Aogi K.,Shikoku Cancer Center |
Masuda N.,National Hospital Organization Osaka National Hospital |
Ohno S.,Kyushu Cancer Center |
Oda T.,Aichi Cancer Center |
And 7 more authors.
Breast Cancer Research and Treatment | Year: 2011
Despite extensive evaluation of first-line bevacizumab-containing therapy in randomized trials in locally recurrent/metastatic breast cancer (LR/mBC), data from Japanese populations are limited. We conducted a phase II study exclusively in Japanese patients to evaluate bevacizumab combined with weekly paclitaxel. Patients with HER2-negative measurable LR/mBC who had received no prior chemotherapy for LR/mBC received bevacizumab 10 mg/kg, days 1 and 15, in combination with paclitaxel 90 mg/m2, days 1, 8, and 15, repeated every 4 weeks, until disease progression, unacceptable toxicity, or patient/physician decision. Co-primary endpoints of this single-arm open-label phase II study were progression-free survival (PFS) and safety. A total of 120 patients (median age 55 years) received study therapy. At the time of data cut-off, the median duration of therapy was 11.1 months (range 0.5-24.7 months). Median PFS was 12.9 months (95% CI: 11.1-18.2) according to Independent Review Committee assessment and 14.9 months by investigator assessment. Median PFS was 9.6 months in the subgroup of 38 patients with triple-negative LR/mBC. The overall response rate was 74% (95% CI: 64.5-81.2%). Median overall survival (OS) was 35.8 months (95% CI: 26.4-not estimated) and the 1-year OS rate was 88.9% (95% CI: 83.2-94.6). The regimen was well tolerated and the safety profile was generally consistent with previous reports of bevacizumab-paclitaxel combination therapy. Grade 3 hypertension was reported in 17% of patients. Grade 4 hypertension, grade 3/4 proteinuria, and gastrointestinal perforation were absent. There were no new bevacizumab safety signals. In 50 patients (42%), treatment was continued for -1 year. Conclusion: The high activity of first-line bevacizumab in combination with weekly paclitaxel observed in our study confirms the results of the E2100 trial. Our results suggest that the activity and tolerability of first-line bevacizumab-containing regimens demonstrated in E2100 can be reproduced in Japanese populations. © 2011 Springer Science+Business Media, LLC.
Subjective and objective assessment of edema during adjuvant chemotherapy for breast cancer using taxane-containing regimens in a randomized controlled trial: The national surgical adjuvant study of breast cancer 02
Ohsumi S.,Shikoku Cancer Center |
Shimozuma K.,Ritsumeikan University |
Ohashi Y.,University of Tokyo |
Takeuchi A.,University of Tokyo |
And 4 more authors.
Oncology | Year: 2012
Objective: To elucidate the time course of taxane-induced edema which may affect the patients' quality of life (QOL). Patients and Methods: Our study included the first 300 Japanese patients assigned to 1 of 4 regimens using docetaxel (DTX) or paclitaxel (PTX) by 1:1:1:1 in a randomized controlled trial to evaluate the efficacy of adjuvant therapies for node-positive breast cancer. Patients' QOL was prospectively assessed by the Functional Assessment of Cancer Therapy (FACT)-breast and-taxane (FACT-T) subscale. The scores of FACT items regarding edema and body weight were used as indicators of edema. Results: The scores for 'anasarca', 'edema of the hands' and 'edema of the legs and feet' of the FACT-T subscale worsened up to 1-2 months after chemotherapy, and body weights increased remarkably until cycle 8 in patients treated with DTX alone (75 mg/m 2, 8 cycles, every 3 weeks). Edema-related symptoms and body weight were relatively stable in the other treatment groups. There were statistically significant differences in the scores of those items and in the changes of body weight both between the DTX-alone group and the other three groups combined, and between the groups using DTX and those using PTX. Conclusion: Many patients receiving DTX for >4 cycles suffered significantly from edema. Copyright © 2012 S. Karger AG, Basel.
Hisaoka M.,University of Occupational and Environmental Health Japan |
Matsuyama A.,University of Occupational and Environmental Health Japan |
Aoki T.,University of Occupational and Environmental Health Japan |
Sakamoto A.,Kokura Medical Center |
Yokoyama K.,Kyushu Cancer Center
Pathology Research and Practice | Year: 2012
Low-grade fibromyxoid sarcoma is a rare soft tissue sarcoma of fibroblastic differentiation characterized by a deceptively benign morphologic appearance with almost consistent MUC4 expression and recurrent chromosomal translocations, t(7;16)(q34;p11) and t(11;16)(p11;p11), resulting in the FUS-CREB3L2 and FUS-CREB3L1 fusion genes, respectively. A subset of the tumors show peculiar histologic features, designated as giant rosettes, and were formerly referred to as hyalinizing spindle cell tumor with giant rosettes. We herein report a case of low-grade fibromyxoid sarcoma showing the presence of numerous giant rosettes, with and without collagenous centers, distributed throughout the lesion and unusual rim-like heterotopic ossification. Such a case might present a diagnostic challenge. The diagnosis of the tumor was confirmed by positive immunoreactivity to MUC4 and the FUS-CREB3L2 fusion detected by molecular testing using formalin-fixed, paraffin-embedded tissue. This case, which has such unusual clinicopathologic features, would help to further expand our knowledge regarding the morphologic diversities of low-grade fibromyxoid sarcoma. © 2012 Elsevier GmbH.
Phase III randomised controlled trial of neoadjuvant chemotherapy plus radical surgery vs radical surgery alone for stages IB2, IIA2, and IIB cervical cancer: A Japan Clinical Oncology Group trial (JCOG 0102)
Katsumata N.,Nippon Medical School |
Yoshikawa H.,University of Tsukuba |
Kobayashi H.,Kyushu University |
Saito T.,Kyushu Cancer Center |
And 11 more authors.
British Journal of Cancer | Year: 2013
Background:A phase III trial was conducted to determine whether neoadjuvant chemotherapy (NACT) before radical surgery (RS) improves overall survival.Methods:Patients with stage IB2, IIA2, or IIB squamous cell carcinoma of the uterine cervix were randomly assigned to receive either BOMP (bleomycin 7 mg days 1-5, vincristine 0.7 mg m-2 day 5, mitomycin 7 mg m-2 day 5, cisplatin 14 mg m-2 days 1-5, every 3 weeks for 2 to 4 cycles) plus RS (NACT group) or RS alone (RS group). Patients with pathological high-risk factors received postoperative radiotherapy (RT). The primary end point was overall survival.Results:A total of 134 patients were randomly assigned to treatment. This study was prematurely terminated at the first planned interim analysis because overall survival in the NACT group was inferior to that in the RS group. Patients who received postoperative RT were significantly lower in the NACT group (58%) than in the RS group (80%; P=0.015). The 5-year overall survival was 70.0% in the NACT group and 74.4% in the RS group (P=0.85).Conclusion: Neoadjuvant chemotherapy with BOMP regimen before RS did not improve overall survival, but reduced the number of patients who received postoperative RT. © 2013 Cancer Research UK. All rights reserved.
Yone Y.,Kyushu Cancer Center
Japanese Journal of Clinical Radiology | Year: 2015
A 60-year-old man was referred to our hospital because of incidentaly detected anterior mediastinal mass. On MRI, the lobulated mass was hyperintense on the T2 and diffusion weighted image, and had high ADC value. After contrast agents injection, the mass was enhanced persistently. Based on these findings, we considered malignant tumors with myxoid change as differential diagnoses. Surgical resection was performed and the histological diagnosis was malignant peripheral nerve sheath tumor.