Three-Arm Randomized Trial of Sodium Alginate for Preventing Radiation-Induced Esophagitis in Locally Advanced Non-Small Cell Lung Cancer Receiving Concurrent Chemoradiotherapy: The OLCSG1401 Study Protocol
PubMed | Okayama University of Science, Red Cross, National Hospital Organization Shikoku Cancer Center, Chugoku Central Hospital and 7 more.
Type: | Journal: Clinical lung cancer | Year: 2016
Concurrent chemoradiotherapy (CRT) is the standard of care for locally advanced non-small cell lung cancer (LA-NSCLC). However, this intensive therapy often causes severe esophagitis, which could deteriorate a patients quality of life (QOL), leading to poor treatment compliance. Sodium alginate, approved in Japan for gastritis, is sufficiently highly viscous to remain in the esophageal mucosa, providing a protective effect in the esophagus. To investigate whether this compound has a preventive effect against severe esophagitis in patients receiving concurrent CRT, we plan a 3-arm randomized trial of sodium alginate with 2 different schedules versus water. The primary endpoint is set as the proportion of patients with grade 3 esophagitis using the Common Terminology Criteria for Adverse Events, version 4.0. With stratification by institute, performance status, and percentage of the esophageal volume receiving >35 Gy, the patients will be randomly assigned to 1 of the following groups: sodium alginate initiated concomitantly with CRT (group A), sodium alginate initiated soon after the development of extremely mild esophagitis during CRT (group B), or water administered throughout CRT (group C). Assuming that the proportion of grade 3 esophagitis would be 8% in groups A and B and 27% in group C, the required sample size would be 200 patients, with 70% power and 5% . The secondary endpoints include QOL, the frequency of additional prescriptions of analgesics, treatment response, and survival. The results of the present study will clarify whether sodium alginate can prevent esophagitis in patients with LA-NSCLC undergoing CRT.
Yokota K.,Jichi Medical University |
Yokota K.,Iwakuni Medical Center |
Yokota K.,St. Marianna University School of Medicine |
Fukuda M.,Iwakuni Medical Center |
And 3 more authors.
Journal of Clinical Hypertension | Year: 2014
The authors previously reported that the visit-to-visit variability of blood pressure is correlated with renal function decline in nondiabetic chronic kidney disease. Little is known about the association between visit-to-visit variability and renal function decline in patients with diabetic chronic kidney disease. The authors retrospectively studied 69 patients with diabetic chronic kidney disease stage 3a, 3b, or 4. The standard deviation and coefficient of variation of blood pressure in 12 consecutive visits were defined as visit-to-visit variability of blood pressure. The median observation period was 32 months. In univariate correlation, the standard deviation and coefficient of variation of blood pressure were not significantly associated with the slope of estimated glomerular filtration rate. There was no significant association between the visit-to-visit variability of blood pressure and renal function decline in patients with diabetic chronic kidney disease, in contrast with our previous study of nondiabetic patients with chronic kidney disease. ©2014 Wiley Periodicals, Inc.
Yoshioka H.,Kurashiki Central Hospital |
Hotta K.,Okayama University |
Kiura K.,Okayama University |
Takigawa N.,Okayama University |
And 9 more authors.
Journal of Thoracic Oncology | Year: 2010
BACKGROUNDS: Efficacy of gefitinib therapy strongly depends on epidermal growth factor receptor (EGFR)-mutation status in Asian patients with non-small cell lung cancer. Recently, the survival advantage of erlotinib, another tyrosine kinase inhibitor, was not affected by EGFR mutation status in a phase III trial, indicating that patients with EGFR-wild-type (EGFR-wt) tumors might also benefit from this tyrosine kinase inhibitor. The aim of this trial was to evaluate the efficacy and toxicity of erlotinib in Japanese patients with EGFR-wt tumors. METHODS: The primary end point was an objective response. Patients with EGFR-wt tumors previously receiving one to three chemotherapy regimens were enrolled in this trial. The mutation status was assessed using the peptide nucleic acid-locked nucleic acid polymerase chain reaction clamp method. Erlotinib was administered (150 mg/d) until disease progression or unacceptable toxicities occurred. RESULTS: Thirty patients were enrolled between January and December 2008. Objective response was observed in one patient (3.3%), and the disease became stable in 18 patients (60.0%). Skin rash was the most common side effect. Grades 3-4 adverse events included pulmonary embolism, keratitis, and anemia. Two other patients developed interstitial lung disease (grades 1 and 2). Nevertheless, all these events were reversible, resulting in no treatment-related deaths. With a median follow-up time of 10.7 months, the median survival time and median progression-free survival times were 9.2 and 2.1 months, respectively. CONCLUSION: This is the first prospective biomarker study showing that erlotinib therapy for pretreated patients with EGFR-wt tumors seems to have a modest activity with no irreversible toxicity. Copyright © 2009 by the International Association for the Study of Lung Cancer.
Matsui Y.,Jichi Medical University |
Matsui Y.,Iwakuni Medical Center |
O'Rourke M.F.,University of New South Wales |
Ishikawa J.,Jichi Medical University |
And 2 more authors.
American Journal of Hypertension | Year: 2012
Background We aimed to investigate the association of the change in the ambulatory arterial stiffness index (AASI) with that in carotid-femoral pulse wave velocity (cfPWV) during treatment with antihypertensive medication. Methods We enrolled 207 hypertensive patients treated with olmesartan monotherapy for 12 weeks. Patients were randomly assigned to treatment with hydrochlorothiazide (HCTZ; n = 104) or azelnidipine (n = 103) for 24 weeks. The cfPWV and 24-h ambulatory blood pressure monitoring (ABPM) Results were assessed at baseline and 24 weeks later. The AASI was defined as 1 minus the regression slope of diastolic blood pressure (DBP) on systolic BP (SBP), and was calculated by standard and symmetric regression. Results The changes in the AASI and symmetrical AASI were similar between the two groups, while cfPWV in the azelnidipine group decreased more than in the HCTZ group (P>0.001). The change in AASI was not significantly correlated with change in cfPWV (r = 0.08, P = 0.26), whereas the change in symmetrical AASI was significantly but weakly correlated with change in cfPWV (r = 0.22, P>0.001). The multivariable linear regression analysis revealed that the association of the change in symmetrical AASI with change in cfPWV remained significant even after adjustments for covariates derived from ABPM (regression coefficient (95% confidence interval): 1.33 (0.35-2.30), P = 0.01). Conclusions The present study demonstrated that neither AASI nor symmetrical AASI may be an unequivocal marker of arterial stiffness during antihypertensive treatment. © 2012 American Journal of Hypertension, Ltd.
Inoue A.,Tohoku University |
Sugawara S.,Sendai Kousei Hospital |
Harada M.,Hokkaido Cancer Center |
Kobayashi K.,Saitama University |
And 8 more authors.
Journal of Thoracic Oncology | Year: 2014
Background: There has been no standard chemotherapy for advanced or recurrent thymic malignancies including thymic carcinoma (TC) and invasive thymoma (IT), though platinum and anthracycline have been reported as effective agents for the treatment of these diseases. The objective of this study was to evaluate the efficacy and safety of the combination of amrubicin (AMR), a new anthracycline agent, and carboplatin (CBDCA) in patients with advanced thymic malignancies. Methods: Patients with histologically confirmed thymic malignancies received AMR (35 mg/m2, days 1-3) and CBDCA (area under the curve 4.0, day 1) every 3 weeks. Patients who had received previous chemotherapy were treated with a reduced dose of AMR (30 mg/m2). The primary end point was objective response rate (ORR), and secondary endpoints were progression-free survival, overall survival, and toxicity profile. Results: From December 2008 to October 2012, 51 patients (33 TC and 18 IT) were enrolled. The median number of treatment cycles was four in each group. The ORR and progression-free survival were 30% (95% confidence interval, 14-46) and 7.6 months in the TC group, and 17% (95% confidence interval, 0-34) and 7.6 months in the IT group, respectively. The ORR of TC patients without previous chemotherapy (n = 19) was 42%. Although grade 3 or 4 hematological toxicities were common including neutropenia (82%) and febrile neutropenia (22%), these were transient and manageable. Nonhematological toxicities were moderate and no treatment-related death was observed. Conclusions: The combination of AMR with CBDCA was active for TC with acceptable toxicity, although it was not effective for IT. Further investigation of this regimen for advanced TC is warranted. Copyright © 2014 by the International Association for the Study of Lung Cancer.
Yokota K.,Jichi Medical University |
Yokota K.,Iwakuni Medical Center |
Fukuda M.,Iwakuni Medical Center |
Matsui Y.,Jichi Medical University |
And 4 more authors.
Hypertension Research | Year: 2013
An association between visit-to-visit variability (VVV) of blood pressure (BP) and renal damage was recently reported in a cross-sectional study. We aimed to clarify the longitudinal effect of VVV of BP on deterioration of renal function in patients with non-diabetic chronic kidney disease (CKD). We retrospectively studied 56 patients with non-diabetic CKD (stage 3 or 4) who visited our nephrology clinic between September 1994 and May 2011. VVV of BP was defined as the standard deviation and coefficient of variation (CV) of office BP measured at 12 consecutive visits. Main outcomes were the annual decline in the estimated glomerular filtration rate (eGFR) and the composite renal end point defined as a doubling of serum creatinine or the need for dialysis. The median observation period was 83 months. Standard deviation and CV of office systolic BP (SBP) were significantly associated with the slope of the eGFR after adjustments for confounders. The adjusted risk for composite renal end points more than doubled for each increment of 1-standard deviation of the standard deviation of office SBP (hazard ratio (HR) 2.20, P=0.001), and for each increment of 1-standard deviation of the CV of office SBP (HR 2.12, P=0.002). The present study demonstrated that the visit-to-visit variability of BP is an independent determinant of deterioration of renal function in patients with non-diabetic CKD. © 2013 The Japanese Society of Hypertension All rights reserved.
Ito K.,Osaka Prefecture University |
Nonaka K.,Osaka Prefecture University |
Ogaya S.,Osaka Prefecture University |
Ogi A.,Kansai Electric Power Co. |
And 2 more authors.
Journal of Electromyography and Kinesiology | Year: 2016
We aimed to characterize rectus abdominis, internal oblique, and external oblique muscle activity in healthy adults under expiratory resistance using surface electromyography. We randomly assigned 42 healthy adult subjects to 3 groups: 30%, 20%, and 10% maximal expiratory intraoral pressure (PEmax). After measuring 100% PEmax and muscle activity during 100% PEmax, the activity and maximum voluntary contraction of each muscle during the assigned experimental condition were measured. At 100% PEmax, the external oblique (p < 0.01) and internal oblique (p < 0.01) showed significantly elevated activity compared with the rectus abdominis muscle. Furthermore, at 20% and 30% PEmax, the external oblique (p < 0.05 and < 0.01, respectively) and the internal oblique (p < 0.05 and < 0.01, respectively) showed significantly elevated activity compared with the rectus abdominis muscle. At 10% PEmax, no significant differences were observed in muscle activity.Although we observed no significant difference between 10% and 20% PEmax, activity during 30% PEmax was significantly greater than during 20% PEmax (external oblique: p < 0.05; internal oblique: p < 0.01). The abdominal oblique muscles are the most active during forced expiration. Moreover, 30% PEmax is the minimum intensity required to achieve significant, albeit very slight, muscle activity during expiratory resistance. © 2016 Elsevier Ltd.
PubMed | Iwakuni Medical Center
Type: Case Reports | Journal: Internal medicine (Tokyo, Japan) | Year: 2014
Familial Mediterranean fever (FMF) is an autosomal recessive disorder characterized by periodic fever and serosal inflammation. FMF is mostly reported in the Mediterranean region and is considered to be rare in Japan with estimated 292 cases. We treated three unrelated FMF patients in one year in a city with 144,000 residents. Two of the three patients were over 70 years old. FMF may therefore be underdiagnosed in Japan.
PubMed | Red Cross, Ehime Prefectural Central Hospital, Chugoku Central Hospital, Iwakuni Medical Center and 4 more.
Type: Journal Article | Journal: Cancer chemotherapy and pharmacology | Year: 2016
Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) are now key agents in treating EGFR-mutant non-small cell lung cancer (NSCLC). The efficacy of gefitinib or erlotinib monotherapy can be predicted by the development of a skin rash. However, it has not been fully evaluated if this is the case with afatinib monotherapy.We retrospectively studied 49 consecutive patients with EGFR-mutant NSCLC who received afatinib therapy between 2009 and 2015. The relationship of several toxicities with tumor response was examined.Grade 2, or more severe, common adverse events (AEs) included skin rash in 17 patients (35%), diarrhea in 19 (39%) and mucositis in 15 (31%). Of these, the number of patients who developed Grade 2 AEs during the first week after the initiation of afatinib therapy was: five patients had skin rash (10%), 12 patients had diarrhea (25%) and four patients had mucositis (8%). As for an objective response, 21 (43%) of the 49 had a partial response. Associating the AEs with the antitumor effect, those who had a Grade 2 skin rash within the first week tended to have a greater tumor response compared with those without a rash (80 vs. 39%; p=0.077).Our small study demonstrated that the early development of a skin rash might be associated with the response to afatinib monotherapy.
PubMed | Iwakuni Medical Center, Osaka Prefecture University, Kyoto Tachibana University and Kansai Electric Power Co.
Type: | Journal: Journal of electromyography and kinesiology : official journal of the International Society of Electrophysiological Kinesiology | Year: 2016
We aimed to characterize rectus abdominis, internal oblique, and external oblique muscle activity in healthy adults under expiratory resistance using surface electromyography. We randomly assigned 42 healthy adult subjects to 3 groups: 30%, 20%, and 10% maximal expiratory intraoral pressure (PEmax). After measuring 100% PEmax and muscle activity during 100% PEmax, the activity and maximum voluntary contraction of each muscle during the assigned experimental condition were measured. At 100% PEmax, the external oblique (p<0.01) and internal oblique (p<0.01) showed significantly elevated activity compared with the rectus abdominis muscle. Furthermore, at 20% and 30% PEmax, the external oblique (p<0.05 and<0.01, respectively) and the internal oblique (p<0.05 and<0.01, respectively) showed significantly elevated activity compared with the rectus abdominis muscle. At 10% PEmax, no significant differences were observed in muscle activity. Although we observed no significant difference between 10% and 20% PEmax, activity during 30% PEmax was significantly greater than during 20% PEmax (external oblique: p<0.05; internal oblique: p<0.01). The abdominal oblique muscles are the most active during forced expiration. Moreover, 30% PEmax is the minimum intensity required to achieve significant, albeit very slight, muscle activity during expiratory resistance.