17 research outputs found

    Epirubicin With Cyclophosphamide Followed by Docetaxel With Trastuzumab and Bevacizumab as Neoadjuvant Therapy for HER2-Positive Locally Advanced Breast Cancer or as Adjuvant Therapy for HER2-Positive Pathologic Stage III Breast Cancer: A Phase II Trial of the NSABP Foundation Research Group, FB-5

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    Background The purpose of this study was to determine the cardiac safety and clinical activity of trastuzumab and bevacizumab with docetaxel after epirubicin with cyclophosphamide (EC) in patients with HER2-positive locally advanced breast cancer (LABC) or pathologic stage 3 breast cancer (PS3BC). Patients and Methods Patients received every 3 week treatment with 4 cycles of EC (90/600 mg/m2) followed by 4 cycles of docetaxel (100 mg/m2). Targeted therapy with standard-dose trastuzumab with bevacizumab 15 mg/kg was given for a total of 1 year. Coprimary end points were (1) rate of cardiac events (CEs) in all patients defined as clinical congestive heart failure with a significant decrease in left ventricular ejection fraction or cardiac deaths; and (2) pathologic complete response (pCR) in breast and nodes in the neoadjuvant cohort. An independent cardiac review panel determined whether criteria for a CE were met. Results A total of 105 patients were accrued, 76 with LABC treated with neoadjuvant therapy and 29 with PS3BC treated with adjuvant therapy. Median follow-up was 59.2 months. Among 99 evaluable patients for cardiac safety, 4 (4%; 95% confidence interval [CI], 1.1%-10.0%) met CE criteria. The pCR percentage in LABC patients was 46% (95% CI, 34%-59%). Five-year recurrence-free survival (RFS) and overall survival (OS) for all patients was 79.9% and 90.8%, respectively. Conclusion The regimen met predefined criteria for activity of interest with an acceptable rate of CEs. Although the pCR percentage was comparable with chemotherapy regimens with trastuzumab alone the high RFS and OS are of interest in these high-risk populations

    Breast Magnetic Resonance Imaging: Are Those Who Need It Getting It?

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    Background: Indications for breast magnetic resonance imaging (MRI), a very sensitive but less-specific tool for breast investigation, remain controversial, and accessibility is limited. The purposes of our study were to determine the proportion of breast MRI exams performed for various clinical indications, to assess the wait times for breast MRI, and to create a list of evidence-based indications for breast MRI. Methods: The indications for breast MRI exams performed in September 2013 at our academic centre were audited. A multidisciplinary meeting held in May 2014 established a list of evidence-based indications for breast MRI, after which, in September 2014 and 2015, breast MRI exams were re-audited for clinical indications, and pending requests were calculated. Results: In September 2013, surveillance of women with a prior diagnosis of breast cancer represented 21% of breast MRI exams (24 of 113), with preoperative staging representing 18% of exams (20 of 113) and high-risk screening representing 12% (13 of 113). Of pending MRI requests, 230 were within the recommended delay period, and 457 exceeded the recommended delay. After elaboration of evidence-based guidelines, repeat audits in September 2014 and September 2015 showed that MRI performed for women with a prior breast cancer diagnosis represented 23% (33 of 141) and 7% (10 of 143) of exams respectively, with preoperative staging having declined to 9% (13 of 141) and 11% (16 of 143) of exams, and high-risk screening having increased to 36% (51 of 141) and 46% (66 of 143) of exams. Overall, wait times were improved for all breast MRI indications. Conclusions: Through multidisciplinary discussion, we actualized a list of breast MRI indications, prioritized requests more adequately, and improved wait times
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