BREAST CANCER

In October 2019, the FDA approved a new treatment option for patients with advanced ovarian, fallopian tube, or primary peritoneal cancer, as well as a new dosing regimen for patients receiving moderately emetogenic chemotherapy. Additionally, the FDA granted breakthrough therapy designations to 2 therapies, as well as an orphan drug designation, a priority review, and 2 fast track designations.

Hope S. Rugo, MD, discusses the potential role of immunotherapy for the treatment of patients with triple-negative breast cancer (TNBC), based on data from the KEYNOTE-522 clinical trial. Immunotherapy has been very exciting in this setting.

William Gradishar, MD, began his discussion at the 2019 Lynn Sage Breast Cancer Symposium by summarizing the improvements different modalities have brought to pCR rates in recent years.

An expanded treatment array that uses PARP inhibitors, antibody–drug conjugates, and inhibitors of the AKT and MEK pathways gives patients with triple-negative breast cancer reason for hope.

Updated breast cancer guidelines have led to clearer diagnosis and management protocols in the past 2 decades, making them a necessary tool to help oncologists stay current in the face of a rapidly evolving knowledge base. To address less common HER2 result patterns, updated guidelines are reclassifying these cases to either HER2-negative or -positive groupings.

Immunotherapy may become one of the most prevalent forms of therapy for breast cancer, explained Rita Nanda, MD, during a presentation at the 2019 Lynn Sage Breast Cancer Symposium.

In an interview with Targeted Oncology, Hannah Linden, MD, discussed the current treatment landscape during Breast Cancer Awareness Month. She also highlighted the value of liquid biopsy, tissue biopsy, and imaging techniques in this space for identifying patients with targetable mutations and how these assays and techniques can further impact treatment and outcomes of these patients.

According to a statement from the FDA, the agency has issued a draft guidance proposing labeling recommendations for breast implant manufacturers that would help patients understand the benefits and risks of implants. The labeling recommendations would include the addition of a boxed warning.

An updated Biologics License Application has been submitted to the FDA for eflapegrastim for the treatment of neutropenia in patients with cancer receiving myelosuppression drugs, according to a press release from Spectrum Pharmaceuticals.

In an interview with <em>Targeted Oncology</em>, at the Lynn Sage Breast Cancer Symposium, Susan Domchek, MD, explained the meaning of low to moderate penetrance genes and how they are indicative of breast cancer risk. She also explained the importance of germline and genetic testing to reveal mutations in these genes.&nbsp;

Margetuximab, an investigational monoclonal antibody, prolonged survival in pretreated patients with HER2-positive metastatic breast cancer when combined with chemotherapy, according to the second interim analysis of the phase III SOPHIA trial, which was reported in a press release from MacroGenics.<br /> &nbsp;

The FDA has approved a supplemental New Drug Application for a single dose of aprepitant injectable emulsion for intravenous use in patients receiving moderately emetogenic chemotherapy. The approval expands the dose for aprepitant to include a 130 mg single-dose regimen for the prevention of acute and delayed chemotherapy-induced nausea and vomiting.<br /> &nbsp;

In the HER2CLIMB trial, the addition of tucatinib to trastuzumab and capecitabine significantly improved progression-free survival in patients with locally advanced, unresectable, or metastatic HER2-positive breast cancer, meeting the primary endpoint of the study, according to a press release from Seattle Genetics.<br /> &nbsp;

The triplet combination of abemaciclib, trastuzumab, and fulvestrant showed a significant statistical improvement in progression-free survival compared with chemotherapy and trastuzumab in patients with heavily pretreated, hormone receptor&ndash;positive, HER2-positive breast cancer, according to the results of the phase II monarcHER trial.

The FDA has accepted and granted a priority review to a biologics license application for [fam-] trastuzumab deruxtecan (DS-8201) for the treatment of patients with HER2-positive metastatic breast cancer.

A phase III trial, HER2CLIMB-02, has been initiated to investigate the combination of tucatinib and ado-trastuzumab emtansine in patients with locally advanced or metastatic HER2-positive breast cancer.&nbsp;The results of the trial will support registration for tucatinib in the United States.

A greater understanding of the mechanisms underlying endocrine resistance, along with the development of targeted agents directed at key regulatory oncogenic pathways, continue to lead to new options in the treatment of hormone receptor&ndash;positive, HER2-negative breast cancer. These therapies offer the promise of better disease control rates and improved quality of life for patients with advanced disease.

Following the 2019 ESMO Congress, experts across various fields highlighted some next steps and how these treatment options will improve the treatment landscape for patients with ovarian, lung, breast, GI, or GU cancers. Overall, the abstracts presented at this year&rsquo;s meeting will change the treatment paradigm in a number of patient populations.

The introduction of<strong> </strong>CDK4/6 inhibitors for the treatment of hormone receptor&ndash;positive, HER2-negative breast cancer has transformed therapy management and extended survival for this patient population. The next step in the process of tailoring therapy towards individual patients is the introduction of targeted therapies for patient subsets with driver aberrations.

The addition of direct oral oral anticoagulants for the management of venous thromboembolism in patients with cancer is the latest change to previous guidelines issued by the American Society of Clinical Oncology.

Cynthia X. Ma, MD, PhD discusses the challenges with understanding treatment duration for adjuvant endocrine therapy in patients with breast cancer.

The approval of alpelisib in May 2019 poses a challenge to oncologists and their practices with the emergence of hyperglycemia as an AE associated with PI3K inhibitors. Managing the patient effectively requires a multidisciplinary team approach that involves counseling up front, monitoring throughout the course of therapy, and input and feedback from the team of oncologists, advanced practice providers, pharmacists, and dietitians.

Using a measure known as the growth modulation index, patients with TRK fusion&ndash;positive cancers who were treated with larotrectinib had a clinically meaningful improvement in progression-free survival compared with the time to progression on their prior treatment, an analysis of patients enrolled in 1 of 3 clinical trials has found.

The FDA has approved a labeling supplement for neratinib for the extended adjuvant treatment of patients with HER2-positive early-stage breast cancer. The labeling supplement adds safety information based on interim findings from the phase II CONTROL trial, which investigated the use of preventive strategies to reduce the incidence and severity of neratinib-associated diarrhea.

George Sledge, Jr., MD, discusses the overall survival data of the phase III MONARCH-2 trial in advanced hormone receptor-positive, HER2-negative breast cancer.

CDK4/6 inhibitor&nbsp;abemaciclib plus endocrine therapy led to significant benefits in a population of predominantly Chinese women with advanced&nbsp;hormone receptor&ndash;positive/HER2-negative breast cancer, according to data from 2 randomized trials presented at the 2019 ESMO Congress.

Three clinical trials presented at the 2019 ESMO Congress show that the tropomyosin receptor kinase&nbsp;inhibitor larotrectinib continues to show anti-tumor activity, including long-lasting objective responses and low toxicity, according to results from an integrated analysis.

Results from the phase III MONARCH 2 trial showed that the addition of the CDK4/6 inhibitor abemaciclib to fulvestrant improved overall survival by 9.4 months compared with fulvestrant and placebo in patients with hormone receptor&ndash;positive, HER2-negative advanced breast cancer who progressed on prior endocrine therapy, according to data presented at the 2019 ESMO Congress.

A subgroup of patients with triple-negative breast cancer who had immune cell PD-L1 expression, by the SP142 immunohistochemistry assay had responses to atezolizumab and nab-paclitaxel, regardless of whether they had primary or metastatic disease, according to an exploratory biomarker substudy of IMpassion130.

Patients with advanced hormone receptor&ndash;positive, HER2-positive breast cancer had improved progression-free survival when receiving the CDK4/6 inhibitor abemaciclib and endocrine therapy with trastuzumab compared with trastuzumab and chemotherapy, according to findings from the randomized phase II monarcHER trial.¹