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Patient-Centered Outcomes Research Institute Develops Prioritized Research Agenda for the Management of DCIS

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Key Points

  • Ductal carcinoma in situ is a common finding in women having mammography screening, and considerable uncertainty exists about the harms and benefits of different management options.
  • Researchers have identified and prioritized knowledge gaps in the optimal clinical management of DCIS—including the incorporation of patient-centered outcomes, development of better methods to predict risk of invasive cancer, evaluation of a strategy of active surveillance, and testing of decision-making tools—that should be addressed by future research.

There is currently a lack of reliable methods for distinguishing ductal carcinoma in situ (DCIS) that would never become symptomatic from DCIS that is likely to progress to life-threatening invasive cancer. Spurred by uncertainty about the optimal clinical management of DCIS, researchers have identified and ranked knowledge gaps that should be addressed by future studies. The prioritized gaps include the incorporation of patient-centered outcomes, development of better methods to predict risk of invasive cancer, evaluation of a strategy of active surveillance, and testing of decision-making tools. The article is published in Annals of Internal Medicine.

Identifying Evidence Gaps

A diverse group of stakeholders that included clinical experts, members of professional societies, patients, and advocates have recommended a process for developing a prioritized research agenda for the Patient-Centered Outcomes Research Institute in the management of DCIS. According to the American Cancer Society, about 55,000 new cases of DCIS were expected to occur in 2013 in the United States, accounting for approximately 24% of all new breast “cancer” diagnoses. According to the report, although the annual incidence of DCIS is less than that of invasive breast cancer, expanded use of screening mammography has led to a dramatic increase in the diagnosis of DCIS (32.5 cases per 100,000 women).

The researchers used an iterative process to identify evidence gaps for DCIS management, including the appraisal of published systematic reviews, clinical practice guidelines, and future research needs documents to develop an initial list of evidence gaps. Then they organized the gaps according to the populations, interventions, comparators, outcomes, timing, and setting of interest and transformed them into research questions informed by criteria.

Future Research Needs for Management of DCIS

The prioritized future research needs in the management of DCIS identified by the researchers, ranked by order of importance, include the following recommendations:

  1. Validate risk-stratification models. Recommended study designs include meta-analysis or individual patient data analysis across randomized, control trials or observational study using existing data sources.
  2. Compare safety and effectiveness of a management strategy involving no immediate treatment (ie, observation/active surveillance) vs immediate treatment with surgery, radiation therapy, and/or medical therapy through prospective observational study.
  3. Determine whether safety and effectiveness of DCIS management strategies differ depending on variations in clinical, pathologic, and genomic presentations of DCIS. Recommended study designs include meta-analysis or individual patient data analysis across randomized, controlled trials or observational study using existing data sources.
  4. Comparative effectiveness of different approaches to communicating the diagnosis of DCIS to the patient through randomized, controlled trials
  5. Comparative effectiveness of decision-making tools compared with usual care through randomized, controlled trials.
  6.  Comparative sensitivity and specificity of breast magnetic resonance imaging, mammography, and other preoperative imaging evaluations for detecting occult invasive breast cancer. Recommended study designs include observational study either collecting new data or using existing data sources.
  7. Assess effect of DCIS management strategies on comorbid conditions through randomized, controlled trials.
  8. Compare safety and effectiveness of partial-breast radiation therapy vs whole-breast radiation therapy through randomized, controlled trials.
  9. Identify most important patient-centered outcomes for women diagnosed with DCIS through observational study requiring new data collection.
  10. Assess effect of DCIS management strategies on rates of invasive cancer through observational study using existing data.

“As long as mammography continues to be the primary tool available to reduce breast cancer mortality rates, many women will be given a DCIS diagnosis during their lifetime. Thus, improvement of the ability of women given a DCIS diagnosis to make informed decisions about management options will be a critical need for the foreseeable future,” concluded the authors.

The study was funded by the Patient-Centered Outcomes Research Institute. For full disclosures of the study authors, visit www.acponline.org.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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