IV on day 1 once every 3 weeks until the disease progressed, unacceptable adverse events occurred, or consent was withdrawn. The primary endpoint was the response rate (RR), while the secondary endpoints were progression-free survival, overall survival, and adverse effects. RESULTS: Forty-eight participants were enrolled, and 46 were eligible to receive treatment. The patients' median age was 61 years (range, 43-76 years). Twenty-two participants had experienced recurrence, and the remaining patients had primary advanced endometrial cancer. There were 10 cases of serous carcinoma, 3 cases of endometrioid carcinoma G3, 2 cases of carcinosarcoma, and 2 cases of clear-cell carcinoma according to histology. Twenty-nine participants (63.0%) received ≥6 cycles of chemotherapy. The RR (complete, 13 cases; partial, 20 cases) was 71.3% (95% confidence interval: 59.0%-84.5%). CONCLUSION: The dd PTX with CBDCA is feasible and available as a treatment option for advanced or recurrent endometrial cancer. TRIAL REGISTRATION: UMIN Clinical Trials Registry Identifier: UMIN000017138.

Hypovolaemic shock due to intra-abdominal haemorrhage from multiple uterine fibroids.

Intra-abdominal bleeding due to uterine fibroids is extremely rare, and preoperative diagnosis is difficult. Herein, we report a case of preoperatively diagnosed hypovolaemic shock due to intra-abdominal haemorrhage, in which fatal sequelae were prevented. A 46-year-old non-pregnant woman was brought to the hospital with a sudden-onset lower abdominal pain. On admission, she was in shock, and abdominal CT showed severe intra-abdominal haemorrhage. Since bleeding from uterine fibroids was suspected, an emergency simple total hysterectomy was performed, and her condition became stable after the operation. Intra-abdominal haemorrhage with hypovolaemic shock requires prompt surgical intervention. Although it occurs very rarely due to bleeding from uterine fibroids, imaging shows large fibroids; if the patient is not pregnant, bleeding from the fibroids should be considered.

[Clinical Application of Gemcitabine plus Cisplatin plus Bevacizumab Combination Chemotherapy for Ovarian Clear Cell Carcinoma].

Ovarian clear cell carcinoma(OCCC)shows a poor response to standard chemotherapy, and it is often difficult to choose a regimen for patients with recurrent OCCC. Several reports have suggested a synergistic effect between gemcitabine and cisplatin; another report suggested that gemcitabine, platinum, and bevacizumab are efficacious against recurrent ovarian cancer. We treated patients with OCCC using a combination chemotherapy regimen consisting of gemcitabine(1,000 mg/ m2)and cisplatin(40 mg/m2)on days 1 and 15, and bevacizumab(15 mg/kg)on day 1, with the cycle repeated every 4 weeks. Six patients received this therapy after informed consent, and 2 evaluable patients showed a partial response. Adverse events were mild, with Grade 3 anemia, leukopenia, and neutropenia occurring in 67%, 33%, and 17% of cases, respectively. No Grade 4 events were observed, including hematological or non-hematological toxicities. This suggests that a regimen of combined gemcitabine, platinum, and bevacizumab can be efficacious and feasible for the treatment of OCCC.

Phase 2 single-arm study on the efficacy and safety of niraparib in Japanese patients with heavily pretreated, homologous recombination-deficient ovarian cancer.

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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03759600.

Effective Use of Keishibukuryogan in Subcutaneous Hematoma after Implantable Cardiac Device Surgery in Two Cases.

Keishibukuryogan is a Kampo medicine that induces vasodilation and improves the blood flow velocity in subcutaneous blood vessels. We herein report two cases in which keishibukuryogan completely diminished subcutaneous hematoma after cardiac resynchronization therapy pacemaker implantation and defibrillator battery replacement within a month. Keishibukuryogan can be a good option for treating or preventing subcutaneous hematoma after surgical procedures for devices.

Multiple metastases after laparoscopic surgery for early-stage endometrial cancer: A case report.

INTRODUCTION: Laparoscopic surgery for early-stage endometrial cancer is associated with lower morbidity compared to open surgery and has comparable oncologic outcomes. We observed unexpected multiple metastases after laparoscopic surgery for endometrial cancer, the recurrence risk of which has previously been estimated to be low. Herein, we present this case and discuss the optimal management of endometrial cancer. PRESENTATION OF CASE: A 58-year-old woman complaining of atypical genital bleeding lasting for 5 months was diagnosed with stage IA endometrioid carcinoma grade 1. According to our primary strategy, she underwent a total laparoscopic hysterectomy and bilateral salpingo-oophorectomy. The post-operative diagnosis was consistent with the pre-operative diagnosis. Since the recurrence risk was post-operatively revised to an intermediate level, she was administered adjuvant chemotherapy. However, multiple metastases were observed 4 months post-operatively, and despite treatment for recurrent disease, she died 2 months later. The uterine specimen was re-examined after the diagnosis of recurrence, and the post-operative diagnosis was revised to endometrioid carcinoma grade 3, indicating that her recurrence risk might have been underestimated. DISCUSSION: The multiple metastases observed in this case, including those in the subcutaneous tissue, were presumably caused by pneumoperitoneum. Aspiration biopsy was used to confirm the histological diagnosis pre-operatively. However, dilation and curettage would have been preferable, considering aspiration biopsy provides limited diagnostic accuracy in some cases. Laparoscopic surgery is less invasive; however, it leads to a peculiar recurrence pattern, which is sometimes difficult to assess pre-operatively. CONCLUSION: Physicians should carefully consider indications for laparoscopic surgery for malignant diseases.

[Efficacy of Olaparib Treatment for Platinum-Sensitive Recurrent Ovarian, Fallopian Tube, and Primary Peritoneal Cancers].

We reviewed our clinical experience of olaparib treatment for patients with platinum-sensitive recurrent ovarian, fallopian tube, and peritoneal cancer. Of the 10 cases, the primary sites of cancer were the ovaries, fallopian tubes, and peritoneum in 7, 1 and 2 cases, respectively. The median period of treatment administration was 10 months. The observed Grade 3 or 4 adverse events as per the Common Terminology Criteria for Adverse Events version 4.0 were: anemia, leukopenia and neut r openia in 4, 4 and 3 cases, respectively. Eight cases needed treatment to be interrupted, and 5 cases required a reduction in dose. Three patients were treated for more than 12 months, while the others had to discontinue due to disease progression. However, none of the patients had to discontinue treatment due to adverse events. Therefore, it appears that olaparib can be safely used despite some patients requiring a withdrawal or reduction in treatment.