BREAST CANCER

23andMe, Inc. has received authorization from the FDA for the first-ever direct-to-consumer genetic test for cancer risk.

Susan M. Domchek, MD, director of the Basser Center for BRCA at Penn Medicine, discusses the role biomarkers have in the treatment of patients with breast cancer. Identifying biomarkers in patients early on, such as knowledge of estrogen receptor status, can lead to better treatment plans, Domchek says.

Fatima Cardoso, MD, medical oncologist at the Champalimaud Clinical Centre in Portugal, explains the biggest issue in treatment of male breast cancer is due to lack of education. Male patients are most commonly diagnosed in the advanced stages because of this and are commonly given the wrong treatments, says Cardoso.

Lung Cancer

According to findings published in<em> Nature Communications, </em>a&nbsp;blood test detecting early changes in circulating tumor DNA (ctDNA) may provide earlier indication of whether patients with hormone receptor&ndash;positive, HER2-negative breast cancer are responding to the CDK4/6 inhibitor palbociclib (Ibrance).

A wave of novel treatments and FDA approvals have flooded the HER2-positive breast cancer space.

New indications were approved by the FDA within the last month, including abemaciclib for HER2-negative breast cancer, durvalumab for non&ndash;small cell lung cancer, and abiraterone acetate for castration-sensitive prostate cancer.

According to results from a retrospective study published in the <em>Journal of Clinical Oncology, </em>low-coverage genome-wide sequencing of cell-free DNA from plasma is capable of profiling cancer genomes from blood and predicting survival outcomes for patients with metastatic triple-negative breast cancer.

Based on data from the phase III MONARCH 3 trial, abemaciclib has been granted FDA approval for use in combination with an aromatase inhibitor for the frontline treatment of postmenopausal women with HR-positive, HER2-negative advanced or metastatic breast cancer,&nbsp;according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

In a final analysis of the phase III CALOR trial, the survival benefit demonstrated with adjuvant chemotherapy&nbsp;was sustained in patients with ER-negative breast cancer with isolated locoregional recurrence.

The optimal neoadjuvant chemotherapy regimen in triple-negative breast cancer has not been clearly defined. Achieving a pathologic complete response provides important prognostic information, and, especially in TNBC, is considered a surrogate endpoint for event-free survival.

Lisa A. Carey, MD, professor, UNC Lineberger Comprehensive Cancer Center, discusses the CALGB 40502/NCCTG N063H trial in patients with triple-negative breast cancer, a randomized phase III trial of paclitaxel compared with nab-paclitaxel or ixabepilone with bevacizumab as first-line chemotherapy for locally recurrent or metastatic breast cancer.<br /> &nbsp;

A novel therapeutic vaccine, TPIV200, is being investigated in a new randomized, multicenter, double-blinded, placebo-controlled phase II clinical trial in patients with triple-negative breast cancer TNBC.

Priyanka Sharma, MD, has been named vice chair of SWOG&rsquo;s Breast Committee. Formerly known as the Southwest Oncology Group, SWOG is a global cancer research community and 1 of 5 National Cancer Institute (NCI) National Clinical Trials Network-funded groups.

Findings from a phase Ia, multicenter, open-label, study published in the&nbsp;<em>Journal of Clinical Oncology</em>&nbsp;showed a disease control rate of 58.2% with alpelisib (BYL719) in patients with advanced solid tumors.

Eflapegrastim (Rolontis), a novel long-acting granulocyte-colony stimulating factor, has met its primary endpoint of non-inferiority in duration of severe chemotherapy-induced neutropenia in comparison with pegfilgrastim (Neulasta) in the phase III ADVANCE study, according to Spectrum Pharmaceuticals, Inc., the biotechnology company developing the agent.