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Gabriel N. Hortobagyi, MD, Chair of Medical Breast Oncology at The University of Texas MD Anderson Cancer Center, Houston, said he was “disappointed but not surprised” at the FDA decision to withdraw the bevacizumab (Avastin) indication in breast cancer. “Once the FDA put this in the hands of ODAC, ...
On November 18, FDA Commissioner Margaret A. Hamburg, MD, said she is revoking the agency’s approval of the breast cancer indication for bevacizumab (Avastin) after concluding that the drug has not been shown to be safe and effective for that use. Bevacizumab will remain on the market as an...
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. “After breast-conserving surgery,...
Women with HER2-positive advanced breast cancer are much less likely to have disease progression or die when two agents are used instead of one to target the HER2 signaling pathway, investigators for the international phase III CLEOPATRA trial found. The 808 women studied were randomly assigned to...
Adding an inhibitor of the mammalian target of rapamycin (mTOR) to hormonal therapy for advanced breast cancer effectively circumvents resistance, suggest updated results of the randomized BOLERO-2 trial. With a median follow-up of 12.5 months, the likelihood of disease progression or death among...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. Indications In September 2011, the monoclonal antibody RANKL...
Oncologists should be aware that common clinical tumor markers (denoting hormonal and HER2 status) change as breast cancer progresses, because these changes can affect treatment selection. Estrogen receptor (ER), progesterone receptor (PR), and HER2 receptor status was changed from the time of the...
The Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) study, which is evaluating various anti-HER2 therapy approaches in breast cancer, has discontinued the single-agent lapatinib (Tykerb) arm, according to study sponsor GlaxoSmithKline. Following a preplanned interim analysis...
Chemotherapy can be delivered before breast-conserving therapy or after surgery, without influencing long-term local-regional recurrence, a large study from The University of Texas MD Anderson Cancer Center confirmed. The data were presented at the 2011 Breast Cancer Symposium in San Francisco.1 “A ...
Vulvovaginal atrophy is a concern for the majority of patients with breast cancer, not only because of its physical and psychosexual consequences, but because the optimal treatment—estrogen replacement—is controversial. Patients and physicians alike remain concerned that external estradiol may...
Research in cancer staging, surgical procedures, outcomes, and medical treatment was included among the 2,000 abstracts presented at the 97th Annual American College of Surgeons Clinical Congress in San Francisco. The ASCO Post was there to capture the latest findings. Neoadjuvant Chemotherapy in...
A new gene classifier differentiates between women with estrogen receptor (ER)-positive breast cancer who go on to develop metastases early vs late, possibly paving the way for tailored adjuvant therapy. Using pretreatment tumor biopsies, a team led by Minetta C. Liu, MD, of the Georgetown...
Leading up to FDA’s resolution to revoke the breast cancer indication for bevacizumab (Avastin), the debate over the drug’s clinical value was imbued with contentious ideologic overtones, which culminated in a 2-day public hearing that exposed deep divisions not only in the scientific community,...
Women diagnosed with atypical hyperplasia have a substantial risk of subsequent development of breast cancer, with a cumulative incidence of approximately 30% at 25 years. Atypical hyperplasia is considered to be a precursor to ductal carcinoma in situ (DCIS). p16 (a nuclear protein encoded by the...
Accelerated partial breast irradiation using brachytherapy (APBIb) as an alternative to whole-breast irradiation (WBI) after breast-conserving surgery has been rapidly adopted in the United States, but the majority of patients receiving APBIb may not be considered suitable for it. A retrospective...
Mortality rates for breast cancer have declined steadily in the United States since 1990, resulting in an improvement in survival. Multiple factors have contributed to this positive trend, one of which is the combination of earlier detection and more sophisticated surgical techniques. The ASCO Post ...
Local treatment of breast cancer is trending toward less invasive procedures that achieve comparable outcomes to standard interventions. What will the next step along this continuum be? According to Michael S. Sabel, MD, a surgical oncologist at the University of Michigan Comprehensive Cancer...
Partial breast brachytherapy is less effective and more toxic than whole-breast irradiation when used after lumpectomy, suggests an analysis of Medicare claims data. In the 2000–2007 study of more than 130,000 older women with breast cancer—the largest of its kind to date—the rate of mastectomy in...
In findings likely to intensify the debate about the role of bevacizumab (Avastin) in advanced breast cancer, the AVEREL trial concludes that adding this antiangiogenic antibody to standard therapy prolongs progression-free survival by about 3 months in women with HER2-positive locally recurrent...
Signaling of mammalian target of rapamycin (mTOR) is required for estrogen-induced breast tumor cell proliferation, and hyperactivation of the mTOR pathway is observed in endocrine-resistant breast cancer cells. Clinically, this makes for a rational one-two punch in endocrine-resistant breast...
Adding an inhibitor of mammalian target of rapamycin (mTOR) to an aromatase inhibitor more than doubled the time to disease progression in patients with advanced, treatment-refractory breast cancer in the phase III BOLERO-2 trial, whose updated results were presented at the San Antonio Breast...
Understanding the different relapse patterns within estrogen receptor (ER)-positive breast cancer is important for guiding treatment decisions, said Laura Esserman, MD, of the University of California, San Francisco, Medical Center. Women who fall into the two separate categories may have different ...
Eastern Cooperative Oncology Group (ECOG) trials have demonstrated that recurrence patterns are different for estrogen receptor (ER)-positive vs ER-negative breast cancer. While ER-negative disease carries a high risk for early recurrence—peaking around year 1.5 from diagnosis—risk steadily...
Estrogen receptor (ER)-positive breast cancer often recurs years after the initial diagnosis, and understanding the patterns of timing regarding relapse could identify patients needing more aggressive treatment. At the 2011 San Antonio Breast Cancer Symposium, several investigative teams reported...
James Ingle, MD, of the Mayo Clinic, Rochester, Minnesota, formally discussed the ABCSG-12 and ZO-FAST bisphosphonate studies presented at the 2011 San Antonio Breast Cancer Symposium, noting, “There is a lot of interest in the effect of bisphosphonates on the tumor microenvironment and the impact ...
The story of bisphosphonates, and their disease-modifying potential in breast cancer, is still evolving. While some studies presented at the 2011 San Antonio Breast Cancer Symposium failed to show gains, others found benefits. The theme that is emerging is that bisphosphonates may be most...
Modest benefit reported from AVEREL1 triggered comments among trialists about the future of bevacizumab (Avastin) in breast cancer. “Although there’s controversy about the recent revoking of FDA approval of bevacizumab for metastatic breast cancer, I think there is a consensus in our disappointment ...
Bevacizumamb (Avastin) added to trastuzumab (Herceptin) and docetaxel as first-line therapy for HER2-positive advanced breast cancer moderately improved progression-free survival in the phase III AVEREL trial, presented at the 2011 San Antonio Breast Cancer Symposium by Luca Gianni, MD, of the San ...
The availability of effective therapies for HER2-positive tumors has made breast cancer a better managed disease, but outcomes could be further enhanced through the targeting of other players in this pathway, emerging data suggest. C. Kent Osborne, MD, of Baylor College of Medicine, Houston,...
There is an emerging theme in HER2-positive breast cancer: The greater the pathway inhibition, the better the outcome. The latest evidence comes from the phase III Clinical Evaluation of Pertuzumab and Trastuzumab (CLEOPATRA) trial of 808 patients with previously untreated metastatic disease. The...
The FDA has accepted Roche’s Biologics License Application for pertuzumab (Omnitarg) and granted Priority Review. The proposed indication is pertuzumab in combination with trastuzumab (Herceptin) and docetaxel chemotherapy for people with HER2-positive metastatic or locally recurrent, unresectable ...
A year ago, I was living my dream. Married to a wonderful man, Danny, and with two young children to raise, Karl, 7, and Marcus, 4, I had given up a career in accounting to be a stay-at-home mom. At age 34, I was enjoying life, helping my children with their homework and going to their soccer and...
Two studies reported in The New England Journal of Medicine showed that the addition of bevacizumab (Avastin) to neoadjuvant chemotherapy significantly increased the pathologic complete response rate in women with HER2-negative breast cancer. In one study, from the German Breast Group, the benefit...
The Six1 gene is a key regulator of embryonic development that requires interaction with the Eya family of proteins (Eya1-4) to activate transcription of genes involved in neurogenesis, myogenesis, and nephrogenesis. Overexpression of Six1 and Eya is observed in a number of cancers. In breast...
In the News focuses on media reports that your patients may have questions about at their next visit. This continuing column will provide summaries of articles in the popular press that may prompt such questions, as well as comments from colleagues in the field. Reexcision rates for women with...
Two hormonal therapies combined are more efficacious than one when used as first-line treatment for hormone receptor–positive metastatic breast cancer in postmenopausal women, finds Southwest Oncology Group trial S0226. Results of the phase III trial, reported at the 2011 CTRC-AACR San Antonio...
Two large collaborative genomics projects are producing new and sometimes surprising findings about what makes breast cancers tick—information that may ultimately be applied to improve clinical outcomes. In a special session titled “Genome Data for the Masses: Presentation of TCGA and ICGC Breast...
Women with atypical breast lesions have approximately a 5% to 11% risk of developing breast cancer within 5 years, depending on histology, and this risk can be reduced with chemoprevention, according to a presentation at the 2011 San Antonio Breast Cancer Symposium.1 Investigators tracked the...
The best advice I received after getting a diagnosis of stage I invasive lobular carcinoma in my left breast was from my radiologist, who told me, “Remember, be your own best advocate.” Those words have stayed with me through my 6-year struggle with breast cancer and its aftermath. Extraordinary...
Patient and tumor characteristics can stratify women with breast cancer and a BRCA mutation into groups having different risks of contralateral disease, which may help tailor follow-up, suggests a study of more than 5,000 women in the Netherlands. Confirming findings of other studies, the study...
A benefit of the oral bisphosphonate clodronate when used as adjuvant therapy for early breast cancer may depend on factors such as the endpoint assessed and patient age, suggests the randomized B-34 trial conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP). The trial,...
Ventana Medical Systems, Inc, received 510(k) clearance from the FDA for the Ventana Companion Algorithm Ki-67 (30-9) image analysis application used with the Ventana iScan Coreo Au scanner running Virtuoso software. Ventana is currently the only company offering an FDA-cleared Ki-67 image...
Hope Rugo, MD, of the University of California, San Francisco, commented on Dr. O’Shaughnessy’s presentation on molecular pathways in triple-negative breast cancer at the 2011 San Antonio Breast Cancer Symposium. “The really exciting thing is that we have moved from intrinsic subtyping of breast...
The startling molecular heterogeneity of metastatic triple-negative breast cancer is now obvious and helps to explain the poor outcomes observed in this patient subset. Comprehensive genomic and transcriptomic interrogation of metastatic triple-negative breast cancer is elucidating the molecular...
In a population-based cohort study in Ontario, Canada, reported in the Journal of Clinical Oncology, Levine et al found that use of the 21-gene recurrence score (RS) assay altered decisions regarding receipt of chemotherapy compared with use of Adjuvant! Online in patients with axillary...
In the phase II LUX-Breast 3 trial reported in The Lancet Oncology, Cortés et al found that afatinib (Gilotrif) alone or combined with vinorelbine did not increase patient benefit vs investigator choice of treatment in patients with HER2-positive breast cancer and progressive brain...
Retrospective analyses of hormone receptors among patients enrolled in the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-24 study showed that women with estrogen receptor (ER)-positive ductal carcinoma in situ (DCIS) who received tamoxifen after standard therapy had significant...
The addition of sorafenib (Nexavar) to capecitabine (Xeloda) improved progression-free survival among women with locally advanced or metastatic HER2-negative breast cancer in a randomized, double-blind, placebo-controlled phase IIB trial. “There was no significant improvement for overall survival,” ...
The FDA recently approved a silicone gel-filled breast implant manufactured by Sientra Inc for breast augmentation in women at least 22 years old and breast reconstruction in women of any age. As a condition of approval, Sientra is required to conduct postapproval studies that will assess long-term ...
Preliminary findings of the International Breast Cancer Study Group (IBCSG) 23-01 trial1 show no benefit for axillary lymph node dissection in patients with only minimally involved sentinel nodes, thereby supporting the results of the American College of Surgeons Oncology Group (ACOSOG) Z0011...