E-Newsletter - April 2018

Evaluating DCIS Treatment Methods: DCIS Special Study

Alliance researchers Shelley Hwang, MD, MPH, Alastair M. Thompson, MD and Ann H. Partridge, MD, MPH, recently received funding from the Patient-Centered Outcomes Research Institute (PCORI) in support of AFT-25: Comparison of Operative to Monitoring and Endocrine Therapy (COMET) Trial for Low Risk DCIS: A Phase III Prospective Randomized Trial. What follows are details about the DCIS Special Study, a separate yet interrelated component of the PCORI-funded research project.

Ductal carcinoma in situ (DCIS)) is the earliest detectable form of breast cancer, often referred to as ‘stage 0’ breast cancer. Of the 65 million U.S. women who undergo annual mammographic screening, one out of 1,300 will detect DCIS. Almost all of these 60,000-plus diagnoses are made in completely asymptomatic individuals, which have a common but concerning effect: overdiagnosis.

Currently, all women diagnosed with DCIS are treated as if they have invasive breast cancer: surgery and/or radiation, along with endocrine therapy as part of Guideline Concordant Care (GCC). These recommendations, while appropriate for an aggressive DCIS or invasive breast cancer, may be unnecessary when applied to some patients with noninvasive DCIS. Many breast cancer experts believe that low-risk DCIS is being overtreated, even going so far as to suggest that women may do just as well if monitored more frequently – a ‘watch and wait’ approach commonly referred to as active surveillance (AS). Importantly, neither randomized trials nor retrospective studies have demonstrated any survival advantage of any DCIS option over another.

Alliance members are likely already aware of the existing the COMET clinical trial, which activated in June 2017 and prospectively randomizes patients to receive AS or GCC. The overarching goal of the trial is to examine the risks and benefits of AS compared to GCC, which will allow a better understanding of the medical and psychosocial tradeoffs that accompany management of DCIS with AS compared to GCC. The trial’s specific aims are to: 1) develop the infrastructure necessary to implement a large-scale comparative effectiveness research (CER) study comparing GCC to AS for DCIS; 2) use the study infrastructure to implement a prospective randomized controlled trial to address high-priority evidence gaps related to the impact of GCC or AS on patient-centered outcomes for DCIS; and 3) compare findings to outcomes in the Low-Risk DCIS (LORIS) study in the UK.  As of April 2018, 52 Alliance institutions are active, 20 sites are working towards activation, and 21 sites have recruited patients.

What may be news to Alliance members, however, is that one of the sub-aims of the larger COMET trial involves a Commission on Cancer (CoC) special study. The purpose of the DCIS Special Study mechanism is to capture additional data beyond what is routinely collected for the National Cancer Database (NCDB). The COMET trial team along with staff within the Alliance/American College of Surgeons Clinical Research Program and NCDB have spent the last 12 months refining the data elements to be abstracted, the data collection instructions, and the web-based data collection form for this special study.

The purpose of the DCIS Special Study is to retrospectively investigate outcomes of patients with DCIS to compare those who had surgery or radiation and those who underwent active surveillance. Registrars from CoC accredited institutions with eligible patients will submit data on 20 patients diagnosed between 2008-2014. Data pertaining to the patient’s DCIS diagnosis; comorbidities; first course treatment; radiation, hormone and endocrine therapies; and subsequent breast events and distant metastases will be comprehensively abstracted for analysis.

The DCIS Special Study will begin June 1, 2018 at about 1,400 CoC accredited facilities, including many Alliance sites, and will fulfill the requirement for CoC Standard 5.7 (Special Studies). A pilot study to inform development of the DCIS Special Study was conducted in fall 2017. Through that pilot, 20 registrars provided integral feedback on data elements, instructions, and the web form, and input from the pilot trial has been included in DCIS Special Study. Information about the DCIS Special Study, including site eligibility, timeline, and data collection instructions, will be sent to staff members at CoC accredited institutions. This sub-study is related, but distinct from the COMET trial.  Both studies will ultimately help translate research results into more informed, value-concordant care for patients and stakeholders affected by DCIS through dissemination activities. Information about the DCIS Special Study, including site and patient eligibility, timeline, and data collection instructions, will be sent to staff members at CoC accredited institutions. For questions about the DCIS Special Study, please contact Anne McCarthy at specialstudy@facs.org.



For other articles in this issue of the Alliance E-News newsletter, see below.