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12:00 AM
Apr 20, 2015
 |  BioCentury  |  Regulation

Getting personal in breast cancer

Breast cancer patients tell FDA they want more precision in risk-benefit data

At its patient-focused drug development workshop on breast cancer, FDA departed from its normal script of asking patients what they were seeking in a new treatment and instead probed how patients weigh benefits and risks when choosing among existing therapies.

Some of the suggestions from patients who attended the April 2 workshop reflect ideas that industry has already adopted, such as developing prognostic tests that can predict responses to treatment and side effects. But the discussion also highlighted that in some cases, what is logical and desirable to patients cannot easily be delivered within the current regulatory and drug development framework.

The discussion also highlighted that patient decision-making criteria are highly variable, both across and within different subgroups.

"For young women out there, particularly those raising families - they are willing to put up with so much more toxicity for the sake of being there as long as they possibly can for their children," said Ginny Knackmuhs, VP of the Metastatic Breast Cancer Network (MBCN), who was initially diagnosed in 1992 and was diagnosed with metastatic disease in 2009.

Quality of life played a bigger role for Susan Faris, who was diagnosed with metastatic breast cancer in 2012.

"My goal is to avoid systemic chemotherapy due to extreme side effects and disabling qualities. When I've exhausted targeted treatment, if my quality of life is greatly minimized, I will turn the systemic chemotherapies down and I will choose the right to die," she said.

"The challenges really lie in the metastatic setting, where treatment right now goes on until you die, and the toxicities can be very consuming and impact quality of life," said MBCN President Shirley Mertz. She was diagnosed with early stage breast cancer in 1991 and metastatic disease in 2003.

However, for Colleen Duffey, who was diagnosed with stage IV HER2+ breast cancer in 2012, the biggest downside of any treatment was becoming resistant to it.

"I would be...

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