Trials Show Improved Outcome in Metastatic Breast Cancer Patients


The trial was partially funded by pharmaceutical giant, Novartis. Hortobagyi acts as a consultant and receives research fund from the company, as well.

"The BOLERO study will likely have the most immediacy in terms of patient care," Dr. Ben Ho Park, associate professor in the oncology breast cancer research program at Johns Hopkins Medical Center, wrote in an email. "The drugs used are already FDA approved and so adding the mTOR inhibitor (everolimus) to aromatase inhibitors would be relatively easy to get widespread usage and may afford oncologists the ability to overcome hormone resistance in a subset of breast cancers."

In a similar, second study presented at the symposium, researchers of the CLEOPATRA (CLinical Evaluation Of Pertuzumab And TRAstuzumab) trial found that adding pertuzumab (a medication that is believed to slow tumor growth) and certain chemotherapies lengthened progression-free survival by an average 6.1 months in patients with metastatic breast cancer patients.

"This is huge," Dr. Jose Baselga, lead author of the study and professor of medicine at Harvard Medical School," said in a statement. "It is very uncommon to have a clinical trial show this level of improvement in PFS. ... The fact that we now have an agent that can be added to current treatment to delay progression is very exciting."

While Dr. Vered Stearns, co-director of the Breast Cancer Program at Johns Hopkins, said the results of both trials could be game changers for treatment of metastatic breast cancer patients, progression free survival is a complicated point of treatment.

"The breast cancer community, government agencies and stakeholders should be evaluating what endpoints are most relevant and set proper guidelines," said Stearns.

While some experts argue that progression-free survival lowers the bar for treatment interventions and potential cures, Park said the debate is not so simple.

"It's hard to tell patients that living without overt signs of cancer is of no benefit," said Park. "Symptoms can improve, as well as overall mental well-being. Given the costs and potential side effects associated with new drugs, we understand the reasons behind using certain criteria (i.e. overall survival) as our gold standard for clinical interventions, but this has to be weighed against "meaningful" benefit for patient care which is often harder to define."

Nevertheless, Dr. Jennifer Litton, the principle investigator for Hebert's clinical trial at MD Anderson, said It's always an exciting day to show a patient their tumor has not grown.

"[It's] even better if we can show them their tumor is shrinking, and that they're having a good quality of life -- spending time with their family and doing the things they want to do on their day to day," said Litton.

As for Hebert, the mother of two says the potential for new treatments is a "huge gift."

"I'd like to stay on this treatment as long as possible," said Hebert. "There are so many women out there just like me. We just want options that work better and are less toxic."

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