Browsing by Author "Gradishar, William"

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    Double-Blind Phase III Trial of Adjuvant Chemotherapy With and Without Bevacizumab in Patients With Lymph Node-Positive and High-Risk Lymph Node-Negative Breast Cancer (E5103)
    (American Society of Clinical Oncology, 2018-09) Miller, Kathy D.; O’Neill, Anne; Gradishar, William; Hobday, Timothy J.; Goldstein, Lori J.; Mayer, Ingrid A.; Bloom, Stuart; Brufsky, Adam M.; Tevaarwerk, Amye J.; Sparano, Joseph A.; Le-Lindqwister, Nguyet Anh; Hendricks, Carolyn B.; Northfelt, Donald W.; Dang, Chau T.; Sledge, George W.; Medicine, School of Medicine
    Purpose Bevacizumab improves progression-free survival but not overall survival in patients with metastatic breast cancer. E5103 tested the effect of bevacizumab in the adjuvant setting in patients with human epidermal growth factor receptor 2-negative disease. Patients and Methods Patients were assigned 1:2:2 to receive placebo with doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (arm A), bevacizumab only during AC and paclitaxel (arm B), or bevacizumab during AC and paclitaxel followed by bevacizumab monotherapy for 10 cycles (arm C). Random assignment was stratified and bevacizumab dose adjusted for choice of AC schedule. Radiation and hormonal therapy were administered concurrently with bevacizumab in arm C. The primary end point was invasive disease-free survival (IDFS). Results Four thousand nine hundred ninety-four patients were enrolled. Median age was 52 years; 64% of patients were estrogen receptor positive, 27% were lymph node negative, and 78% received dose-dense AC. Chemotherapy-associated adverse events including myelosuppression and neuropathy were similar across all arms. Grade ≥ 3 hypertension was more common in bevacizumab-treated patients, but thrombosis, proteinuria, and hemorrhage were not. The cumulative incidence of clinical congestive heart failure at 15 months was 1.0%, 1.9%, and 3.0% in arms A, B, and C, respectively. Bevacizumab exposure was less than anticipated, with approximately 24% of patients in arm B and approximately 55% of patients in arm C discontinuing bevacizumab before completing planned therapy. Five-year IDFS was 77% (95% CI, 71% to 81%) in arm A, 76% (95% CI, 72% to 80%) in arm B, and 80% (95% CI, 77% to 83%) in arm C. Conclusion Incorporation of bevacizumab into sequential anthracycline- and taxane-containing adjuvant therapy does not improve IDFS or overall survival in patients with high-risk human epidermal growth factor receptor 2-negative breast cancer. Longer duration bevacizumab therapy is unlikely to be feasible given the high rate of early discontinuation.
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    The National Physicians Cooperative: transforming fertility management in the cancer setting and beyond.
    (Future Medicine, 2018-12) Smith, Brigid M.; Duncan, Francesca E.; Ataman, Lauren; Smith, Kristin; Quinn, Gwendolyn P.; Chang, R. Jeffrey; Finlayson, Courtney; Orwig, Kyle; Valli-Pulaski, Hanna; Moravek, Molly B.; Zelinski, Mary B.; Irene Su, H.; Vitek, Wendy; Smith, James F.; Jeruss, Jacqueline S.; Gracia, Clarisa; Coutifaris, Christos; Shah, Divya; Nahata, Leena; Gomez-Lobo, Veronica; Appiah, Leslie Coker; Brannigan, Robert E.; Gillis, Valerie; Gradishar, William; Javed, Asma; Rhoton-Vlasak, Alice S.; Kondapalli, Laxmi A.; Neuber, Evelyn; Ginsberg, Jill P.; Muller, Charles H.; Hirshfeld-Cytron, Jennifer; Kutteh, William H.; Lindheim, Steven R.; Cherven, Brooke; Meacham, Lillian R.; Rao, Pooja; Torno, Lilibeth; Sender, Leonard S.; Vadaparampil, Susan T.; Skiles, Jodi L.; Schafer-Kalkhoff, Tara; Frias, Oliva J.; Byrne, Julia; Westphal, Lynn M.; Schust, Danny J.; Klosky, James L.; McCracken, Kate A.; Ting, Alison; Khan, Zaraq; Granberg, Candace; Lockart, Barbara; Scoccia, Bert; Laronda, Monica M.; Mersereau, Jennifer E.; Marsh, Courtney; Pavone, Mary Ellen; Woodruff, Teresa K.; Pediatrics, School of Medicine
    Once unimaginable, fertility management is now a nationally established part of cancer care in institutions, from academic centers to community hospitals to private practices. Over the last two decades, advances in medicine and reproductive science have made it possible for men, women and children to be connected with an oncofertility specialist or offered fertility preservation soon after a cancer diagnosis. The Oncofertility Consortium's National Physicians Cooperative is a large-scale effort to engage physicians across disciplines - oncology, urology, obstetrics and gynecology, reproductive endocrinology, and behavioral health - in clinical and research activities to enable significant progress in providing fertility preservation options to children and adults. Here, we review the structure and function of the National Physicians Cooperative and identify next steps.