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Articles by N Masuda
Total Records ( 7 ) for N Masuda
  N Katsumata , T Watanabe , H Minami , K Aogi , T Tabei , M Sano , N Masuda , J Andoh , T Ikeda , T Shibata and S. Takashima
 

Background: This randomized, multicenter, phase III trial compared doxorubicin plus cyclophosphamide (AC), single-agent docetaxel (D), and an alternating regimen of AC and docetaxel (AC–D) as first-line chemotherapy in metastatic breast cancer (MBC).

Patients and methods: Patients with MBC resistant to endocrine therapy were entered in a randomized study to receive either six cycles of AC (doxorubicin 40 mg/m2 plus cyclophosphamide 500 mg/m2), D (60 mg/m2), or alternating treatment with AC–D (i.e. three cycles of AC and three cycles of D). Treatment was administered every 3 weeks.

Results: A total of 441 patients were entered in a randomized study. Response rates were 30% for AC, 41% for D, and 35% for AC–D. The median times to treatment failure (TTFs) were 6.4, 6.4, and 6.7 months (one-sided log-rank test, P = 0.13 for AC versus D, P = 0.14 for AC versus AC–D) and median overall survival (OS) was 22.6, 25.7, and 25.0 months (P = 0.09 for AC versus D, P = 0.13 for AC versus AC–D) in the AC, D, and AC–D, respectively.

Conclusion: There was no difference in the TTF among the three arms. However, there was a trend toward a better response and better OS in the D than in the AC.

  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.

  C Shimizu , N Masuda , K Yoshimura , H Tsuda , M Mano , M Ando , K Tamura and Y. Fujiwara
  Objective

Determinants of long-term outcome of patients with human epidermal growth factor receptor 2 (HER2)-positive breast cancer who received neoadjuvant chemotherapy (NAC) are not clear. The purpose of this study was to explore the prognostic factors of HER2-positive breast cancer patients administered NAC.

Methods

A retrospective analysis of 125 HER2-positive breast cancer patients treated by NAC using an anthracycline plus taxane with (HCN group, n = 54) or without trastuzumab (non-HCN group, n = 71) was performed. The clinical parameters, including the pathological complete remission (pCR) rate, disease-free survival (DFS) and organ-specific recurrence-free survival, were measured.

Results

According to the results of the univariate analyses, age, clinical stage, pCR and axillary lymph node status were the factors significantly associated with the DFS. The inclusion of trastuzumab in the NAC regimen did not yield a significant difference in the DFS. Only the axillary lymph node status and age were found to be the significant factors affecting the DFS in a multivariate model. There were no significant differences in the patient/tumor characteristics between the HCN and non-HCN groups except for the pCR rate (50% in the HCN group vs. 24% in the non-HCN group) and the median follow-up time (738 days in the HCN group vs. 1579 days in the non-HCN group). Within the first 2 years from the initiation of NAC treatment, the central nervous system (CNS) was the most common site of first recurrence in the HCN group, whereas no cases of CNS metastasis were observed in the non-HCN group.

Conclusions

The pathological axillary node status and age were found to be the significant prognostic factors in HER2-positive breast cancer patients who received NAC. The pattern of recurrence may be different between HCN-treated and non-HCN-treated patients.

  M Danbara , M Yoshida , Y Kanoh , S. X Jiang , N Masuda , T Akahoshi and M. Higashihara
 

A lot of hematologists are often faced with the difficulty of diagnosing bone marrow micrometastasis of carcinoma cells. We employed a new flow cytometric immunophenotyping by a combination of CD45 with three neuroendocrine markers: CD56, microtubule-associated protein-2 and synaptophysin, and successfully detected micrometastatic tumor cells in the bone marrow of a 61-year-old male patient with small cell lung cancer (SCLC), whose marrow smears never showed a distinct morphology of metastasis. It was noteworthy that these SCLC cells accompanied the aberrant expression of CD45, leukocyte common antigen known as a specific marker for hematolymphoid neoplasms, which was not detected in the tumor of primary lesion. We describe this rare case to arouse an attention that tumors of non-hematolymphoid origin can exhibit exceptional CD45-positvity in metastatic sites.

  T Tominaga , I Kimijima , M Kimura , Y Takatsuka , S Takashima , Y Nomura , F Kasumi , A Yamaguchi , N Masuda , S Noguchi and N. Eshima
  Objective

Toremifene and tamoxifen have been used for adjuvant therapy in post-menopausal patients with breast cancer in Japan. Dyslipidemias are common in post-menopausal women. However, limited data are available on the effects of these agents on lipid profiles in Japanese patients. The Japan Toremifene Cooperative Study Group has been conducting a Phase III randomized trial of post-menopausal patients with breast cancer. One of its secondary endpoints is to confirm the effects of these agents on serum lipid profiles.

Methods

The subjects were post-menopausal Japanese patients who had undergone surgery for early breast cancer. Toremifene or tamoxifen was administered for 2 years. Lipid levels were measured before and up to 24 months after initiation.

Results

Compared with baseline, at 24 months, the toremifene group (n = 123) showed significantly decreased total cholesterol (P < 0.001) and low-density lipoprotein cholesterol levels (P < 0.001), and significantly increased high-density lipoprotein cholesterol levels (P < 0.001). Their triglyceride levels were not affected (P = 0.677). The tamoxifen group (n = 120) also showed significantly decreased total cholesterol (P < 0.001) and low-density lipoprotein cholesterol levels (P < 0.001); no significant changes occurred in high-density lipoprotein cholesterol (P = 0.297) or triglyceride levels (P = 0.120).

Conclusions

Distinct differences between two selective estrogen receptor modulators on lipids were observed. Toremifene improved lipid profiles, particularly as an enhancer of high-density lipoprotein cholesterol. To a large extent, tamoxifen improved low-density lipoprotein cholesterol levels. The impact of these improved lipid profiles on the risk of cardiovascular diseases needs further confirmation.

  H Mukai , T Takashima , Y Hozumi , T Watanabe , S Murakami , N Masuda , S Mitsuyama , T Ohmura , T Yajima and Y. Ohashi
 

This randomized controlled trial will compare oral 5-fluorouracil derivatives, TS-1, with intravenous standard chemotherapy such as taxanes in women with metastatic or recurrent breast cancer. Patients with hormone-resistant breast cancer are assigned to either TS-1 (40–60 mg twice daily for 28 consecutive days, followed by a 14-day rest period) or standard chemotherapy (docetaxel 60–75 mg/m2 at 3- or 4-week intervals, paclitaxel 175 mg/m2 at 3- or 4-week intervals or paclitaxel 80–100 mg/m2 weekly, followed by a 1-week rest period). Treatment will be repeated until tumor progression or ≥4 courses for TS-1 and ≥6 courses for taxanes. The primary endpoint is overall survival. Secondary endpoints are progression-free survival, time to treatment failure, adverse events, health-related quality of life and cost-effectiveness. A threshold hazard ratio of 1.333 will be used to determine whether overall survival in the TS-1 group is equivalent (not inferior) to that in the taxane group. The target number of registered patients is 600.

 
 
 
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