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Showing 101 - 150FDA Pipeline: Updates on Treatments for Cervical Cancer, Myelofibrosis, Chemotherapy-Induced Nausea and Vomiting, and More
The FDA recently issued announcements on a Fast Track designation, a Priority Review, two supplemental new drug applications, an investigational new drug application, and a marketing clearance. The agency also released a safety communication on cancer-related surgery. Fast Track Designation for...
G. Travis Clifton, MD, on Breast Cancer and Disease Recurrence: Final Analysis From a Study of Nelipepimut-S, GM-CSF, and Trastuzumab
G. Travis Clifton, MD, of Brooke Army Medical Center, discusses phase IIb trial findings on nelipepimut-S plus GM-CSF with trastuzumab vs trastuzumab alone to prevent recurrences of high-risk, HER2 low-expressing breast cancer (Abstract 1).
Elizabeth A. Mittendorf, MD, PhD, on Breast Cancer Immunotherapy: Building on Recent Successes
Elizabeth A. Mittendorf, MD, PhD, of Dana-Farber Cancer Institute, discusses the encouraging data on atezolizumab plus nab-paclitaxel in the first-line setting for metastatic triple-negative breast cancer, and the potential benefits of combining immune checkpoint inhibitors with targeted treatment...
Biologic Age and Elevated Breast Cancer Risk
Biologic age—a DNA-based estimate of a person’s age—may be associated with development of breast cancer, according a report published by Kresovich et al in the Journal of the National Cancer Institute. Study Methods Scientists from the National Institute of Environmental Health...
Does Adjuvant Denosumab Improve DFS in Postmenopausal Women With Hormone Receptor–Positive Breast Cancer Receiving Aromatase Inhibitors?
As reported by Gnant et al in The Lancet Oncology, disease-free survival (DFS) was improved with adjuvant denosumab vs placebo in postmenopausal women with hormone receptor–positive, early-stage breast cancer receiving aromatase inhibitor treatment. A primary analysis of the phase III...
Can Cognitive Behavioral Therapy Improve Treatment-Induced Menopausal Symptoms in Survivors of Breast Cancer?
In a Dutch study reported in the Journal of Clinical Oncology, Atema et al found that an Internet-based cognitive behavioral therapy (iCBT) intervention improved treatment-induced menopausal symptoms in breast cancer survivors compared with a waiting list control group. In the study, 254 women...
2019 ASCO-SITC: Combination Immunotherapy for Breast Cancer With Trastuzumab and a HER2-Targeted Vaccine
After preclinical findings showed shared activity between trastuzumab and HER2-targeted vaccines, researchers evaluated adjvuant nelipepimut-S plus granulocyte-macrophage colony-stimulating factor (GM-CSF) with trastuzumab compared to trastuzumab with GM-CSF alone in patients with HER2...
FDA Approves Trastuzumab and Hyaluronidase-oysk for Subcutaneous Injection in Certain HER2-Positive Breast Cancers
On February 28, the U.S. Food and Drug Administration (FDA) approved trastuzumab and hyaluronidase-oysk (Herceptin Hylecta) for subcutaneous injection for the treatment of certain patients with HER2-positive early breast cancer (node-positive, or node-negative and estrogen receptor/progesterone...
Sacituzumab Govitecan-hziy in Heavily Pretreated, Metastatic Triple-Negative Breast Cancer
In a phase I/II trial reported in The New England Journal of Medicine, Bardia et al found durable responses with the antibody-drug conjugate sacituzumab govitecan-hziy in patients with heavily pretreated, metastatic triple-negative breast cancer. The monoclonal antibody sacituzumab targets the...
Addition of Pembrolizumab to Trastuzumab in PD-L1–Positive, Trastuzumab-Resistant, HER2-Positive Breast Cancer
In the phase II portion of a phase Ib/II trial reported in The Lancet Oncology, Loi et al found evidence of activity of pembrolizumab plus trastuzumab in programmed cell death protein ligand 1 (PD-L1)-positive, trastuzumab-resistant, HER2-positive advanced breast cancer. Study Details In the...
Benefit of Annual Screening in Women Aged 35–39 With a Family History of Breast Cancer
Annual screening for women aged 35–39 who have a family history of breast cancer may be highly effective in detecting tumors earlier, according to findings published by Evans et al in The Lancet’s online journal EClinicalMedicine. The FH02 trial found that annual mammograms for...
Meta-analysis of Outcomes With Dose-Intense Adjuvant Chemotherapy in Early Breast Cancer
In a patient-level meta-analysis reported in The Lancet, the Early Breast Cancer Trialists’ Collaborative Group (EBCTCG) found that an increased dose intensity of adjuvant taxane and anthracycline chemotherapy in early breast cancer was associated with a decreased risk of recurrence and death ...
New Approach to Predicting Response to Pertuzumab and Trastuzumab in Breast Cancer
In the phase II TBCRC026 study reported in the Journal of Clinical Oncology, Connolly et al found that early changes in tumor maximum standardized uptake values corrected for lean body mass (SULmax) on [18F]fluorodeoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) were...
Recent Decrease in Deaths Attributable to Breast Cancer in the United States
The latest U.S. estimates indicate that since 1989, hundreds of thousands of women's lives have been saved by mammography and improvements in breast cancer treatment. In a study published by Hendrick et al in Cancer, findings point to progress made in the early detection and management of...
MRI and Assay Results May Influence Treatment of DCIS
In a prospective cohort clinical trial reported in JAMA Oncology, Lehman et al found that multiple factors, including magnetic resonance imaging (MRI) findings, played a role in conversion to mastectomy among women with ductal carcinoma in situ (DCIS) who were candidates for wide local excision...
Postmastectomy Hypofractionated vs Conventionally Fractionated Radiotherapy for High-Risk Breast Cancer
In a Chinese, single-center, noninferiority phase III trial reported in The Lancet Oncology, Wang et al found that postmastectomy hypofractionated radiotherapy was noninferior to and associated with similar toxicities vs conventionally fractionated radiotherapy in patients with high-risk breast...
CYP2D6 Genotypes, Endoxifen Levels, and Clinical Outcome in Early-Stage Breast Cancer Treated With Adjuvant Tamoxifen
In a Dutch-Belgian study (CYPTAM) reported in the Journal of Clinical Oncology, Sanchez-Spitman et al found no associations between CYP2D6 genotypes or levels of endoxifen (active metabolite of tamoxifen) and clinical outcomes in patients receiving adjuvant tamoxifen for early-stage breast cancer....
Effect of Peer Review Within a Cancer Care Network on Use of Hypofractionated Radiotherapy for Early-Stage Breast Cancer
In a study reported in the Journal of Oncology Practice, Ganju et al found that implementation of a cancer care network–wide peer review process aimed at standardizing treatment resulted in increasing use of hypofractionated radiotherapy in early-stage breast cancer at community-based...
Racial Differences in Time to Breast Cancer Surgery and Survival in the U.S. Military Health System
In a retrospective cohort study reported in JAMA Surgery, Eaglehouse et al found that time to breast cancer surgery was delayed for non-Hispanic black vs non-Hispanic white women in the Military Health System but that this difference did not account for poorer overall survival in non-Hispanic black ...
Cost-Effectiveness Analysis of Gene-Expression Profiling Assay in Breast Cancer
A new report published by Wang et al in JNCCN—Journal of the National Comprehensive Cancer Network found that using Oncotype DX—the most commonly used test for predicting the benefit of adjuvant chemotherapy to reduce the risk of disease recurrence—is not...
Short-Term Safety Outcomes in Mastectomy and Immediate Implant-Based Breast Reconstruction
In a prospective cohort study reported in The Lancet Oncology, Potter et al found that complications following immediate implant-based breast reconstruction—with or without mesh—were higher than considered acceptable by UK national standards. As noted by the investigators, the study was ...
Tumor-Infiltrating Lymphocytes and Prognosis in Early-Stage Triple-Negative Breast Cancer
In a pooled analysis reported in the Journal of Clinical Oncology, Loi et al found that levels of stromally located tumor infiltrating lymphocytes (sTILs) are strongly prognostic in early-stage triple-negative breast cancer, with improved survival observed in patients with higher levels of sTILs...
MRI Background Parenchymal Enhancement and Risk of Breast Cancer
In a population-based study reported in the Journal of Clinical Oncology, Arasu and colleagues found that increased breast magnetic resonance imaging (MRI) background parenchymal enhancement was associated with an increased risk of breast cancer, with risk being independent of breast density. The...
FDA Approves Biosimilar Trastuzumab-dttb
On January 18, the U.S. Food and Drug Administration (FDA) approved trastuzumab-dttb (Ontruzant), a biosimilar referencing trastuzumab, across all eligible indications—namely, adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric cancer or...
Breast Cancer Surveillance Consortium Analysis of Trends in Breast Density Assessment
In a study reported in the Journal of the National Cancer Institute, Sprague et al found that only small changes in the proportions of women found to have dense breasts on digital mammography have occurred with revisions in Breast Imaging Reporting and Data System (BI-RADS) density classification...
BRCA Exchange: Resource Aggregates Data on BRCA Variants
A global resource that includes data on thousands of inherited variants in the BRCA1 and BRCA2 genes is available to the public. The BRCA Exchange was created through the BRCA Challenge, a long-term demonstration project initiated by the Global Alliance for Genomics and...
Neoadjuvant Degarelix vs Triptorelin in Premenopausal Women Receiving Letrozole for Locally Advanced, Endocrine-Responsive Breast Cancer
In a phase II trial reported in the Journal of Clinical Oncology, Dellapasqua et al found that neoadjuvant treatment with the gonadotropin-releasing hormone (GnRH) antagonist degarelix was more effective than the GnRH agonist triptorelin in achieving ovarian function suppression (OFS) in...
Study Assesses Impact of Digital Mammography on Breast Cancer Detection and Recall Rates
The shift from film to digital mammography increased the detection of breast cancer overall in the United Kingdom—without increasing the recall rate—according to a study published by Blanks et al in Radiology. “Image quality with digital mammography is improved over that of...
Adjuvant Trastuzumab Emtansine vs Trastuzumab in Patients With HER2-Positive Breast Cancer With Residual Disease After Neoadjuvant Therapy
As reported at the recent San Antonio Breast Cancer Symposium and in The New England Journal of Medicine by von Minckwitz et al, an interim analysis of the phase III KATHERINE trial has shown that adjuvant trastuzumab emtansine (T-DM1; Kadcyla) improved invasive disease–free survival vs...
Disease-Free Survival With Letrozole vs Placebo After Aromatase Inhibitor–Based Therapy in Postmenopausal Breast Cancer
As reported by Mamounas et al in The Lancet Oncology, the phase III NRG Oncology/NSABP B-42 trial has shown no disease-free survival benefit with 5 years of letrozole (Femara) vs placebo after 5 years of aromatase inhibitor–based therapy in women with hormone receptor–positive...
Increased Risk for Breast Cancer After Childbirth May Last More Than 2 Decades
Although parity—time since most recent birth— is recognized as a protective factor against breast cancer, an analysis of data from 15 prospective cohort studies to assess breast cancer risk in relation to recent childbirth has found that compared to women of the same age who had never...
Addition of Neoadjuvant Palbociclib to Letrozole in Estrogen Receptor–Positive Early Breast Cancer
In the phase II PALLET trial reported in the Journal of Clinical Oncology, Johnston et al found that the addition of neoadjuvant palbociclib (Ibrance) to letrozole increased rates of complete cell-cycle arrest, reduced apoptosis, and did not significantly improve clinical response rate in patients...
FDA Approves Trastuzumab-pkrb for HER2-Overexpressing Breast Cancer
On December 14, the U.S. Food and Drug Administration (FDA) approved trastuzumab-pkrb (Herzuma), a HER2/neu receptor antagonist biosimilar to trastuzumab (Herceptin), for the following indications: Adjuvant breast cancer of HER2 overexpressing node-positive or node-negative (estrogen...
Palbociclib Plus Fulvestrant in Advanced Breast Cancer: Overall Survival Analysis of PALOMA-3
An overall survival analysis of the PALOMA-3 trial reported by Turner et al in The New England Journal of Medicine found that the addition of the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor palbociclib (Ibrance) to fulvestrant (Faslodex) improved survival among patients with hormone...
RSNA 2018: Mammography Screening Beyond Age 75
Women aged 75 years and older may benefit from continued screening mammograms because of the comparatively high incidence of breast cancer found in this age group, according to a study presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSA01-04)....
RSNA 2018: Breast Cancer Risk-Based Mammography Screening in Younger Women
A new, large-scale study of more than 5 million mammograms found that annual mammography screening beginning at age 30 may benefit women with at least 1 of 3 specific risk factors: dense breasts, a personal history of breast cancer, or a family history of breast cancer. The study was presented at...
RSNA 2018: Preliminary Results of Primary Cryoablation in Treating Low-Risk Breast Cancers
Cryoablation has shown early indications of effectiveness in treating women with low-risk breast cancers, according to research presented at the Annual Meeting of the Radiological Society of North America (RSNA) (Abstract SSM01-01). “If the positive preliminary findings are maintained as the ...
Hope S. Rugo, MD, on Metastatic Breast Cancer: Treatment for Pretreated Hormone Receptor–Positive Disease
Hope S. Rugo, MD, of the University of California, San Francisco, discusses how treatment with a lower dose of palbociclib (100 mg vs 125 mg) in combination with fulvestrant or tamoxifen is associated with a lower rate of high-grade neutropenia (Abstract PD2-12).
POEMS/SWOG Intergroup S0230 Study on Preventing Early Menopause
In the long-term follow-up of the Prevention of Early Menopause Study (POEMS)/SWOG Intergroup S0230 trial reported in the Journal of the National Cancer Institute, Moore et al found that the addition of goserelin (Zoladex) to cyclophosphamide-containing chemotherapy was associated with a higher...
FDA Pipeline: New Priority Reviews, Designations, and Clearances, Plus Statements on Genetic Testing and Class Labeling
The U.S. Food and Drug Administration (FDA) recently issued the following new approvals and designations: Priority Review for Atezolizumab in Combination With Chemotherapy for the Initial Treatment of Extensive-Stage SCLC The FDA accepted a supplemental biologics license application...
Shanu Modi, MD, on Low HER2-Expressing Breast Cancer: Updated Trial Findings
Shanu Modi, MD, of Memorial Sloan Kettering Cancer Center, discusses study findings from a large phase I study on trastuzumab deruxtecan in patients with low HER2-expressing breast cancer (Abstract P6-17-02).
Hope S. Rugo, MD, on Immunotherapy for Breast Cancer: Expert Perspective
Hope S. Rugo, MD, of the University of California, San Francisco, summarizes a spotlight session she chaired, which included discussion of new immunotherapy drug combinations, predictive factors, and the immune microenvironment.
Monica Morrow, MD, on View From the Trenches: What Will You do on Monday Morning?
Monica Morrow, MD, of Memorial Sloan Kettering Cancer Center reviews lessons learned from top abstracts, including how to tailor the extent of local therapy to minimize morbidity, the diminishing role of axillary lymph node dissection, long-term sequelae of breast surgical procedures, and the need...
Shom Goel, MD, PhD, on Breast Cancer: Impact of CDK4/6 Inhibitors on Immunity
Shom Goel, MD, PhD, of the Dana-Farber Cancer Institute, discusses preclinical data that suggest CDK4/6 inhibitors not only stop the growth of breast cancer cells, but also enhance antitumor immunity, a phenomenon that might help improve outcomes for people with advanced disease.
Roisin M. Connolly, MD, on Breast Cancer Treatment Advances in 2018: Expert Perspective
Roisin M. Connolly, MD, of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, discusses clinical trials during the past year on studies on CDK and PI3K inhibitors in estrogen receptor–positive breast cancer and immune checkpoint agents in triple-negative breast cancer.
Reshma Jagsi, MD, DPhil, and Rachel A. Freedman, MD, MPH, on Over- and Undertreatment: Getting It Right
Reshma Jagsi, MD, DPhil, of the University of Michigan, and Rachel A. Freedman, MD, MPH, of Dana-Farber Cancer Institute, discuss the twin challenges of overtreating people with cancer and the missed opportunities and dangers of undertreatment.
Kathy S. Albain, MD, on Breast Cancer, Ethnicity, and Clinical Outcomes: Results From the TAILORx Trial
Kathy S. Albain, MD, of Loyola University Stritch School of Medicine, discusses study findings on race, ethnicity, and patient outcomes in hormone receptor–positive, HER2-negative, node-negative breast cancer (Abstract GS4-07).
Allison Magnuson, DO, on Older Patients With Breast Cancer: A New Tool to Help Guide Treatment Decisions
Allison Magnuson, DO, of the University of Rochester Strong Memorial Hospital, discusses the development of a chemotherapy toxicity risk score that is associated with dose reduction as well as reduced respiratory distress and fewer hospitalizations (Abstract GS6-04).
Roberto A. Leon-Ferre, MD, on Decreasing Hot Flashes: Results From an ACCRU Trial
Roberto A. Leon-Ferre, MD, of the Mayo Clinic, discusses study findings on the effectiveness of oxybutynin in decreasing the frequency and severity of hot flashes (Abstract GS6-01).
Dejan Juric, MD, on Advanced Breast Cancer: Results From the SOLAR-1 Trial
Dejan Juric, MD, of Massachusetts General Hospital, discusses phase III study findings on liquid biopsy–based assessment of PIK3CA mutational status and the combination of the selective PI3K-alpha inhibitor alpelisib plus fulvestrant in the treatment of advanced breast cancer (Abstract GS3-08).
