FDA Approves New Indication for FASLODEX® (Fulvestrant)

“AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved a new indication expanding the use of FASLODEX® (fulvestrant) to include use in combination with palbociclib. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy. FASLODEX has been approved since 2002 as a monotherapy for the treatment of postmenopausal women with HR+ MBC whose cancer has progressed following antiestrogen therapy.

“Estrogen receptor (ER) positive breast cancer is the most common subtype of breast cancer and one of the key drivers of disease progression for this subtype is through the ER. Laboratory studies show that FASLODEX directly targets the ER by blocking and degrading the ER, helping to inhibit tumor growth.”


ASCO Recommends Ovarian Suppression for ER-Positive Breast Cancer

“An American Society of Clinical Oncology (ASCO) expert panel issued an updated guideline recommending that higher-risk premenopausal women with estrogen receptor (ER)-positive breast cancer receive ovarian suppression in addition to adjuvant endocrine therapy. Lower-risk patients, however, should not receive ovarian suppression.

“ ‘In the past year, randomized trials with robust methodological designs have analyzed the effect of ovarian suppression among premenopausal women with ER-positive breast cancers treated with tamoxifen,’ wrote the panel, led by ASCO expert Harold J. Burstein, MD, PhD, of Dana-Farber Cancer Institute in Boston. In the past, studies of this therapy have suffered from problems such as selection criteria confounding.

“The guideline update is based on four randomized controlled trials. These include the Eastern Cooperative Oncology Group 3193 (E-3193) trial, the Suppression of Ovarian Function Trial (SOFT), the Tamoxifen and Exemestane Trial (TEXT), and the Austrian Breast Cancer Study Group (ABCSG)-12 trial. Overall, the studies did not find a significant difference with regard to overall survival between tamoxifen alone, tamoxifen plus ovarian suppression, or aromatase inhibitors (AIs) plus ovarian suppression. The guideline update was published in the Journal of Clinical Oncology.”


New Image Analytics May Offer Quick Guidance for Breast Cancer Treatment

“For women with the most common type of breast cancer, a new way to analyze magnetic resonance images (MRI) data appears to reliably distinguish between patients who would need only hormonal treatment and those who also need chemotherapy, researchers from Case Western Reserve University report.

“The analysis may provide women diagnosed with estrogen positive-receptor (ER-positive)  answers far faster than current tests and, due to its expected low cost, open the door to this kind of testing worldwide.

“The research is published in the journal Nature Scientific Reports.”


Putting Immune Checkpoint Blockade to the Test in Breast Cancer


About 10 months ago, we asked: Is There a Future for Immunotherapy in Breast Cancer? Now, we can answer this question with a qualified “yes.” The data show why:

Triple-negative breast cancer (TNBC)

TNBC has long been considered to be more amenable to immune system-based treatments than other types of breast cancer because it is more immunogenic; that is, relatively high levels of immune cells accumulate within or adjacent to TNBC tumors. These immune cells could be triggered to attack tumors if properly activated. TNBC tumors are also likely to have a higher mutational burden (number of genetic mutations). This is one of the predictors of sensitivity to a type of treatment called immune checkpoint blockade.  Drugs known as checkpoint inhibitors block the proteins PD-1 or PD-L1. In cancer, PD-L1 proteins on tumor cells bind to PD-1 proteins on immune T cells and inhibit their tumor-killing activity. Immune checkpoint drugs disable this interaction and enable activation of T cells. These drugs are actively being explored in TNBC in clinical trials.

Continue reading…


Resistance Mutations: Next in ER+ Metastatic Breast Cancer?

“Estrogen receptor (ER) mutations can be easily detected in the plasma of patients with metastatic breast cancer and may hold the key to targeted treatments for women with endocrine-resistant disease, according to new analysis of patients in the BOLERO-2 trial.

” ‘Patients who had mutations had a shorter median survival than those who did not…and patients with different mutations might have different responses to therapies,’ Sarat Chandarlapaty, MD, PhD, a breast medical oncologist from Memorial Sloan Kettering Cancer Center in New York reported at the San Antonio Breast Cancer Symposium.

“BOLERO-2 enrolled postmenopausal women with metastatic, endocrine-resistant, ER-positive breast cancer and changed the standard of care in this setting, as reported by Medscape Medical News.”


One-Two Punch of Palbociclib, Paclitaxel Shows Promise against Advanced Breast Cancer

“Combining the new breast cancer drug palbociclib with paclitaxel (Taxol) shrank tumors in nearly half of patient with estrogen-receptor (ER) positive breast cancer, according to new research from the Perelman School of Medicine at the University of Pennsylvania. The results will be presented Saturday at the 2015 San Antonio Breast Cancer Symposium. A second study provides new clues to how breast cancer develops resistance to the palbociclib, a common occurrence among many patients who take the drug.

” ‘Results of the first study found that palbociclib and paclitaxel can be safely combined on an alternating dosing schedule,’ said Angela DeMichele, MD, MSCE, the Alan and Jill Miller Associate Professor in Breast Cancer Excellence in Penn’s Abramson Cancer Center, and senior author on the study. ‘The high response rate we saw suggests this combination may hold benefits for patients over paclitaxel alone. Based on these results, a larger clinical trial to determine the benefits is warranted.’ “


To Type or to Print? Oncotype DX and Mamma/BluePrint Tests for Breast Cancer


Women diagnosed with localized breast cancer face difficult decisions with their doctors. What kind of neoadjuvant (before surgery) treatment to choose? Should chemotherapy follow surgery? Based on the subtype of breast cancer, should specific chemotherapy drugs be used? Continue reading…


Four-Gene Model Predicts Response to Aromatase Inhibitor Therapy for Breast Cancer

“As reported in the Journal of Clinical Oncology, Turnbull et al identified a four-gene predictive model of response to aromatase inhibitor therapy that was highly predictive of response on the basis of pretreatment and 2-week on-treatment measurements. The classifier was a significant predictor of recurrence-free and breast cancer–specific survival.

“In the study, 89 postmenopausal women who had estrogen receptor-alpha–positive breast cancer and were receiving neoadjuvant letrozole underwent biopsy for transcript profiling before letrozole treatment and at 2 weeks and 3 months after starting treatment. Dynamic clinical response was assessed by three-dimensional ultrasound measurements.

“Molecular response to letrozole was characterized, and a four-gene classifier of clinical response was identified. The classifier consisted of levels of two genes before treatment (IL6ST, associated with immune signaling, and NGFRAP1, associated with apoptosis) and the levels of two proliferation genes (ASPM and MCM4) after 2 weeks of therapy.”


ASCO Highlight: Another Treatment Option for ER-Positive Breast Cancer


Earlier this year, a new treatment option was added to the arsenal for ER-positive breast cancer in postmenopausal women when the U.S. Food and Drug Administration (FDA) approved the combination of letrozole (Femara) and palbociclib (Ibrance). Continue reading…