Jul 18, 2017 9:00 AM


Matthew Poppe, MD
Matthew Poppe, MD

Phase II Study Demonstrated Safety; Phase III Trial in Development

SALT LAKE CITY – Research published in the Journal of Clinical Oncology demonstrates that a shorter course of radiation may be a good option for breast cancer patients who need radiation following mastectomy. The Phase II clinical trial examined the safety of treating women with a three-week course of radiation instead of the traditional six weeks.

The study was run by physician Matthew Poppe, MD, of Huntsman Cancer Institute (HCI) at the University of Utah. He explains, “These women did as well, if not better, than expected, in regards to their treatment side effects and low breast cancer recurrence rates. Based on this small study, it appears likely that a short course of radiation may be as safe and effective as the traditional six-week course.”

The clinical trial was designed to discover a more convenient schedule of radiation for women who’ve undergone a mastectomy. Receiving radiation treatments five days a week for six weeks can cause financial, work, family, and emotional stress. At HCI, many patients live more than an hour away and often need to relocate to Salt Lake City for the duration of treatment.

A shorter radiation course holds significant benefits for patients. “It’s about improving the quality of life of women with breast cancer,” says Poppe. “It gives them three weeks of their life back. There will be significant cost savings in not having to miss three extra weeks of work. There’s less strain on their family, less time away from home, less financial out-of-pocket costs. We also know that getting post-mastectomy radiation actually improves survival. But six weeks of radiation is often not possible for women living away from a cancer center, so many women elect to forgo radiation therapy after mastectomy. In making radiation therapy more convenient, we are potentially saving lives.”  

With early stage breast cancer, women usually undergo a lumpectomy and radiation. In these patients a short course of radiation has been shown to be safe and effective. At HCI, this has been the standard for over five years.

With more advanced stage breast cancer, though, where women require mastectomy, their lymph nodes are often involved. For patients who require lymph node radiation, the treatment can sometimes cause permanent arm swelling. Because patients in a shorter course of radiation receive higher daily doses of radiation, doctors wanted to make sure the higher daily doses wouldn’t increase these or other complications, such as infections or wound healing problems from breast reconstruction. 

The results from the Phase II clinical trial suggest a shorter course of radiation can be offered safely without increasing complications. Poppe notes that after patients were followed for an average of 32 months, “Women had less skin redness and less fatigue than historical averages.  We had no significant toxicities, which is very promising. Only half of women had breast reconstruction in our study, but the reconstruction complications were similar to what we’ve seen in other trials with a longer course of radiation. We hope in time this will result in improved cosmetic outcomes, as other studies have shown that by shortening the course of radiation, cosmetic outcomes are improved.”

The Phase II clinical trial was a combined effort of HCI and Rutgers Cancer Institute of New Jersey.  The trial enrolled 69 patients, 45 of whom participated at HCI. 

The next step is a Phase III clinical trial, which is set to begin later this year. This Phase III trial will directly compare the shorter course versus the longer course of radiation.  This is necessary to prove that a shorter course is just as safe and effective as longer radiation treatments. The Phase III trial will specifically look at women who have undergone reconstruction with mastectomy.

The Phase III trial will be led by Dr. Poppe and is expected to enroll approximately 900 patients at HCI and numerous additional cancer centers throughout the U.S. and Canada.

 

Media Contact

Ashlee Bright
Public Relations – Huntsman Cancer Institute
public.affairs@hci.utah.edu
801-585-1954

Cancer Center Research Program Experimental Therapeutics

About Huntsman Cancer Institute at the University of Utah

Huntsman Cancer Institute (HCI) at the University of Utah is the official cancer center of Utah. The cancer campus includes a state-of-the-art cancer specialty hospital as well as two buildings dedicated to cancer research. HCI treats patients with all forms of cancer and is recognized among the best cancer hospitals in the country by U.S. News and World Report. As the only National Cancer Institute (NCI)-Designated Comprehensive Cancer Center in the Mountain West, HCI serves the largest geographic region in the country, drawing patients from Utah, Nevada, Idaho, Wyoming, and Montana. More genes for inherited cancers have been discovered at HCI than at any other cancer center in the world, including genes responsible for hereditary breast, ovarian, colon, head, and neck cancers, along with melanoma. HCI manages the Utah Population Database, the largest genetic database in the world, with information on more than 11 million people linked to genealogies, health records, and vital statistics. HCI was founded by Jon M. and Karen Huntsman.

Cancer touches all of us.

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