Results Summary

What was the research about?

Ductal carcinoma in situ, or DCIS, is a condition where abnormal cells are present in the breast. DCIS may or may not turn into invasive cancer that spreads and causes illness.

Doctors often treat DCIS like invasive cancer; standard treatment is surgery or radiation given right away. Another care approach is active monitoring with mammograms and physical exams. With active monitoring, during the year after diagnosis, women may have no treatment or their treatment may be delayed.

The research team did two studies that compared how well standard treatment versus active monitoring worked for women with DCIS. In the first study, the research team looked at the risk of death. In the second, the team looked at health and quality of life.

What were the results?

Study 1. Overall, women who had active monitoring were more likely to die from any cause, including breast cancer, than women who had standard treatment.

When the research team looked more closely at the active monitoring approach, compared with women who had standard treatment,

  • Women who received no treatment had a higher risk of dying from any cause, including breast cancer.
  • Women who received delayed treatment had no difference in risk of dying.

Study 2. Fewer women with active monitoring had lasting breast or chest wall pain compared with women who received standard treatment (21 percent versus 37 percent). General pain, quality of life, anxiety, depression, and concerns about cancer coming back didn’t differ between the two approaches. 

Who was in the study?

Study 1 used data from a national Medicare database that included 22,576 women diagnosed with DCIS between 1992 and 2011. Of these women, 9 percent were Black; 45 percent were over age 74 when diagnosed.

Study 2 included 912 women diagnosed with DCIS or similar conditions. These women had treatment at one of four cancer centers between 2012 and 2017 and were at least one year from their diagnosis. Of these women, 87 percent were White, 6 percent were Black, 5 percent were Asian, and 3 percent were other races. Also, 5 percent were Hispanic. The average age was 60.

What did the research team do?

The research team compared

  • Data from women with standard treatment versus active monitoring to see how likely they were to die up to eight years after diagnosis in study 1
  • Survey responses from women with standard treatment versus active monitoring in study 2

Members of breast cancer advocacy groups gave input to the research team.

What were the limits of the study?

In study 1, women were older than 64; many had high-risk DCIS. In study 2, most women were White, and most women who had active monitoring had precancerous conditions other than DCIS. Results may differ for other patients.

Future research could compare treatment approaches among a more diverse group of women and those with lower risk DCIS.

How can people use the results?

Women and their doctors can use the results when considering treatment for DCIS.

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • The reviewers noted that although the goals of the study all involved comparisons of guideline-concordant care (GCC) versus active surveillance (AS) for ductal carcinoma in situ (DCIS), some patients were included in the AS group who had other types of high-risk lesions. Reviewers expressed concern that these patients were not comparable to those with DCIS because clinicians and patients tend to consider DCIS to be cancer, but that is not true for the other types of lesions included, and patient-reported outcomes would likely be different. The researchers acknowledged this, saying that very few women choose an AS approach for DCIS so they added women with other high-risk lesions as proxies since these patients would receive similar treatment under AS conditions. They also stated that if AS was accepted as a standard option for DCIS, it would likely also become a viable approach for women with these other conditions.  Moreover, they did not observe differences in patient-reported outcomes between women with DCIS and women with other types of lesions in the AS group.
  • The reviewers questioned the treatment category definitions in this study, since AS1, which is treatment after active surveillance, would seem to be the same as GCC, assuming both groups received treatment within the observation window. The researchers explained that women in the GCC group received treatment within one year of DCIS diagnosis, whereas women in the AS1 group initially refused treatment but received treatment after surveillance demonstrated cancer progression.
  • The reviewers noted that the report was missing a model of treatment choice which could explain patient choices of GCC versus AS. The researchers acknowledged that a more complete treatment choice model would have improved their conclusions, but they were limited to the data available for them to measure patients’ care choices. They could not, for instance, consider patient motivations in their analyses because this information was not available in the databases the researchers used.

Project Information

E. Shelley Hwang, MD, MPH
Duke University
$1,760,018
10.25302/07.2021.CER.150329572
PORTAL: Patient-reported Outcomes after Routine Treatment of Atypical Lesions

Key Dates

September 2015
January 2021
2015
2021

Study Registration Information

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Last updated: January 20, 2023