FDA Pipeline: What’s New in Biosimilars, Drug Reviews, Designations, and More
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Approval for Pegfilgrastim Biosimilar The FDA recently approved a pegfilgrastim biosimilar, pegfilgrastim-cbqv (Udenyca). The biosimilar has been approved to decrease the incidence...
Patient-Reported Cosmetic Outcomes With Radiotherapy in Early Breast Cancer
As reported in the Journal of Clinical Oncology by Shaitelman et al, 3-year outcomes of a phase III noninferiority trial indicate that hypofractionated whole-breast irradiation (HF-WBI) followed by a tumor bed boost is not inferior to conventionally fractionated whole-breast irradiation (CF-WBI)...
Expert Point of View: Giuseppe Curigliano, MD, PhD
“IMPASSION130 IS a positive study of immuno-oncology that brings breast cancer into the immunotherapy era,” said the invited discussant of the trial, Giuseppe Curigliano, MD, PhD, Associate Professor of Oncology at the University of Milan and Chair of Early Drug Development at the Institute of...
Immunotherapy Improves Survival in a Subset of Patients With Metastatic Triple-Negative Breast Cancer
IMMUNOTHERAPY APPEARS to be the new upfront standard of care for patients with metastatic triple-negative breast cancer, based on a late-breaking presentation at the European Society for Medical Oncology (ESMO) 2018 Congress1 and simultaneously published in The New England Journal of Medicine.2 In ...
Final Analysis of SWOG POEMS: Goserelin and Chemotherapy in Breast Cancer
Final results of SWOG Cancer Research Network’s international Prevention of Early Menopause Study (POEMS) showed continued evidence that women who get injections of the hormone drug goserelin along with standard breast cancer chemotherapy are more likely to become pregnant, without developing ...
Whole-Genome Sequencing May Help Identify Young Childhood Cancer Survivors at High Risk for Breast Cancer
Female survivors of childhood cancer, especially those treated with chest irradiation, have a substantially higher risk of developing breast cancer later in life. As a result, current clinical screening of this high-risk population relies primarily on the radiation dose and volume to the...
The Persephone Trial Reconsidered
Persephone is a 4,088-patient trial that Helena Margaret Earl, MBBS, PhD, reported at the 2018 ASCO Annual Meeting as establishing that 6 months of trastuzumab (Herceptin) is not inferior to 12 months in 4-year survival without invasive or local regional recurrence or distant metastases. Dr. Earl...
The Persephone Trial Reconsidered
The Persephone presentation by Helena Margaret Earl, MBBS, PhD, got a lot of publicity after a pre–ASCO Annual Meeting press release, suggesting that 6 months of adjuvant trastuzumab (Herceptin) is enough. The advice of experts has been that the evidence is inconclusive, but I have not heard a...
Prognostic Risk Model for African American Women With Breast Cancer
A prognostic model developed using a machine learning approach may be able to identify African American patients with breast cancer who have an increased risk of death, according to results of a study presented by Bhattarai et al at the 11th AACR Conference on The Science of Cancer Health...
Quality of Life With Postmastectomy Radiotherapy vs No Radiotherapy in Intermediate-Risk Breast Cancer
In a 2-year follow-up of the phase III SUPREMO trial reported in The Lancet Oncology, Velikova et al found worse chest wall symptoms in women with intermediate-risk breast cancer who did vs did not receive postmastectomy radiotherapy. No other differences in quality-of-life outcomes were found ...
ESMO 2018: HOBOE-2: Zoledronic Acid in Premenopausal Hormone Receptor–Positive Early Breast Cancer
Adjuvant treatment with zoledronic acid, plus hormonal therapy with the aromatase inhibitor letrozole, significantly increases disease-free survival compared to tamoxifen in premenopausal women with hormone receptor–positive early breast cancer, according to results reported by Perrone et al...
Novel Statistical Model in Estimating the Risk of Breast Cancer Recurrence
Although population-based cancer registries data are useful in tracking and reporting the evolving burden of cancer in the population, the information they capture reflects the outcomes of diagnosis and death, regardless of whether the death is due to the disease or to other causes, and not data on ...
2018 ASTRO: Radiation After Breast-Conserving Surgery in 'Good-Risk' DCIS
A subset of patients with low-risk breast cancer is highly unlikely to see cancer return following breast conservation surgery, but can lower that risk even further with radiation therapy, finds a new long-term clinical trial report. These 12-year follow-up data from the only prospective,...
2018 ASTRO: FAST Trial Finds Long-Term Side Effects Similar for Once-Weekly and Conventional Breast Radiation Therapies
In a 10-year study of women who received radiation therapy to treat early-stage breast cancer, those receiving fewer, larger individual radiation doses experienced similarly low rates of late-onset side effects as those undergoing conventional radiation therapy. Findings from the...
Talazoparib Approved for BRCA-Mutated, HER2-Negative Breast Cancer
On October 16, 2018, the U.S. Food and Drug Administration approved talazoparib (Talzenna), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated, HER2-negative locally advanced or metastatic breast cancer. Patients must be...
Sibylle Loibl, MD, PhD, on Metastatic Breast Cancer: Research Highlights
Sibylle Lobil, MD, PhD, of the German Breast Group, discusses findings in metastatic breast cancer from the IMpassion130 trial in triple-negative disease and from the PALOMA3 and SOLAR-1 trials in hormone receptor–positive, HER2-negative disease (Abstracts LBA1_PR, LBA2_PR, LBA3_PR).
Lisa A. Carey, MD, and Sherene Loi, MD, PhD, on TNBC: Combination Immune Checkpoint Inhibitor Therapy
Lisa A. Carey, MD, of the University of North Carolina, and Sherene Loi, MD, PhD, of the Peter MacCallum Cancer Centre, discuss the phase III IMpassion 130 trial testing the first-line combination of the PD-L1 inhibitor atezolizumab plus nab-paclitaxel in metastatic triple-negative breast cancer (Abstract LBA1_PR).
ESMO 2018: SOLAR-1: Alpelisib in Patients With PIK3CA-Mutated HR-Positive, HER2-Negative Advanced Breast Cancer
Targeting a common mutation in patients with hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer with the alpha-specific phosphatidylinositol-3-kinase (PI3K) inhibitor alpelisib improved progression-free survival, according to...
ESMO 2018: PALOMA-3: Palbociclib in Hormone Receptor–Positive, HER2-Negative Advanced Breast Cancer
Treatment with the cyclin-dependent kinase (CDK) 4/6 inhibitor palbociclib (Ibrance) achieved a clinically meaningful improvement in overall survival in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer that has relapsed or ...
ESMO 2018: IMpassion 130: Atezolizumab Plus Nab-Paclitaxel in Metastatic Triple-Negative Breast Cancer
A combination of immunotherapy and chemotherapy improves survival in some patients with metastatic triple-negative breast cancer, according to late-breaking results from the IMpassion130 trial reported by Schmid et al at the European Society for Medical Oncology (ESMO) 2018 Congress (Abstract...
ESMO 2018: HDAC Inhibitor Therapy in Advanced Hormone Receptor–Positive Breast Cancer
A phase III trial presented by Jiang et al at the European Society for Medical Oncology (ESMO) 2018 Congress showed activity of histone deacetylase (HDAC) inhibitor therapy in advanced hormone receptor–positive breast cancer (Abstract 283O_PR). Endocrine therapies are the foundation of...
Sibylle Loibl, MD, PhD, on Metastatic Breast Cancer: Research Highlights
Sibylle Lobil, MD, PhD, of the German Breast Group, discusses findings in metastatic breast cancer from the IMpower 130 trial in triple-negative disease and from the PALOMA3 and SOLAR-1 trials in hormone receptor–positive, HER2-negative disease.
Matthew J. Ellis, MB, BChir, PhD, on Breast Cancer: Neoadjuvant Endocrine Therapy
Matthew J. Ellis, MB, BChir, PhD, of the Baylor College of Medicine, discusses data on endocrine therapy alone or in combination with targeted treatments for postmenopausal women with strongly ER-positive/HER2-negative tumors.
ESMO 2018: About 1 in 6 Premenopausal Patients With Early Breast Cancer Do Not Adhere to Adjuvant Endocrine Therapy
Nearly 1 in 6 premenopausal women being treated for early-stage breast cancer do not adhere adequately to tamoxifen therapy after 1 year of treatment, potentially putting themselves at increased risk of recurrence and reduced survival, reported a French prospective study at the European Society for ...
ESMO 2018: Short-HER Trial Examines Abbreviated Course of Trastuzumab in Some HER2-Positive Early Breast Cancers
Women with HER2-positive early breast cancer with small tumors have similar disease-free survival and lower risk of cardiac toxicity with a 9-week course of adjuvant trastuzumab (Herceptin) compared to those treated for 1 year, according to a subgroup analysis of the Short-HER trial reported by...
FDA Approves Talazoparib for Deleterious Germline BRCA-Mutated HER2-Negative Locally Advanced or Metastatic Breast Cancer
On October 16, 2018, the U.S. Food and Drug Administration (FDA) approved talazoparib (Talzenna), a poly (ADP-ribose) polymerase (PARP) inhibitor, for patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm), HER2-negative locally advanced or metastatic breast cancer....
Study Finds Deep Learning Can Distinguish Recalled-Benign Mammogram Images From Malignant and Negative Cases
Although digital mammography is effective in detecting early-stage breast cancer and in reducing mortality, high recall rates after a screening mammogram often result in unnecessary medical procedures, including breast biopsies, medical costs, and psychological stress for patients. A...
ESMO 2018: Patients With Breast Cancer Use Twitter as a Nonmedical Forum to Share Experiences
Twitter is a place where many patients with cancer go to share and discuss their experiences of the disease, according to a recent exploratory study to be presented by Sánchez-Bayona et al at the European Society for Medical Oncology (ESMO) 2018 Congress (360P_PR). The...
Adherence to Endocrine Therapy for Breast Cancer in Black Women and White Women
In a study reported in the Journal of the National Cancer Institute, Wheeler et al found that black women reported nonadherence to endocrine therapy for breast cancer more often than white women, although no significant difference in discontinuation of treatment was observed. The study...
Estradiol as Potential Treatment for Subset of Triple-Negative Breast Cancers
Mayo Clinic researchers have identified estradiol as a potential new treatment for a subset of women with triple-negative breast cancer. Their findings were published by Reese et al in the Proceedings of the National Academy of Sciences of the United States of America. “Triple-negative...
Report Examines Shortages of Oncologists, Variation in Cancer Rates
Doximity has released a new study detailing a concerning trend that could potentially impact cancer care in the United States. Doximity researchers examined retirement trends, percentage of state-trained specialists, and prevalence of breast cancer on a city-by-city basis. The report is the...
Cognitive Outcomes Among Older Survivors of Breast Cancer
In a study (Thinking and Living with Cancer) reported in the Journal of Clinical Oncology, Mandelblatt et al found that poorer cognitive function in older survivors of breast cancer was associated with chemotherapy, hormone therapy, and ApoE genotype. The ApoE ε4 allele has been associated...
Cognitive Impairment in Patients With Breast Cancer Treated With Chemotherapy
In a study reported in the Journal of Clinical Oncology, Janelsins et al found cognitive impairment in women receiving chemotherapy for breast cancer that persisted for at least 6 months after treatment. Study Details The study, conducted within the National Cancer Institute Community Clinical...
Living a Purposeful Life Is My Revenge on Cancer
There is a lot of breast cancer in my family history. My mother was diagnosed with the disease at 44, and my paternal grandmother died of breast cancer when she was just 33, so I’ve always been diligent about performing breast self-exams— often weekly—to ensure that if I did get breast cancer, it...
Actively Recruiting Clinical Trials Focused on Targeted Therapy for HER2-Positive Breast Cancer
THE INFORMATION contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies focused on targeted therapy in HER2-positive breast cancer. These trials are studying imaging as a predictor of treatment response, combination therapies, treatments for metastatic...
An Early Love of Literature Gives Way to a Career in Breast Cancer Research for Jennifer K. Litton, MD
Breast cancer specialist Jennifer K. Litton, MD, was born and reared in Leominster, Massachusetts, a small city in the north central part of the state. “I went to parochial schools until seventh grade and then went on to high school in Worcester. Although I enjoyed science early on, I was...
Lurbinectedin in BRCA-Mutated and Unselected Metastatic Breast Cancer
In a phase II study reported in the Journal of Clinical Oncology, Cruz et al found that the trabectedin (Yondelis) analog lurbinectedin was active in patients with metastatic breast cancer with germline BRCA mutations, with much lower activity in those without BRCA mutation or unknown mutation...
Neoadjuvant Paclitaxel With LCL161 in Localized Triple-Negative Breast Cancer
In a phase II study reported in the Journal of Clinical Oncology, Bardia et al evaluated the effects of adding an antagonist of inhibitor of apoptosis proteins (LCL161) to paclitaxel as neoadjuvant therapy in patients with localized triple-negative breast cancer who did or did not have a tumor...
Long-Term Outcomes With Anti–PD-L1 Treatment in Metastatic Triple-Negative Breast Cancer
In a long-term follow-up of a phase I trial reported in JAMA Oncology, Emens et al found that single-agent atezolizumab (Tecentriq) produced enduring benefit in patients with metastatic triple-negative breast cancer after stable or responding disease and in first-line treatment. Study Details In...
More to Learn About Using PARP Inhibitors for Advanced Breast Cancer With Germline BRCA Mutation
Germline mutations in the breast cancer–susceptibility genes 1 and 2 (BRCA1/2) increase the risk for cancer due to an inability to repair DNA double-strand breaks, and about 5% of patients with unselected breast cancer carry a germline BRCA mutation.1 These DNA repair–deficient tumors are...
Talazoparib Improves Progression-Free Survival in Advanced Breast Cancer With Germline BRCA Mutation
As reported in The New England Journal of Medicine by Jennifer K. Litton, MD, of The University of Texas MD Anderson Cancer Center, and colleagues, the phase III EMBRACA trial has shown significantly improved progression-free survival with the poly (ADP-ribose) polymerase (PARP) inhibitor...
High Levels of Fertility-Related Hormone May Be Linked to Increased Breast Cancer Risk
Having high levels of anti-Müllerian hormone (AMH)—a hormone that indicates the size of a woman’s ovarian reserve—before menopause may be associated with an increased risk of breast cancer, a study by Ge et al in the International Journal of Cancer found. In a major study,...
NCI Breast Cancer Working Group Report on Appropriate Endpoints for Clinical Trials in Metastatic Breast Cancer
As reported in the Journal of Clinical Oncology by Seidman et al, the National Cancer Institute (NCI) Breast Cancer Steering Committee Working Group has issued a report on meaningful and appropriate endpoints for clinical trials in metastatic breast cancer. With the goal of providing...
Omission of Axillary Dissection in Early Breast Cancer
In a study reported in JAMA Oncology, Monica Morrow, MD, of the Breast Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, and colleagues found that surgeon acceptance of more limited surgery in early breast cancer was more likely among high-volume surgeons and those preferring ...
TGFβ Polymorphism and Radiation-Induced Fibrosis in Breast Cancer
In an analysis reported in JAMA Oncology, Benjamin D. Smith, MD, of the Department of Radiation Oncology, The University of Texas MD Anderson Cancer Center, and colleagues found that a single nucleotide polymorphism (C−509T) in the transforming growth factor β1 (TGFβ1) gene was associated with...
Expect Questions About Genetic Testing for Breast Cancer
A STUDY finding that pathogenic variants in 5 genes are associated with a high risk of triple-negative breast cancer and a 20% lifetime risk for overall breast cancer1 may increase interest in genetic testing. “This is the first study to establish which genes are associated with high lifetime risks ...
Mutations in Five Genes Linked to Higher Lifetime Risks for Aggressive Breast Cancer
USING MULTIGENE hereditary cancer panels to test for mutations in five genes can identify women at high risk for triple-negative breast cancer who may then benefit from more frequent screening, risk management, and potentially targeted therapies as well. A study that looked at multigene panel...
Pertuzumab in Adjuvant Treatment of HER2-Positive Breast Cancer
AT THE END OF 2017, pertuzumab (Perjeta) was granted regular approval for use in combination with trastuzumab (Herceptin) and chemotherapy as adjuvant treatment of patients with HER2- positive early breast cancer at high risk of recurrence.1,2 Supporting Efficacy Data APPROVAL WAS BASED on...
2018 Quality Care: Few Women With Breast Cancer Discuss Costs With Physicians Before Beginning Treatment
Findings from a new study reveal that while many women with breast cancer experience significant financial burden and most prefer to discuss the cost of their cancer care before beginning treatment, few are having conversations about treatment costs with their cancer care teams. These findings will ...
2018 Quality Care: Nationwide Survey Reveals Patients With Metastatic Breast Cancer Face Major Financial Stress Due to Treatment Costs
A new nationwide analysis of more than 1,000 people living with metastatic breast cancer from 41 states reveals significant cancer-related financial burden known as financial toxicity, particularly for uninsured patients. The study will be presented by Wheeler et al at the upcoming 2018 ASCO...
