Trials of adjuvant endocrine therapy for breast cancer have shown that aromatase inhibitors have little impact on global health-related quality of life (HRQoL), but have significant effects on patient-reported endocrine symptoms (ESs). There are few studies of HRQoL and psychological distress during preoperative endocrine therapy performed to determine endocrine responsiveness. The NEOS trial is a multicenter, phase 3 randomized controlled trial in postmenopausal women with hormone receptor-positive breast cancer. The primary aim of the trial was to evaluate the need for adjuvant chemotherapy in patients with clinical T1c-T2N0M0, hormone receptor-positive tumors who responded to neoadjuvant letrozole (LET) administered for 24-28 weeks before surgery. The primary endpoint was disease-free survival and the secondary endpoints included adverse events, HRQoL, and cost-effectiveness. In a HRQoL sub-study, subjects were assessed at baseline and 4 and 16 weeks after starting neoadjuvant LET, using the functional assessment of cancer therapy-breast and its ES subscale, and the hospital anxiety and depression scale. HRQoL and psychosocial distress were analyzed in the uncontrolled phase during 24-28 weeks of neoadjuvant LET therapy in the NEOS trial. From May 16, 2008, to December 14, 2011, 503 patients were recruited into the HRQoL sub-study. The full analysis set included 497 patients with a mean age of 63-years old. The questionnaire response rates at enrollment and 4 and 16 weeks were 94.4, 90.7, and 89.1 %, respectively. There were no significant changes in the FACT-G or B-trial outcome index over time, but the social and family well-being score and the ES subscale deteriorated significantly, and the number of patients with clinically significant hot flush increased significantly. Anxiety, depression, and emotional well-being improved significantly after neoadjuvant LET. Neoadjuvant endocrine therapy with LET had no impact on global HRQoL, but did influence endocrine-related symptoms such as hot flush. This study is registered as UMIN000001090.
In order to facilitate assists in surgical procedure, it is important for scrub nurses to understand the operation procedure and to share the operation status with attending surgeons. The potential utility of head-mounted display as a new imaging monitor has been proposed in the medical field. This study prospectively evaluated the usefulness of see-through-type head-mounted display as a novel intraoperative instructional tool for scrub nurses. From January to March 2014, scrub nurses who attended gasless laparoendoscopic single-port radical nephrectomy and radical prostatectomy wore the monocular see-through-type head-mounted display (AiRScouter; Brother Industries Ltd, Nagoya, Japan) displaying the instruction of the operation procedure through a crystal panel in front of the eye. Following the operation, the participants completed an anonymous questionnaire, which evaluated the image quality of the head-mounted display, the helpfulness of the head-mounted display to understand the operation procedure, and adverse effects caused by the head-mounted display. Fifteen nurses were eligible for the analysis. The intraoperative use of the head-mounted display could help scrub nurses to understand the surgical procedure and to hand out the instruments for the operation with no major head-mounted-display wear-related adverse event. This novel approach to support scrub nurses will help facilitate technical and nontechnical skills during surgery.
This paper describes a method to estimate the direction from which the signal molecule reaches the sensor by using living cells. In this context, biohybrid sensors that utilize a sophisticated sensing system of cells can potentially offer high levels of chemical-detection sensitivity and selectivity. However, biohybrid-sensor-based chemical-source-direction estimation has not received research attention because the cellular response to chemicals has not been examined in the context of directional information. In our approach, we fabricated a device that can limit the interface between the cell-laden hydrogel and the chemical solution of interest to enhance the time difference over which the chemical solution reaches the cells. Chemical detection by cells that express specific receptors is reflected as the fluorescence of the calcium indicator within the cells. Our device has eight chambers that each house 3D cell-laden collagen hydrogels facing circularly outward. The device also works as a cover to prevent chemicals from permeating the hydrogel from above. In our study, by observing the time course of the fluorescence emission of each chamber, we were able to successfully estimate the chemical-source direction within an error range of 7–13°. Our results suggest that a combination of microstructure devices embedded with living cells can be used to exploit cell functionalities to yield chemical-source directional information.
Objective:This study was performed to compare health-related quality of life (HRQOL) of gemcitabine plus S-1 (GS), S-1 alone and gemcitabine alone as first-line chemotherapy for locally advanced or metastatic pancreatic cancer in the GEST (Gemcitabine and TS-1 Trial) study and to assess the impacts of adverse events and tumour response on HRQOL.Methods:Patients were randomly assigned to receive gemcitabine alone (1000 mg/m2 weekly for 3 of 4 weeks), S-1 alone (80, 100 or 120 mg/day twice daily for 4 of 6 weeks) or GS (gemcitabine at 1000 mg/m2 weekly plus S-1 at 60, 80 or 100 mg/day twice daily for 2 of 3 weeks). HRQOL was assessed using the EuroQoL-5D (EQ-5D) questionnaire at baseline and weeks 6, 12, 24, 48 and 72. EQ-5D scores, quality-adjusted life months (QALMs), quality-adjusted progression-free months (QAPFMs) and time until definitive HRQOL deterioration (TUDD) were compared among the three groups. The impacts of adverse events and tumour response on EQ-5D scores were analysed.Results:Including EQ-5D scores after death as 0, the mean profile was significantly better in the GS than gemcitabine group (difference, 0.069; p=0.003), but not the S-1 group (difference, −0.011; p=0.613). The mean profiles until death were similar in the three groups. QALMs, QAPFMs and TUDD were significantly longer in the GS than gemcitabine group (p<0.001, p<0.001 and p=0.004, respectively), but not the S-1 group (p=0.563, p=0.741 and p=0.701, respectively). Fatigue, anorexia and tumour response were significantly associated with changes in EQ-5D scores.Conclusions:GS achieved better HRQOL than gemcitabine alone, resulting a good balance between overall survival and HRQOL benefits. S-1 alone provides HRQOL similar to that provided by gemcitabine alone. Preventing fatigue and anorexia and maintaining better response would improve HRQOL.
Few studies have focused on the relationship between hormone replacement therapy (HRT) for postmenopausal women or those with breast cancer and the occurrence of cerebral embolism. Results are conflicting as to whether there is a link between the two. We describe three patients who experienced cerebral embolism during HRT. A 73-year-old woman had a transient ischemic attack (TIA) 6 years prior to the present admission. She then took HRT oestrogen plus medroxyprogesterone acetate for about 6 years. The HRT had been prescribed by a gynaecologist for amelioration of postmenopausal symptoms. Six years after beginning HRT, she experienced sudden onset left hemiparesis due to cerebral embolism. Two other patients had been taking HRT for breast cancers. One, a 47-year-old woman, had taken medroxyprogesterone acetate for more than one year, for recurrence of breast cancer. She had developed sudden complete left hemiparesis due to an embolism at the carotid bifurcation. The other patient, a 72-year-old woman who was taking tamoxifen citrate for prevention of breast cancer relapse, experienced cerebral embolism just 2 months after beginning tamoxifen. The risk of cerebral embolism in those on HRT should be emphasized, along with the beneficial effects in terms of postmenopausal symptoms and prevention of breast cancer recurrence.
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