Abstract IA021: Challenges of conducting active surveillance for ductal carcinoma in situ (DCIS)


 The COMET (Comparing an Operation to Monitoring, with or without Endocrine Therapy) multicenter Phase III prospective trial randomizes women with low-risk DCIS to either standard of care (surgery +/- radiation therapy) or active surveillance (AS), a management approach in which mammograms and physical exams are used to monitor breast changes and determine when, or if, surgery is needed. It is currently open at 85 Alliance for Clinical Trials in Oncology sites and has accrued 905 patients as of 08/01/22.
 Initial recruitment challenges related to standardizing pathology eligibility criteria, with re-evaluation regarding the merits of central versus second pathology review, and discordance among pathologists regarding DCIS grade and necrosis. These discussions resulted in evidence-based protocol amendments that subsequently increased accrual. Patients that express a specific treatment preference often decline the arm to which they are randomized (not uncommon in trials of surgery de-escalation). Two consultants were recruited to implement the Quintet Recruitment Intervention, an initiative that utilizes qualitative/quantitative strategies to better understand recruitment in trials with very different treatment arms; acceptance rates in each randomized arm stabilized following this intervention.
 Patient and provider attitudes also presented a potential barrier to recruitment. Some surgeons lacked equipoise with the concept of AS and possess a “more is more” mentality; others express concern about younger patients undergoing AS; there are also financial implications of conducting AS rather than surgery for some surgeons. Radiologists often provide the initial diagnosis of DCIS to the patient; if the patient is told “DCIS is breast cancer”, they will expect to have surgery. Potential to consider AS may be limited if this preconceived notion about the need for surgery becomes established at the outset. DCIS has been disproportionately influenced by its terminology and classification, which may contribute to women feeling rushed into treatment decisions. Because of the way that DCIS is described to them, women considering AS may feel anxious knowing that the ‘threat’ of invasive breast cancer (IBC) has not been removed.
 Specific challenges to conducting AS for patients include those with a family history of breast cancer who express a strong desire for surgery. Women who undergo AS may experience ‘anticipatory anxiety’ regarding ongoing surveillance for the disease. Insufficient research exists about how relevant the outcomes of undergoing AS are to women and how patient perception around the potential ‘risk’ of IBC may impact upon their acceptance of AS. Collection of patient-reported outcomes in currently enrolling studies enables the challenges of undergoing AS to be understood from a patient perspective.
 Changing the treatment paradigm for DCIS requires multidisciplinary collaboration to drive change. However, providing more safe options for patients with low-risk DCIS will significantly reduce treatment-related harms.
 Citation Format: Thomas Lynch. Challenges of conducting active surveillance for ductal carcinoma in situ (DCIS) [abstract]. In: Proceedings of the AACR Special Conference on Rethinking DCIS: An Opportunity for Prevention?; 2022 Sep 8-11; Philadelphia, PA. Philadelphia (PA): AACR; Can Prev Res 2022;15(12 Suppl_1): Abstract nr IA021.