Comparing two treatment approaches for women with ductal carcinoma in situ (DCIS) : the PORTAL study / Shelley Hwang.

Format:

Book

Author/Creator:

Hwang, Shelley, author.

Series:

Final research report (Patient-Centered Outcomes Research Institute (U.S.))

Language:

English

Subjects (All):

Outcome assessment (Medical care).

Physical Description:

1 online resource (110 pages) : illustrations.

Other Title:

Comparing two treatment approaches for women with ductal carcinoma in situ

Place of Publication:

Washington, DC : Patient-Centered Outcomes Research Institute (PCORI), 2021.

Summary:

BACKGROUND: More than 62 000 women are diagnosed with ductal carcinoma in situ (DCIS) in the United States annually. Without treatment, approximately 20% to 30% of DCIS will progress to invasive cancer. However, 97% of women are treated according to guideline-concordant care (GCC) (surgery and/or radiation). An alternative for low-risk DCIS is active surveillance (AS), where mammography and physical examinations are used to monitor potential breast changes. Evidence from registries and collection of patient-reported outcomes is critical to understanding the benefits and harms of GCC vs AS for DCIS. AIM 1A: 1. Objective: Conduct an observational study of breast cancer (BC)/other health outcomes in patients aged ≥65 years electing GCC or AS for DCIS in Surveillance, Epidemiology, and End Results (SEER) and Medicare data sets.2. Methods: Information during the first year postdiagnosis identified GCC and AS cohorts. The AS group was separated into 2 subgroups: AS1 (treatment after AS) and AS2 (no treatment/ongoing AS). A propensity score-based approach provided pseudorandomization between subgroups.3. Results: Comorbidities strongly influenced the treatment received for all age groups, with the greatest burden observed in the AS2 group. All-cause/BC-specific mortality hazard ratios (HRs) for AS1 were not statistically different from HRs for GCC; AS2 was associated with a higher risk for both all-cause mortality (HR, 3.54; 95% CI, 3.29-3.82) and BC-specific mortality (HR, 10.73). After pseudorandomization, the HRs of BC-related death did not differ significantly between the GCC and AS1 groups.4. Conclusions: Women managed with AS had higher all-cause and BC-specific mortality than did those managed with GCC; the AS1 group showed a mortality risk comparable to that of the GCC group.5. Limitations: Retrospective study/reliance on an administrative database. AIM 1B: 1. Objective: Characterize cancer outcomes in DCIS patients without locoregional treatment in the SEER registry.2. Methods: We used survival analysis data recorded in SEER (1992-2014) from DCIS patients who did not receive surgery/radiation. Kaplan-Meier curves were used to estimate the net risk of subsequent ipsilateral invasive BC (iIBC). Cumulative incidences of iIBC, contralateral BC (CBC), and death were estimated using competing-risk methods.3. Results: A total of 1286 patients who did not undergo immediate locoregional therapy were identified among 55 151 DCIS patients. The 10-year risks of iIBC were 12.2% (grade I/II), 17.6% (grade III), 10.1% (unknown grade). Overall, the 10-year risks of iIBC, CBC, and all-cause mortality were 10.5%, 3.9%, and 24.1%, respectively.4. Conclusions: DCIS patients without locoregional treatment have a limited risk of invasive progression in the absence of other-cause death; these findings suggest that there may be overtreatment among older patients/patients with elevated comorbidities.5. Limitations: This cohort is not representative of the general population; the data reflect outcomes for Medicare patients and thus have a higher median age/greater burden of comorbidities than those of patients diagnosed with DCIS overall. AIM 2: 1. Objective: Use cross-sectional patient survey data to evaluate the benefits/harms of GCC for DCIS compared with AS.2. Methods: Patients aged ≥18 years, diagnosed with DCIS, atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), or lobular carcinoma in situ (LCIS) from 2012-2017 from 4 academic medical centers completed a 1-time, cross-sectional survey. Clinical, pathological, and treatment information was obtained from electronic medical record review.3. Results: The GCC group was more likely to report pain within the last month than was the AS group; the prevalences of clinically relevant pain, physical, and cognitive/emotional impact scores were all higher in the GCC group. Pain severity and interference with function scores, quality of life (QOL), and symptoms of anxiety and depression were similar between groups.4. Conclusions: Compared with women who have undergone AS, women with DCIS who have undergone GCC are more likely to experience breast/chest wall pain, report a greater pain/severity burden, and report the physical, cognitive, and emotional impact of pain.5. Limitations: The results of this aim have limited generalizability (ie, a predominantly White, insured population), and prediagnostic comorbidities were not accounted for. AIM 3: 1. Objective: Patients need to be able to make an informed decision about the extra years of life expected from a course of treatment and the QOL to be gained. We measured the incremental utility of GCC compared with AS according to a preference-based quality-adjusted life year metric.2. Methods: The Six-Dimensional Health State Short Form (SF-6D) was used as a measure of health. Valuation of health states used the Time Trade-off (TTO) method. Records of patients with cancer were systematically screened to identify women meeting the eligibility criteria who were then informed about the study by mail and asked to respond if interested in participating. Patients were emailed or mailed the TTO and also given the option to complete the TTO by phone.3. Results: A total of 1565 patients diagnosed with DCIS, ADH, ALH, or LCIS were invited to participate; 927 (59%) responded. In relation to low levels of disease severity, respondents had difficulty trading years of life to avoid limitation in their health status. Individuals were willing to give up at least an equivalent number of years to avoid higher severity levels. Pain and vitality were of particular concern. Older age (ie, aged ≥65 years) was associated with greater willingness to give up years of life to avoid an adverse health state.4. Conclusions: Individuals aged ≥65 years who are diagnosed with DCIS are willing to give up at least an equivalent number of years of life to avoid an adverse health condition, and they judge their QOL to be lower for any given health state.5. Limitations: The TTO method asks the participant to imagine being faced with a defined length of life in a health state, which is an unrealistic scenario given that people face a varied life expectancy.

Contents:

Background

Patient and Stakeholder Engagement

Aim 1a: Compare BC/Other Health Outcomes Between Patients Electing GCC or AS for DCIS in SEER and Medicare Data Sets

Aim 1b: Characterize Cancer Outcomes in DCIS Patients Without Locoregional Treatment in the SEER Registry

Aim 2: Evaluate the Benefits and Harms of Currently Accepted GCC for DCIS Compared with An AS Strategy Using Prospective Cross-Sectional Patient Survey Data

Aim 3: Measure the Incremental Utility of GCC Compared with AS According to a Preference-Based QALY Metric

References

Related Publications

Acknowledgments

Appendices.

Notes:

Description based on publisher supplied metadata and other sources.