Hokkaido Pwfac Sapporo Kosei General Hospital

Japan

Hokkaido Pwfac Sapporo Kosei General Hospital

Japan
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Yamaue H.,Wakayama Medical University | Shimizu A.,Wakayama Medical University | Hagiwara Y.,University of Tokyo | Sho M.,Nara Medical University | And 17 more authors.
Cancer Chemotherapy and Pharmacology | Year: 2017

Purpose: Non-inferiority for overall survival (OS) following alternate-day treatment with the oral anticancer drug S-1 compared with standard daily treatment was assessed in Japanese patients with unresectable advanced pancreatic cancer in a multicenter, randomized, phase II study. This trial was registered at the UMIN Clinical Trials Registry (no. 000008604). Methods: Chemotherapy-naïve patients with locally advanced or metastatic pancreatic cancer were randomly assigned 2:1 to treatment with alternate-day (twice daily on alternate days from days 1 through 42 of a 42-day cycle) or daily (twice daily on days 1 through 28 of a 42-day cycle) treatment with S-1. The primary endpoint was OS. Secondary endpoints were progression-free survival (PFS), time to treatment failure, response rate, quality of life assessments, and safety. Results: A total of 190 patients were enrolled, of which 185 were included in the final analysis (alternate-day: 121; daily: 64). Median OS was 9.4 for the alternate-day group and 10.4 months for the daily group [hazard ratio (HR), 1.19; 95% credible interval, 0.86 to 1.64], indicating that non-inferiority of alternate-day treatment to daily treatment was not demonstrated. Median PFS was 3.0 for the alternate-day group and 4.2 months for the daily group (HR, 1.65; 95% credible interval, 1.20–2.29). The incidence of anorexia, fatigue, neutrophils, pigmentation, and pneumonitis was lower in alternate-day treatment compared with daily treatment. Conclusion: S-1 for advanced pancreatic cancer should be taken daily as recommended, based on the decreased OS and PFS and marginal improvement in safety observed in the alternate-day group. © 2017, Springer-Verlag Berlin Heidelberg.


Sakaida I.,Yamaguchi University | Kawazoe S.,Saga Prefectural Hospital Koseikan | Kajimura K.,Kishiwada City Hospital | Saito T.,Yamagata University | And 72 more authors.
Hepatology Research | Year: 2014

Aim: Hepatic edema is manifested by ascites, lower limb edema and intolerable symptoms. Some patients insufficiently respond to the conventional diuretic therapy. Therefore, a novel therapeutic option is required. We conducted a phase 3 study to confirm therapeutic effect of tolvaptan on hepatic edema associated with liver cirrhosis. Methods: In our multicenter, randomized, double-blind, placebo-controlled trial, liver cirrhosis patients who showed insufficient response to conventional diuretics were randomly assigned to 7-day administration of either tolvaptan at 7.5mg/day or placebo as an add-on therapy to conventional diuretics. The primary outcome was change in bodyweight from baseline. Results: Of 164 eligible patients, 84 were assigned to tolvaptan and 80 to placebo. Change in bodyweight from baseline on the final dosing day was -0.44kg (standard deviation [SD], 1.93) in the placebo group and -1.95kg (SD, 1.77) in the tolvaptan group (P<0.0001). Improvement rates for lower limb edema and ascites-related clinical symptoms were higher with tolvaptan than with placebo. Even in patients with low serum albumin (<2.5g/dL), decrease in bodyweight was greater with tolvaptan than with placebo (P=0.0163). In addition, tolvaptan significantly increased serum sodium concentration from baseline. Conclusion: Add-on therapy with tolvaptan was effective for the treatment of hepatic edema and ascites-related clinical symptoms. Furthermore, tolvaptan is expected to improve low serum sodium concentration and to exert its effect regardless of serum albumin level. Add-on therapy with tolvaptan is therefore considered to be a novel therapeutic option for hepatic edema. © 2013 The Japan Society of Hepatology.


Kumada H.,Toranomon Hospital | DaCosta DiBonaventura M.,Kantar Health | Yuan Y.,Bristol Myers Squibb | Kalsekar A.,Bristol Myers Squibb | And 7 more authors.
Value in Health Regional Issues | Year: 2014

Objectives: Pegylated-interferon-α (IFN-α)-based therapies for viral hepatitis C (HCV) are effective, but they are associated with several adverse events (AEs). The primary objectives of this study were to quantify the burden of IFN-α-based treatment and to measure the prevalence and burden of IFN-α-related AEs in Japan. Methods: A cross-sectional survey was administered online to patients with HCV in 2013. Patients who were currently taking IFN-α-based therapy (n = 188) were compared with patients who were taking a liver protectant but not IFN-α-based therapy (n = 180) and with patients who were untreated (n = 365) on measures of health-related quality of life (using the Hepatitis Quality of Life Questionnaire, version 2), work productivity, and health care resource use, controlling for sociodemographic characteristics and health history. Among patients taking IFN-α-based therapy, the prevalence and burden of AEs was examined on the same set of health outcomes as noted above along with treatment satisfaction and adherence. Results: Compared with untreated patients, patients using IFN-α reported poorer health-related quality of life (physical component summary score, 50.13 vs. 52.04; mental component summary score, 44.12 vs. 47.97), more overall work impairment (32.73 vs. 25.64), more physician visits in the past 6 months (14.51 vs. 8.36), and an increased likelihood of an emergency room visit (odds ratio = 7.25) and hospitalization (odds ratio = 4.05) (all P < 0.05). The mean number of AEs was 6.05 for patients using IFN-α. All AEs were associated with poorer health outcomes (particularly the mental component summary score), and most were also associated with lower treatment satisfaction and medication adherence. Conclusions: A significant patient burden for IFN-α treatment itself and various AEs was observed. The results suggest that effective, non-IFN-α-based treatments may reduce the societal burden. © 2014 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).


Matsuya Y.,Hokkaido University | Ohtsubo Y.,Hokkaido PWFAC Sapporo Kosei General Hospital | Tsutsumi K.,Hokkaido University | Sasaki K.,Kyoto University | And 2 more authors.
Journal of Radiation Research | Year: 2014

The microdosimetric-kinetic (MK) model is one of the models that can describe the fraction of cells surviving after exposure to ionizing radiation. In the MK model, there are specific parameters, k and yD, where k is an inherent parameter to represent the number of potentially lethal lesions (PLLs) and yD indicates the dose-mean lineal energy in keV/μm. Assuming the PLLs to be DNA double-strand breaks (DSBs), the rate equations are derived for evaluating the DSB number in the cell nucleus. In this study, we estimated the ratio of DSBs for two types of photon irradiation (6 MV and 200 kVp X-rays) in Chinese hamster ovary (CHO-K1) cells and human non-small cell lung cancer (H1299) cells by observing the surviving fraction. The estimated ratio was then compared with the ratio of α-H2AX foci using immunofluorescent staining. For making a comparison of the number of DSBs among a variety of radiation energy cases, we next utilized the survival data in the literature for both cells exposed to other photon types, such as 60Co α-rays, 137Cs α-rays and 100 kVp X-rays. The ratio of DSBs based on the MK model with conventional data was consistent with the ratio of α-H2AX foci numbers, confirming that the α-H2AX focus is indicative of DSBs. It was also shown that the larger yD is, the larger the DSB number is. These results suggest that k and yD represent the characteristics of the surviving fraction and the biological effects for photon irradiation. © 2014 The Author 2014. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.


Matsumoto S.,Hokkaido Pwfac Sapporo Kosei General Hospital | Takahashi M.,Hokkaido Pwfac Sapporo Kosei General Hospital | Ishizu H.,Hokkaido Pwfac Sapporo Kosei General Hospital | Takahashi H.,Hokkaido Pwfac Sapporo Kosei General Hospital | And 9 more authors.
Japanese Journal of Cancer and Chemotherapy | Year: 2014

The recommended dose of imatinib for recurrent gastrointestinal stromal tumors (GIST) is 400 mg/day. However adverse effects limit the use of the standard dose in elderly patients. We report a case of an elderly patient with recurrent GIST where long-term control of the disease was achieved with low-dose imatinib therapy. An 86-year-old man presenting with tarry stool was admitted to the hospital; upper Gl endoscopy revealed a gastnc submucosal tumor of the stomach a the posterior wall of the cardia. Partial gastrectomy was performed laparoscopically. The submucosal lesion was histopathologically diagnosed as malignant GIST. Administration of imatinib was initiated 17 months after surgery because of recurrence of GIST. Te initial dose of imatinib was 400mg/day, which was later adjusted to 200mg or 300mg/day because of adverse effects. Though imatinib was withdrawn several times due to strong side effects, the disease was well controlled for 6 years after surgery.


Kuji M.,Hokkaido Pwfac Sapporo Kosei General Hospital | Masuko H.,Hokkaido Pwfac Sapporo Kosei General Hospital | Yamagami H.,Hokkaido Pwfac Sapporo Kosei General Hospital | Matsumoto S.,Hokkaido Pwfac Sapporo Kosei General Hospital | And 4 more authors.
Japanese Journal of Cancer and Chemotherapy | Year: 2014

We examined the treatment condition; adverse events, especially hand-foot syndrome (HFS); and prognosis in 65 patients with colon cancer who received adjuvant chemotherapy with capecitabine. The treatment completion rate was 75.4%; however, only 15.4% of patients completed treatment without dose reduction or treatment interruption. HFS occurred in 78.5% of all cases. The 3-year relapse-free survival rate was 73.8% for all cases, 80.8% for treatment-completed cases, and 51.1% for treatment-discontinued cases; however, there were no differences in relapse-free survival rates for cases that required dose reduction or treatment interruption. We conclude that adjuvant chemotherapy with capecitabine is effective in colon cancer and that completing treatment (even with dose reduction or dose interruption) improves prognosis.

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