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Kidney Cancer
Lung Cancer
Myelodysplastic Syndromes
Solid Tumors
Skin Cancer
Lymphoma
Pancreatic Cancer
Breast Cancer
Immunotherapy

FDA Pipeline: Designations in Kidney and Lung Cancers, Myelodysplastic Syndromes, and More

Over the past few weeks, the U.S. Food and Drug Administration (FDA) has issued designations and accepted applications for novel agents, as well as approved companion diagnostics. We summarize these regulatory movements below. Breakthrough Therapy Designation for MK-6482 in von Hippel-Lindau...

Hematologic Malignancies
Breast Cancer

Risk of Breast Cancer After Total-Body Irradiation and Blood or Marrow Transplantation for Hematologic Malignancies

In an analysis from the Blood or Marrow Transplantation Survivor Study reported in the Journal of Clinical Oncology, McDonald et al found that total-body irradiation in women undergoing autologous or allogeneic blood or marrow transplantation for hematologic malignancies was associated with an...

Breast Cancer

NALA Trial: Neratinib/Capecitabine vs Lapatinib/Capecitabine for Pretreated Patients With HER2-Positive Metastatic Breast Cancer

As reported in the Journal of Clinical Oncology by Cristina Saura, MD, and colleagues, the phase III NALA trial has shown significantly prolonged progression-free survival with neratinib/capecitabine vs lapatinib/capecitabine in patients with HER2-positive metastatic breast cancer who had received...

COVID-19
Breast Cancer
Colorectal Cancer
Gastroesophageal Cancer
Lung Cancer

Modeling Study Aims to Estimate the Effect of the COVID-19 Pandemic on Cancer Deaths in England

In a population-based modeling study reported in The Lancet Oncology, Maringe et al estimated that delays in diagnosis due to the COVID-19 pandemic could result in 3,291 to 3,621 additional deaths from breast, colorectal, esophageal, and lung cancers within 5 years. As stated by the investigators,...

Breast Cancer
Genomics/Genetics
Survivorship

Impact of Pregnancy After Breast Cancer in Women With Deleterious Germline BRCA Mutations

In a retrospective cohort study reported in the Journal of Clinical Oncology, Matteo Lambertini, MD, PhD, and colleagues found that pregnancy after breast cancer in women harboring deleterious germline BRCA mutations did not appear to be associated with worsened maternal prognosis or fetal...

Breast Cancer

Does Adjuvant Chemotherapy Improve Survival Among Older Patients With ER-Positive, Node-Positive Breast Cancer and Multiple Comorbidities?

In a retrospective cohort study reported in JAMA Oncology, Tamirisa et al found evidence that adjuvant chemotherapy was associated with improved survival among patients age ≥ 70 years with estrogen receptor (ER)-positive, HER2-negative, node-positive breast cancer and multiple comorbidities. Study...

Breast Cancer

Phase III PADA-1 Trial Examines the Impact of ESR1 Mutations in Metastatic Breast Cancer

ESR1 mutations are known to confer resistance to endocrine therapy in the metastatic breast cancer setting. These mutations herald a poor prognosis, so their clearance early in the treatment course may greatly reduce the risk of recurrence, according to the early results of the prospective phase...

Breast Cancer

When Paired With Palbociclib, Fulvestrant and Letrozole Yield Comparable Results in PARSIFAL Trial

When paired with palbociclib in the first-line treatment of metastatic breast cancer, fulvestrant and letrozole performed comparably, with no statistical superiority in progression-free or overall survival shown for either endocrine agent, in the phase II PARSIFAL study presented during the ASCO20...

Breast Cancer

Double PIK3CA Mutations and Response Benefit in Breast Cancer

Patients who have breast cancers with double PIK3CA mutations seem to have a more robust response to PI3Kα inhibitors than those with a single PIK3CA mutation, based on an analysis of the phase III SANDPIPER trial, which tested taselisib plus fulvestrant, according to a presentation during the 2020 ...

Breast Cancer
Immunotherapy

T-DM1 in Patients With HER2-Positive Breast Cancer and Brain Metastases: KAMILLA Trial

An exploratory subgroup analysis of the KAMILLA trial represents the largest reported cohort of patients with HER2-positive breast cancer and brain metastases treated with the anti-HER2 antibody-drug conjugate ado-trastuzumab emtansine, or T-DM1, in a prospective setting. Researchers observed...

Breast Cancer
Genomics/Genetics

Effect of Breast Cancer Pathway Implementation on Rate of Referrals for Genetic Counseling and Testing

In a study reported in JCO Oncology Practice, Stephanie L. Graff, MD, and colleagues found that patients with breast cancer seen by a physician with training in using an established pathway for genetic counseling and testing referral were more frequently referred for such services vs patients seen...

Breast Cancer

Long-Term Normal Tissue Effects With Five-Fraction Whole-Breast Radiotherapy for Early Breast Cancer

As reported in the Journal of Clinical Oncology by Brunt et al, 10-year follow-up in the FAST trial of women with early breast cancer showed greater risk for photographic- and physician-assessed normal tissue effects with an adjuvant radiotherapy regimen of 30 Gy in 5 once-weekly fractions—but not...

Breast Cancer

Outcomes According to BMI in Women Receiving Adjuvant Docetaxel-Based Chemotherapy for Early Breast Cancer

A retrospective analysis from the BIG 2-98 trial reported in the Journal of Clinical Oncology by Desmedt et al showed poorer disease-free and overall survival with increasing baseline body mass index (BMI) in women receiving adjuvant docetaxel-based chemotherapy but not among those receiving...

Breast Cancer
Genomics/Genetics

Presence of ctDNA and CTCs and Prediction of Disease Recurrence in Patients With Triple-Negative Breast Cancer

In a preplanned secondary analysis of the BRE12-158 trial published in JAMA Oncology, Milan Radovich, PhD, and colleagues found that the presence of circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) in the plasma of women who have received neoadjuvant treatment for stage I, II, or...

Breast Cancer
Health-Care Policy

Effect of Medicaid Expansion on Breast Cancer Stage at Diagnosis

In a study reported in JAMA Surgery, Le Blanc et al found that Medicaid expansion under the Affordable Care Act was associated with increased insurance coverage and reduction in rates of diagnosis of breast cancer at later stages. Study Details The study involved data from the National Cancer...

Breast Cancer

Addition of Capecitabine to T-DM1 in Previously Treated Patients With HER2-Positive Metastatic Breast Cancer

In the phase I/II TRAXHER2 trial reported in JAMA Oncology, Cortés et al found that the combination of capecitabine and ado-trastuzumab emtansine (T-DM1) did not improve overall response rate vs T-DM1 alone in previously treated patients with HER2-positive metastatic breast cancer. Study Details In ...

Breast Cancer
Immunotherapy

Roundup of High-Impact Studies in Early Breast Cancer

Clinicians interested in breast cancer who logged into the ASCO20 Virtual Scientific Program were greeted with an abundance of high-impact presentations. The ASCO Post has reported on several studies in depth elsewhere, but here we offer our readers a roundup of several important studies in early...

Breast Cancer
Survivorship

Early Screening With MRI May Reduce Breast Cancer Mortality in Survivors of Childhood Cancer Treated With Chest Radiation

The early initiation—at age 25 to 30—of annual breast cancer screening with magnetic resonance imaging (MRI) with or without mammography may reduce breast cancer mortality by more than half in survivors of childhood cancer who had been previously exposed to chest radiation, according to a study by...

Breast Cancer

Alpelisib Deemed Effective in Advanced Breast Cancer After Treatment With CDK4/6 Inhibitor

The phase II BYLieve trial indicates the effectiveness of the PIK3CA inhibitor alpelisib in patients with PIK3CA-positive, hormone receptor–positive/HER2-negative advanced breast cancer previously treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor plus an aromatase inhibitor. These results...

Breast Cancer

Study Indicates Effectiveness of Tucatinib Combination in Previously Treated HER2-Positive Metastatic Breast Cancer With Brain Metastases

Tucatinib, a small-molecule tyrosine kinase inhibitor that is highly selective for HER2, plus trastuzumab/capecitabine significantly improved central nervous system (CNS) progression-free survival, overall survival, and intracranial response rate vs placebo plus trastuzumab/capecitabine, as shown...

Breast Cancer

No Survival Benefit from Local Therapy in de Novo Metastatic Breast Cancer Study

Results of the phase III E2108 study indicate that surgery and radiotherapy given after systemic treatment afforded no additional survival benefit among women with newly diagnosed metastatic breast cancer. The practice may, however, reduce locoregional progression of disease, according to a report...

Breast Cancer
Bladder Cancer
Colorectal Cancer
Lung Cancer
Multiple Myeloma
Immunotherapy

Conference Highlights From the ASCO20 Virtual Scientific Program

The global outbreak of the COVID-19 pandemic forced many cancer societies, including ASCO, to cancel their in-person meetings this year and instead present the latest advancements and new approaches in oncology care via a virtual platform. For the first time in its 56-year history, the ASCO Annual...

Breast Cancer
Issues in Oncology

Risk of Breast Cancer Recurrence: Serum Detection of Nonadherence to Adjuvant Tamoxifen

In a French study reported in the Journal of Clinical Oncology, Pistilli et al found that serum detection of nonadherence to adjuvant tamoxifen therapy was common and was associated with poorer distant disease-free survival among premenopausal women with breast cancer. Biochemical nonadherence was...

Breast Cancer
Immunotherapy

FDA Approves Combination of Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf for HER2-Positive Breast Cancer

On June 29, the U.S. Food and Drug Administration (FDA) approved a new fixed-dose combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf (Phesgo) for subcutaneous injection in the following indications:  Use in combination with chemotherapy as:  Neoadjuvant treatment for patients with...

Breast Cancer

You-Can-Do-Anything Philosophy Early in Life Inspired Breast Surgeon Laura S. Dominici, MD

Breast surgical oncologist Laura S. Dominici, MD, was born and reared in Litchfield, a small town in the southern portion of New Hampshire. “Our house was on a long dirt road, in a very rural area,” she shared. “There were only about 5,000 residents in the town. My mother was a teacher, and my dad...

Breast Cancer

Study Finds Alpelisib Effective After CDK4/6 Inhibition in Advanced Breast Cancer

The PIK3CA inhibitor alpelisib appears to be effective in patients with PIK3CA-positive, hormone receptor–positive/HER2-negative advanced breast cancer previously treated with a cyclin-dependent kinase (CDK) 4/6 inhibitor plus an aromatase inhibitor, according to the phase II BYLieve trial.1 More...

Breast Cancer

Improving Care for Women With Late-Stage Breast Cancer

The global toll of breast cancer on women is staggering. In 2018, nearly two million new breast cancer cases were diagnosed, an increase of more than 20% since 2008,1 and mortality rates have increased by 14%, bringing the annual number of deaths worldwide from the cancer to more than 611,625.2...

Breast Cancer

Benefit Shown for AKT Inhibitor in LOTUS Survival Analysis

In the phase II LOTUS trial, the addition of the AKT inhibitor ipatasertib to paclitaxel in the first-line treatment of patients with advanced triple-negative breast cancer yielded a strong numerical improvement—a median gain of 9 months—in overall survival, in the final survival analysis reported...

Breast Cancer

Newer Late-Line Treatments May Change Front-Line Standard of Care in HER2-Positive Metastatic Breast Cancer

First- and second-line treatments of HER2-positive metastatic breast cancer have become the standard of care based on solid gains in overall survival, but the prevalence of resistance to these agents is increasing; up to 55% of patients will ultimately develop brain metastases. According to a pair...

Breast Cancer

Repeat Breast Preservation: First Consideration in a Second Ipsilateral Breast Tumor Event

Worldwide, nearly 1.7 million women will be diagnosed with breast cancer. Of that number, nearly 300,000 Americans and more than 500,000 Europeans will be diagnosed with both invasive and in situ breast cancers.1,2 Breast-preserving surgery will initially be performed on approximately 60% of...

Breast Cancer

Early Data Suggest Activity for Oral Selective Estrogen Receptor Degrader in Combination Regimen

The availability of an oral selective estrogen receptor degrader (SERD) would be good news for patients and clinicians as an alternative to intramuscular fulvestrant. The novel agent LSZ102 might fit the bill, based on early activity shown in combination with the targeted agents ribociclib and...

Breast Cancer

Expert Point of View: Julia R. White, MD

Julia R. White, MD, Professor of Radiation Oncology at The Ohio State University, Columbus, and the invited discussant of E2108, put these findings into context with three important studies evaluating the benefit of locoregional therapy for de novo stage IV breast cancer: the study from Tata...

Breast Cancer

Study Finds No Survival Benefit From Local Therapy for de Novo Metastatic Breast Cancer

Women presenting with newly diagnosed de novo metastatic breast cancer derived no additional survival benefit from surgery and radiotherapy given after systemic treatment, although the practice may reduce locoregional progression of disease, according to the results of the phase III E2108 study...

Breast Cancer

Expert Point of View: Susan Domchek, MD, and Aditya Bardia, MD, MPH

“PARP inhibitors are a major advance in the treatment of BRCA1- and BRCA2-mutated tumors, including prostate, breast, ovarian, and pancreatic cancers,” said discussant Susan Domchek, MD, Director of the Basser Center for BRCA at Penn Medicine’s Abramson Cancer Center in Philadelphia. Nevertheless,...

Breast Cancer

Talazoparib Yields No Overall Survival Benefit in EMBRACA Trial Update

The poly (ADP-ribose) polymerase inhibitor talazoparib did not improve overall survival in women with metastatic HER2-negative breast cancer and mutations in the BRCA1 and BRCA2 genes, according to new results from the phase III EMBRACA trial presented at the 2020 American Association for Cancer...

Breast Cancer

Cognitive Impairment in Women Treated for Early Breast Cancer: Chemoendocrine Adjuvant Therapy vs Endocrine Therapy Alone

Women with early-stage breast cancer who received adjuvant chemoendocrine therapy reported greater cognitive impairment at 3 and 6 months than women receiving adjuvant endocrine therapy alone, according to the results from a subgroup of women participating in the TAILORx trial.1 By 12 months, the...

Breast Cancer
Issues in Oncology

Comprehensive Overview of How to Start or Improve a Breast Cancer Unit on the Global Stage

Breast cancer is the leading cause of cancer death among women worldwide. As populations age, the incidence of cancer inevitably increases—the World Health Organization has predicted a dramatic increase in global breast cancer cases during the next 15 years. Moreover, breast cancer is increasing in ...

Breast Cancer

Sacituzumab Govitecan-hziy for Previously Treated Metastatic Triple-Negative Breast Cancer

On April 22, 2020, the antibody-drug conjugate sacituzumab govitecan-hziy was granted accelerated approval for treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.1,2 Supporting Efficacy Data Approval was...

Breast Cancer
Immunotherapy

Study Explores Adding Trastuzumab to Radiotherapy for Women With HER2-Positive DCIS

The addition of trastuzumab to radiotherapy did not reach the protocol objective of a 36% reduction in the ipsilateral breast tumor recurrence rate for women with HER2-positive ductal carcinoma in situ (DCIS) in the NRG Oncology clinical trial NSABP B-43. The trial did find a modest (19%) reduction ...

breast cancer

Sara A. Hurvitz, MD, on Breast Cancer: Four Major Studies on Trastuzumab, Pertuzumab, Anthracyclines, and Chemotherapy De-escalation

Sara A. Hurvitz, MD, of UCLA’s David Geffen School of Medicine, summarizes four breast cancer studies: KATHERINE, on adjuvant trastuzumab vs trastuzumab in patients with residual invasive disease after neoadjuvant therapy for HER2-positive breast cancer; KAITLIN, on trastuzumab emtansine and pertuzumab vs trastuzumab, pertuzumab, and taxane after anthracyclines as adjuvant therapy for high-risk HER2-positive early breast cancer; TRAIN-2, on neoadjuvant chemotherapy with or without anthracyclines for HER2-positive disease; and PHERGain, on chemotherapy de-escalation using an FDG-PET/CT and pathologic response–adapted strategy in HER2-positive early breast cancer (Abstracts 500, 501, 502, and 503).

breast cancer

Cynthia X. Ma, MD, PhD, on Breast Cancer: Neoadjuvant Endocrine Treatment for ER-Positive, HER2-Negative Disease

Cynthia X. Ma, MD, PhD, of Washington University, discusses results from the ALTERNATE trial, which showed neither fulvestrant nor fulvestrant plus anastrozole significantly improved endocrine-sensitive disease rate compared with anastrozole alone in postmenopausal patients with locally advanced estrogen receptor–positive, HER2-negative breast cancer (Abstract 504).

Breast Cancer
Gynecologic Cancers
Genomics/Genetics

Remote Pre- and Posttest Genetic Counseling for Breast and Ovarian Cancer Risk

Genetic testing for cancer risk can significantly improve the prevention or treatment of hereditary cancers, but studies have shown that people who might have a genetic risk often don't get tested. A collaborative team of researchers have tested a possible solution through a clinical trial aimed at ...

Breast Cancer

Renowned Researcher and Surgeon Helps to Transform Treatment of Breast Cancer

Although ‘paradigm shifts’ are frequently referenced in oncology, these are really few and far between. They occur when new data either partially invalidate previously accepted theory or are at complete odds with the existing paradigm. Moving away from the Halsted radical mastectomy, a standard of ...

breast cancer

Seema A. Khan, MD, MPH, on Metastatic Breast Cancer: Systemic vs Locoregional Therapies

Seema A. Khan, MD, MPH, of the Lynn Sage Comprehensive Breast Center, discusses phase III trial results showing that in newly diagnosed metastatic stage IV breast cancer, locoregional treatment of the primary tumor did not offer a greater survival benefit than systemic therapy (Abstract LBA2).

Breast Cancer
Kidney Cancer
Prostate Cancer

Expert in Clinical Trial Methodology Makes His Mark in Genitourinary Cancer

In 2019, at the ASCO Annual Meeting, Ian Tannock, MD, PhD, DSc, FASCO, was honored with the Allen S. Lichter Visionary Award for his contributions to the fields of genitourinary and breast cancers as well as his efforts to optimize clinical trial design. The title of his lecture was “Clinical...

Breast Cancer

Love of Science and a Family Tragedy Set the Course for This Breast Cancer Researcher

When oncology luminary Joyce A. O’Shaughnessy, MD, was in her early teens, her youngest sister, Teri, developed acute lymphocytic leukemia at age 5. Dr. O’Shaughnessy, the oldest of four girls, recalled that her sister’s struggle with the disease had a profound effect on her worldview. “Teri went...

Breast Cancer

Early Local Therapy Did Not Extend Survival in Patients With Newly Diagnosed Metastatic Breast Cancer

Women who present at diagnosis with advanced breast cancer have faced an unanswered question: will local therapy, consisting of surgery and radiation to the tumor in the breast, prolong survival compared to the traditional treatment of systemic treatment alone? Now, data from the randomized phase...

breast cancer

Fatima Cardoso, MD, on Breast Cancer: MammaPrint as Guidance for Adjuvant Chemotherapy

Fatima Cardoso, MD, of Lisbon’s Champalimaud Cancer Center, discusses the long-term results of MINDACT, a large prospective trial showing the clinical utility of the 70-gene signature MammaPrint for adjuvant chemotherapy decision-making. The primary distant metastasis–free survival endpoint at 5 years continued to be met in chemotherapy-untreated women with clinical-high/genomic-low risk disease (Abstract 506).

breast cancer

Nancy U. Lin, MD, on Metastatic Breast Cancer: Tucatinib, Trastuzumab, and Capecitabine

Nancy U. Lin, MD, of Dana-Farber Cancer Institute, discusses the HER2CLIMB study of patients with previously treated HER2-positive metastatic breast cancer that had metastasized to the brain. Adding tucatinib to trastuzumab and capecitabine doubled the intracranial response rate and reduced the risk of death by nearly half, compared with trastuzumab plus capecitabine (Abstract 1005).

Breast Cancer

Tucatinib Combination in Previously Treated HER2-Positive Metastatic Breast Cancer With Brain Metastases

In an analysis of the pivotal phase III HER2CLIMB trial to be reported at the ASCO20 Virtual Scientific Program, Nancy U. Lin, MD, and colleagues found that tucatinib, a small-molecule tyrosine kinase inhibitor that is highly selective for HER2, plus trastuzumab/capecitabine significantly improved...

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