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Articles by M Miyazaki
Total Records ( 6 ) for M Miyazaki
  T Satoh , I Okamoto , M Miyazaki , R Morinaga , A Tsuya , Y Hasegawa , M Terashima , S Ueda , M Fukuoka , Y Ariyoshi , T Saito , N Masuda , H Watanabe , T Taguchi , T Kakihara , Y Aoyama , Y Hashimoto and K. Nakagawa

Purpose: YM155, a novel molecular targeted agent, suppresses survivin, a member of the inhibitor of apoptosis protein family that is overexpressed in many tumor types. The aim of this study was to determine the maximum tolerated dose (MTD) and to assess the safety, pharmacokinetics, and antitumor activity of YM155 in patients with advanced refractory solid tumors.

Experimental Design: Patients with advanced refractory solid tumors were treated with escalating doses of YM155 administered by continuous i.v. infusion for 168 hours in 21-day cycles.

Results: Of the 34 patients enrolled, 33 (median age, 59 years) received at least 1 dose of YM155 (range, 1-19 cycles). The dose levels studied were 1.8, 3.6, 4.8, 6.0, 8.0, and 10.6 mg/m2/d. The MTD was determined to be 8.0 mg/m2/d, based on a dose-limiting toxicity of increased blood creatinine observed in 2 patients receiving 10.6 mg/m2/d. The most common adverse reactions judged to be related to YM155 were urine microalbumin present; fever; injection-site phlebitis; fatigue; and decreased hemoglobin/anemia, blood albumin, and lymphocyte count. The pharmacokinetic profile was almost linear over the dosing range and was similar between cycles 1 and 2. Urinary excretion of YM155 showed no definite difference among doses. Stable disease was achieved in nine patients.

Conclusions: YM155 was safely administered to patients with advanced refractory solid tumors by 168-hour continuous i.v. infusion in 21-day cycles. The MTD was determined to be 8.0 mg/m2/d. The safety profile, plasma concentrations achieved, and antitumor activity observed merit further studies with this survivin suppressant, alone and in combination regimens.

  I Okamoto , T Doi , A Ohtsu , M Miyazaki , A Tsuya , K Kurei , K Kobayashi and K. Nakagawa

To determine the pharmacokinetics and safety of RAD001 (everolimus) in Japanese patients with advanced solid tumors.


An open-label, non-randomized, dose-escalation Phase I study of RAD001 administered continuously once daily in a 28-day cycle was performed. The study had a ‘3 + 3’ design, with three patients recruited to each of three successive cohorts treated with RAD001 at 2.5, 5.0 or 10.0 mg/day.


The pharmacokinetics of RAD001 in Japanese patients were similar to those previously determined in Caucasians. The drug safety profile was consistent with that of a mammalian target of rapamycin inhibitor. No dose-limiting toxicities were observed. One patient with esophageal cancer and one with gastric cancer treated with RAD001 at 10 mg/day showed marked tumor responses.


Treatment of Japanese cancer patients with RAD001 may be undertaken with the expectation that previously determined pharmacokinetic and safety profiles apply. The drug may hold promise for treatment of esophageal and gastric cancer.

  I Okamoto , M Munakata , M Miyazaki , T Satoh , T Takahata , Y Takamatsu , O Muto , K Koike , K Ishitani , T Mukaiyama , Y Sakata , K Nakagawa and K. Tamura

Hormonal imbalance characterized by excessive production of growth hormone (GH) and a low circulating concentration of insulin-like growth factor (IGF)-1 has been demonstrated in individuals with various serious conditions. However, little is known about changes in the GH–IGF-1 axis in cancer patients.


We prospectively examined the circulating levels of several hormones in 58 patients with solid tumors who were classified according to Eastern Cooperative Oncology Group performance status (PS): PS 0–1, n = 15; PS 2, n = 15; PS 3, n = 15; and PS 4, n = 13. The relations of hormone concentrations, with a focus on the GH–IGF-1 system, to PS were evaluated by Spearman's rank correlation test and regression analysis.


The circulating levels of IGF-1, IGF-binding protein-3 and thyroid hormones (total T3 and T4) were inversely correlated with PS score. The concentration of GH was increased irrespective of PS but not statistically significant. The ratio of IGF-I to GH was inversely correlated with PS. The levels of GH and IGF-1 in all patients were also inversely correlated.


The present study suggests that the GH–IGF-1 axis is disturbed in patients with cancer.

  H Daiko , K Nagai , J Yoshida , M Nishimura , T Hishida , M Ebihara , M Miyazaki , T Shinozaki , S Miyamoto , M Sakuraba , M Saikawa and R. Hayashi

The purpose of this study was to determine the role of surgical treatment and to identify factors affecting the survival of patients undergoing pulmonary resection for tumors metastatic from head and neck carcinomas.


Thirty-three patients who had undergone resection of pulmonary tumors metastatic from head and neck carcinomas, other than thyroid cancers and sarcomas of the head and neck, were reviewed.


The operative morbidity rate was only 6%, no patients died within 30 days after resection and complete resection was achieved in 94% of patients. The overall 1- and 3-year survival rates were 76% and 43%, respectively, and the median survival time was 21 months. The factors found on univariate analysis to significantly affect survival were a disease-free interval of ≤2 years, tongue carcinoma and squamous cell carcinoma. The factor found, on multivariate analysis, to most strongly affect survival was tongue carcinoma. The most frequent pattern of initial recurrence after pulmonary resection was distant metastasis (64%).


The safety and effectiveness of surgical treatment for pulmonary tumors metastatic from head and neck carcinomas in adaptive criteria for resection are well demonstrated. The poor survival after surgical resection of pulmonary tumors metastatic from cancers of the tongue should be noted.

  T Kurata , N Yamamoto , T Komiya , J Tsurutani , M Miyazaki , K Tamura , K Takeda , K Nakagawa and M. Fukuoka

A combination Phase I study of gemcitabine and irinotecan in patients with previously untreated advanced non-small-cell lung cancer was conducted. Patients received gemcitabine and irinotecan on Days 1 and 8 every 3 weeks. A total of 11 patients were enrolled. Three of six patients who received the starting dose (gemcitabine, 800 mg/m2; irinotecan, 80 mg/m2) experienced dose-limiting toxicities (Grade 4 neutropenia, Grade 3 elevation of transaminase and Grade 5 interstitial pneumonia). At the reduced dose level (gemcitabine, 800 mg/m2; irinotecan, 60 mg/m2), all two assessable patients could not meet the administration criteria of Day 8 (one, Grade 2 elevation of transaminase; the other, Grade 1 diarrhea). No objective response was observed in eight evaluable patients. We could not determine the recommended dose of this combination because of intolerable toxicities and no efficacy. Therefore, it is difficult to forward this combination chemotherapy toward further studies.

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