Clinical trial NCT02248662: Impact of Radiation Therapy on Breast Conservation in DCIS
Official title: Impact of Radiation Therapy on Breast Conservation in DCIS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: DCIS
Keywords: DCIS
PCORI
ductal carcinoma in situ
radiation
oncology
patient-centered
decision aid
decision-making
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-09-25
Enrollment: 3436
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women identified from SEER and SEER-Medicare data with Stage 0-III breast cancer after DCIS who had received BCS without radiation for initial treatment.

Brief summary: Large regional variation exists in the use of radiotherapy after breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). Although patients who do not receive initial radiotherapy for DCIS are candidates for subsequent BCS if they experience a second breast event, many undergo mastectomy instead.

Detailed description: Patients and their physicians are often confronted with a decision between more intensive versus less intensive treatment for a particular diagnosis. Quality decision-making between these options requires careful balancing of the risks and side-effects, as well as weighing the expected outcomes and their associated value as assessed by the patient.

Although the incidence of DCIS has risen dramatically (1), there exists considerable debate about optimal treatment. In general, people with DCIS have high rates of recurrence-free survival. Intensive therapies for DCIS such as mastectomy (removal of the breast) or radiation therapy following BCS reduce the likelihood of a second breast diagnosis,(2-5) but have not been shown to improve survival.(6) In addition, radiation usually necessitates mastectomy should a new cancer or DCIS develop in the same breast at any point during the patient's lifetime. Patients also have a small chance of experiencing long-term toxicity. Previous radiation can also complicate reconstructive options following mastectomy. The tradeoff between risk of second breast diagnosis and side-effects and potential consequences of radiation therapy underscores the need for patient preference-driven decision making.

Patients who receive BCS alone without radiation therapy may be candidates for repeat BCS if they have a second breast event in the same breast. One study suggests that some women choose not to have radiation after DCIS because they want to preserve a breast-preservation option should a second breast diagnosis occur.(7) However, the likelihood of mastectomy versus BCS at time of new diagnosis in a previously un-irradiated breast is variable.(8-10) Whether a woman receives repeat breast-conserving surgery for a new diagnosis may not only be a function of the stage of diagnosis, but may be also determined by the regional treatment patterns used for management of DCIS. We sought to study whether regional intensity of radiation use for DCIS treatment increases the likelihood of mastectomy at time of second breast event, among women who have not received radiation therapy at initial DCIS diagnosis. (Punglia RS, Cronin AM, Uno H, et al. Association of Regional Intensity of Ductal Carcinoma In Situ Treatment With Likelihood of Breast Preservation. JAMA Oncol. Published online July 21, 2016.)

Eligibility criteria: This study used data from SEER and SEER-Medicare.

Primary outcomes:
measure: Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS
timeFrame: 20 Years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Harvard Pilgrim Health Care Institute
state: Massachusetts
city: Hanover
country: United States
facility: Dartmouth College
state: New Hampshire
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Rinaa S. Punglia, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sumner WE 3rd, Koniaris LG, Snell SE, Spector S, Powell J, Avisar E, Moffat F, Livingstone AS, Franceschi D. Results of 23,810 cases of ductal carcinoma-in-situ. Ann Surg Oncol. 2007 May;14(5):1638-43. doi: 10.1245/s10434-006-9316-1. Epub 2007 Jan 24.
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