Nanoparticle albumin-bound (nab)-paclitaxel has better efficacy and practically eliminates the risk of hypersensitivity reactions associated with solvent-based paclitaxel. We studied weekly nab-paclitaxel and gemcitabine combination in an open-label one-stage, phase II trial in patients with previously untreated metastatic breast cancer (MBC). Nab-paclitaxel (125 mg/m(2)) and gemcitabine (1000 mg/m(2)) were administered on days 1 and 8 of a 21-day cycle until disease progression. Fifty patients were enrolled. Forty (80%) had visceral organ involvement and 30 (60%) had >or= 3 sites of metastases. Four (8%) and 21 (42%) patients had complete and partial responses by Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Median duration of response was 6.9 months [95% confidence interval (CI) 5.7, not reached], median progression-free survival (PFS) 7.9 months (95% CI 5.4-10 months), and median overall survival (OS) was not reached. PFS and OS at 6 months were 60% (95% CI 48% to 76%) and 92% (95% CI 85% to 100%), respectively. Therapy was well tolerated. Neutropenia was commonest toxicity (42% and 12% grades 3 and 4 neutropenia). Only one patient developed febrile neutropenia. Significant activity and favorable toxicity profile provides a basis for considering this regimen for further evaluation in phase III trials or in combination with biologic agents.

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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.

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