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.
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.
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.
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.