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| ID | Type | Description | Link |
|---|---|---|---|
| CE-12-11-4173 | Other Grant/Funding Number | PCORI |
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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveillance, Epidemiology, and End Results (SEER) Database | Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER) with a diagnosis of ductal carcinoma in situ (DCIS) between 1990 and 2011 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis. | ||
| Surveillance, Epidemiology, and End Results (SEER)-Medicare | Data were obtained for women in Surveillance, Epidemiology, and End Results (SEER)-Medicare with a ductal carcinoma in situ (DCIS) diagnosis between 1991 and 2009 who had not undergone radiotherapy for DCIS and experienced a subsequent breast cancer or DCIS diagnosis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS | The investigators defined treatment intensity in a health services area to be the proportion of patients undergoing breast conserving surgery for DCIS who receive radiation therapy. Because a proportion is challenging to analyze statistically given that the precision of the estimate depends on the size of the denominator which varies across service areas, we used hierarchical modeling to categorize the health service areas into three categories (low, medium, high), using a latent variable to determine which health service area belongs to each of the three categories. The cutoffs separating the groups were based on the hierarchical model, taking the precision of the estimated proportion of patients receiving radiation into account. Health service areas with the highest proportions of patients receiving radiation were assigned to the "high" cluster; those with the lowest proportions to the "low" cluster; and those in the between to the "medium" cluster. | 20 Years |
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This study used data from SEER and SEER-Medicare.
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rinaa S. Punglia, MD, MPH | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | United States | ||
| Harvard Pilgrim Health Care Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17245612 | Background | 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. | |
| 28387638 | Background | Kim SY, Han BK, Kim EK, Choi WJ, Choi Y, Kim HH, Moon WK. Breast Cancer Detected at Screening US: Survival Rates and Clinical-Pathologic and Imaging Factors Associated with Recurrence. Radiology. 2017 Aug;284(2):354-364. doi: 10.1148/radiol.2017162348. Epub 2017 Apr 6. |
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Originally, 38,514 total records from each database used for this study were screened for enrollment into the final cohort. After eligibility criteria were applied to the sample, the final sample size was 3,436.
The computer model included data from sources including the NSABP B-17 and B-24 trials; the UK, Australia, and New Zealand ductal carcinoma in situ (DCIS) trial; an observational study of newly diagnosed patients with DCIS treated in British Columbia; and SEER databases. The researchers also conducted two retrospective studies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Surveillance Epidemiology and End Results (SEER)-Medicare | SEER-Medicare diagnoses from 1990-2009 linked to Medicare claims through 2010 Breast Conserving Surgery +/- Radiotherapy or Mastectomy for secondary breast cancer |
| FG001 | Surveillance Epidemiology and End Results (SEER) | Data was collected from the Surveillance Epidemiology and End Results (SEER) database on patients with ductal carcinoma in situ (DCIS) between 1990 and 2011. Breast Conserving Surgery +/- Radiotherapy or Mastectomy for secondary breast cancer |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SEER | Data was collected from the Surveillance Epidemiology and End Results database on patients with DCIS between 1990 and 2011. |
| BG001 | SEER-Medicare | SEER-Medicaid diagnoses from 1990-2009 linked to Medicare claims through 2010 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Association Between Patient Characteristics and Three-Level Cluster of Treatment Intensity for Primary DCIS | The investigators defined treatment intensity in a health services area to be the proportion of patients undergoing breast conserving surgery for DCIS who receive radiation therapy. Because a proportion is challenging to analyze statistically given that the precision of the estimate depends on the size of the denominator which varies across service areas, we used hierarchical modeling to categorize the health service areas into three categories (low, medium, high), using a latent variable to determine which health service area belongs to each of the three categories. The cutoffs separating the groups were based on the hierarchical model, taking the precision of the estimated proportion of patients receiving radiation into account. Health service areas with the highest proportions of patients receiving radiation were assigned to the "high" cluster; those with the lowest proportions to the "low" cluster; and those in the between to the "medium" cluster. | Posted | Count of Participants | Participants | 20 Years |
|
Adverse events were not collected for this study.
This was a retrospective review of data from the SEER and SEER-Medicare registries. There were no adverse events to report because this was not a clinical trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SEER | Breast conservation surgery +/- Radiotherapy or Mastectomy for secondary breast cancer |
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No data set can capture all of the complexity surrounding surgical decision making at the time of a second diagnosis. We did not have information about patient preferences or the clinical characteristics about second breast event.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rinaa Punglia, MD | Dana-Farber Cancer Institute | 617-582-8759 | rinaa_punglia@dfci.harvard.edu |
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| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| Boston |
| Massachusetts |
| 02215 |
| United States |
| Dartmouth College | Hanover | New Hampshire | 03755 | United States |
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| 16801628 | Background | EORTC Breast Cancer Cooperative Group; EORTC Radiotherapy Group; Bijker N, Meijnen P, Peterse JL, Bogaerts J, Van Hoorebeeck I, Julien JP, Gennaro M, Rouanet P, Avril A, Fentiman IS, Bartelink H, Rutgers EJ. Breast-conserving treatment with or without radiotherapy in ductal carcinoma-in-situ: ten-year results of European Organisation for Research and Treatment of Cancer randomized phase III trial 10853--a study by the EORTC Breast Cancer Cooperative Group and EORTC Radiotherapy Group. J Clin Oncol. 2006 Jul 20;24(21):3381-7. doi: 10.1200/JCO.2006.06.1366. Epub 2006 Jun 26. |
| 11498833 | Background | Fisher B, Land S, Mamounas E, Dignam J, Fisher ER, Wolmark N. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol. 2001 Aug;28(4):400-18. doi: 10.1016/s0093-7754(01)90133-2. |
| 16864166 | Background | Emdin SO, Granstrand B, Ringberg A, Sandelin K, Arnesson LG, Nordgren H, Anderson H, Garmo H, Holmberg L, Wallgren A; Swedish Breast Cancer Group. SweDCIS: Radiotherapy after sector resection for ductal carcinoma in situ of the breast. Results of a randomised trial in a population offered mammography screening. Acta Oncol. 2006;45(5):536-43. doi: 10.1080/02841860600681569. |
| 12867108 | Background | Houghton J, George WD, Cuzick J, Duggan C, Fentiman IS, Spittle M; UK Coordinating Committee on Cancer Research; Ductal Carcinoma in situ Working Party; DCIS trialists in the UK, Australia, and New Zealand. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet. 2003 Jul 12;362(9378):95-102. doi: 10.1016/s0140-6736(03)13859-7. |
| 20956824 | Background | Early Breast Cancer Trialists' Collaborative Group (EBCTCG); Correa C, McGale P, Taylor C, Wang Y, Clarke M, Davies C, Peto R, Bijker N, Solin L, Darby S. Overview of the randomized trials of radiotherapy in ductal carcinoma in situ of the breast. J Natl Cancer Inst Monogr. 2010;2010(41):162-77. doi: 10.1093/jncimonographs/lgq039. |
| 21128819 | Background | Kaplan CP, Napoles AM, Hwang ES, Bloom J, Stewart S, Nickleach D, Karliner L. Selection of treatment among Latina and non-Latina white women with ductal carcinoma in situ. J Womens Health (Larchmt). 2011 Feb;20(2):215-23. doi: 10.1089/jwh.2010.1986. Epub 2010 Dec 3. |
| 9469327 | Background | Fisher B, Dignam J, Wolmark N, Mamounas E, Costantino J, Poller W, Fisher ER, Wickerham DL, Deutsch M, Margolese R, Dimitrov N, Kavanah M. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998 Feb;16(2):441-52. doi: 10.1200/JCO.1998.16.2.441. |
| 21630124 | Background | Fong J, Kurniawan ED, Rose AK, Mou A, Collins JP, Miller JA, Mann GB. Outcomes of screening-detected ductal carcinoma in situ treated with wide excision alone. Ann Surg Oncol. 2011 Dec;18(13):3778-84. doi: 10.1245/s10434-011-1748-6. Epub 2011 Jun 1. |
| 16461781 | Background | Wong JS, Kaelin CM, Troyan SL, Gadd MA, Gelman R, Lester SC, Schnitt SJ, Sgroi DC, Silver BJ, Harris JR, Smith BL. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol. 2006 Mar 1;24(7):1031-6. doi: 10.1200/JCO.2005.02.9975. Epub 2006 Feb 6. |
| Background | Pickle LW, MungioleM, Jones GK, White AA. Atlas of United States Mortality. Hyattsville, MD: Centers for Disease Control and Prevention; December 1996. http://www.cdc.gov/nchs/data/misc/atlasmet.pdf. Accessed September 1, 2015. |
| 12703563 | Background | Wennberg JE, Fisher ES, Skinner JS. Geography and the debate over Medicare reform. Health Aff (Millwood). 2002 Jul-Dec;Suppl Web Exclusives:W96-114. doi: 10.1377/hlthaff.w2.96. |
| 21717446 | Background | Jagsi R, Abrahamse P, Hawley ST, Graff JJ, Hamilton AS, Katz SJ. Underascertainment of radiotherapy receipt in Surveillance, Epidemiology, and End Results registry data. Cancer. 2012 Jan 15;118(2):333-41. doi: 10.1002/cncr.26295. Epub 2011 Jun 29. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Number of Participants with Household Income Within Census Data Quintiles | Participants' median income levels were assessed using US Census Data. Income data was gathered from census tract information. The census tract data was then put into quintiles ranging from lowest socioeconomic status (quintile 1) to highest socioeconomic status (quintile 5). | Count of Participants | Participants |
|
| Number of Participants in Education Levels Within Census Data Quintiles | Participants' education levels were assessed using US Census Data. Education data was gathered from census tract information. The census tract data was then put into quintiles ranging from lowest education level (quintile 1) to highest education level (quintile 5). | Count of Participants | Participants |
|
| Residence | Count of Participants | Participants |
|
| Number of Participants with a Secondary SEER Diagnosis | Count of Participants | Participants |
|
| Number of Participants with Secondary SEER Diagnoses and Staging | For the SEER-Medicare sample, frequencies and percentages are calculated only among patients with a secondary SEER diagnosis. The number of cases who had a secondary SEER diagnosis was less than the number of cases included in this cohort at baseline. Sometimes, it was clear that patients had a secondary SEER diagnosis, but the stage was unclear. The total number of SEER-Medicare cases in the final analysis was 387. Staging in the SEER and SEER-Medicare data registries is consistent with general cancer staging. Higher stages indicate worse outcomes. | The number of cases with a secondary SEER diagnosis was less than the number of cases included in this cohort at baseline. Sometimes, it was clear that patients had a secondary SEER diagnosis, but the stage was unclear. The total number of SEER-Medicare cases in the final analysis was 387. | Count of Participants | Participants |
|
| Number of Participants with ER Status for Secondary SEER Diagnosis | For the SEER-Medicare sample, frequencies and percentages are calculated only among patients with a secondary SEER diagnosis. The total number of cases who had ER status information was less than the overall number of cases included in this cohort at baseline. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was not clear whether the diagnosis was ER positive or negative. Therefore, the total number of SEER-Medicare cases in the final analysis was 387. | The total number of cases with ER status information was less than the overall number of cases included in this cohort at baseline. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was unclear whether the diagnosis was ER+ or ER-. | Count of Participants | Participants |
|
| Number of Participants with Laterality for Secondary SEER Diagnosis | For the SEER-Medicare sample, frequencies and percentages are calculated only among patients with laterality information. The total number of cases who had laterality information was less than the number of cases included in this cohort. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was not clear whether the diagnosis was ipsilateral or contralateral. Therefore, the total number of SEER-Medicare cases in the final analysis was 387. | The total number of cases with laterality information was less than the number of cases included in this cohort. Analysis was performed only on the number of cases that had a secondary SEER diagnosis. In some instances, it was clear patients had a secondary SEER diagnosis, but it was not clear whether the diagnosis was ipsilateral or contralateral. | Count of Participants | Participants |
|
| Year of secondary diagnosis | Count of Participants | Participants |
|
| Interval between diagnoses | Mean | Inter-Quartile Range | years |
|
| Treatment intensity for primary DCIS | Regional treatment intensity was measured by using health service areas (HSAs). HSAs were assiged to 1 of 3 clusters based on the observed proportion of radiotherapy used as coded by SEER and SEER-Medicare. The HSAs with the highest proportion of patients receiving radiotherapy were assigned to the high cluster; those with the lowest to the low cluster. This table shows how many people lived in each HSA. | Count of Participants | Participants |
|
| Charlson comorbidity score | The Charlson comorbidity score is used to predict the risk of death within 1 year of hospitalization for patients with specific comorbid conditions. A high score indicates increased risk. | Data was not collected for the SEER group and the data is no longer available to us. | Count of Participants | Participants |
|
| Distance to nearest radiation facility | Data was not collected for the SEER group and is no longer available to us. | Count of Participants | Participants |
|
| Chemotherapy for secondary breast event | Data was not collected for the SEER group and the data is no longer available to us. | Count of Participants | Participants |
|
| MRI in 6 months before secondary breast event | Data was not collected for the SEER group and the data is no longer available to us. | Count of Participants | Participants |
|
| OG000 |
| SEER - Low Treatment Cluster |
Low treatment intensity for primary DCIS |
| OG001 | SEER-Medium Treatment Cluster | Medium treatment intensity for primary DCIS |
| OG002 | SEER - High Treatment Cluster | High treatment intensity for primary DCIS |
| OG003 | SEER-Medicare - Low Treatment Cluster | Low treatment intensity for primary DCIS |
| OG004 | SEER-Medicare - Medium Treatment Cluster | Medium treatment intensity for primary DCIS |
| OG005 | SEER Medicare - High Treatment Cluster | High treatment intensity for primary DCIS |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | SEER-Medicare | Breast conservation surgery +/- Radiotherapy or Mastectomy for secondary breast cancer | 0 | 0 | 0 | 0 | 0 | 0 |
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| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| Unknown or Not Reported |
|
| Other |
|