Breast Cancer

On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.
Lisocabtagene maraleucel (liso-cel), an investigational CD19-directed chimeric antigen receptor (CAR) T-cell therapy, has induced durable responses in high-risk patients with ag­gressive relapsed or refractory non-Hodg­kin lymphoma (NHL), according to data presented at ASCO 2018.
One of the most important stud­­­ies presented at ASCO 2018 showed that endocrine therapy alone was noninferior to endocrine therapy plus chemotherapy in women with estrogen receptor (ER)-positive, HER2-­negative, node-negative early-stage breast cancer and an intermediate risk score (score, 11-25) on the Oncotype DX gene-expression assay for breast cancer.
A novel drug is showing significant promise in metastatic breast cancers, offering renewed hope to patients with late-stage, difficult-to-treat solid tumors. According to data presented at ASCO 2018, sacituzumab govitecan demonstrated significant clinical activity as a single agent in heavily pretreated patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer.
The current standard of care for women with early, HER2-positive breast cancer is 12 months of trastuzumab (Herceptin). Analysis of the phase 3 randomized clinical trial PERSEPHONE showed that 6 months of treatment with trastuzumab was noninferior to 12 months in terms of disease-free survival. Furthermore, a shorter course of trastuzumab was associated with a 50% reduction in cardiotoxicity leading to cessation of therapy.
When breast cancer recurs or is diagnosed at an advanced stage, treatment is complicated by the diverse nature of the disease, with several molecular subgroups with distinct tumor biology responding differently to different therapies.
Chicago, IL—The PARP inhibitor olaparib (Lynparza) significantly improved progression-free survival (PFS) compared with standard chemotherapy in women with HER2-negative metastatic breast cancer with a germline BRCA mutation. Disease progression was delayed by approximately 3 months with olaparib in the multinational, randomized, open-label, phase 3 OlympiAD clinical trial, reported Mark E. Robson, MD, Clinic Director, Clinical Genetics Service, Memorial Sloan Kettering Cancer Center, New York City, at the 2017 ASCO annual meeting.
Chicago, IL—The addition of the investigational CDK4/CDK6 inhibitor abemaciclib to fulvestrant (Faslodex) extended progression-free survival (PFS) by 7 months in women with hormone receptor (HR)-positive, HER2-negative advanced breast cancer, reported George W. Sledge, Jr, MD, Professor, Medical Oncology, Stanford University Medical Center, Palo Alto, CA, who presented the results of a large study at the 2017 ASCO annual meeting.

During each patient’s laboratory work-up, oncology specialists rely on findings related to the tumor’s estrogen receptor (ER) and progesterone receptor status, as well as the amplification and overexpression of the human epidermal growth factor receptor 2 (HER2), to direct treatment planning.2,3

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