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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