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Residents with limited experience of thoracic surgery have difficulty performing video-assisted thoracoscopic surgery (VATS) lobectomy. However, they can learn early in a stepwise training method to safely manage the pulmonary veins (PVs), which are relatively strong vessels. In this study, we investigated whether the time required to manage the PVs could serve as an indicator of technical skill acquisition in VATS lobectomy. To evaluate the acquisition of residents’ technical skills, we retrospectively assessed the PV management time of 5 residents at our institution who had performed more than 15 VATS lobectomies over an 8-year period (2012–2019). Their PV management time was determined from surgical video. We analyzed whether PV management time was affected by patient characteristics, operative factors, and experience of lobectomy. The 5 residents performed a total of 103 VATS lobectomies during the study period. Median PV management time was 9.6 min. The most frequently resected lobe was the right upper lobe (56.3%). Median PV management time for right middle lobe was 5.2 min, which was shorter than that for other lobes. We categorized the lobectomies according to whether PV management time was ≤10 min or > 10 min. Univariate analysis identified that shorter PV management time (≤10 min) was significantly associated with more right middle lobectomies performed (7.3% vs 0%, p = 0.02) and more lobectomies performed (14 vs 8, p = 0.01). Longer PV management time (>10 min) was significantly associated with lower lobectomies performed (18% vs 35%, p

Objective Uterine leiomyosarcoma (uLMS) is a rare gynecologic malignancy for which the currently available treatments do not consistently provide long-term disease control. This study aimed to reveal the current clinical status of uLMS to support future clinical trials. Methods This study enrolled patients with uLMS treated at 53 Japanese institutions from 2000 to 2012. Central pathological review (CPR) was performed. All cases were confirmed by CPR, and epidemiological features, treatment, and prognosis were analyzed statistically. Results A total of 307 patients were enrolled. A diagnosis of uLMS was confirmed in 266 patients (86.6%) of patients after CPR, of whom data for 259 were analyzed. Of these, 186 (71.8%) patients underwent complete gross resection as primary therapy. Ninety-eight patients received no additional adjuvant therapy, while docetaxel and gemcitabine was the most frequent regimen among 155 patients treated with adjuvant chemotherapy. In all cases, the median overall survival (OS) was 44.2 months. Multivariate analyses of prognostic factors in all cases identified stage III and IV disease, high serum lactate dehydrogenase level, and menopausal status as poor prognostic factors. However, in stage I cases, high serum lactate dehydrogenase level and no adjuvant treatment were identified as poor prognostic factors. The 5-year OS of patients with stage I uLMS treated with adjuvant chemotherapy was significantly better than that of those without adjuvant treatment (67.8% vs 46.7%, P = 0.0461). Conclusions Despite complete removal of the primary lesion, the clinical course of patients with uLMS was poor due to recurrence of distant metastasis. The application of a suitable biomarker and effective adjuvant chemotherapy are required to improve the prognosis of patients with uLMS.

The effect of uniportal video-assisted thoracoscopic surgery (uni-VATS) versus that of conventional VATS on postoperative quality of life (QOL) is unclear. This prospective randomized controlled study compared uni-VATS and conventional 3-port VATS in terms of QOL and patient satisfaction. The subjects of this study were 84 patients with pulmonary nodules or bullous formation, randomized to undergo uniportal or conventional 3-port video-assisted thoracoscopic partial lung resection. The primary endpoint was postoperative pain, assessed using a numeric rating scale on postoperative day (POD) 1. No differences were found in the numeric rating scale on POD 1 after uni-VATS and conventional 3-port VATS. There were also no differences in blood loss, operative time, complication rate, surgical margin, analgesic requirement, vital capacity (VC), forced expiratory volume in 1 s (FEV1), the 6-min walk test (6MWT), C-reactive protein (CRP) levels, white blood cell count (WBC), or duration of chest tube drainage and hospital stay. Differences were found in the numeric rating scale on days 2, 3, 5, and 10 and in the patient satisfaction score on PODs 5 and 10. Uni-VATS is associated with less chest pain and better patient satisfaction in the short term but without differences in complication rates or surgical margins from the lesions. University Hospital Medical Information Network Clinical Trial Registry (UMIN000015340 http://www.umin.ac.jp/english/ ).

BACKGROUND: The effectiveness of bevacizumab monotherapy in elderly patients with non-squamous non-small cell lung cancer (NSCLC) is unclear. The efficacy of the combinations for elderly patients was explored. METHODS: Untreated patients (≥75 years; performance status 0–1) with stage IIIB, IV, or recurrent non-squamous NSCLC were included. Patients with epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) gene rearrangements were eligible even if they received tyrosine kinase inhibitors. Patients were randomized 1:1 to receive docetaxel (50 mg/m(2)) (DB) or pemetrexed (500 mg/m(2)) (PB) with bevacizumab (15 m/kg). The primary endpoint was progression-free survival (PFS). Treatment was administered every 3 weeks until disease progression or unacceptable toxicity. RESULTS: Overall, 103 patients (DB: n=51; PB: n=52) were enrolled. In the DB and PB arms, median ages [range] were 78 [75–88] and 79 [75–94] years, respectively; median PFS were 6.1 and 4.6 months, respectively [hazard ratio (HR), 1.03; 95% confidence interval (CI), 0.66–1.61]; and response rates were 43%, and 40%, respectively (P=0.840). Grade ≥3 leukopenia, neutropenia, and fatigue incidences were significantly higher in the DB arm. Febrile neutropenia incidence did not differ significantly (16% vs. 12%, P=0.578). One patient in the PB arm died from a ruptured abdominal aortic aneurysm. Quality of life (QoL) analysis revealed less deterioration in the PB arm. CONCLUSIONS: In previously untreated elderly patients with non-squamous NSCLC, PB shows feasibility, better QoL, and promising efficacy in terms of PFS, and an objective response rate for further analysis (UMIN000012786).

Postoperative shoulder joint dysfunction has been observed at a certain rate after breast cancer surgery with axillary lymph node dissection. The purposes of this study were to verify the feasibility and effects of home-based exercise using a DVD and clarify the target of intensive intervention with physiotherapy by identifying the factors that cause postoperative shoulder dysfunction. The study comprised 237 female patients who underwent breast cancer surgery with axillary lymph node dissection, whose data were acquired until 3 months postoperatively. All patients were instructed to exercise at home using a DVD. Range of motion (ROM) of shoulder flexion and abduction and the disability of the arm, shoulder, and hand (DASH) score were measured before surgery, 1 week and 1, 2, and 3 months after surgery. As factors influencing the recovery of shoulder ROM at 3 months after surgery, the presence or absence of radiation and factors up to 1 month after surgery (age, body mass index, the relationship between operated side and dominant side of the hand, treatment modalities, and complications). Shoulder ROM and DASH scores had gradually recovered from 1 week to 3 months postoperatively. As the results of the multivariate analysis, the factors that were associated with the recovery of ROM of shoulder flexion at 3 months were the side of surgery corresponding to the dominant hand (negative factor) and the presence of paresthesia at 1 week postoperatively (positive factor) (p

Modulation of cardiac contractility by α-adrenoceptor is well known in several mammals. Mice are useful experimental animals, but α-adrenoceptor-mediated responses have been examined only in the ventricles. To determine function of α-adrenoceptors in the atrium, effects of α-adrenoceptor agonists on spontaneous contraction and electrical-field stimulation (EFS)-induced contraction were examined. In addition, expression of α1A, α1B, α1D and β1-adrenoceptor mRNAs were examined. In the right atrium, noradrenaline and phenylephrine caused positive inotropic and positive chronotropic actions. However, methoxamine, clonidine and xylazine caused positive inotropic actions, but contractile frequency was decreased at high concentrations. Phenylephrine-induced positive inotropic and chronotropic actions were partially decreased by propranolol, and both actions remained in the presence of propranolol were inhibited by phentolamine or prazosin. A low concentration of silodosin (

To evaluate the feasibility of image subtraction in late iodine enhancement CT (LIE-CT) for assessment of myocardial infarction (MI). A comprehensive cardiac CT protocol and late gadolinium enhancement MRI (LGE-MRI) was used to assess coronary artery disease in 27 patients. LIE-CT was performed after stress CT perfusion (CTP) and CT angiography. Subtraction LIE-CT was created by subtracting the mask volume of the left ventricle (LV) cavity from the original LIE-CT using CTP dataset. The %MI volume was quantified as the ratio of LIE to entire LV volume, and transmural extent (TME) of LIE was classified as 0%, 1–24%, 25–49%, 50–74% or 75–100%. These results were compared with LGE-MRI using the Spearman rank test, Bland-Altman method and chi-square test. One hundred twenty-five (29%) of 432 segments were positive on LGE-MRI. Correlation coefficients for original and subtraction LIE-CT to LGE-MRI were 0.79 and 0.85 for %MI volume. Concordances of the 5-point grading scale between original and subtraction LIE-CT with LGE-MRI were 75% and 84% for TME; concordance was significantly improved using the subtraction technique (p

Background The long-term outcomes of follow-up care for ground-glass opacity (GGO) lesions need to be clarified. Methods Between 2000 and 2005, a total of 226 patients with pure or mixed GGO lesions ≤ 3 cm in size were registered. The CT findings and changes in the findings during the follow-up period and the outcomes of the 226 patients were subsequently reviewed. Results Overall, 124 patients underwent resections, 57 did not receive follow-up examinations after 68 months because of stable disease or disease reduction, and 45 are continuing to receive follow-up examinations. Thirty-nine patients exhibited tumor growth during the follow-up period. Among the patients with a ratio of the diameter of consolidation relative to the tumor diameter (CTR) > 0, all cases with tumor growth were identified within 3 years; meanwhile, > 3 years were required to identify tumor growth in 16% of the patients with a CTR of 0. Aggressive cancer occurred in 4% of patients with a CTR of 0 and in 70% of patients with a CTR > 25%. Aggressive cancer was observed in 46% of the patients whose CTR increased during the follow-up period and in 8% of the patients whose tumors increased in size. Conclusions A higher CTR and an increase in CTR during follow-up were associated with invasive cancer. A follow-up period of 3 years is considered to be adequate for judging tumor growth in patients with a CTR > 0, whereas a longer follow-up period might be needed for patients with a CTR of 0.

The aim of this study is to assess the effect of blood pressure (BP) on coronary computed tomography angiography (CTA) derived computational fractional flow reserve (CTA-FFR). Twenty-one patients who underwent coronary CTA and invasive FFR were retrospectively identified. Ischemia was defined as invasive FFR ≤0.80. Using a work-in-progress computational fluid dynamics algorithm, CTA-FFR was computed with BP measured before CTA, and simulated BPs of 60/50, 90/60, 110/70, 130/80, 150/90, and 180/100 mmHg respectively. Correlation between CTA-FFR and invasive FFR was assessed using Pearson test. The repeated measuring test was used for multiple comparisons of CTA-FFR values by simulated BP inputs. Twenty-nine vessels (14 with invasive FFR ≤0.80) were assessed. The average CTA-FFR for measured BP (134 ± 20/73 ± 12 mmHg) was 0.77 ± 0.12. Correlation between CTA-FFR by measured BP and invasive FFR was good (r = 0.735, P

Background To evaluate the therapeutic outcomes in patients with bone metastases receiving radiotherapy (RT), it is important to use objective radiological response criteria. The aim of this study was to investigate the changes in pain and re-ossification after RT for painful vertebral bone metastases without paralysis by malignant spinal cord compression. Methods The participants included 55 patients who received RT for painful vertebral bone metastases without paralysis in our institution between 2012 and 2016. Bone modifying agents (BMAs) were administered in all patients. Follow-up assessments were done just before the start of RT and at 1, 2, 3, 4, and 6 months after RT. Radiological responses of irradiated vertebrae by RT were assessed by computed tomography (CT) using MD Anderson response classification criteria (MDA criteria) and the pain response was assessed by Numeric Rating Scale (NRS). Response was classified as complete response (CR), partial response (PR), progressive disease (PD), and stable disease (SD). Results The rates of CR were 2%, 7%, 20%, 30%, and 56% at 1, 2, 3, 4, and 6 months, respectively. The rates of CR or PR were 15%, 49%, 77%, 91%, and 91% at 1, 2, 3, 4, and 6 months, respectively. The rates of CR or PR were significantly higher in patients with breast cancer than in patients with lung cancer (p = 0.043). At one month, there was an association between the NRS and radiological response assessed by MDA criteria. There was a significant trend that, with a better response, there were more patients without pain (p = 0.021). Conclusions Under BMAs administration, successful RT for vertebral bone metastases decreased pain and caused re-ossification. The MD Anderson criteria could be useful for assessment of radiological responses of irradiated vertebrae.

IntroductionIn Japan, the age of patients with pancreatic cancer has increased. Combination chemotherapies such as 5-fluorouracil/leucovorin, oxaliplatin and irinotecan therapy and gemcitabine hydrochloride (GEM) +nab paclitaxel therapy have been developed as the standard treatments for young patients with advanced recurrent pancreatic cancer. However, both therapies produce toxicity and their administration is limited by the patients’ age or performance status. The efficacy and safety data obtained in the GEST study—a large-scale randomised controlled study conducted in patients with pancreatic cancer in Japan—suggested that GEM +S-1 (GS) combination therapy is a promising candidate for those aged between 75 and 80 years. However, for patients aged ≥80 years, no efficacy or safety data on GS therapy are currently available.Methods and analysisThis open-label, randomised phase II study will involve patients with advanced recurrent pancreatic cancer, aged ≥75 years, with favourable general conditions. Using the electronic data capture system, participants will be randomly allocated to groups with standard treatment (GEM therapy alone) and study treatment (GS therapy). The treatments will be administered until the conditions meet the discontinuation criteria. The primary endpoint is overall survival.Ethics and disseminationThis trial has been approved by the National Hospital Organisation’s Central Review Board (H28-NHOD-01).DiscussionThis study will reveal if GS therapy could be a standard treatment option for elderly patients with pancreatic cancer, by clarifying its efficacy and safety.Trial registration numberUMIN000025747; Pre-results.

Radiation therapy (RT) is the common treatment for painful vertebral bone metastases without paralysis by malignant spinal cord compression. However, no studies have focused on the time course of pain after RT. Then, we investigated the change of pain after RT for painful vertebral bone metastases without paralysis.Participants included 101 patients who received RT for painful vertebral bone metastases without paralysis in our institution between 2012 and 2016. All patients received RT and pain response was evaluated by Numeric Rating Scale (NRS). Follow-up assessments were performed just before the start of RT and every month for six months after RT. Pain response was classified as complete response (CR), partial response (PR), pain progression (PP), and indeterminate response (IR) based on the response criteria of International Bone Metastases Consensus Working Party. Responders were classified as either CR or PR, and non-responders as either PP or IR.Median NRS scores for pain were 5 before RT, decreasing to 0 by one month after RT and remaining zero until last follow-up, representing a significant decrease over time (P 0.001). The rate of responders at each month from one to six months was 93, 96, 95, 100, 98, and 96%, respectively. Multivariate analysis revealed that Spinal Instability Neoplastic Score (SINS) was the only risk factor for response to RT at one month. At one month pain disappeared in 88% of the patients with spinal stability (SINS 7), although pain disappeared 58% of the patients with spinal instability (SINS ≥ 7), which was significant (P = 0.002).Pain decreased significantly over time and 93% of patients were classified as responders as early as one month after RT in patients with painful vertebral bone metastases without paralysis. Pretreatment SINS could be a predictor of pain response to RT.

Personalised breast cancer therapy requires pathological characterisation of tumours. The proliferative index, based on Ki67, is pivotal, but a standard method has not been established. Here we look for an easy and practical way to evaluate Ki67.Immunohistochemical staining of estrogen receptors, progesterone receptors, HER2 and Ki67 (MIB-1) was performed on resected specimens from 406 primary invasive ductal carcinomas. Ki67 labelling index (LI) from manual counting was compared with visual assessment using a 5-grade scale (Eye-5). Next, 10 pathologists evaluated 100 samples with marked hot spots by using Eye-5. Another 100 samples without marking were also assessed by eight pathologists. One year later, two pathologists reviewed 222 cases with Eye-5. Prognosis was analysed among estrogen receptor-positive cases with postoperative endocrine therapy.Eye-5 showed good correlation to LI. All 136 cases of score 4-5 had LI20% and all 56 cases of score 1 had LI20%, which means that manual counting was not necessary for about half of the cases. Interobserver and intraobserver variability was low even when a hot spot was not fixed. Eye-5 also correlated with histological grade and lymph node metastasis. Combining Eye-5 and histological grade created a new algorism to predict LI, which allows 80% of all cases (74% of luminal cases) without manual counting. Cases of Eye-5 score 1-2 had significantly better survival than score 3-5.Visual assessment of Ki67 by a 5-grade scale (Eye-5) is fast, easy, and reliable with acceptably low interobserver and intraobserver variability. Eye-5 can replace LI in many luminal tumours, and is a strong candidate as a standard method of evaluating Ki67.

Background Atypical femoral fractures (AFFs) have been reported to occur in patients with bone metastases who received long-term bisphosphonate treatment. However, the incidence of AFFs in breast cancer patients with bone metastases who received intravenous bisphosphonate is unclear. The purpose of this study is to examine the incidence of AFFs in breast cancer patients with bone metastases who received intravenous bisphosphonate. In addition, we estimated the number of dose and duration of intravenous bisphosphonate at the time of occurrence of AFFs. Methods We identified 356 female breast cancer patients with bone metastases who received intravenous bisphosphonate between November 2004 and October 2013 in our institution. The median number of doses of intravenous bisphosphonate was 18 (range, 1–103). The median duration of intravenous bisphosphonate treatment was 16 months (range, 1–102 months). We estimated the incidence of AFFs in patients who received intravenous bisphosphonate and used Poisson regression model to obtain the incidence rates of AFFs. Results Three AFFs in two patients were identified and the estimated incidence of AFFs was 2.99 per 1000 person-years. At the time of occurrence of AFFs, the patients had received 41 and 83 doses of intravenous bisphosphonate, for 37 and 79 months, respectively. The patients underwent open reduction and internal fixation with intramedullary nail. The frequency and incidence of AFFs in patients who received intravenous bisphosphonate for at least 41 or 83 doses or for more than 37 or 79 months were 2/60 (3.3%), 1/7 (14.3%), 2/70 (2.9%), and 1/9 (11.1%), respectively. Conclusions The incidence of AFFs is low in breast cancer patients with bone metastases who received intravenous bisphosphonate. Careful observation is warranted and radiography should be performed to investigate AFFs when clinical signs such as thigh pain appear. Study design Clinical study.

Background: One of surgical goals is decreasing of positive resection margin (PRM). In radical prostatectomy, PRM is important because of prognostic factor. We examine the relationship of PRM, cancer location and learning curve after laparoscopic radical prostatectomy (LRP). Methods: Between May, 2009 and May, 2015, 331 consecutive patients were treated with LRP. The resection margin status, Gleason score, pathological stage, cancer location and diameter were assessed in each surgical specimen, and the independent factors for PRM and prostate-specific antigen (PSA) failure were identified. The learning curve for PRM was calculated and the number of cases until the plateau was obtained. Results: PRM was found in 30.5% of all patients, with 27.7% in the pT2 patients and 39.0% in the pT3 patients. The most common site of PRM was in the apex-anterior. The 5-year PSA failure-free survival rate was 73.9%. In patients with a negative resection margin, the 5-year PSA failure-free survival rate was 81.6%, and in patients with PRM, it was 57.4%. The factors associated with PSA failure-free survival were PRM and elevated PSA. The tumor location was not associated with PSA failure-free survival. The factors associated with PRM were tumor location, nerve sparing procedure, and tumor diameter. When the tumor was localized in the apex-anterior, the rate of PRM was elevated 3-fold comparing the tumor in apex-posterior. The learning curve of all surgeons for obtaining a negative resection margin plateaus after 167 cases. The curve of a single surgeon was more improved than all surgeons and the rate of PRM was 16.7%. Conclusions: PRM was associated with both cancer location and diameter. The learning curve of PRM reached a plateau in about 170 cases. However, PRM can be further reduced. These findings related to LRP outcomes are useful for improvement in surgical techniques and for determining prognosis.

Background Patients with lung cancer often present with recurrence, even after resection. The identification of risk factors for recurrence after resection is useful. Methods Among 1,338 patients with lung cancer who underwent a complete resection, 277 developed recurrences post surgery. Data regarding the TNM factors, histologic subtype, and presence/absence of vessel invasion were analyzed retrospectively using the survival tree method to identify groups with a high risk of recurrence after resection. Results The results revealed that the T factor, the N factor, and lymphatic (ly) and blood (v) vessel invasion were related to the risk of recurrence, and six combinations of these factors were identified using the survival tree method: group A: v = 0, T ≤ 1b, ly = 0; group B: v = 0, T ≤ 1b, ly ≥ 1; group C: v = 0, T ≥ 2a; group D: v ≥ 1, N ≤ 1, T ≤ 2b; group E: v ≥ 1, N ≤ 1, T ≥ 3; and group F: v ≥ 1, N ≥ 2. The six groups were then further classified into three groups: a low-risk group (group A), a moderate-risk group (groups B, C, and D), and a high-risk group (groups E and F). The 5-year recurrence-free survival rate was approximately 98% for the low-risk group, 75% for the moderate-risk group, and 30% for the high-risk group. Conclusions Combining the T, N, v, and ly factors allowed the precise identification of a group with a high risk of recurrence after resection.

The Ki67 labeling index (LI) reflects the proliferative activity of breast cancers and defines luminal A and B tumors; however, no detailed method to measure Ki67 has been standardized. Here, we propose a fast and easy way to evaluate Ki67.Immunohistochemical staining of estrogen receptor (ER), progesterone receptor (PgR), HER2 and Ki67 (MIB-1) was performed on 235 primary invasive ductal carcinomas. For each sample, a hot spot with many Ki67+ cells was identified using a low-power field (40×, 4× objective). Three independent areas in high-power field (400×) were selected at the hot spot, and all cancer cells in the 3 areas were manually counted to calculate LI (% Ki67+ cells). Alternatively, micrographs taken at 100× and 200× fields including the hot spot were shown to 2 pathologists, who visually assessed percentages of Ki67+ cells in 10 % intervals at a glance (Eye-10).Eye-10 and LI were strongly correlated (r = 0.9412, P 0.0001). All cases of Eye-10 ≥ 30 % had LI 14 %; most of those10 % had LI 14 %. Of 170 ER+/HER2- tumors, Eye-10-based subtypes matched 87 % of LI-driven subtypes, and interobserver agreement was good (κ = 0.705).Eye-10 is far easier than counting many cancer cells and useful for classifying breast cancers. Eye-10 can exclude obviously high and low Ki67 cases, leaving a "gray zone" around a cutoff point. Combining Eye-10 and manual counting is a good candidate for a standard method to evaluate Ki67.

We evaluated the image quality and diagnostic performance of late iodine enhancement computed tomography (LIE-CT) with knowledge-based iterative model reconstruction (IMR) for the detection of myocardial infarction (MI) in comparison with late gadolinium enhancement magnetic resonance imaging (LGE-MRI). The study investigated 35 patients who underwent a comprehensive cardiac CT protocol and LGE-MRI for the assessment of coronary artery disease. The CT protocol consisted of stress dynamic myocardial CT perfusion, coronary CT angiography (CTA) and LIE-CT using 256-slice CT. LIE-CT scans were acquired 5 min after CTA without additional contrast medium and reconstructed with filtered back projection (FBP), a hybrid iterative reconstruction (HIR), and IMR. The signal-to-noise ratio (SNR) and contrast-to-noise ratio (CNR) were assessed. Sensitivity and specificity of LIE-CT for detecting MI were assessed according to the 16-segment model. Image quality scores, and diagnostic performance were compared among LIE-CT with FBP, HIR and IMR. Among the 35 patients, 139 of 560 segments showed MI in LGE-MRI. On LIE-CT with FBP, HIR, and IMR, the median SNRs were 2.1, 2.9, and 6.1; and the median CNRs were 1.7, 2.2, and 4.7, respectively. Sensitivity and specificity were 56 and 93% for FBP, 62 and 91% for HIR, and 80 and 91% for IMR. LIE-CT with IMR showed the highest image quality and sensitivity (p

Objectives: To examine the association between cancer location, resection margins and oncological outcome in patients undergoing radical prostatectomy. Methods: A total of 505 patients who underwent radical prostatectomy between 1993 and 2009 were included in this analysis. Cancer location, resection margins and pathological factors were assessed based on the 2010 General Rules for Clinical and Pathological Studies on Prostate Cancer. Biochemical recurrence was defined as prostate-specific antigen >0.2 ng/mL. Results: Positive resection margins were found in 38.4% of all cases, in 30.3% of pT2 cases and in 57.7% of pT3 cases. The cancer was distributed evenly among the apex-anterior, apex-posterior and middle lesions, which each accounted for approximately 30% of the whole lesion in the main tumor. A higher rate of positive resection margins (47.6%) was found in the apex-anterior lesions. In minor tumors, most cancer was located in the middle lesion and accounted for approximately 60% of the lesion. However, positive resection margins were detected significantly more frequently in the apex-anterior lesion of minor tumors. The 5-year and 10-year biochemical recurrence-free survival rates were 36.2% and 32.0%, respectively, in patients with a positive resection margin, and 82.7% and 77.4%, respectively, in those with a negative resection margin. Cancer location was an independent risk factor for biochemical recurrence and a positive resection margin. Recurrence-free survival was lower in pT2 cases with a positive resection margin compared with pT3 cases with a negative resection margin. Conclusions: Cancer location and occurrence of positive resection margins can have negative effects on recurrence-free survival. Thus, it is of utmost importance to avoid positive resection margins during radical prostatectomy.

1Urology, 2 Radiation Oncology, and 3 Objectives: To examine quality of life (QOL) for 3 years after radical retropubic prostatectomy (RRP) or permanent prostate brachytherapy (PPB) and to determine differences between the two procedures. Methods: In all 107 patients who underwent RRP and 91 who received PPB between October 2005 and July 2007 were included in this study. QOL surveys were performed using the international prostate symptom score (IPSS), the Medical Outcome Study 8-items short form health survey and the expanded prostate cancer index composite at baseline and 1, 3, 6, 12 and 36 months after treatment. Results: At 3 years, all parameters for general QOL and almost all for disease-specific QOL were similar to those at 12 months. Urinary continence after RRP slightly improved from 12 months to 3 years, but it was still significantly worse than that after PPB. Scores for urinary irritation or obstruction and for bowel function and bother at 3 years were similar between the two groups. Sexual function and bother did not change between 12 months and 3 years in either group. Sexual function at 3 years after RRP was worse than that after PPB. Recovery from urinary incontinence and sexual function after RRP with nerve sparing were similar to those after PPB. Urinary incontinence at 3 years correlated with the treatment method and patients’ age, whereas urinary irritation/obstruction and urinary bother correlated with the pretreatment IPSS. Conclusion: QOL assessment represents an important issue in prostate cancer management. Our findings are likely to be of aid in the development of a treatment plan for prostate cancer patients.

Background: Sleep pattern is an important factor in a child’s mental, behavioural and physical status. To evaluate the sleep patterns of children, subjective tools such as sleep logs and questionnaires are still widely used in addition to objective methods of sleep assessment. Despite the established correlation between subjective and objective sleep variables, the characteristic features of subjective assessment have not been elucidated.Methods: To investigate the characteristics of parental sleep assessment (daily sleep log and brief questionnaire) in preschool children, a 7-day actigraphic sleep study was conducted in 48 healthy 5-year-old children.Results: Sleep schedule variables in the parental reports generally correlated well with actigraphic assessment of sleep patterns; however, sleep periods were longer in parental reports than in actigraphic recordings. Although the daily sleep log was better correlated with actigraphy, the brief questionnaire showed a good correlation with sleep pattern on weekday actigraphic assessments. Parental reports recorded fewer than 10% of the night wakings recorded by actigraphy.Conclusions: Subjective sleep assessments remain useful, although their utility depends on the purpose and size of the study in question. However, knowledge of the potential biases and characteristics of such assessments is essential for correct interpretation of the data.

In clinical trials for dietary supplements and functional foods, the study population tends to be a mixture of healthy subjects and those who are not so healthy but are not definitely diseased (called "borderline subjects"). For such heterogeneous populations, the t-test and ANCOVA method often fail to provide the desired treatment efficacy. We propose an alternative approach for the efficacy evaluation of dietary supplements and functional foods based on a change-point linear regression model. The model does not require the assumption of a constant treatment effect and provides clinically interpretable results. By employing the AIC-based profile likelihood method, inferences can be made easily using standard statistical software. The proposed method was applied to the Garcinia study data, and the merit of the method was demonstrated by comparing it with traditional methods.

While HER2 gene detection in cytological specimens using fluorescence in situ hybridization (FISH) has been reported, the appropriate criteria for such specimens remain controversial. Fine needle aspiration (FNA) samples collected from surgically resected breast cancer specimens were rinsed in a cytopreservative solution containing fixative. Then, slides of the FNA samples were prepared by liquid-based cytology (LBC) (ThinPrep system, Hologic) according to the manufacturer’s instructions, and a PathVision HER2 DNA probe kit (Abbott) was used for FISH staining. The results were evaluated using an automated MetaCyte imaging system (MetaSystems, Altlussheim, Germany). HER2 gene amplification was scored using the HER2/chromosome enumeration probe 17 (CEP17) signal count ratio as follows: amplified, >2.2; equivocal, 1.8–2.2; and unamplified

e21640Background: Bone metastasis is frequently observed in advanced non-small cell lung cancer (NSCLC) accounting for 30-40%. Bone metastasis is sometimes symptomatic and causes severe pain or par...

260 Background: Patient-reported experiences of cancer care are an important outcome of cancer control programs. To establish a nation-wide system to monitor progress in cancer control policies, we piloted a patient experience survey to six hospitals in Japan. Methods: We conducted a self-administered questionnaire survey to a total of 1,804 adult cancer patients receiving cancer treatment in six hospitals (three cancer centers, two general hospitals, and one academic institution) from July 2013 to Mar 2014. Patients were asked to answer 94 questions covering eight dimensions of cancer experience: 1) decision-making, 2) care coordination, 3) patient education, 4) pain control, 5) emotional support, 6) family support, 7) access to care, and 8) care continuity. Results: Eighty percent of the patients reported that their treatment preferences were respected in the decision-making process, but a large proportion of patients (60%) also noted that they preferred to have their treatment decisions made for them by their physicians. Many (32%) expressed difficulty in communicating their questions and concerns to their physicians at the time of diagnosis. Only one fifth of patients were informed at the time of diagnosis that they can seek for a second opinion from other providers. Average patient-reported wait time to surgery was 30 days, which was considered to be long by a third of the patients. Eighty percent of patients felt that their care was well-coordinated by a multidisciplinary team, while % also felt that they received adequate emotional support from their medical staff. Relatively small proportion of outpatients (77%) felt that they had access to medical staff when they had medical questions, compared to nearly all patients in an inpatient setting. Only 65% of inpatients and 40% of outpatients felt that they had received best available pain control during their care. Less than half of the patients were able to communicate their preferred place of care after discharge with their healthcare provider. Conclusions: Patient-reported experiences of cancer care are an important outcome measure of cancer policy performance. This pilot study served to reveal some of the important on in future nationwide surveys.

Background HER2 testing for samples from recurrent or metastatic disease is recommended by the 2013 update of the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines and cytological analysis can be applied to several types of metastatic lesions. However, the practical method to assess the HER2 testing of breast cancer cytology specimens has yet to be resolved. Therefore, we conducted the bright-field HER2 dual in situ hybridization (DISH) assay on cell blocks (CBs) prepared from breast cancer cell samples as a validation study before clinical use. Methods CBs were prepared from tumor cell samples collected from 54 surgically excised breast tumors. The cells were fixed in 10 % buffered formalin for 16–28 h, and embedded in paraffin. The INFORM HER2/neu Dual ISH DNA Probe Cocktail was used for the DISH assay on the Ventana BenchMark ULTRA (Roche Diagnostics). Results Successful results were obtained in 51 of 54 CB specimens, and the results from the CB specimens were in agreement with those from the histological sections in 48 of the 51 cases (concordance rate, 94 %; kappa, 0.846). The intraclass correlation coefficient (ICC) between the CB and histological specimens in the continuous HER2/CEP17 signal count ratio was 0.89 (95 % CI 0.81–0.93), and the Pearson’s CC was 0.91 (95 % CI 0.85–0.94). Conclusion The HER2 DISH assay, utilizing 10 % buffered formalin-fixed CB, would be a reliable and ideal method to assess the HER2 gene status of breast cancer cytological specimens.