13 research outputs found

    Safety analysis of two different regimens of uracil–tegafur plus leucovorin as adjuvant chemotherapy for high-risk stage II and III colon cancer in a phase III trial comparing 6 with 18 months of treatment: JFMC33-0502 trial

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    PURPOSE: The JFMC33-0502 trial is a phase III clinical study designed to determine the most appropriate duration of postoperative adjuvant chemotherapy with uracil–tegafur (UFT) plus leucovorin in patients with stage IIB or III colon cancer. We report the interim results of preplanned safety analyses. METHODS: Patients with stage IIB or III colon cancer who had undergone curative resection were randomly assigned to receive UFT (300 mg/m(2)) plus leucovorin (75 mg/day) for 6 months (control group, 4 weeks of treatment followed by a 1-week rest, five courses) or for 18 months (study group, 5 days of treatment followed by a 2-day rest, 15 courses). Treatment status and safety were evaluated. RESULTS: A total of 1,071 patients were enrolled, and 1,063 were included in safety analyses. Treatment completion rate at 6 months was 74.0 % in the control group and 76.7 % in the study group. Treatment completion rate in the study group at 18 months was 56.0 %. The overall incidence of adverse events (AEs) was 75.3 % in the control group and 77.6 % in the study group. The incidences of grade 3 or higher AEs were low in both groups. During the first 6 months, the incidences of the subjective AEs were significantly lower in the study group. CONCLUSIONS: Oral UFT plus leucovorin given by either dosage schedule is a very safe regimen for adjuvant chemotherapy. In particular, 5 days of treatment followed by a 2-day rest was a useful treatment option from the viewpoint of toxicity even when given for longer than 6 months. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1007/s00280-014-2461-5) contains supplementary material, which is available to authorized users

    SHEAR STRENGTHS OF RC BEAMS RETROFITTED WITH CONTINUOUS FIBER SHEET

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    Clinicopathological Study on Gastric Lesions Treated by Strip Biopsy

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    Clinicopathological significance of strip biopsy was evaluated in 23 gastric lesions in 22 patients. The 23 lesions consisted of 16 adenomas, 4 adenomas with focal carcinoma, 1 carcinoma, and 2 "no atypical cell"l. Strip biopsy provided precise information for accurate histological diagnosis and the depth of cancer invasion. Eleven % of lesions diagnosed as Group III by forceps biopsy and 66.7% of Group IV lesions had focal carcinoma in adenoma. Sixteen of 23 lesions were completely resected by strip biopsy. Seven lesions resulted in incomplete resection. One patient of the 7 cases underwent piece-meal resection because the lesion was too large to be resected by single strip biopsy. Four of the 7 lesions received additional endoscopic coagulation by laser or heater probe. All lesions except for 2 lesions which were resected by operation were followed by repeated endoscopy and all remained disappeared. The combination of strip biopsy and coagulation therapy appears to give great benefit in eradicating lesions

    Clinicopathological Study on Gastric Lesions Treated by Strip Biopsy

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    Clinicopathological significance of strip biopsy was evaluated in 23 gastric lesions in 22 patients. The 23 lesions consisted of 16 adenomas, 4 adenomas with focal carcinoma, 1 carcinoma, and 2 "no atypical cell"l. Strip biopsy provided precise information for accurate histological diagnosis and the depth of cancer invasion. Eleven % of lesions diagnosed as Group III by forceps biopsy and 66.7% of Group IV lesions had focal carcinoma in adenoma. Sixteen of 23 lesions were completely resected by strip biopsy. Seven lesions resulted in incomplete resection. One patient of the 7 cases underwent piece-meal resection because the lesion was too large to be resected by single strip biopsy. Four of the 7 lesions received additional endoscopic coagulation by laser or heater probe. All lesions except for 2 lesions which were resected by operation were followed by repeated endoscopy and all remained disappeared. The combination of strip biopsy and coagulation therapy appears to give great benefit in eradicating lesions

    Atherosclerosis of the carotid bulb is associated with the severity of orthostatic hypotension in non-diabetic adult patients: a cross-sectional study

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    Background: The carotid bulb has a high density of baroreceptors that play an important role in maintaining blood pressure. We hypothesized that atherosclerosis of the carotid bulb would reflect the severity of orthostatic hypotension more accurately than would atherosclerosis of other carotid artery segments. Methods: This cross-sectional study included 198 non-diabetic adults. We measured the cardio-vascular ankle index as an index of arterial stiffness, intima-media thickness in each carotid artery segment (internal carotid artery, carotid bulb, distal and proximal portions, respectively, of the common carotid artery) as a measure of atherosclerosis, and heart rate variability as a measure of cardiac autonomic function. The sit-to-stand test was used to assess severity of orthostatic hypotension. Results: Intima-media thickness of the carotid bulb was correlated with orthostatic systolic blood pressure change (r = −0.218, p = 0.002), cardio-ankle vascular index (r = 0.365, p < 0.001) and heart rate variability parameters. Multivariate regression analysis revealed that among all of the segments, only intima-media thickness of the carotid bulb was an independent predictor of orthostatic systolic blood pressure change (p = 0.022). Conclusion: Atherosclerosis of the carotid bulb was associated with severity of orthostatic hypotension, arterial stiffening and cardiac autonomic dysfunction than that of other carotid artery segments
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