Earlier Indicator of Palbociclib Response Found for Patients with Breast Cancer

Excerpt:

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

“The test could detect a response within 2 to 3 seeks, said investigators with The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust. Women currently wait 2 to 3 months to find out if palbociclib treatment is working for them.”

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Updated Data from Phase 3 Trial of Ibrance® (Palbociclib) plus Letrozole in ER+, HER2- Metastatic Breast Cancer Confirm Improvement in Progression-Free Survival

Excerpt:

“Pfizer Inc. (NYSE:PFE) today announced updated progression-free survival (PFS) results from the Phase 3 PALOMA-2 trial reinforcing the clinical benefit of IBRANCE® (palbociclib) combined with letrozole. The data, which will be presented at the 2017 San Antonio Breast Cancer Symposium (SABCS) on December 8 [abstract #P5-21-03], demonstrate that the combination of IBRANCE plus letrozole reduced the risk of disease progression by 44 percent and improved median PFS by more than one year compared to letrozole plus placebo (27.6 months [95% CI: 22.4, 30.3] vs 14.5 months [95% CI: 12.3, 17.1]) when used as the initial treatment for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer (HR=0.56 [95% CI: 0.46, 0.69]). This updated, post-hoc analysis included a median follow-up of more than three years, which is the longest to date of any Phase 3 study of a CDK 4/6 inhibitor.”

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Novartis Takes Fight to Pfizer’s Ibrance with New Kisqali Data

Excerpt:

“New data from Novartis’s breast cancer drug Kisqali underscored its effectiveness in pre-menopausal women, the Swiss drugmaker said, amid efforts to muscle in on turf dominated by rival Pfizer’s Ibrance.

“A late-stage trial showed Kisqali, in concert with hormonal therapies, halted the advance of hormone-receptor positive, human epidermal growth factor receptor-2 negative advanced breast cancer in pre-menopausal women for longer than in women getting hormonal therapy alone, Novartis said on Wednesday.”

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Fulvestrant Gains New Breast Cancer Indication

Excerpt:

“The FDA expanded the indications for fulvestrant (Faslodex) to include use as first-line monotherapy in postmenopausal women with estrogen receptor-positive, HER-2 negative breast cancer, drugmaker AstraZeneca said Monday.

“Previously the drug was approved as second-line monotherapy for women failing anti-estrogen therapy, and as second-line combination therapy with palbociclib (Ibrance). It was first approved by the FDA in 2002.”

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Potential Treatment for Brain Cancer as Drug Shrinks Tumours

Excerpt:

“An international team of researchers has found a drug previously approved to treat breast cancer could also be used to shrink medulloblastoma, a common form of childhood brain tumour.

“The discovery, made by The University of Queensland’s Institute for Molecular Bioscience and the Fred Hutchinson Cancer Research Center in Seattle, has led to a clinical trial using the drug palbociclib to treat children with medulloblastoma, the most common malignant brain tumour found in children.”

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Expert Explains Individualized Decision on Endocrine Therapy Beyond 5 Years in Breast Cancer

Excerpt:

“Endocrine therapy remains an integral part of the treatment paradigm for patients with estrogen receptor (ER)–positive breast cancer; however, questions remain on which patients should continue their therapy beyond 5 years.

” ‘The idea [is] that most patients with hormone receptor (HR)-positive breast cancer who are still on endocrine therapy at 5 years are going to merit some sort of discussion about whether they should continue or not, and it is okay to individualize that decision on the basis of the patient preferences, side effects, and symptom burden,’ said Amye J. Tevaarwerk, MD.”

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In Metastatic Breast Cancer Treatment, Not All CDK Inhibitors Are Equal


Doctors prescribe drugs known as CDK inhibitors to treat some women with estrogen-receptor-positive (ER+) metastatic breast cancer. Research into these drugs is ongoing, and new, promising CDK inhibitor options are on the horizon. Here, I address the current outlook for CDK inhibitors in ER+ breast cancer.

First, some background: ER+ breast cancers comprise about 70% of all breast cancers. The name reflects the fact that cells of these cancers express estrogen receptors (ERs), which are protein features targeted by many treatment strategies for this cancer type. The estrogen receptor (ER) protein is a treatment target not only because “it is there,” but mainly because it drives tumor cell proliferation in ER+ breast cancer. The activity of the ER depends on its binding to the hormone estrogen, and treatments known as endocrine drugs aim to prevent this interaction. Some endocrine drugs inhibit the synthesis of estrogen in the body (e.g., aromatase inhibitors, such as letrozole and anastrozole), and others prevent the interaction of estrogen with ERs (e.g., ER modulators such as tamoxifen, or the pure anti-estrogen drug fulvestrant). The problem of course is that, in metastatic breast cancer, resistance develops to each and every endocrine drug used. Continue reading…


Results of Two Practice-Changing Breast Cancer Trials Upheld

Excerpt:

“Results of two pivotal breast cancer trials reported at the 2016 ASCO Annual Meeting confirmed the practice-changing findings that resulted from earlier findings.

“The phase III PALOMA-2 trial confirmed results from the smaller, open-label phase II PALOMA-1 trial that led to the U.S. Food and Drug Administration (FDA) approval of the cyclin-dependent kinase 4/6 inhibitor palbociclib (Ibrance). The drug was approved in combination with letrozole for the first-line treatment of metastatic disease.

“ ‘These data represent the longest front-line improvement in median progression-free survival seen to date in women with advanced estrogen receptor (ER)-positive breast cancer,’ said Dennis Slamon, MD, Director of Clinical/Translational Research and Professor of Medicine at the University of California, Los Angeles, and Director of the Revlon/UCLA Women’s Cancer Research Program.”

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Palbociclib Addition to Letrozole Improved PFS in ER+/HER2- Breast Cancer

Excerpt:

“Palbociclib (Ibrance), when added to letrozole, increased the median progression-free survival (PFS) rate in patients with ER-positive, HER2-negative advanced or metastatic breast cancer by >10 months, according to results from the phase III PALOMA-2 trial presented at the 2016 ASCO Annual Meeting. 

“The risk of disease progressed was reduced by 42 with the addition of palbociclib, a CDK4/6 inhibitor, when compared with letrozole alone. The combination of palbociclib and letrozole was granted an accelerated approval in February 2015, based on the phase II PALOMA-1 study. These results from PALOMA-2 provide confirmation of the combination’s benefits in the frontline setting.

“ ‘These data represent the longest frontline improvement in median PFS seen to date in women with advanced ER+ breast cancer,’ senior study author Dennis J. Slamon, MD, PhD, chief of the Division of Hematology/Oncology in the UCLA Department of Medicine, said when presenting the findings at ASCO.”

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