Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 37
Filter
1.
Plast Reconstr Surg Glob Open ; 11(8): e5163, 2023 Aug.
Article in English | MEDLINE | ID: mdl-37547349

ABSTRACT

The extended latissimus dorsi (ELD) flap is a safe and aesthetically acceptable method to reconstruct small to medium-sized breasts. However, the long time required for flap elevation and intraoperative bleeding contributes to various postoperative complications. We investigated the use of alternative devices, such as the Harmonic ACE+7, which has a long arm that can help simultaneously detach and seal tissues to prevent such complications. Methods: We compared 27 patients who underwent breast reconstruction with the ELD flap using the Harmonic ACE +7 scalpel, and 28 patients who underwent breast reconstruction using an electrocautery scalpel, between May 2019 and March 2022. Data on patient demographics, surgery, and postoperative complications were collected. Surgical outcomes were compared between electrocautery (EC) and Harmonic ACE+7 (HA) groups. Results: The median age of the patients was 50.2 years. The patient demographics between the groups did not show significant differences. Flap necrosis and hematomas did not occur, and seroma was the major postoperative complication (65.7% in the EC group and 70% in the HA group). The time required for flap elevation was significantly shorter in the HA group than in the EC group (286.0 minutes and 179.0 minutes, respectively). Blood loss reduced significantly in the HA and EC groups (138.5 mL and 78.2 mL, respectively). Moreover, decreased drainage was observed for the breast area. There were no significant differences in other end points. Conclusion: In breast reconstruction with ELD flaps, using the Harmonic ACE+7 can help reduce the rate of seroma, operative time, and intraoperative bleeding without further disadvantages.

2.
Breast ; 47: 1-9, 2019 Oct.
Article in English | MEDLINE | ID: mdl-31229857

ABSTRACT

BACKGROUND: It is important to determine whether anthracycline-containing regimens or taxane-containing regimens are more effective in individual patients. The present study compared the efficacy of six cycles of docetaxel and cyclophosphamide (TC6) with that of three cycles of 5-fluorouracil, epirubicin and cyclophosphamide followed by docetaxel (FEC-D) in Japanese patients with hormone receptor (HR)-negative breast cancer (BC) to identify subtypes requiring anthracycline treatment. METHODS: The study included 103 patients with operable HR-negative BC. Of these patients 53 received FEC-D and 50 received TC6. The primary endpoint was pathological complete response (pCR). The secondary endpoints were safety, breast-conserving surgery, disease-free survival (DFS) and overall survival (OS). The predictive factors for each regimen were evaluated. RESULTS: Of the 103 patients, 97 completed the study (FEC-D, 50 patients; TC6, 47 patients). The pCR rate was higher with FEC-D (36%) than with TC6 (25.5%); however, the difference was not significant (P = 0.265). TC6 was safer than FEC-D, as the adverse events with docetaxel in the FEC-D regimen were similar to those with the TC6 regimen. Among patients with basal BC, the pCR rate was significantly higher with FEC-D (42.9%) than with TC6 (13.6%; P = 0.033). Among patients with triple-negative breast cancer (TNBC), the DFS and OS were significantly better with FEC-D than with TC6 (P = 0.016 and P = 0.034, respectively). CONCLUSION: TC6 was not as effective as FEC-D for treating HR-negative BC, as TC6 was not sufficient to treat TNBC, particularly the basal subtype. Our findings suggest that anthracyclines are better treatment options than taxanes for basal BC.


Subject(s)
Anthracyclines/therapeutic use , Breast Neoplasms/drug therapy , Docetaxel/therapeutic use , Fluorouracil/therapeutic use , Triple Negative Breast Neoplasms/drug therapy , Adult , Aged , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/diagnosis , Breast Neoplasms/mortality , Breast Neoplasms/surgery , Chemotherapy, Adjuvant , Cyclophosphamide/therapeutic use , Disease-Free Survival , Dose-Response Relationship, Drug , Drug Administration Schedule , Epirubicin/therapeutic use , Female , Humans , Japan , Kaplan-Meier Estimate , Mastectomy, Segmental/methods , Middle Aged , Prognosis , Prospective Studies , Risk Assessment , Statistics, Nonparametric , Survival Analysis , Treatment Outcome , Triple Negative Breast Neoplasms/diagnosis , Triple Negative Breast Neoplasms/mortality , Triple Negative Breast Neoplasms/surgery
3.
Cancer ; 123(5): 759-768, 2017 Mar 01.
Article in English | MEDLINE | ID: mdl-28081304

ABSTRACT

BACKGROUND: In postoperative patients with breast cancer, the combination of an anthracycline and cyclophosphamide (AC) followed by a taxane is a standard regimen. In the current study, the authors examined whether AC could be safely omitted, and compared the effectiveness of paclitaxel versus docetaxel. METHODS: Female postoperative patients with axillary lymph node-positive breast cancer were eligible for enrollment in this phase 3, open-label, randomized controlled trial at 84 centers in Japan. Patients were randomized to 4 cycles of doxorubicin at a dose of 60 mg/m2 and cyclophosphamide at a dose of 600 mg/m2 (AC) followed by 4 cycles of paclitaxel at a dose of 175 mg/m2 (ACpT) or AC followed by 4 cycles of docetaxel at a dose of 75 mg/m2 (ACdT), or 8 cycles of paclitaxel (PTx) or docetaxel (DTx) every 3 weeks. The primary endpoint was disease-free survival (DFS). Secondary endpoints included overall survival adverse events. The authors adopted a 2 × 2 factorial design to examine the AC containing-regimens (ACpT and ACdT) versus the AC free-regimens (PTx and DTx), and the paclitaxel-containing regimens (ACpT and PTx) versus the docetaxel-containing regimens (ACdT and DTx). RESULTS: Of 1060 patients, 1049 were treated and included in the intention-to-treat population. The DFS results did not demonstrate noninferiority between the AC-containing and the AC-free regimens (hazard ratio [HR], 1.19; 95% confidence interval [95% CI], 0.982-1.448 [Pnoninferiority = .30]). Better outcomes were noted in patients treated with the docetaxel-containing regimens compared with the paclitaxel-containing regimens with respect to DFS (HR, 0.72; 95% CI, 0.589-0.875 [P = .0008]) and overall survival (HR, 0.75; 95% CI, 0.574-0.980 [P = .035]). Neutropenia, nausea, and vomiting were found to occur more often in the AC-containing arms, whereas the incidence of edema was greater in the docetaxel-containing treatment arms. CONCLUSIONS: Noninferiority in DFS was not demonstrated between the AC-containing and AC-free regimens. Compared with a similar regimen of paclitaxel, docetaxel appeared to increase the DFS. Cancer 2017;123:759-68. © 2016 American Cancer Society.


Subject(s)
Anthracyclines/administration & dosage , Breast Neoplasms/drug therapy , Bridged-Ring Compounds/administration & dosage , Cyclophosphamide/administration & dosage , Paclitaxel/administration & dosage , Taxoids/administration & dosage , Adolescent , Adult , Aged , Anthracyclines/adverse effects , Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/pathology , Bridged-Ring Compounds/adverse effects , Cyclophosphamide/adverse effects , Disease-Free Survival , Docetaxel , Female , Humans , Japan , Lymph Nodes/pathology , Lymphatic Metastasis , Middle Aged , Paclitaxel/adverse effects , Taxoids/adverse effects , Treatment Outcome
4.
Support Care Cancer ; 24(3): 1405-11, 2016 Mar.
Article in English | MEDLINE | ID: mdl-26349772

ABSTRACT

PURPOSE: Dexamethasone, plus a 5-HT3 receptor antagonist and an NK-1 receptor antagonist are recommended for controlling the chemotherapy-induced nausea and vomiting (CINV) of highly emetogenic chemotherapy. Several days of dexamethasone are effective for CINV; however, dexamethasone also has side effects. The purpose of this trial was to investigate whether the use of a second-generation 5-HT3 receptor antagonist and an NK-1 receptor antagonist could allow a reduced dose of dexamethasone for breast cancer patients receiving highly emetogenic chemotherapy. METHODS: Eighty breast cancer patients who received an anthracycline-cyclophosphamide combination regimen were enrolled. The patients were randomized to arm A (dexamethasone days 1-3) and arm B (dexamethasone day 1). The primary endpoint was complete response (CR) (no emetic episodes and no rescue medication) during the overall phase (days 1-5). The secondary endpoints were the CR during the delayed phase (days 2-5), complete control (CC) (no emetic episodes, no rescue medication, and no more than mild nausea) during the overall phase, and the safety of this antiemetic therapy. RESULTS: There were no significant differences in the rates of CR and CC between arm A and B as follows: CR overall phase--arm A: 82.9%, 90% confidence interval [CI] 71.3-90.5% vs arm B: 82.1%, 90% CI 70.0-90.0%; p = 1.00; CR delayed phase--arm A: 87.8%, 90% CI 77.0-93.9% vs arm B: 94.9%, 90% CI 85.6-98.3%; p = 0.43; CC overall phase--arm A: 48.8%, 90% CI 36.4-61.3% vs arm B: 61.5%, 90% CI 48.4-73.2%; p = 0.27. There were very few adverse events and no severe adverse events associated with this antiemetic therapy. CONCLUSIONS: The results suggest that the antiemetic effect provided by dexamethasone administered for 3 days can be obtained by dexamethasone administered for 1 day.


Subject(s)
Anthracyclines/adverse effects , Antiemetics/therapeutic use , Antineoplastic Agents/therapeutic use , Breast Neoplasms/drug therapy , Dexamethasone/therapeutic use , Isoquinolines/therapeutic use , Morpholines/therapeutic use , Nausea/drug therapy , Quinuclidines/therapeutic use , Vomiting/drug therapy , Adult , Aged , Antineoplastic Agents/administration & dosage , Aprepitant , Dexamethasone/administration & dosage , Female , Humans , Isoquinolines/administration & dosage , Japan , Middle Aged , Morpholines/administration & dosage , Nausea/chemically induced , Palonosetron , Quinuclidines/administration & dosage , Vomiting/chemically induced
5.
Chemotherapy ; 60(1): 1-6, 2014.
Article in English | MEDLINE | ID: mdl-25301171

ABSTRACT

BACKGROUND: It is recommended that administration of trastuzumab should be carried out in a volume of 250 ml of saline solution over 90 min. Since 2011, recommendations have allowed a shortening of the administration time to 30 min at the second administration. However, the volume to be administered is still 250 ml. The purpose of this study was to evaluate the safety of trastuzumab administered in 100 ml of saline solution over 30 min. METHODS: This study enrolled patients with HER2-positive breast cancer. Three dose levels of trastuzumab, each in 100 ml of saline solution, were used (2, 6 and 8 mg/kg). The primary end point was the determination of safety. RESULTS: Nine patients were enrolled. Since no adverse events were observed, the 8 mg/kg/100 ml saline solution dose level was the recommended dose. CONCLUSIONS: A 30-min administration of trastuzumab in 100 ml of saline solution is safe in patients with HER2-positive breast cancer.


Subject(s)
Antibodies, Monoclonal, Humanized/therapeutic use , Breast Neoplasms/drug therapy , Receptor, ErbB-2/metabolism , Sodium Chloride/chemistry , Adult , Aged , Antibodies, Monoclonal, Humanized/administration & dosage , Breast Neoplasms/metabolism , Breast Neoplasms/pathology , Drug Dosage Calculations , Female , Humans , Middle Aged , Neoplasm Metastasis , Trastuzumab , Treatment Outcome , Ventricular Function, Left
6.
Jpn J Clin Oncol ; 44(9): 818-25, 2014 Sep.
Article in English | MEDLINE | ID: mdl-25028697

ABSTRACT

OBJECTIVE: The purpose of this study was to examine the relationship between emotional suppression and psychological distress in breast cancer patients after surgery. We examined this relationship using questionnaires at the first visit to the breast cancer outpatient clinic at our hospital and after surgery, as well as interviews after surgery. METHODS: A total of 31 breast cancer patients were asked to complete the Courtauld Emotional Control Scale and the Profile of Mood States at their first visit to the outpatient clinic. Patients were also asked to complete the Profile of Mood States between 1 and 6 months after surgery. Trained clinical psychologists conducted the interviews, asking patients to speak freely about their current anxieties, worries and thoughts. Based on the median Courtauld Emotional Control Scale score of 42 points, participants were divided into emotional suppression and emotional expression groups. RESULTS: The Total Mood Disturbance score, as well as each of the subscale (except vigor) scores of the Profile of Mood States, were significantly higher in the emotional suppression group than the emotional expression group. The emotional suppression group expressed significantly more negative emotions and fewer positive emotions than the emotional expression group. CONCLUSIONS: Patients with emotional suppression felt and expressed more psychological distress after surgery. This finding highlights the need for medical staff to comprehend the psychological traits of breast cancer patients, including emotional suppression, in the early stages of breast cancer in order to provide adequate psychological support.


Subject(s)
Breast Neoplasms/psychology , Breast Neoplasms/surgery , Emotions , Stress, Psychological/etiology , Affect , Aged , Anxiety/etiology , Female , Humans , Middle Aged , Surveys and Questionnaires
7.
Anticancer Res ; 34(1): 259-68, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24403472

ABSTRACT

BACKGROUND/AIM: In order to define accurate survival outcome in breast cancer, 10-year follow-up is required and such long-term survival information are few and difficult to gather. PATIENTS AND METHODS: We recruited 253 breast cancer patients who undertook operation with no prior chemotherapy. Ten-year survival outcomes were evaluated by clinicopathological factors. RESULTS: Significant univariate prognostic factors were: T factor, N factor, preoperative values of tumor markers, and biological factors. T-factor, CEA, hormone receptor, and Ki-67 were the final independent prognostic factors of recurrence-free survival through multivariate analysis. The Luminal A group except for the Ki-67-positive cases showed the best survival outcomes, while the HER2-positive or triple-negative (TN) groups showed worse prognosis than the Luminal A group, and Ki-67 was shown to be an excellent prognostic factor in each stage (p<0.01). CONCLUSION: Ki-67 has a great potential as a prognostic biomarker while prognostic information of this sort could be beneficial for development of novel therapeutic strategies.


Subject(s)
Biomarkers, Tumor/metabolism , Breast Neoplasms/mortality , Carcinoma, Ductal, Breast/mortality , Carcinoma, Lobular/mortality , Ki-67 Antigen/metabolism , Neoplasm Recurrence, Local/mortality , Postoperative Complications , Adult , Aged , Aged, 80 and over , Breast Neoplasms/pathology , Breast Neoplasms/surgery , Carcinoma, Ductal, Breast/pathology , Carcinoma, Ductal, Breast/surgery , Carcinoma, Lobular/pathology , Carcinoma, Lobular/surgery , Female , Follow-Up Studies , Humans , Immunoenzyme Techniques , Lymphatic Metastasis , Male , Middle Aged , Neoplasm Invasiveness , Neoplasm Recurrence, Local/pathology , Neoplasm Recurrence, Local/surgery , Neoplasm Staging , Prognosis , Receptor, ErbB-2/metabolism , Receptors, Estrogen/metabolism , Receptors, Progesterone/metabolism , Survival Rate , Time Factors , Young Adult
8.
Breast Cancer ; 21(4): 453-62, 2014 Jul.
Article in English | MEDLINE | ID: mdl-22976288

ABSTRACT

BACKGROUND: The aim of this study was to evaluate the impact of chemotherapy and psychological distress on cognitive function in patients with breast cancer receiving chemotherapy compared to healthy controls. METHODS: Eighteen women with non-metastatic breast cancer who have been exposed to chemotherapy were evaluated with a battery of neuropsychological and psychological tests before (time 1) and 1 month after chemotherapy (time 2). Twenty healthy women were assessed at matched intervals. RESULTS: The relationship between cognitive change and mood change from time 1 to time 2 was compared between breast cancer patients and healthy controls. Independent t tests revealed no differences in change scores for each neuropsychological test and psychological questionnaire between the chemotherapy and control groups. However, in the chemotherapy group, change scores for verbal memory test and executive function test were significantly and negatively correlated with change score for Hospital Anxiety and Depression Scale (HADS)-D (r ≤ -0.498, p < 0.05). Furthermore, change scores for the verbal memory test and processing function test were also significantly and negatively correlated with change score for HADS-A (r ≤ -0.503, p < 0.05). The multiple regression model for the processing function test accounted for a significant amount of variance (model adjusted R (2) = 0.157, p < 0.05), where the standard partial regression coefficient for HADS-A change score was statistically significant (ß = -0.441, p < 0.01), whereas the standard partial regression coefficients for the group and for the HADS-D change score were -0.297 (p = 0.071) and 0.026 (p = 0.868), respectively. CONCLUSIONS: Higher psychological distress was associated with poor cognitive function in patients receiving chemotherapy in this study.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Breast Neoplasms/psychology , Cognition/drug effects , Stress, Psychological , Adult , Aged , Breast Neoplasms/pathology , Case-Control Studies , Cyclophosphamide/administration & dosage , Docetaxel , Doxorubicin/administration & dosage , Epirubicin/administration & dosage , Female , Follow-Up Studies , Humans , Middle Aged , Neoplasm Staging , Neuropsychological Tests , Paclitaxel/administration & dosage , Prognosis , Taxoids/administration & dosage
10.
Gan To Kagaku Ryoho ; 39(12): 1938-41, 2012 Nov.
Article in Japanese | MEDLINE | ID: mdl-23267936

ABSTRACT

Patient 1 was a 63-year-old woman whose chief complaint was a mass in the left breast. Physical examination revealed an inverted left nipple, a very large mass on the anterior aspect of the sternum, and erythema. Because the tumor had directly invaded the sternum, T4cN3M0, stage IIIC breast cancer was diagnosed. The patient preoperatively received chemotherapy with 6 courses of FEC100 (5-fluorouracil, epirubicin, and cyclophosphamide) and 5 courses of nanoparticle albumin -bound paclitaxel (260 mg/m2), which enabled a partial response. Patient 2 was an 83-year-old woman whose chief complaint was a mass in the upper internal and external quadrants of the right breast measuring 20×15 cm and erythema. The mass was accompanied by enlarged right axillary lymph nodes(T4bN1M0, stage IIIB breast cancer). Both patients underwent core needle biopsy of the skin and breast masses. They were both diagnosed with invasive, lobular, triple-negative breast cancer (estrogen receptor negative, progesterone receptor negative, human epidermal growth factor receptor 2 negative). The surgical resection line was drawn to include the extensive skin invasion, and mastectomy and axillary dissection were performed. Skin grafting was scheduled but the retromammary space on the healthy side was dissected to the anterior border of the latissimus dorsi muscle, and the skin of the healthy side was used to cover the defect on the affected side. Consequently, the pendulous breast on the healthy side was elevated. This surgical technique provided an excellent aesthetic outcome without any skin problems, because autologous skin was used to fill the defect. Radiotherapy could subsequently be administered as scheduled. This procedure may be useful for elderly patients.


Subject(s)
Breast Neoplasms/surgery , Mastectomy/methods , Skin Diseases/surgery , Aged, 80 and over , Breast Neoplasms/pathology , Female , Humans , Middle Aged , Neoplasm Invasiveness , Neoplasm Staging , Skin Diseases/etiology
11.
Gan To Kagaku Ryoho ; 39(12): 2063-5, 2012 Nov.
Article in Japanese | MEDLINE | ID: mdl-23267977

ABSTRACT

Breast cancer metastases to the skin significantly decrease quality of life(QOL) due to bleeding or dull pain. However, an effective treatment has not yet been established. In this study, we achieved an effective result by using lidocaine hydrochloride jelly[Xylocaine jelly(XJ)] when patients complained of temporarily increased dull pain. For the pain treatment for 5 women who developed the skin metastases of breast cancer after mastectomy, non-steroid anti-inflammatory drugs (NSAIDs) were used. In cases with defective control, both NSAIDs and opioids were used. However, it was difficult to control temporarily increased dull pain. Therefore, we applied 5 g XJ to the area of recurrence when the patients complained of increasing dull pain. This treatment rapidly reduced the pain and it was possible to reduce the use of analgesics and reduce side effects. After 5 g XJ was applied to the patients, their level of lidocaine in blood was reduced to within the safe zone, and no undesirable effects were observed. Treatment with XJ was easy to perform and was safe for the control of dull pain due to skin metastases of breast cancer. In conclusion, we believe that treatment with XJ is effective for dull pain.


Subject(s)
Breast Neoplasms/pathology , Lidocaine/therapeutic use , Pain/drug therapy , Skin Neoplasms/secondary , Adult , Female , Gels , Humans , Lidocaine/adverse effects , Middle Aged , Pain/etiology
12.
Breast Cancer Res ; 14(5): R140, 2012 Oct 31.
Article in English | MEDLINE | ID: mdl-23113927

ABSTRACT

INTRODUCTION: Identification of useful markers associated with poor prognosis in breast cancer patients is critically needed. We previously showed that expression of vascular endothelial growth factor receptor-1 mRNA in peripheral blood may be useful to predict distant metastasis in gastric cancer patients. However, expression of vascular endothelial growth factor receptor-1 mRNA in peripheral blood of breast cancer patients has not yet been studied. METHODS: Real-time reverse transcriptase-PCR was used to analyze vascular endothelial growth factor receptor-1 mRNA expression status with respect to various clinical parameters in 515 patients with breast cancer and 25 controls. RESULTS: Expression of vascular endothelial growth factor receptor-1 mRNA in peripheral blood was higher in breast cancer patients than in controls. Increased vascular endothelial growth factor receptor-1 mRNA expression was associated with large tumor size, lymph node metastasis and clinical stage. Patients with high vascular endothelial growth factor receptor-1 mRNA expression also experienced a poorer survival rate than those with low expression levels, including those patients with triple-negative type and luminal-HER2(-) type disease. CONCLUSIONS: Expression of vascular endothelial growth factor receptor-1 mRNA in peripheral blood may be useful for prediction of poor prognosis in breast cancer, especially in patients with triple-negative type and luminal-HER2(-) type disease.


Subject(s)
Breast Neoplasms/genetics , Gene Expression , RNA, Messenger/genetics , Vascular Endothelial Growth Factor Receptor-1/genetics , Adult , Aged , Aged, 80 and over , Biomarkers, Tumor , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Case-Control Studies , Female , Gene Expression Regulation, Neoplastic , Humans , Lymphatic Metastasis , Middle Aged , Neoplasm Recurrence, Local , Neoplasm Staging , Prognosis , Receptor, ErbB-2/genetics , Tumor Burden
13.
Shinrigaku Kenkyu ; 83(2): 126-34, 2012 Jun.
Article in Japanese | MEDLINE | ID: mdl-22834089

ABSTRACT

This study examined the relationship between emotional suppression and psychological distress in response to a diagnosis related to breast cancer. After their first visit, 31 patients with breast cancer and 90 with benign breast conditions completed the courtauld emotional control scale (CECS) and the profile of mood states (POMS) and were interviewed about their concerns after being diagnosed. Breast cancer and benign breast condition patients were divided into separate emotional suppression groups or emotional expression groups based on their median CECS score. The POMS scores of breast cancer patients were higher than those of benign breast condition patients; scores in the emotional suppression groups were higher than in the emotional expression groups. Breast cancer patients in the emotional suppression group expressed more negative emotions and fewer positive emotions than benign breast condition patients. Our results suggest that patients who suppressed their emotions experienced and reported more psychological distress when diagnosed with breast cancer.


Subject(s)
Breast Neoplasms/psychology , Emotions , Stress, Psychological , Affect , Breast Neoplasms/diagnosis , Female , Humans , Interview, Psychological , Middle Aged
14.
Cancer Sci ; 103(9): 1708-13, 2012 Sep.
Article in English | MEDLINE | ID: mdl-22676245

ABSTRACT

This randomized phase II study was intended to identify the optimal dose of TAS-108, a novel steroidal antiestrogen, for the treatment of breast cancer in postmenopausal Japanese women. The potential clinical effects of TAS-108 on the uterus, bone, serum lipids, and hormones were also investigated. Postmenopausal women with hormone receptor-positive metastatic breast cancer who had previously received one or two endocrine therapies were randomly assigned to one of the three possible dose levels of TAS-108 (40, 80 or 120 mg/day). Oral TAS-108 was given daily, and the efficacy and safety of the three doses were evaluated. A total of 97 patients (33, 32, and 32 in the 40-, 80-, and 120-mg groups, respectively) were treated with TAS-108. The clinical benefit rate was 30.3% for the 40-mg, 25.0% for the 80-mg, and 25.0% for the 120-mg group. The 40-mg group achieved the prespecified target threshold. TAS-108 at all dose levels was well tolerated and appeared to have no harmful effects in terms of the variables examined in this study. We conclude that the optimal dose of TAS-108 among the three doses is 40 mg, once daily, for further studies. JAPIC Clinical Trials Information number: Japic CTI - 121754.


Subject(s)
Antineoplastic Agents, Hormonal/administration & dosage , Breast Neoplasms/drug therapy , Breast Neoplasms/pathology , Estradiol/analogs & derivatives , Adult , Aged , Aged, 80 and over , Antineoplastic Agents, Hormonal/adverse effects , Breast Neoplasms/mortality , Estradiol/administration & dosage , Estradiol/adverse effects , Female , Humans , Middle Aged , Neoplasm Metastasis , Postmenopause , Treatment Outcome
15.
Support Care Cancer ; 20(12): 3355-64, 2012 Dec.
Article in English | MEDLINE | ID: mdl-22584733

ABSTRACT

PURPOSE: To elucidate whether adjuvant taxane monotherapy is a feasible and tolerable for postoperative breast cancer patients, we evaluated the severity of chemotherapy-induced peripheral neuropathy (CIPN) and the relative tolerability of regimens by health-related quality of life (HRQOL) assessment in node-positive breast cancer patients treated with taxane-containing regimens. METHODS: We evaluated CIPN and HRQOL in the first 300 patients enrolled in a larger (1,060 total) multicenter phase III trial randomized to one of four adjuvant regimens: (1) anthracycline-cyclophosphamide followed by paclitaxel (ACP), (2) AC followed by docetaxel (ACD), (3) paclitaxel alone (PTX), or (4) docetaxel alone (DTX). CIPN was assessed by the Patient Neurotoxicity Questionnaire (PNQ) and the National Cancer Institute Common Toxicity Criteria, and HRQOL by Functional Assessment of Cancer Therapy-General (FACT-G). CIPN and HRQOL scores were compared between ACP and ACD vs. PTX and DTX, and ACP and PTX vs. ACD and DTX. RESULTS: PNQ sensory scores were significantly higher in patients treated with taxane monotherapy compared to treatment with AC followed by taxane (P = .003). No significant differences in PNQ sensory scores were observed between the ACP and PTX vs. ACD and DTX regimens (P = .669). Regardless of taxane regimen, PNQ severity scores for CIPN appear to be largely reversible within 1 year of adjuvant treatment. No significant difference in FACT-G scores was observed between any regimens during the study treatments. CONCLUSIONS: Patient-reported CIPN was significantly more severe with single-agent adjuvant taxane compared to AC followed by taxane treatment; however, the HRQOL findings support that single-agent taxane treatment is tolerable.


Subject(s)
Antineoplastic Agents/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Neurotoxicity Syndromes , Peripheral Nervous System Diseases/chemically induced , Taxoids/adverse effects , Adult , Aged , Breast Neoplasms/surgery , Chemotherapy, Adjuvant , Clinical Trials, Phase II as Topic , Docetaxel , Female , Humans , Middle Aged , Paclitaxel/adverse effects , Paresthesia/chemically induced , Quality of Life , Surveys and Questionnaires
16.
Oncology ; 82(3): 131-8, 2012.
Article in English | MEDLINE | ID: mdl-22433221

ABSTRACT

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.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Edema/chemically induced , Quality of Life , Adult , Aged , Chemotherapy, Adjuvant , Docetaxel , Female , Humans , Middle Aged , Paclitaxel/administration & dosage , Prognosis , Prospective Studies , Taxoids/administration & dosage
17.
Support Care Cancer ; 20(7): 1507-14, 2012 Jul.
Article in English | MEDLINE | ID: mdl-21808994

ABSTRACT

PURPOSE: Prevention of chemotherapy-induced nausea and vomiting (CINV) is of great importance for the completion of multiple cycles of cancer chemotherapy. Palonosetron is a second-generation 5-HT(3) receptor antagonist with proven efficacy for both acute and delayed CINV. This study was designed to assess the safety and efficacy of 0.75 mg palonosetron in repeated cycles of highly emetogenic chemotherapy or anthracycline-cyclophosphamide combination (AC/EC). METHODS: We gave 0.75 mg palonosetron to 538 patients 30 min prior to ≥ 50 mg/m(2) cisplatin or AC/EC on day 1. Prophylactic dexamethasone was administered on days 1-3. The primary endpoint was the incidence rate of adverse events (AEs). The secondary endpoint was complete response rate (CR, defined as no emesis and no rescue medication) throughout the study period. RESULTS: Treatment-related AEs were seen in 44% (237 of 538 patients). Serious AEs were seen in 4% (23 of 538 patients), all considered unrelated or unlikely to be related to palonosetron. Only one patient discontinued the study due to a treatment-related AE. No trend toward worsening of AEs was observed in subsequent cycles of chemotherapy. Complete response rates were maintained throughout repeated cycles. CONCLUSION: The extraordinary safety profile and maintenance of efficacy of 0.75 mg palonosetron combined with dexamethasone were demonstrated throughout repeated chemotherapy cycles.


Subject(s)
Antiemetics/therapeutic use , Isoquinolines/therapeutic use , Nausea/prevention & control , Quinuclidines/therapeutic use , Vomiting/prevention & control , Aged , Antiemetics/adverse effects , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Dexamethasone/adverse effects , Dexamethasone/therapeutic use , Drug Therapy, Combination , Female , Humans , Isoquinolines/adverse effects , Male , Middle Aged , Nausea/chemically induced , Neoplasms/drug therapy , Palonosetron , Quinuclidines/adverse effects , Serotonin 5-HT3 Receptor Antagonists/adverse effects , Serotonin 5-HT3 Receptor Antagonists/therapeutic use , Treatment Outcome , Vomiting/chemically induced
18.
Gan To Kagaku Ryoho ; 38(12): 2071-4, 2011 Nov.
Article in Japanese | MEDLINE | ID: mdl-22202287

ABSTRACT

A 38-year-old premenopausal woman with a right axillary mass was told that she had an atheroma. The mass enlarged. An infectious atheroma was suspected, and incision and drainage were performed. A mass 4 cm in diameter was palpated in the right axillary region. Ultrasonography showed a mass 6 cm in diameter, and magnetic resonance imaging revealed a hypervascular mass at the same site. Stage IIIB triple-negative of accessory breast cancer (T4bN1M0) was diagnosed. The patient received four courses of FEC 100 (5-fluorouracil, epirubicin, and cyclophosphamide) as preoperative chemotherapy, but progressive disease was diagnosed, and the regimen was switched to weekly paclitaxel. The tumor became ulcerated and friable, and the hemoglobin level fell to 6 g/dL. Emergency surgery was thus performed. Postoperatively, the patient received six courses of chemotherapy with paclitaxel plus gemcitabine. Accessory breast cancer is extremely rare, but should be borne in mind when an axillary mass is encountered. In our patient, progressive disease had developed during the preoperative chemotherapy for accessory breast cancer. Although treatment was switched to a different regimen, bleeding was detected, and the patient underwent a semi-emergency surgery.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/drug therapy , Adult , Biopsy , Breast Neoplasms/chemistry , Breast Neoplasms/pathology , Disease Progression , Female , Humans , Neoplasm Staging
19.
Gan To Kagaku Ryoho ; 38(12): 2174-6, 2011 Nov.
Article in Japanese | MEDLINE | ID: mdl-22202320

ABSTRACT

A case was a 40-year-old woman. Her right breast was presented with massive bleeding ulcer and fixed with a pectoral muscle. Diagnosis of Stage IIIb breast cancer( T4b, N1, M0) showed a high inflammatory response and severe anemia. Palliative surgery was difficult because of hemostasis, and her general health also was in poor condition. The pathological diagnosis was squamous cell cancer. We underwent a total of 30 Gy radiation emergency hemostasisose. After radiation and chemotherapy, the lesion was undergone a radical surgery, and was reduced in size significantly. It was diagnosed as squamous cell cancer, which was more sensitive to general radiation so neoadjuvant chemoradiation therapy was effective.


Subject(s)
Breast Neoplasms/surgery , Carcinoma, Squamous Cell/surgery , Hemorrhage/radiotherapy , Adult , Breast Neoplasms/complications , Breast Neoplasms/pathology , Carcinoma, Squamous Cell/complications , Carcinoma, Squamous Cell/pathology , Female , Hemorrhage/etiology , Hemostatic Techniques , Humans , Neoadjuvant Therapy , Neoplasm Staging , Tomography, X-Ray Computed
20.
Value Health ; 14(5): 746-51, 2011.
Article in English | MEDLINE | ID: mdl-21839414

ABSTRACT

OBJECTIVE: To examine health-related quality of life, we investigated the effect of adjuvant chemotherapy regimens on utility scores assessed by the EuroQoL-5D (EQ-5D) instrument in a randomized, controlled trial for breast cancer patients after surgery. We also investigated the relationship between Functional Assessment of Cancer Therapy (FACT) scale scores and EQ-5D utilities. METHODS: Patients were randomly assigned to the following four chemotherapy regimens: four cycles of anthracycline followed by paclitaxel (ACP), four cycles of anthracycline-containing regimens followed by docetaxel (ACD), eight cycles of paclitaxel (PTX), and eight cycles of docetaxel (DTX). Of 1060 registered, the first 300 consecutive patients were included in the current utility study. Utility scores were assessed using the EQ-5D instrument at baseline; cycles 3, 5, and 7; 7 months; and 1 year. We also evaluated the correlation between these scores and FACT-G, -B, and -Taxane scores at each time point. RESULTS: Utility scores were significantly lower in the DTX group than in the ACP and ACD groups. Mean utility scores in the DTX group were lowest at 7 months and tended to remain low for a long time. The combined anthracycline followed by taxane group had significantly higher utility scores that the taxane-alone group, with no significant difference depending on the type of taxane. Only the FACT-G social/family well-being subscale had no relationship with EQ-5D responses and utility scores. CONCLUSIONS: Although the regimens in this study were similar in that they included taxane, the mean utility scores and longitudinal patterns of utility scores were different among regimens.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/therapy , Health Status Indicators , Health Status , Mastectomy , Quality of Life , Surveys and Questionnaires , Adult , Anthracyclines/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/adverse effects , Breast Neoplasms/drug therapy , Breast Neoplasms/mortality , Breast Neoplasms/pathology , Breast Neoplasms/psychology , Breast Neoplasms/surgery , Chemotherapy, Adjuvant , Disease-Free Survival , Female , Humans , Linear Models , Lymphatic Metastasis , Middle Aged , Predictive Value of Tests , Taxoids/administration & dosage , Time Factors , Treatment Outcome
SELECTION OF CITATIONS
SEARCH DETAIL
...