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Sara A. Hurvitz, Ruben G. W. Quek, Helen Bhattacharyya, Johannes Ettl, Anthony Gonçalves and Hope S. Rugo

Background: Key subgroup analyses of EMBRACA (NCT01945775) demonstrated improvements in progression-free survival for talazoparib vs PCT in white and non-white pts with HER2-negative g BRCA1/2 mut LA/mBC. We present post hoc analyses evaluating PRO

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Rodrigo Goncalves and Ron Bose

+/- chemotherapy in patients with 1-3 positive nodes, hormone receptor–positive and HER2-negative breast cancer with recurrence score (RS) of 25 or less: SWOG S1007 [abstract]. Presented at the 2011 San Antonio Breast Cancer Symposium; December 6–10, 2011; San

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Richard L. Theriault, Robert W. Carlson, Craig Allred, Benjamin O. Anderson, Harold J. Burstein, Stephen B. Edge, William B. Farrar, Andres Forero, Sharon Hermes Giordano, Lori J. Goldstein, William J. Gradishar, Daniel F. Hayes, Clifford A. Hudis, Steven J. Isakoff, Britt-Marie E. Ljung, David A. Mankoff, P. Kelly Marcom, Ingrid A. Mayer, Beryl McCormick, Lori J. Pierce, Elizabeth C. Reed, Lee S. Schwartzberg, Mary Lou Smith, Hatem Soliman, George Somlo, John H. Ward, Antonio C. Wolff, Richard Zellars, Dorothy A. Shead and Rashmi Kumar

highlight the important updates/changes specific to the management of HER2-positive metastatic breast cancer in the 2013 version of the NCCN Guidelines. These include clinical data and NCCN recommendations regarding the new therapeutic options, pertuzumab

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Linda M. Sutton, Joseph Geradts, Erika P. Hamilton, Kathleen A. Havlin, Gretchen G. Kimmick, P. Kelly Marcom, Neil L. Spector, Melanie Watson, Daniel U. Rabin, Theodore O. Bruno, Amanda Noe, Stacy Miller, Chitra Subramaniam, Sherry Layton and Katherine Grichnik

% of breast tumors overexpress human epidermal growth factor receptor-2 (HER2), 2 , 3 and targeted therapies for patients with HER2+ breast cancer have been developed. 4 , 5 Supportive care remains an unmet need in cancer management; only a small

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Davinia S.E. Seah, Ines Vaz Luis, Erin Macrae, Jessica Sohl, Georgia Litsas, Eric P. Winer, Nancy U. Lin and Harold J. Burstein

receptor (HR)-positive, HER2-amplified, and triple-negative breast cancer (TNBC). 8 - 11 TNBC is characterized by a younger patient distribution and a higher mortality rate compared with other subtypes. 9 , 10 HER2 amplification historically conferred a

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Sriman Swarup, Anita Sultan, Somedeb Ball, Francis Mogollon-Duffo, Nimesh Adhikari, Yin M. Myat, Myo H. Zaw, Catherine Jones and Kyaw Z. Thein

Background: Breast cancer is the most common cancer in women, and the majority of breast cancers express the estrogen receptor or progesterone receptor. Inhibition of CDK4/6 signaling pathway has shown survival benefit in advanced breast cancer by overcoming endocrine therapy resistance. Yet, there are considerable hematologic toxicities associated with CDK 4/6 inhibitors and hence, we performed a systematic review and meta-analysis of randomized controlled trials (RCT) to determine the risk. Methods: MEDLINE, EMBASE databases, and meeting abstracts from inception through September 2018 were queried. RCTs that mention anemia, thrombocytopenia, leukopenia, neutropenia, and neutropenic fever as adverse effects were incorporated in the analysis. Mantel-Haenszel method was used to calculate the estimated pooled risk ratio (RR) and risk difference (RD) with 95% CI. Random effects model was applied. Results: 8 RCTs (7 phase III and 1 phase II studies) with a total of 4,557 patients were eligible. The study arms used palbociclib/ribociclib/abemaciclib with letrozole or anastrozole or fulvestrant or other hormonal agent while the control arms utilized placebo in combination with letrozole or anastrozole or fulvestrant or other hormonal agent. The RR of all-grade side effects were as follows: anemia, 3.494 (95% CI: 2.535–4.814; P<.0001); thrombocytopenia, 6.066 (95% CI: 3.055–12.046; P<.0001); leukopenia, 10.376(95% CI: 7.236–14.879; P<.0001); and neutropenia, 14.387 (95% CI: 10.877–19.031; P<.0001). The RR of high-grade adverse effects were as follows: anemia, 2.251 (95% CI: 1.393–3.637; P=.001); thrombocytopenia, 3.696 (95% CI: 1.417–9.642; P=.008); leukopenia, 22.083(95% CI: 12.126–40.217; P<.0001); neutropenia, 33.527(95% CI: 17.271–65.082; P<.001). Neutropenic fever was noted in 71 (3.73%) in CDK 4/6 inhibitors group vs 28 (2.18%) in control arm. The pooled RR was statistically significant at 12.056 (95% CI: 1. 352–3.127; P=.001) and RD was 0.014 (95% CI: −0.002–0.029; P=.078) Conclusion: CDK 4/6 inhibitors–based regimen significantly contributed to all hematologic toxicities as well as febrile neutropenia. The improved efficacy outcomes and manageable toxicities with CDK 4/6 inhibitors are observed with proper supportive care and close monitoring.

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Anita Sultan, Sriman Swarup, Somedeb Ball, Miguel Quirch, Meily Arevalo, Yin M. Myat, Ye Aung, Myo H. Zaw and Kyaw Z. Thein

Background: CDK4 and CDK6 are cyclin-dependent kinases that control transition between G1 and S phases of the cell cycle, hence controlling cell cycle progression by reversible combination with cyclin D1. In cancer cell, CDK4/6 activity is overexpressed, which can lead to amplification or overexpression of the genes encoding for CDK 4/6 or the cyclin D. Additionally, loss of endogenous INK4 inhibitors can also lead to over activity of CDK4 and CDK6. We undertook a meta-analysis of randomized controlled trials (RCT) to determine the risk of gastrointestinal (GI) and hepatic toxicities associated with CDK 4/6 inhibitors. Methods: We conducted a comprehensive literature search using MEDLINE, EMBASE databases, and meeting abstracts from inception through September 2018. In our analysis, we incorporated RCTs that mention GI toxicities and elevation of aspartate aminotransferase (AST) or alanine aminotransferase (ALT) as adverse effects. Mantel-Haenszel (MH) method was used to calculate the estimated pooled risk ratio (RR) with 95% CI. Random effects model was applied. Results: A total of 4,557 patients with advanced breast cancer from 7 phase III and 1 phase II RCTs were eligible. The study arms used were palbociclib/ribociclib/abemaciclib or placebo in combination with letrozole or anastrozole or fulvestrant or other hormonal agents. The RR of all-grade side effects were as follows: diarrhea, 1.691 (95% CI: 1.220–2.345; P=.002); nausea, 1.632 (95% CI: 1.447–1.840; P<.001); vomiting, 1.684 (95% CI: 1.256–2.259, P=.001); stomatitis, 2.160 (95% CI: 1.332–3.503; P=.002); elevated AST, 1.832 (95% CI: 1.312–2.558; P<.001); and elevated ALT, 2.150 (95% CI: 1.649–2.803; P<.001). The RR of high-grade side effects were as follows: diarrhea, 2.592 (95% CI: 0.853–7.877; P=.093); nausea, 1.326 (95% CI: 0.589–2.988; P=.496); vomiting, 1.089 (95% CI: 0.479–2.476; P=.839); stomatitis, 2.097 (95% CI: 0.502–0.753; P=.310); elevated AST, 2.274 (95% CI: 1.173–4.410; P=.015); and elevated ALT, 3.988 (95% CI: 2.387–6.663; P<.001). Conclusions: Our study demonstrated that the risk of developing all grade GI toxicities and all grades of hepatic side effects including grade 3 and 4, was high in CDK 4/6 inhibitors group, compared to control arm, and prompt intervention with good supportive care is required.

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Courtney P. Williams, Andres Azuero, Kelly M. Kenzik, Maria Pisu, Ryan D. Nipp, Smita Bhatia and Gabrielle B. Rocque

antineoplastic treatment (hormonal medication, chemotherapy, or HER2-targeted therapy) after index diagnosis date. Details regarding the categorization of guideline discordance in this population were previously published. 4 , 5 In brief, treatment regimens

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in HER2-negative breast cancers, whereas non-anthracycline–based regimens, especially the combination of docetaxel and cyclophosphamide (TC), accounts for 45%. The vast majority of patients in this setting now receive taxane-based treatments. Among

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NCCN Guidelines Insights: Breast Cancer, Version 3.2018

Featured Updates to the NCCN Guidelines

Matthew P. Goetz, William J. Gradishar, Benjamin O. Anderson, Jame Abraham, Rebecca Aft, Kimberly H. Allison, Sarah L. Blair, Harold J. Burstein, Chau Dang, Anthony D. Elias, William B. Farrar, Sharon H. Giordano, Lori J. Goldstein, Steven J. Isakoff, Janice Lyons, P. Kelly Marcom, Ingrid A. Mayer, Meena S. Moran, Joanne Mortimer, Ruth M. O'Regan, Sameer A. Patel, Lori J. Pierce, Elizabeth C. Reed, Hope S. Rugo, Amy Sitapati, Karen Lisa Smith, Mary Lou Smith, Hatem Soliman, Melinda L. Telli, John H. Ward, Jessica S. Young, Dorothy A. Shead and Rashmi Kumar

guide decisions on adjuvant systemic chemotherapy therapy for women with hormone receptor (HR)–positive, HER2-negative early-stage invasive breast cancer. This report summarizes these updates and discusses the rationale behind them. Adjuvant Systemic