Breast Neoplasms: Burstein HJ

Carlson RW, Allred DC, Anderson BO, Burstein HJ, Carter WB, Edge SB, Erban JK, Farrar WB, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis CA, Jahanzeb M, Kiel K, Ljung BM, Marcom PK, Mayer IA, McCormick B, Nabell LM, Pierce LJ, Reed EC, Smith ML, Somlo G, Theriault RL, Topham NS, Ward JH, Winer EP, Wolff AC, Anonymous00042. · No affiliation provided · J Natl Compr Canc Netw. · Pubmed #19200416 No free full text.

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Carlson RW, Moench SJ, Hammond ME, Perez EA, Burstein HJ, Allred DC, Vogel CL, Goldstein LJ, Somlo G, Gradishar WJ, Hudis CA, Jahanzeb M, Stark A, Wolff AC, Press MF, Winer EP, Paik S, Ljung BM, Anonymous00047. · Stanford Hospital and Clinics. · J Natl Compr Canc Netw. · Pubmed #16813731 No free full text.

Abstract: The NCCN HER2 Testing in Breast Cancer Task Force was convened to critically evaluate the ability of the level of HER2 expression or gene amplification in breast cancer tumors to serve as a prognostic and a predictive factor in the metastatic and adjuvant settings, to assess the reliability of the methods of measuring HER2 expression or gene amplification in the laboratory, and to make recommendations regarding the interpretation of test results. The Task Force is a multidisciplinary panel of 24 experts in breast cancer representing the disciplines of medical oncology, pathology, radiation oncology, surgical oncology, epidemiology, and patient advocacy. Invited members included members of the NCCN Breast Cancer Panel and other needed experts selected solely by the NCCN. During a 2-day meeting, individual task force members provided didactic presentations critically evaluating important aspects of HER2 biology and epidemiology: HER2 as a prognostic and predictive factor; results from clinical trials in which trastuzumab was used as a targeted therapy against HER2 in the adjuvant and metastatic settings; the available testing methodologies for HER2, including sensitivity, specificity, and ability to provide prognostic and predictive information; and the principles on which HER2 testing should be based. Each task force member was charged with identifying evidence relevant to their specific expertise and presentation. Following the presentations, an evidence-based consensus approach was used to formulate recommendations relating to the pathologic and clinical application of the evidence to breast cancer patient evaluation and care. In areas of controversy, this process extended beyond the meeting to achieve consensus. The Task Force concluded that accurate assignment of the HER2 status of invasive breast cancer is essential to clinical decision making in the treatment of breast cancer in both adjuvant and metastatic settings. Formal validation and concordance testing should be performed and reported by laboratories performing HER2 testing for clinical purposes. If appropriate quality control/assurance procedures are in place, either immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH) methods may be used. A tumor with an IHC score of 0 or 1+, an average HER2 gene/chromosome 17 ratio of less than 1.8, or an average number of HER2 gene copies/cell of 4 or less as determined by FISH is considered to be HER2 negative. A tumor with an IHC score of 3+, an average HER2 gene/chromosome 17 ratio of greater than 2.2 by FISH, or an average number of HER2 gene copies/cell of 6 or greater is considered HER2 positive. A tumor with an IHC score of 2+ should be further tested using FISH, with HER2 status determined by the FISH result. Tumor samples with an average HER2 gene/chromosome ratio of 1.8 to 2.2 or average number of HER2 gene copies/cell in the range of greater than 4 to less than 6 are considered to be borderline, and strategies to assign the HER2 status of such samples are proposed.

Carlson RW, Brown E, Burstein HJ, Gradishar WJ, Hudis CA, Loprinzi C, Mamounas EP, Perez EA, Pritchard K, Ravdin P, Recht A, Somlo G, Theriault RL, Winer EP, Wolff AC, Anonymous00401. · Stanford Hospital and Clinics, Stanford University, Stanford, CA, USA. · J Natl Compr Canc Netw. · Pubmed #16507275 No free full text.

Abstract: The National Comprehensive Cancer Network (NCCN) first published the NCCN Breast Cancer Treatment Guidelines in 1996. The Guidelines address the treatment of all stages of breast cancer across the spectrum of patient care and have been updated yearly. Adjuvant therapy for breast cancer has undergone an especially rapid evolution over the past few years. Therefore, the NCCN Breast Cancer Guidelines Panel was supplemented by additional experts to form the Adjuvant Therapy Task Force to provide a forum for an extended discussion and expanded input to the adjuvant therapy recommendations for the Breast Cancer Treatment Guidelines. Issues discussed included methods of risk-stratification for recurrence; how biologic markers such as HER2 status, quantitative estrogen receptor, or genetic markers can be incorporated as prognostic or predictive factors; and how age, menopausal status, and estrogen receptor levels impact benefits from chemotherapy and endocrine therapy. Additionally, the task force discussed the strategies for use of aromatase inhibitors in postmenopausal women and the potential incorporation of trastuzumab into adjuvant therapy of women with HER2/neu positive breast cancer. This supplement summarizes the background data and ensuing discussion from the Adjuvant Task Force meeting.

Lyman GH, Giuliano AE, Somerfield MR, Benson AB, Bodurka DC, Burstein HJ, Cochran AJ, Cody HS, Edge SB, Galper S, Hayman JA, Kim TY, Perkins CL, Podoloff DA, Sivasubramaniam VH, Turner RR, Wahl R, Weaver DL, Wolff AC, Winer EP, Anonymous00154. · University of Rochester School of Medicine and Dentistry, Rochester, NY, USA. · J Clin Oncol. · Pubmed #16157938 No free full text.

Abstract: PURPOSE: To develop a guideline for the use of sentinel node biopsy (SNB) in early stage breast cancer. METHODS: An American Society of Clinical Oncology (ASCO) Expert Panel conducted a systematic review of the literature available through February 2004 on the use of SNB in early-stage breast cancer. The panel developed a guideline for clinicians and patients regarding the appropriate use of a sentinel lymph node identification and sampling procedure from hereon referred to as SNB. The guideline was reviewed by selected experts in the field and the ASCO Health Services Committee and was approved by the ASCO Board of Directors. RESULTS: The literature review identified one published prospective randomized controlled trial in which SNB was compared with axillary lymph node dissection (ALND), four limited meta-analyses, and 69 published single-institution and multicenter trials in which the test performance of SNB was evaluated with respect to the results of ALND (completion axillary dissection). There are currently no data on the effect of SLN biopsy on long-term survival of patients with breast cancer. However, a review of the available evidence demonstrates that, when performed by experienced clinicians, SNB appears to be a safe and acceptably accurate method for identifying early-stage breast cancer without involvement of the axillary lymph nodes. CONCLUSION: SNB is an appropriate initial alternative to routine staging ALND for patients with early-stage breast cancer with clinically negative axillary nodes. Completion ALND remains standard treatment for patients with axillary metastases identified on SNB. Appropriately identified patients with negative results of SNB, when done under the direction of an experienced surgeon, need not have completion ALND. Isolated cancer cells detected by pathologic examination of the SLN with use of specialized techniques are currently of unknown clinical significance. Although such specialized techniques are often used, they are not a required part of SLN evaluation for breast cancer at this time. Data suggest that SNB is associated with less morbidity than ALND, but the comparative effects of these two approaches on tumor recurrence or patient survival are unknown.

Carlson RW, Anderson BO, Burstein HJ, Cox CE, Edge SB, Farrar WB, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis C, Jahanzeb M, Ljung BM, Marks LB, McCormick B, Nabell LM, Pierce LJ, Reed EC, Silver SM, Smith ML, Somlo G, Theriault RL, Ward JH, Winer EP, Wolff AC, Anonymous00249. · Stanford Hospital & Clinics, USA. · J Natl Compr Canc Netw. · Pubmed #16002000 No free full text.

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Burstein HJ. · No affiliation provided · J Natl Compr Canc Netw. · Pubmed #19241643 No free full text.

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Mayer EL, Burstein HJ. · No affiliation provided · J Clin Oncol. · Pubmed #18323544 No free full text.

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Mayer EL, Carey LA, Burstein HJ. · Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115, USA. · Breast Cancer Res. · Pubmed #17888189 links to  free full text

Abstract: Neoadjuvant chemotherapy for breast cancer has a well-established role in the management of patients with locally advanced or early stage disease. Multiple trials have demonstrated superior survival outcomes in individuals achieving a pathologic complete response at the time of definitive surgery, and sophisticated genetic methods may predict which patients will be in this category. Those with less than a pathologic complete response remain at significant risk of recurrent disease, and currently no further standard therapy exists. Ongoing studies of novel agents may lead to improved therapeutic outcomes for this high-risk population.

Burstein HJ, Winer EP. · No affiliation provided · J Clin Oncol. · Pubmed #17761968 No free full text.

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Burstein HJ, Winer EP. · No affiliation provided · J Clin Oncol. · Pubmed #15738533 No free full text.

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Burstein HJ. · No affiliation provided · N Engl J Med. · Pubmed #14551340 No free full text.

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Burstein HJ. · No affiliation provided · J Clin Oncol. · Pubmed #10893279 No free full text.

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Figlin RA, Brown E, Armstrong AJ, Akerley W, Benson AB, Burstein HJ, Ettinger DS, Febbo PG, Fury MG, Hudes GR, Kies MS, Kwak EL, Morgan RJ, Mortimer J, Reckamp K, Venook AP, Worden F, Yen Y. · No affiliation provided · J Natl Compr Canc Netw. · Pubmed #18926092 No free full text.

Abstract: The mammalian target of rapamycin (mTOR) protein complex functions as an integration center for various intracellular signaling pathways involving cell cycle progression, proliferation, and angiogenesis. These pathways are frequently dysregulated in cancer, and therefore mTOR inhibition is a potentially important antitumor target. Commercially available mTOR inhibitors include rapamycin (i.e., sirolimus) and temsirolimus. Other agents under investigation include everolimus and deforolimus. mTOR inhibition has been studied in various solid tumors, including breast, gynecologic, gastrointestinal, prostate, lung, and head and neck cancers. Studies have focused on mTOR inhibition as a monotherapy or in combination with other drugs based on the principle that inhibiting as many targets as possible reduces the emergence of drug resistance. Temsirolimus is currently the only mTOR inhibitor that is specifically labeled for treatment of solid tumors. However, preclinical studies and early-phase trials are rapidly evolving. Additionally, research is further defining the complicated mTOR pathways and how they may be disordered in specific malignancies. To address these issues, NCCN convened a task force to review the underlying physiology of mTOR and related cellular pathways, and to review the current status of research of mTOR inhibition in solid tumors.

Carlson RW, Moench S, Hurria A, Balducci L, Burstein HJ, Goldstein LJ, Gradishar WJ, Hughes KS, Jahanzeb M, Lichtman SM, Marks LB, McClure JS, McCormick B, Nabell LM, Pierce LJ, Smith ML, Topham NS, Traina TA, Ward JH, Winer EP. · No affiliation provided · J Natl Compr Canc Netw. · Pubmed #18597715 No free full text.

Abstract: Breast cancer is common in older women, and the segment of the U.S. population aged 65 years and older is growing rapidly. Consequently, awareness is increasing of the need to identify breast cancer treatment recommendations to assure optimal, individualized treatment of older women with breast cancer. However, the development of these recommendations is limited by the heterogeneous nature of this population with respect to functional status, social support, life expectancy, and the presence of comorbidities, and by the underrepresentation of older patients with breast cancer in randomized clinical trials. The NCCN Breast Cancer in the Older Woman Task Force was convened to provide a forum for framing relevant questions on topics that impact older women with early-stage, locally advanced, and metastatic breast cancer. The task force is a multidisciplinary panel of 18 experts in breast cancer representing medical oncology, radiation oncology, surgical oncology, geriatric oncology, geriatrics, plastic surgery, and patient advocacy. All task force members were from NCCN institutions and were identified and invited solely by NCCN. Members were charged with identifying evidence relevant to their specific expertise. During a 2-day meeting, individual members provided didactic presentations; these presentations were followed by extensive discussions during which areas of consensus and controversy were identified on topics such as defining the "older" breast cancer patient; geriatric assessment tools in the oncology setting; attitudes of older patients with breast cancer and their physicians; tumor biology in older versus younger women with breast cancer; implementation of specific interventions in older patients with breast cancer, such as curative surgery, surgical axillary staging, radiation therapy, reconstructive surgery, endocrine therapy, chemotherapy, HER2-directed therapy, and supportive therapies; and areas requiring future studies.

Burstein HJ. · Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts, USA. · Cancer Invest. · Pubmed #18317961 No free full text.

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Gralow JR, Burstein HJ, Wood W, Hortobagyi GN, Gianni L, von Minckwitz G, Buzdar AU, Smith IE, Symmans WF, Singh B, Winer EP. · Seattle Cancer Care Alliance, Department of Medicine, 825 Eastlake Ave, EMS G3-200, Seattle, WA 98109-1023, USA. · J Clin Oncol. · Pubmed #18258991 No free full text.

Abstract: PURPOSE: To review the state of the science with respect to preoperative systemic therapy and pathologic assessment in operable breast cancer. METHODS: This article reviews data presented at the National Cancer Institute State of the Science Conference on Preoperative Therapy in Invasive Breast Cancer as well as supporting published data. RESULTS: Preoperative chemotherapy in operable breast cancer has been shown to improve breast conservation rates as a result of tumor response to therapy. When patients are given preoperative systemic therapy, regimens should be the same as those established as safe and active in the adjuvant setting. At present, there are no data to suggest that systemic treatment should be tailored based on initial tumor response, or based on the extent of residual disease. In operable breast cancer, there seems to be no survival advantage from initiation of systemic therapy before surgery. A variety of clinical, imaging, and pathologic measurements are available to gauge tumor response to treatment. There is a clear correlation between tumor response in the breast and lymph nodes and both disease-free and overall survival. Pathologic complete response and other pathologic measures may be useful as surrogate end points in evaluating and understanding new therapies. CONCLUSION: In operable breast cancer, preoperative systemic therapy is effective and can improve breast conservation rates. Unless the tumor is large or the patient is in a clinical trial, postoperative adjuvant systemic therapy is the standard of care. To achieve optimal outcomes, preoperative systemic therapy must be administered as part of a coordinated, multimodality treatment program. The preoperative setting provides a unique opportunity to study the impact of systemic therapies on breast cancer biology.

Burstein HJ. · Dana-Farber Cancer Institute, Harvard Medical School, 44 Binney Street, Boston, MA 02115, USA. · Breast. · Pubmed #17719225 No free full text.

Abstract: Symptoms associated with cognitive dysfunction-difficulties with memory, concentration, and language-are frequent among breast cancer survivors after chemotherapy. The true incidence, functional significance, and causes of these symptoms remain unclear. Models of cognitive dysfunction suggest multiple possible contributors including changes in hormonal milieu, direct effects of chemotherapy, medications given as supportive care, psychiatric changes including depression and anxiety, and mediators of inflammation. Novel neuro-cognitive testing and imaging methods are being evaluated in breast cancer survivors to better understand cognitive side-effects of therapy.

Mayer EL, Burstein HJ. · Dana-Farber Cancer Institute, Brigham and Women's Hospital, Harvard Medical School, 44 Binney Street, Boston, MA 02115, USA. · Hematol Oncol Clin North Am. · Pubmed #17512448 No free full text.

Abstract: Cytotoxic chemotherapy is a mainstay of treatment for advanced breast cancer. Treatment of metastatic (also called stage IV, advanced, or recurrent) breast cancer is not considered curative. Rather, the goals of treatment with chemotherapy are to prolong survival, alleviate or prevent tumor-related symptoms or complications, and improve quality of life. While the purpose of chemotherapy is to prevent or alleviate symptoms, chemotherapy paradoxically carries considerable toxicities that cause substantial symptoms in patients, notoriously including fatigue, nausea, vomiting, diarrhea, hair loss, mucositis, neutropenia, and neuropathy. Balancing the benefits and the side effects of chemotherapy is further complicated by the natural history of advanced breast cancer, which can be quite prolonged and typically involves multiple lines of chemotherapy, especially in patients whose tumors respond to treatment.

Mayer EL, Lin NU, Burstein HJ. · Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115, USA. · J Natl Compr Canc Netw. · Pubmed #17439759 No free full text.

Abstract: New biological therapies continue to emerge in breast cancer. Recent advances with anti-angiogenesis therapies and anti-HER2 therapies highlight the next generation of treatments that will be entering clinical practice. Important questions regarding these targeted treatments remain, however. There are uncertainties as to how best to integrate new drugs into existing treatment algorithms, whether to use monotherapy or combination therapy with chemotherapy, and how to manage novel side effects seen with these agents. This review highlights recent advances with the anti-vascular endothelial growth factor antibody, bevacizumab, and the dual kinase inhibitor, lapatinib, in the treatment of metastatic breast cancer.

Carlson RW, Anderson BO, Burstein HJ, Carter WB, Edge SB, Farrar WB, Goldstein LJ, Gradishar WJ, Hayes DF, Hudis CA, Jahanzeb M, Ljung BM, Kiel K, Marks LB, McCormick B, Nabell LM, Pierce LJ, Reed EC, Silver SM, Smith ML, Somlo G, Theriault RL, Ward JH, Winer EP, Wolff AC. · National Comprehensive Cancer Network · J Natl Compr Canc Netw. · Pubmed #17439758 No free full text.

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Burstein HJ. · Dana-Farber Cancer Institute, Harvard Medical School, Boston, Massachusetts 02115, USA. · Oncology (Williston Park). · Pubmed #17370924 No free full text.

Abstract: Anthracycline- and taxane-based adjuvant chemotherapy regimens have become the most commonly used regimens in the United States for high-risk, early-stage breast cancer. Growth factor support is an essential component of therapy for several of the most commonly used adjuvant chemotherapy regimens that frequently cause substantial myelosuppression and anemia. Extensive data now exist to demonstrate the efficacy of both long- and short-acting myeloid growth factors in patients receiving dose-dense AC --> paclitaxel. This article will explore prophylactic use of both filgrastim (Neupogen) and pegfilgrastim (Neulasta) in recent clinical trials.

Burstein HJ. · Dana-Farber Cancer Institute, 44 Binney Street, Boston, MA 02115, USA. <> · Breast. · Pubmed #17368903 No free full text.

Abstract: Aromatase inhibitors (AIs) are widely used as an adjuvant endocrine treatment in postmenopausal women with early-stage breast cancer. Clinical trials have assessed 5 years of AI therapy, either as an alternative to tamoxifen for primary adjuvant therapy of breast cancer, or after 5 years of adjuvant tamoxifen. Treatment of 2-3 years' duration after 2-3 years of tamoxifen has also been studied. AI therapy brings side effects related to estrogen deprivation, and this side effect profile differs in clinically relevant ways from that seen with tamoxifen. In particular, the selective estrogen receptor modulatory effects of tamoxifen contribute to menopausal symptoms, vaginal discharge, and the rare but worrisome risks of thromboembolism and uterine carcinoma. By contrast, the low levels of estrogen achieved with aromatase inhibition contribute to menopausal symptoms, vaginal dryness and sexual dysfunction, and accelerated bone demineralization with risk of osteoporosis and osteoporotic fracture. Clinical experience also suggests that AI therapy is associated with a novel musculoskeletal side effect consisting of an arthralgia syndrome. The actual incidence of AI-associated arthralgias or musculoskeletal symptoms is not known, though such symptoms are quite prevalent and appear more commonly with AI use than with tamoxifen. Arthralgias can be a reason for discontinuation of AI treatment. The possible mechanisms of AI-associated arthralgia are unclear. Estrogen deficiency causes bone loss, which in turn contributes to arthralgia. Less well-studied functions of estrogen include regulating immune cells and cytokines involved in bone remodeling, and modulating pain sensitivity at the level of the central nervous system. Arthralgia and arthritis have seldom been rigorously differentiated in clinical trials of AIs. Assessment of inflammatory and rheumatologic markers, as well as detailed evaluation of patient symptoms using appropriate quality-of-life instruments, may be warranted in order to understand both the symptoms and the etiology of the arthralgia syndrome. Treatment options for arthralgia (primarily non-steroidal anti-inflammatory drugs) are currently inadequate, but areas of active research include high-dose vitamin D and new-targeted therapies to inhibit bone loss.

Sledge GW, Rugo HS, Burstein HJ. · Indiana University Cancer Center, Indianapolis, Ind, USA. · Clin Adv Hematol Oncol. · Pubmed #17139244 No free full text.

Abstract: In recent years, antiangiogenic therapy with the monoclonal antibody bevacizumab has demonstrated significant activity in patients with metastatic breast cancer. Bevacizumab is targeted against vascular endothelial growth factor (VEGF), a primary mediator of angiogenesis. Research is ongoing to define the mechanism of action of anti-VEGF treatment in order to predict who will respond to treatment and to monitor responses to treatment at the molecular level. The initial randomized phase III trial of bevacizumab evaluated capecitabine with bevacizumab versus capecitabine alone in patients with heavily pretreated metastatic breast cancer. The addition of bevacizumab to capecitabine did not improve progression-free survival in these patients. However, in the subsequent Eastern Cooperative Oncology Group 2100 trial of patients with previously untreated metastatic breast cancer, bevacizumab combined with paclitaxel doubled progression-free survival compared to paclitaxel alone. Based on these encouraging findings, current studies are evaluating bevacizumab in the adjuvant setting. The oral tyrosine kinase inhibitor sunitinib has shown activity in metastatic breast cancer, and additional agents are being investigated. Combination therapy consisting of antiangiogenic agents with chemotherapy, hormone therapy, or other agents is also being evaluated in hopes of improving treatment options for these patients.

Peppercorn J, Partridge A, Burstein HJ, Winer EP. · No affiliation provided · Breast. · Pubmed #16288876 No free full text.

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Winer EP, Hudis C, Burstein HJ, Wolff AC, Pritchard KI, Ingle JN, Chlebowski RT, Gelber R, Edge SB, Gralow J, Cobleigh MA, Mamounas EP, Goldstein LJ, Whelan TJ, Powles TJ, Bryant J, Perkins C, Perotti J, Braun S, Langer AS, Browman GP, Somerfield MR. · Dana-Farber Cancer Institute, 44 Binney St, D1210, Boston, MA 02115, USA. · J Clin Oncol. · Pubmed #15545664 No free full text.

Abstract: PURPOSE: To update the 2003 American Society of Clinical Oncology technology assessment on adjuvant use of aromatase inhibitors. RECOMMENDATIONS: Based on results from multiple large randomized trials, adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer should include an aromatase inhibitor in order to lower the risk of tumor recurrence. Neither the optimal timing nor duration of aromatase inhibitor therapy is established. Aromatase inhibitors are appropriate as initial treatment for women with contraindications to tamoxifen. For all other postmenopausal women, treatment options include 5 years of aromatase inhibitors treatment or sequential therapy consisting of tamoxifen (for either 2 to 3 years or 5 years) followed by aromatase inhibitors for 2 to 3, or 5 years. Patients intolerant of aromatase inhibitors should receive tamoxifen. There are no data on the use of tamoxifen after an aromatase inhibitor in the adjuvant setting. Women with hormone receptor-negative tumors should not receive adjuvant endocrine therapy. The role of other biomarkers such as progesterone receptor and HER2 status in selecting optimal endocrine therapy remains controversial. Aromatase inhibitors are contraindicated in premenopausal women; there are limited data concerning their role in women with treatment-related amenorrhea. The side effect profiles of tamoxifen and aromatase inhibitors differ. The late consequences of aromatase inhibitor therapy, including osteoporosis, are not well characterized. CONCLUSION: The Panel believes that optimal adjuvant hormonal therapy for a postmenopausal woman with receptor-positive breast cancer includes an aromatase inhibitor as initial therapy or after treatment with tamoxifen. Women with breast cancer and their physicians must weigh the risks and benefits of all therapeutic options.