BREAST CANCER

Breast Cancer

Several oncology experts discuss the FDA approvals they found most significant in 2018.

During a presentation at the 2018 San Antonio Breast Cancer Symposium, data from a subgroup analysis of the phase III TAILORx trial demonstrated worse outcomes in African-American patients compared to Caucasian patients with early breast cancer following adjuvant therapy. Both groups had a similar risk of recurrence and had received similar types of therapy, according the report.

Leisha A. Emens, MD, PhD, professor of medicine at the UPMC Cancer Center, discusses how the data from the IMpassion130 trial have demonstrated benefit for immunotherapy in metastatic triple-negative breast cancer.

CT-P6 received approval from the FDA as a biosimilar for trastuzumab for the treatment of patients with HER2-overexpressing breast cancer.

The first in-human study of CAR T cells targeting the tyrosine kinase receptor ROR1 in patients with solid tumors showed that the cells could be transferred into patients safely and expanded in vivo, according to findings from the ongoing phase I study presented at the 2018 San Antonio Breast Cancer Symposium.

Jame Abraham, MD, discusses the results for the phase Ib study of trastuzumab emtansine with neratinib in patients with HER2-positive breast cancer.

Women who received 5 fractions of 28.5 Gy over 5 weeks experienced similar adverse events as women who received 50.0 Gy in 25 fractions over 5 weeks, according to findings presented by A. Murray Brunt, MB, BS.

Clinicians need to consider the inherent heterogeneity of each case of triple-negative breast cancer during diagnosis and treatment planning, said Stuart J. Schnitt, MD, because not all cases present the same way. During the 2018 Lynn Sage Breast Cancer Symposium, Schnitt reviewed the conventional views of TNBC and emphasized that they may not fit all cases of TNBC.

Based on data from the phase III TAM-01 trial presented at the 41st Annual San Antonio Breast Cancer Symposium, investigators concluded that giving women diagnosed with breast intraepithelial neoplasia a lower dose of tamoxifen following surgery could be as effective and less toxic than the current standard dose.

Charles E. Geyer, Jr, MD, professor of medicine at Virginia Commonwealth University School of Medicine, associate director for clinical research and Harrigan, Haw, Luck Families Chair in Cancer Research at Massey Cancer Center, discusses the impact of pertuzumab (Perjeta) in the treatment of patients with HER2-positive breast cancer at the 2018 San Antonio Breast Cancer Symposium.

At the 2018 San Antonio Breast Cancer Symposium, data demonstrated that use of circulating tumor-cell counts had strong value for selecting endocrine therapy compared to chemotherapy in patients with estrogen receptor–positive, HER2-negative metastatic breast cancer.

Sara A. Hurvitz, MD, director of the Breast Oncology Program, medical director of the Clinical Research Unit, University of California, Los Angeles Jonsson Comprehensive Cancer Center, discusses response to abemaciclib (Verzenio) in the neoMONARCH trial at the 2018 San Antonio Breast Cancer Symposium.

A biomarker subgroup analysis of the phase III IMpassion130 study in patients with metastatic triple negative breast cancer or inoperable locally advanced TNBC found that progression-free survival and overall survival improvements with the addition of first-line atezolizumab  to nab-paclitaxel were exclusive to patients with PD-L1 expression ≥1% in immune cells.

Patients with triple-negative breast cancer who received chemotherapy treatment more than 30 days after surgery had worse survival rates and outcomes than patients who received adjuvant chemotherapy within 30 days of surgery, according to findings from a retrospective study presented at the 2018 San Antonio Breast Cancer Symposium.

Roberto A. Leon Ferre, MD, oncologist, Mayo Clinic, discusses the identification of patients with luminal androgen receptor (LAR) triple-negative breast cancer (TNBC) during the 2018 San Antonio Breast Cancer Symposium.

Adding adjuvant capecitabine to the standard treatment for patients with early-stage triple-negative breast cancer did not lead to a significant improvement in disease-free or overall survival compared with observation, according to findings presented during the 2018 San Antonio Breast Cancer Symposium

Patients with breast cancer who achieved pathologic complete response following neoadjuvant chemotherapy were more likely to have improved survival outcomes, according to findings of a meta-analyses data presented at the 2018 San Antonio Breast Cancer Symposium.

Findings from the phase III KATHERINE study showed adjuvant treatment with ado-trastuzumab emtansine (T-DM1; Kadcyla) reduced the risk of invasive disease recurrence or death by 50% compared with trastuzumab (Herceptin) in patients with HER2-positive early breast cancer who had residual invasive disease following neoadjuvant therapy.

A look back at all the FDA news that happened in the month of November 2018, including several new approvals, priority reviews, a fast track designation, and an accelerated approval, across a variety of cancer types.

Complex drug trials that use a single protocol to test either 1 agent against multiple cancers or multiple agents against 1 cancer can make drug testing faster, cheaper, and more informative, particularly when those trials use the data to constantly improve protocols.