Thoracic radiotherapy with or without daily low-dose carboplatin in elderly patients with non-small-cell lung cancer: A randomised, controlled, phase 3 trial by the Japan Clinical Oncology Group (JCOG0301)
Atagi S.,Kinki chuo Chest Medical Center |
Kawahara M.,Otemae Hospital |
Yokoyama A.,Niigata Cancer Center Hospital |
Okamoto H.,Yokohama Municipal Citizens Hospital |
And 8 more authors.
The Lancet Oncology | Year: 2012
Background: It is unknown whether combined chemoradiotherapy improves overall survival in elderly patients with locally advanced non-small-cell lung cancer (NSCLC). The aim of this study was to assess whether radiotherapy plus carboplatin results in longer survival than radiotherapy alone in elderly patients with NSCLC. Methods: This was a randomised, controlled, phase 3 trial by the Japan Clinical Oncology Group (JCOG0301). Patients older than 70 years with unresectable stage III NSCLC were randomly assigned to chemoradiotherapy (60 Gy plus concurrent low-dose carboplatin [30 mg/m2 per day, 5 days a week for 20 days]) or radiotherapy alone, using a minimisation method with biased-coin assignment balancing on Eastern Cooperative Oncology Group (ECOG) performance status (0 vs 1 vs 2), stage (IIIA vs IIIB), and institution. The primary endpoint was overall survival, which was analysed for the eligible population and stratified by ECOG performance status, stage, and institution. The trial was stopped early as a result of the second planned interim analysis. This study is registered with UMIN Clinical Trials Registry, number C000000060, and ClinicalTrials.gov, number NCT00132665. Findings: 200 patients were enrolled from Sept 1, 2003 to May 27, 2010: 100 in the chemoradiotherapy group and 100 in the radiotherapy group. The second planned interim analysis was done 10 months after completion of patient accrual. At this time, median follow-up for censored cases was 19·4 months (IQR 10·3-33·5). In accordance with the prespecified stopping rule, the JCOG data and safety monitoring committee recommended early publication of this trial because the difference in overall survival favoured the chemoradiotherapy group. Median overall survival for the chemoradiotherapy and radiotherapy alone groups were 22·4 months (95% CI 16·5-33·6) and 16·9 months (13·4-20·3), respectively (hazard ratio 0·68, 95·4% CI 0·47-0·98, stratified log-rank test one-sided p value=0·0179). More patients had grade 3-4 haematological toxic effects in the chemoradiotherapy group than in the radiotherapy alone group, including leucopenia (61 [63·5%] vs none), neutropenia (55 [57·3%] vs none), and thrombocytopenia (28 [29·2%] vs two [2·0%]). Grade 3 infection was more common with chemoradiotherapy (12 patients [12·5%]) than with radiotherapy (four patients [4·1%]). Incidences of grade 3-4 pneumonitis and late lung toxicity were similar between groups. There were seven treatment-related deaths: three of 100 patients (3·0%) in the chemoradiotherapy group and four of 100 (4·0%) in the radiotherapy group. Interpretation: For a select group of elderly patients with locally advanced NSCLC, combination chemoradiotherapy provides a clinically significant benefit over radiotherapy alone, and should be considered for this population. Funding: Ministry of Health, Labour, and Welfare of Japan. © 2012 Elsevier Ltd.
Khoo H.M.,Osaka University |
Kishima H.,Osaka University |
Hosomi K.,Osaka University |
Maruo T.,Osaka University |
And 8 more authors.
Movement Disorders | Year: 2014
Background: Low-frequency, bilateral stimulation of the subthalamic nucleus can improve axial symptoms of advanced Parkinson's disease (PD), but it is not particularly effective for segmental symptoms. Methods: The optimal contacts for low-frequency (60 Hz) and high-frequency (130 Hz) single monopolar stimulation were determined. Then, in a randomized, double-blind, prospective crossover manner, 60-Hz and 130-Hz stimulations via the respective optimal contacts were compared for immediate efficacy in improving the motor function of patients with PD. Results: The optimal contacts for 60-Hz stimulation were situated more ventrally than those for 130-Hz stimulation (P=0.038). Under the respective optimal, single monopolar stimulation, 60 Hz provided superior efficacy over 130 Hz in improving the total Unified Parkinson's Disease Rating Scale motor score (P<0.001) and the akinesia (P=0.011) and axial motor signs (P=0.012) subscores without compromising the therapeutic effect on tremor and rigidity. Conclusions: Low-frequency stimulation via the optimal contacts is effective in improving overall motor function of patients with PD. © 2014 International Parkinson and Movement Disorder Society.
Iwazawa J.,Nissay Hospital |
Ohue S.,Komatsu Hospital |
Kitayama T.,Otemae Hospital |
Sassa S.,Nissay Hospital |
Mitani T.,Nissay Hospital
American Journal of Roentgenology | Year: 2011
OBJECTIVE. The purpose of our study was to assess the feasibility of using C-arm CT to detect incomplete accumulation of iodized oil in hepatocellular carcinoma immediately after transarterial chemoembolization (TACE). MATERIALS AND METHODS. This retrospective study included 80 hepatocellular carcinoma lesions in 55 patients (41 men and 14 women; mean age, 69.2 years; mean tumor size, 18.1 mm [range, 5-55 mm]) who underwent TACE with a flat-detector C-arm angiographic system. C-arm CT images were acquired at the end of each session, and unenhanced MDCT images were obtained 7 days later. Two independent observers scored both sets of images, using a predefined detection scale for incomplete iodized oil accumulation. The accuracy for predicting residual lesions was compared using the area under the receiver-operating characteristic curve (Az). Contrast-enhanced CT findings obtained 1 month after TACE served as reference standards. RESULTS. Viable lesions were observed in 18 of the 80 study lesions by contrast-enhanced CT. The accuracy of the C-arm CT (Az = 0.816) was not significantly different (p = 0.449) from that of the MDCT (Az = 0.841). Sensitivity, specificity, and positive and negative predictive values for C-arm CT (80.5%, 74.2%, 47.5%, and 92.9%, respectively) and MDCT (86.1%, 75.0%, 50.0%, and 94.9%, respectively) did not differ significantly. CONCLUSION. C-arm CT is nearly equivalent to MDCT for detecting incomplete iodized oil accumulation after TACE, suggesting that the immediate assessment of iodized oil accumulation with C-arm CT without the need to perform follow-up unenhanced MDCT is likely feasible. © American Roentgen Ray Society.
Kiuchi Y.,Hiroshima University |
Yanagi M.,Hiroshima University |
Nakamura T.,Otemae Hospital
Clinical Ophthalmology | Year: 2010
Purpose: To compare the effectiveness of standard revision surgery using mitomycin C (MMC) with revision using amniotic membrane transplantation and MMC for elevated intraocular pressure (IOP) after trabeculectomy. Patients and methods: A retrospective, nonrandomized comparative study of 36 eyes of 36 patients with a failed trabeculectomy. Patients were divided into two groups, ie, a nonamniontransplanted group and an amnion-transplanted group. The amniotic membrane was placed on the scleral flap under the conjunctiva in the amnion-transplanted group. Both groups recovered filtration of aqueous humor from the surgical site with the adjunctive use of MMC. The changes in IOP and cumulative survival rate were compared for the two groups. Success was defined as a 30% reduction in IOP from the preoperative IOP and maintenance below 21 mmHg with or without the use of antiglaucomatous agents. Results: The mean preoperative IOP was not significantly different in the two groups. The mean postoperative IOP in the nonamnion group, 12.1 ± 5.5 mmHg, was significantly lower than the IOP in the amnion group, 16.0 ± 3.7 mmHg. Survival curves in the two groups did not reach significantly different levels. Conclusions: Conventional surgical bleb revision with MMC can significantly reduce the elevated IOP associated with a failed filtration bleb. The use of an amniotic membrane transplant did not improve the surgical outcome in our cases. © 2010 Kiuchi et al.
PubMed | Otemae Hospital, Sasebo City General Hospital, Kanagawa Cancer Center, National Cancer Center and 4 more.
Type: Journal Article | Journal: Medical physics | Year: 2017
Actual irradiated prescription dose to patients cannot be verified. Thus, independent dose verification and second treatment planning system are used as the secondary check. AAA dose calculation engine has contributed to lung SBRT. We conducted a multi-institutional study to assess variation of prescription dose for lung SBRT when using AAA in reference to using Acuros XB and Clarkson algorithm.Six institutes in Japan participated in this study. All SBRT treatments were planed using AAA in Eclipse and Adaptive Convolve (AC) in Pinnacle3. All of the institutes used a same independent dose verification software program (Simple MU Analysis: SMU, Triangle Product, Ishikawa, Japan), which implemented a Clarkson-based dose calculation algorithm using CT image dataset. A retrospective analysis for lung SBRT plans (73 patients) was performed to compute the confidence limit (CL, Average2SD) in dose between the AAA and the SMU. In one of the institutes, a additional analysis was conducted to evaluate the variations between the AAA and the Acuros XB (AXB).The CL for SMU shows larger systematic and random errors of 8.79.9 % for AAA than the errors of 5.74.2 % for AC. The variations of AAA correlated with the mean CT values in the voxels of PTV (a correlation coefficient : -0.7) . The comparison of AXB vs. AAA shows smaller systematic and random errors of -0.71.7%. The correlation between dose variations for AXB and the mean CT values in PTV was weak (0.4). However, there were several plans with more than 2% deviation of AAPM TG114 (Maximum: -3.3 %).In comparison for AC, prescription dose calculated by AAA may be more variable in lung SBRT patient. Even AXB comparison shows unexpected variation. Care should be taken for the use of AAA in lung SBRT. This research is partially supported by Japan Agency for Medical Research and Development (AMED).
Asami K.,Kinki chuo Chest Medical Center |
Kawahara M.,Otemae Hospital |
Atagi S.,Kinki chuo Chest Medical Center |
Kawaguchi T.,Kinki chuo Chest Medical Center |
Okishio K.,Kinki chuo Chest Medical Center
Lung Cancer | Year: 2011
Purpose: We investigated survival potential in patients receiving erlotinib after failure of gefitinib, focusing on response and time to progression (TTP) with gefitinib. Methods: We retrospectively reviewed lung adenocarcinoma patients who received erlotinib after experiencing progression with gefitinib. Our primary objective was to evaluate the prognostic significance of erlotinib therapy. Results: A total 42 lung adenocarcinoma patients were included in this study. Overall disease control rate was 59.5% (partial response [PR], 2.4%; stable disease [SD], 57.1%). Median overall survival was 7.1 months, and median progression-free survival was 3.4 months. The number of patients who achieved PR and non-PR (SD+ progressive disease [PD]) with gefitinib were 22 (52%) and 20 (48%), respectively. Patients with PR for gefitinib showed significantly longer survival times than those with non-PR (9.2 vs. 4.7 months; p= 0.014). In particular, among PR patients, those with TTP <12 months on gefitinib showed significantly longer survival times than those with TTP ≥12 months (10.3 vs. 6.4 months; p= 0.04). Conclusions: Erlotinib may exert survival benefit for lung adenocarcinoma patients with less than 12 months of TTP of prior gefitinib who achieved PR for gefitinib. © 2011 Elsevier Ireland Ltd.
Sugiura T.,Otemae Hospital |
Wada A.,Osaka National Hospital
Clinical and Experimental Nephrology | Year: 2011
Background: While the clinical validity of Doppler ultrasonography in chronic kidney disease (CKD) is still controversial, we have shown in a 2-year follow-up study that the resistive index (RI) could estimate renal prognosis in CKD. The purpose of the present study is to determine whether RI could predict long-term renal prognosis in CKD. Methods: We performed a 4-year follow-up study with an observational cohort of 281 CKD patients (GFR 51 ± 31 ml/min/1.73 m 2, age 54 ± 17 years). The patients were examined by Doppler ultrasonography for RI [(peak-systolic velocity - end-diastolic velocity)/peak-systolic velocity] to be calculated. Glomerular filtration rate (GFR) was estimated with the revised Japanese equation. Worsening renal function was defined as a decrease in GFR of at least 20 ml/min/1.73 m 2 or the need for long-term dialysis therapy until the end of the 4-year follow-up. Results: Among the 281 CKD patients, 89 patients presented with worsening renal function during the 4-year follow-up. When we divided the patients into two groups by RI value of 0.70, Kaplan-Meier analysis showed that the event-free rates of worsening renal function at 48 months were 0.86 and 0.37 in patients with RI 0.70 and RI > 0.70, respectively (log-rank test, p < 0.001). Cox proportional-hazard analysis identified overt proteinuria (≥1.0 g/g creatinine), high RI (>0.70), low GFR (<50 ml/min/1.73 m 2) and high systolic blood pressure (≥140 mmHg) as independent predictors of worsening renal function. Conclusions: This study demonstrated that high RI as well as proteinuria, low GFR, and hypertension were independent risk factors for the progression of CKD in the 4-year follow-up. © 2010 Japanese Society of Nephrology.
Hosomi K.,Osaka University |
Kishima H.,Osaka University |
Oshino S.,Osaka University |
Hirata M.,Osaka University |
And 6 more authors.
Pain | Year: 2013
Central poststroke pain (CPSP) is one of the most refractory chronic pain syndromes. Repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex has been demonstrated to provide moderate pain relief for CPSP. However, the mechanism underlying the pain relief remains unclear. The objective of this study was to assess changes in cortical excitability in patients with intractable CPSP before and after rTMS of the primary motor cortex. Subjects were 21 patients with CPSP of the hand who underwent rTMS. The resting motor threshold, the amplitude of the motor evoked potential, duration of the cortical silent period, short interval intracortical inhibition, and intracortical facilitation were measured as parameters of cortical excitability before and after navigation-guided 5 Hz rTMS of the primary motor cortex corresponding to the painful hand. Pain reduction from rTMS was assessed with a visual analog scale. The same parameters were measured in both hemispheres of 8 healthy controls. Eight of 21 patients experienced ≥30% pain reduction after rTMS (responders). The resting motor threshold in the patients was higher than those in the controls at baseline (P =.035). Intracortical facilitation in the responders was lower than in the controls and the nonresponders at baseline (P =.035 and P =.019), and significantly increased after rTMS (P =.039). There were no significant differences or changes in the other parameters. Our findings suggest that restoration of abnormal cortical excitability might be one of the mechanisms underlying pain relief as a result of rTMS in CPSP. © 2013 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.
Uchiyama C.,Otemae Hospital |
Kondoh H.,Otemae Hospital |
Shintani H.,Otemae Hospital
Thoracic and Cardiovascular Surgeon | Year: 2010
We describe the first reported case of acute methemoglobinemia associated with ochronotic valvular heart disease. A 79-year-old man with ochronotic valvular heart disease experienced decreased urinary output starting 9 days after an operation. Thereafter, the patient's methemoglobin concentration acutely increased, indicating systemic cyanosis, while the arterial partial oxygen pressure (PaO was maintained at around 200mmHg. In patients with ochronotic valvular heart disease, acute methemoglobinemia may occur, as in cases of renal failure or oliguresis. © Georg Thieme Verlag KG Stuttgart.
Efficacy and safety of single-dose fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin: A multicentre, randomised, double-blind, placebo-controlled phase 3 trial
Saito H.,Aichi Cancer Center Research Institute |
Yoshizawa H.,Niigata University |
Yoshimori K.,Fukujuji Hospital |
Katakami N.,Institute of Biomedical Research and Innovation Hospital |
And 3 more authors.
Annals of Oncology | Year: 2013
Background: We evaluated the efficacy and safety of single-dose fosaprepitant in combination with intravenous granisetron and dexamethasone. Patients and methods: Patients receiving chemotherapy including cisplatin (≥70 mg/m. 2) were eligible. A total of 347 patients (21% had received cisplatin with vomiting) were enrolled in this trial to receive the fosaprepitant regimen (fosaprepitant 150 mg, intravenous, on day 1 in combination with granisetron, 40 μg/kg, intravenous, on day 1 and dexamethasone, intravenous, on days 1-3) or the control regimen (placebo plus intravenous granisetron and dexamethasone). The primary end point was the percentage of patients who had a complete response (no emesis and no rescue therapy) over the entire treatment course (0-120 h). Results: The percentage of patients with a complete response was significantly higher in the fosaprepitant group than in the control group (64% versus 47%, P = 0.0015). The fosaprepitant regimen was more effective than the control regimen in both the acute (0-24 h postchemotherapy) phase (94% versus 81%, P = 0.0006) and the delayed (24-120 h postchemotherapy) phase (65% versus 49%, P = 0.0025). Conclusions: Single-dose fosaprepitant used in combination with granisetron and dexamethasone was well-tolerated and effective in preventing chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic cancer chemotherapy, including high-dose cisplatin. © The Author 2012.