This project was selected for PCORI funding not only for its scientific merit…, but also for its potential to answer an important question about DCIS and fill a crucial evidence gap.
Joe Selby, MD, MPH
A funding award of $13.4 million hopes to answer one of the biggest questions in the current management of breast cancer: Do women with the earliest form of the disease, ductal carcinoma in situ (DCIS), need invasive surgery?
Researchers at The University of Texas MD Anderson Cancer Center, Duke Cancer Institute, and Dana-Farber Cancer Institute have been awarded the funding from the Patient-Centered Outcomes Research Institute (PCORI) to launch a national prospective, randomized trial comparing guideline-concordant care of invasive surgery with or without radiation to active surveillance. The study will also research the quality-of-life and psychosocial outcomes of women with DCIS.
More than 60,000 women each year in the United States alone are diagnosed with the condition—about 1 in 5 breast cancers. Most guidelines suggest that women with DCIS undergo a lumpectomy, with or without radiation. Many women, however, opt for the more invasive mastectomy or a prophylactic mastectomy as preventive measures.
The challenge is that the vast majority of the women will not develop invasive disease. This uncertainty has led many physicians to begin to question what should be removed, and a woman with DCIS is often left with a difficult personal decision of which surgery, if any, is best for her.
E. Shelley Hwang, MD
Alastair M. Thompson, MD
Ann H. Partridge, MD
E. Shelley Hwang, MD, of Duke, is the study’s Principal Investigator, and Alastair M. Thompson, MD, of MD Anderson, and Ann H. Partridge, MD, of Dana-Farber, will serve as Co–Principal Investigators.
The prospective, randomized trial’s official title is Comparing Operative to Medical Endocrine Therapy for low-risk DCIS (COMET).
The institutions will partner with The Alliance for Clinical Trials in Oncology, which will provide the network and infrastructure to support the study. The researchers estimate that in the 4-year study recruitment period, approximately 40,000 women will be diagnosed with low-risk DCIS at the 100 Alliance sites. Of those women, approximately 5% will participate in the trial.
Participants will be randomized to receive either (1) guideline-concordant care of surgical intervention, with or without radiation, or (2) active surveillance of a mammogram every 6 months for 5 years. Both cohorts may opt for endocrine therapy.
The researchers will also survey for health-related quality-of-life measures, including anxiety, depression, and other psychosocial outcomes in all participants in the first and second year postdiagnosis.
Invasive cancer rates and patient-reported quality-of-life outcomes in both groups will be compared, with the hypothesis that active surveillance doesn’t yield inferior cancer or quality-of-life outcomes compared to those receiving guideline concordant care.
“This project was selected for PCORI funding not only for its scientific merit and commitment to engaging patients and other health-care stakeholders in a major study conducted in real-world settings, but also for its potential to answer an important question about DCIS and fill a crucial evidence gap,” said PCORI Executive Director Joe Selby, MD, MPH. “We look forward to following the study’s progress results.” ■