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Improving Survival for Advanced Breast Cancer with Massimo Cristofanilli, MD

It is possible to improve and prolong the life of patients with hormone receptor-positive metastatic breast cancer, according to the results of a new phase III clinical trial. Massimo Cristofanilli, MD, principal investigator of the trial explains the results and the state of breast cancer in America today.



Massimo Cristofanilli, MD

"We set the new standard. We would like to have every drug from now on to have such an impact on overall survival like Palbociclib did."

Massimo Cristofanilli, MD

  • Professor of Medicine in the Division of Hematology and Oncology

  • Associate Director for Translational Research at the Robert H. Lurie Comprehensive Cancer Center of Northwestern University

Episode Summary

Breast cancer survival rates have been improving since the 1990s, but there's still a significant need for new therapies. Every year, more than 40,000 American women die from breast cancer. Dr. Massimo Cristofanilli has exciting results from a phase three clinical trial he led, published in the New England Journal of Medicine, that shows improved survival rates for women with common forms of advanced breast cancer.

Massimo Cristofanilli: “We have seen a dramatic improvement in survival for a number of reasons. We know early detection has an impact … in advanced disease, patients with metastatic breast cancer, no doubt live much longer with no symptoms. This is due primarily ... to the understanding of the disease and the availability of new drugs that we can offer to our patients.” 

The majority of breast cancers are classified as hormone receptor-positive (HR-positive), indicating that the cancer cells grow in response to hormones, such as estrogen. Patients with HR-positive breast cancer are typically treated with hormone therapy, which prevents estrogen from attaching to receptors and fueling cancer growth. But over time, many patients develop resistance to such treatment, and there is significant need for new therapies for patients with advanced disease.

Massimo Cristofanilli: “As you mentioned, 40,000 women are still dying of advanced breast cancer. Many of these women have aggressive treatment-resistant disease, and they're younger than they used to be … having drugs that improve survival is a very difficult and a challenging call for every new drug. In fact, most of the drugs that we have available in breast cancer have been approved primarily because they prolonged disease control, what is called the progression-free survival and very few, if any, have shown a survival advantage in women that have been treated with a specific type of drug.”

PALOMA-3 evaluated palbociclib in 521 women with HR-positive metastatic breast cancer who had relapsed or progressed after prior hormone therapy. (All participants also had HER2-negative breast cancer, a classification that indicates the cancer has little or no HER2, a protein which drives cancer growth.)

Massimo Cristofanilli: “The group of patients that received the medication had a median overall survival of 34.9 months compared to 28 months ... the overall survival difference was 10 months, so very remarkable, very statistically significant.”

Not only are the women living longer, there is meaningful clinical survival improvement, because use of the drug improves different measures of quality of life.

Massimo Cristofanilli: “Patient are delaying chemotherapy and were staying on the drug for a longer time and when they start the next treatment, they continued to respond to the next treatment. So that's one of the reasons why we feel this is a remarkable result. We set the new standard. We would like to have every drug from now on to have such an impact on overall survival like palbociclib did.”

Read more about the study, which was published in New England Journal of Medicine.

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Continuing Medical Education Credit

Physicians who listen to this podcast may claim continuing medical education credit after listening to an episode of this program.

Target Audience

Academic/Research, Multiple specialties

Learning Objectives

At the conclusion of this activity, participants will be able to:

  1. Identify the research interests and initiatives of Feinberg faculty.
  2. Discuss new updates in clinical and translational research.
Accreditation Statement

The Northwestern University Feinberg School of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Credit Designation Statement

The Northwestern University Feinberg School of Medicine designates this Enduring Material for a maximum of 0.5 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Disclosure Statement

Massimo Cristofanilli, MD, disclosed external professional relationships (consulting) with Pfizer, Inc., Novartis AG, CytoDyn and Merus. Leo Gordon, MD, disclosed external professional relationships (advisory) with Gilead, Bayer Corporation, Celgene/Juno, (founder) Zylem, Inc. Course director, Robert Rosa, MD, has nothing to disclose. Planning committee member, Erin Spain, has nothing to disclose. Feinberg School of Medicine's CME Leadership and Staff have nothing to disclose: Clara J. Schroedl, MD, Medical Director of CME, Sheryl Corey, Manager of CME, Jennifer Banys, Senior Program Administrator, Allison McCollum, Senior Program Coordinator, and Rhea Alexis Banks, Administrative Assistant 2.

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