Post mastectomy radiation therapy (PMRT) is commonly recommended for women with stage I-III breast cancer to prevent local recurrence. While PMRT has been clinically proven to be effective in reducing local recurrence and improving survival, it also presents significant short- and long-term side effects such as pain, fatigue, skin changes, and lymphedema, as well as damage to the heart and lungs than can reduce cardiac or pulmonary function.
The field of radiation oncology is rapidly changing as new technologies and delivery methods become available. The advance of precision medicine, targeted therapies and improved systemic therapy have also reduced the need for PMRT for some women and paved the way for more personalize radiation therapy approaches.
A Phase II clinical trial led by BCRF Investigator, Bruce Haffty, is the first trial specifically designed to explore an accelerated course of radiation using modern radiation technology.
The conventional PMRT schedule is 5 days a week for five to six weeks, but some studies suggest that a shorter regime, called hypofractionated PMRT may be just as effective. A shorter course of radiation therapy could reduce the side effects, but studies to date have been difficult to interpret due variations in study design and outdated radiation technologies, limited their use in guiding clinical recommendations.
In an article published in the Journal of Clinical Oncology, Dr. Haffty and colleagues report that hypofractionated PMRT over 11-15 days was safe and effective with comparable estimated local and distant recurrence rates to conventional therapy.
“This prospective Phase II trial demonstrates the safety and effectiveness of a shorter course of radiation for patients receiving radiation to the chest wall and regional nodes after mastectomy,” Dr. Haffty told BCRF.
While shorter courses of radiation are increasingly adopted and broadly embraced for many patients receiving radiation to the breast alone after lumpectomy, shorter courses have not been adopted in patients requiring more extensive radiation to the breast or chest wall and regional nodes.
“Our support from BCRF over the years allowed us the opportunity to explore these types of options for patients undergoing radiation therapy for breast cancer,” Haffty said.
Dr. Haffty and colleagues have already initiated a follow up Phase III study through the Alliance for Clinical Trials in Oncology Cooperative Group. The Phase III study will compare the standard five-week course of radiation to a 16-day course of radiation for patients who require post-mastectomy radiation to the chest wall and regional nodes, and who are intending to undergo breast reconstruction. The primary objective of the Phase III study will be to assess the rate of complications in breast construction that may result from the accelerated MPRT. The investigators will also study other radiation toxicities, recurrence free survival and the health care costs of the accelerated therapy.
More on Dr. Haffty’s BCRF research can be found here.