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Ando M.,Aichi Cancer Center Hospital | Yamauchi H.,St. Lukes International Hospital | Aogi K.,Shikoku Cancer Center | Shimizu S.,Kanagawa Cancer Center | And 9 more authors.
Breast Cancer Research and Treatment | Year: 2014

Addition of carboplatin to neoadjuvant chemotherapy in HER2-negative breast cancer may improve pathological complete response (pCR) rates. We evaluated the efficacy and safety of carboplatin and weekly paclitaxel (wPTX) followed by cyclophosphamide, epirubicin, and 5-fluorouracil (CEF) as neoadjuvant chemotherapy for HER2-negative breast cancer. Patients with stage II/IIIA HER2-negative breast cancer were randomly assigned to preoperatively receive CP-CEF (four 3-week cycles of carboplatin [area under the curve 5 mg/mL/min, day 1] and wPTX [80 mg/m2, day 1, 8, 15] followed by four 3-week cycles of CEF [500/100/500 mg/m2] or P-CEF (four cycles of wPTX followed by four cycles of CEF). The primary objective was pCR rate. Of 181 eligible patients, 89 were randomly assigned to the CP-CEF and 92 to the P-CEF. Two patients in each arm refused to receive neoadjuvant chemotherapy. Overall 88 patients in the CP-CEF and 91 patients in the P-CEF were assessable for efficacy and safety. The pCR rate in the CP-CEF was significantly higher than that in the P-CEF (31.8 vs. 17.6 %, one-sided P = 0.01). Among patients with triple-negative breast cancer, the pCR rate in the CP-CEF was significantly higher than that in the P-CEF [61.2 (23/37) vs. 26.3 % (10/38), P = 0.003]. Grade 3-4 neutropenia was observed in the CP-CEF more frequently than in the P-CEF (65.9 vs. 38.5 %). Adding carboplatin to neoadjuvant wPTX followed by CEF for HER2-negative breast cancer improved the pCR rate and exacerbated hematotoxicity. © 2014 Springer Science+Business Media New York.

Ueda Y.,National Cancer Center Hospital | Shimoyama T.,National Cancer Center Hospital | Shimoyama T.,Infectious Diseases Center Komagome Hospital | Murakami H.,National Cancer Center Hospital | And 5 more authors.
Cancer Chemotherapy and Pharmacology | Year: 2011

Purpose: A single-agent dose-escalating phase I and pharmacokinetic study on TSU-68, a novel multiple receptor tyrosine kinase inhibitor, was performed to determine the safety profile, maximum-tolerated dose for Japanese patients with advanced solid tumors and to define the recommended dose of phase II studies. Methods: Study design was a dose escalation method on a three-patient cohort. TSU-68 was given orally twice daily (bid) between meals without interruption; the estimation of dose escalation was based on the toxicity within 4 week administration at each dose level. Results: Fifteen patients were enrolled into the study. Dose levels studied were 200, 400, 800, and 1,200 mg/m2 bid. Grade 3 arrhythmia and anemia/thrombocytopenia were observed in 1 patient each at 800 mg/m2 bid. Three patients discontinued continuous oral administration for 4 weeks at 400 and 800 mg/m2 bid. At 1,200 mg/m2 bid, 2 patients discontinued the treatment over 4 weeks for intolerable fatigue and abdominal pain, respectively. No serious drug-related toxicities have been observed. Grade 1-2 toxicity included urinary/feces discoloration, diarrhea, fatigue, anorexia, abdominal/chest pain, and edema. Tumor shrinkage was observed in 1 patient of NSCLC. In the pharmacokinetics, at any dose levels, Cmax and AUC0-t after repeated administration of TSU-68 on days 8 and 29 were ~2-fold lower that those after the first administration on day 1; these parameters are similar between days 8 and 28. In addition, no obvious dose-dependent increase in plasma exposure to TSU-68 repeatedly administered was observed over the four dose levels, including the higher dose levels. Conclusions: The tolerable dose in this administration schedule for continuing treatment is thought to be 800 mg/m2 or less bid. © 2010 The Author(s).

Murakami H.,National Cancer Center Hospital | Murakami H.,Shizuoka Cancer Center | Ueda Y.,National Cancer Center Hospital | Shimoyama T.,National Cancer Center Hospital | And 5 more authors.
Cancer Chemotherapy and Pharmacology | Year: 2011

Purpose: TSU-68 is a low molecular weight inhibitor of the tyrosine kinases for vascular endothelial growth factor receptor 2, platelet-derived growth factor receptor β, and fibroblast growth factors receptor 1. In this study, we assessed the recommended dose with TSU-68 administration of twice-daily (b.i.d.) or thrice-daily (t.i.d.) after meals for 4 weeks in Japanese patients with solid tumors based on the safety and tolerability and investigated the relationship between angiogenesis biomarker and clinical outcomes. Methods: The study design was a dose-escalation method with alternating enrollment of b.i.d. administration and t.i.d. administration after meal by traditional three-patient cohort. Results: We enrolled 24 patients at doses of 200, 400, and 500 mg/m2 b.i.d. or 200 and 400 mg/m2 t.i.d. No dose-limiting toxicity (DLT) occurred in the 200 mg/m2 b.i.d. or t.i.d., and 3 patients experienced DLTs at 400 mg/m2 b.i.d. or 400 mg/m2 t.i.d. As main toxicity, blood albumin decreased, malaise, diarrhea, alkaline phosphatase increased, anorexia, abdominal pain, nausea, and vomiting were observed as almost all grade 1-2. There were no apparent differences in pharmacokinetic parameters between days 2 and 28 after the repeated b.i.d. and t.i.d. doses. Although tumor shrinkage was not observed, the disease control rate was 41.7%. As an angiogenesis-related factor of stratified analysis, plasma vascular endothelial growth factor and plasminogen activator inhibitor-1 were detected as a significant increase with progressive disease patients. Conclusions: A recommended dosage of TSU-68 for this administration schedules was estimated to be 400 mg/m2 or less b.i.d. © 2010 The Author(s).

Kageyama S.,Infectious Diseases Center Komagome Hospital
Japanese Journal of Clinical Radiology | Year: 2015

In late years efficacy of the cetuximab combination radiation therapy is established and it became the insurance adaptation in Japan from December, 2012. Because there are not cisplatin and the result of the direct comparison, cetuximab combination radiation therapy tend to use for the case that it is hard to give of cisplatin in our hospital. However, the validity for the case having complications is unidentified. We report cetuximab combination radiation therapy for the head and neck squamous carcinoma having the complications e in our hospital and consider its validity.

Okamiya T.,Gunma University | Takahashi K.,Gunma University | Kamada H.,Gunma University | Hirato J.,Gunma University | And 3 more authors.
Auris Nasus Larynx | Year: 2015

Oncogenic osteomalacia (OOM) is a rare bone disease characterized by inadequate bone mineralization and is caused by a humoral factor mainly produced by benign mesenchymal tumors. We report a case of OOM caused by an occult phosphaturic mesenchymal tumor in the paranasal sinus. The causative tumor was small and localized in the ethmoid sinus, and the patient did not exhibit any nasal symptoms. 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) depicted the location of the occult tumor, and systemic venous sampling followed by assessments of the samples' fibroblast growth factor 23 (FGF23) concentrations confirmed that the tumor secreted FGF23. The tumor was resected via an external surgical approach, resulting in the complete relief of the patient's symptoms. The combination of FDG-PET and systemic venous sampling to assess serum FGF23 levels is useful for identifying small asymptomatic OOM-associated tumors. Such tumors are rare, but a significant proportion of them develop in the head and neck region, and complete resection is the most effective treatment. It is important that ENT surgeons are aware of the characteristics of OOM. © 2014 Elsevier Ireland Ltd.

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