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1.  Prognosis and Outcome of Small (≤1 cm), Node-Negative Breast Cancer on the Basis of Hormonal and HER-2 Status 
The Oncologist  2010;15(10):1043-1049.
This study evaluated whether human epidermal growth factor receptor 2 status is an independent, poor prognostic marker in patients with small (≤1 cm), node-negative breast cancer and whether a subgroup of patients with these small tumors who might benefit from adjuvant systemic therapy could be identified.
Long-term outcomes and hence the role of adjuvant therapy in patients with small (≤1 cm), node-negative breast cancer remain unclear. This study's objective was to evaluate whether human epidermal growth factor receptor (HER)-2 status is an independent, poor prognostic marker in patients with these tumors and to identify a subgroup of patients with these small tumors who might benefit from adjuvant systemic therapy. All patients with a diagnosis of a node-negative breast tumor measuring ≤1 cm and available HER-2 test results between January 1, 2001, and December 31, 2005, at the three Mayo Clinic sites were identified. Clinicopathologic data were compared in three groups: HER-2−, HER-2+, and triple-negative (TN) tumors. Of the 421 tumors identified, 364 (86.5%) were HER-2−, 28 (6.7%) were HER-2+, and 29 (6.9%) were TN. The median follow-up time was 1,015 days (range, 1–2,549 days). Groups were balanced in terms of patient age and tumor histology. Eleven patients with HER-2− tumors (3.0%), seven with HER-2+ tumors (25.0%), and eight with TN tumors (27.6%) received adjuvant chemotherapy. Follow-up data were available for 357, 28, and 28 patients in the three groups, respectively. Death rates in the three groups were 6.4% (23 of 357) (one recurrence-related death), 0% (0 of 28), and 7.1% (2 of 28) (one recurrence-related death), respectively. During follow-up, the tumor recurred in nine patients: four were HER-2− tumors (1.1%), two were HER-2+ tumors (7.1%), and three were TN tumors (10.7%). Patients with small, node-negative breast tumors have an excellent prognosis, but HER-2+ and TN tumors appear to have a higher recurrence rate, warranting consideration for broad use and optimization of systemic adjuvant treatments.
PMCID: PMC3227894  PMID: 20930097
HER-2–positive tumor; Prognosis; Small breast cancer; Triple-negative tumor
2.  RC0639: phase II study of paclitaxel, trastuzumab, and lapatinib as adjuvant therapy for early stage HER2-positive breast cancer 
Lapatinib adds to the efficacy of trastuzumab in preclinical models and also in the neo-adjuvant setting. This study assesses the safety and feasibility of adding lapatinib to paclitaxel and trastuzumab (THL) as part of the adjuvant therapy for HER2-positive breast cancer (HER2+ BC). In this single-arm phase II study, patients with stages I–III HER2+ BC received standard anthracycline-based chemotherapy followed by weekly taxane, with concurrent standard trastuzumab, plus daily lapatinib for a total of 12 months. The primary endpoint was symptomatic congestive heart failure, secondary endpoints included overall safety. A total of 109 eligible patients were enrolled. Median follow-up is 4.3 years. No patients experienced congestive heart failure while on treatment. Mean left ventricular ejection fraction at baseline and at the end of THL were 63.6 % (N = 109, SD = 5.7) and 59.8 % (N = 98, SD = 8.1), respectively [mean change −3.95 % (N = 98, SD = 8.3), p < 0.001]. One hundred and two patients initiated post-AC treatment; of them, 31 % experienced grade 3 (no G4) diarrhea with lapatinib at 750 mg/day. The addition of lapatinib to paclitaxel and trastuzumab following AC does not add cardiac toxicity. Lapatinib dose of 750 mg/day in combination with standard chemotherapy plus trastuzumab has acceptable overall tolerability.
PMCID: PMC3608861  PMID: 23479422
Breast cancer; HER2 cardiac; Gastrointestinal; Tolerability; Lapatinib; Adjuvant
3.  Managing the Early and Locally Advanced Breast Cancer Patient at High Risk for Recurrence: Recent Advances and Nursing Implications 
Seminars in oncology nursing  2007;23(1):29-36.
To identify breast cancer patients at high risk for recurrence.
To describe current evidence for clinical management of early and locally advanced breast cancer and integrate this knowledge into nursing practice.
Articles, abstracts, and practice guidelines.
Recent clinical trials have integrated the biology of breast cancer into individualized systemic therapy. Risk-adjusted treatment is driven by the addition of taxane therapy to systemic therapy, aromatase inhibitors and perhaps most markedly, trastuzumab into adjuvant therapy strategies.
The decision to initiate systemic adjuvant therapy requires knowledge of risk of relapse, integration of evidence from clinical trials, and facilitation of patient decision making.
PMCID: PMC1880870  PMID: 17303514
4.  Comprehensive Diagnostic Program for Medically Underserved Women With Abnormal Breast Screening Evaluations in an Urban Population 
Mayo Clinic Proceedings  2009;84(4):317-322.
OBJECTIVE: To institute a patient navigator program for underinsured women to eliminate delays in diagnostic resolution of abnormal screening mammograms, provide services for abnormalities noted during breast cancer screening, describe demographic and clinical characteristics of enrollees, and assess postscreening follow-up care.
PATIENTS AND METHODS: Coordinators from area health departments worked with a navigator nurse at Mayo Clinic Cancer Center in Jacksonville, FL, to refer patients for additional diagnostic services, including diagnostic mammography, ultrasonography, ultrasonography-guided biopsy, stereotactic biopsy, breast magnetic resonance imaging, and biopsy guided by magnetic resonance imaging. Women with abnormal screening mammograms (Breast Imaging Reporting and Data System [BI-RADS] category 4 or 5) or palpable suspect breast masses were eligible. Data were extracted from clinical service records. Timeliness of postscreening follow-up was assessed.
RESULTS: The study enrolled 447 women from June 30, 2000, to December 29, 2006. Data on the time from screening to diagnosis were available for 399 women, and median time from detection of screening abnormality to diagnosis was 37 days. Time between screening and diagnosis was 60 days or less for 325 (81%) of the 399 women for whom data were available and for 60 (82%) of the 73 women with BI-RADS category 4 or 5 assessments. Both of these percentages exceeded the Centers for Disease Control and Prevention quality benchmark of 75%. Mean time from study enrollment to diagnosis was 2 days for women with BI-RADS category 3 or 4 assessments and 7 days for women with BI-RADS category 5 assessments.
CONCLUSION: This program demonstrated a successful collaboration between an academic medical center and community health centers. Most women with BI-RADS category 4 or 5 assessments received a diagnosis within 60 days of screening.
A collaboration between an academic medical center and community health centers was found to be successful; most women with Breast Imaging Reporting and Data System category 4 or 5 assessments received a diagnosis within 60 days of screening.
PMCID: PMC2665975  PMID: 19339648

Results 1-4 (4)