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Outcomes following local therapy for early-stage breast cancer in non-trial populations.

ABSTRACT: Recent studies suggest trends toward more mastectomies for primary breast cancer treatment. We assessed survival after mastectomy and breast-conserving surgery (BCS) with radiation for early-stage breast cancer among non-selected populations of women and among women similar to those in clinical trials. Using population-based data from Surveillance Epidemiology, and End Results cancer registries linked with Medicare administrative data from 1992 to 2005, we conducted propensity score analysis of survival following primary therapy for early-stage breast cancer, including BCS with radiation, BCS without radiation, mastectomy with radiation, and mastectomy without radiation. Adjusted survival was greatest among women who had BCS with radiation (median survival = 10.98 years). Compared with this group, mortality was higher among women who had mastectomy without radiation (median survival 10.04 years, adjusted hazard ratio (HR) = 1.19, 95% confidence interval (CI) = 1.14-1.23), mastectomy with radiation (median survival 10.02 years, HR = 1.20, 95% CI = 1.14-1.27), and BCS without radiation (median survival 7.63 years, HR = 1.81, 95% CI = 1.70-1.92). Among women representative of those eligible for clinical trials (age ?70 years, Charlson comorbidity score = 0/1, and stage 1 tumors), there were no differences in survival for women who underwent BCS with radiation or mastectomy. In conclusion, after careful adjustment for differences in patient, physician, and hospital characteristics, we found better survival for BCS with radiation versus mastectomy among older early-stage breast cancer patients, with no difference in survival for BCS with radiation versus mastectomy among women representative of those in clinical trials. These findings are reassuring in light of recent trends towards more aggressive primary breast cancer therapy.

SUBMITTER: Keating NL

PROVIDER: S-EPMC2924956 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature

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Outcomes following local therapy for early-stage breast cancer in non-trial populations.

Keating Nancy L NL Landrum Mary Beth MB Brooks John M JM Chrischilles Elizabeth A EA Winer Eric P EP Wright Kara K Volya Rita R

Breast cancer research and treatment 20100408 3

Recent studies suggest trends toward more mastectomies for primary breast cancer treatment. We assessed survival after mastectomy and breast-conserving surgery (BCS) with radiation for early-stage breast cancer among non-selected populations of women and among women similar to those in clinical trials. Using population-based data from Surveillance Epidemiology, and End Results cancer registries linked with Medicare administrative data from 1992 to 2005, we conducted propensity score analysis of ...[more]

PMID: 20376555

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Project description:Guideline-concordant local therapy options for early breast cancer include lumpectomy plus whole breast irradiation (Lump+WBI), lumpectomy plus brachytherapy, mastectomy alone, mastectomy plus reconstruction, and, in older women, lumpectomy alone. We performed a comparative examination of each treatment's complications and cost to assess their relative values. Using the MarketScan database of younger women with private insurance and the SEER-Medicare database of older women with public insurance, we identified 105 211 women with early breast cancer diagnosed between 2000 and 2011. We used diagnosis and procedural codes to identify treatment complications within 24 months of diagnosis and compared complications by treatment using two-sided logistic regression. Mean total and complication-related cost, relative to Lump+WBI, were calculated from a payer's perspective and adjusted for differences in covariables using linear regression. All statistical tests were two-sided. Lump+WBI was the most commonly used treatment. Mastectomy plus reconstruction was associated with nearly twice the complication risk of Lump+WBI (Marketscan: 54.3% vs 29.6%, relative risk [RR] = 1.87, 95% confidence interval [CI] = 1.82 to 1.91, P < .001; SEER-Medicare: 66.1% vs 37.6%, RR = 1.75, 95% CI = 1.69 to 1.82, P < .001) and was also associated with higher adjusted total cost (Marketscan: $22 481 greater than Lump+WBI; SEER-Medicare: $1748 greater) and complication-related cost (Marketscan: $9017 greater; SEER-Medicare: $2092 greater). Brachytherapy had modestly higher total cost and complications than WBI. Lumpectomy alone entailed lower cost and complications in the SEER-Medicare cohort only. Mastectomy plus reconstruction results in substantially higher complications and cost than other guideline-concordant treatment options for early breast cancer. These findings are relevant to patients evaluating their local therapy options and to value-based population health management.

Project description:ImportancePatients should have an active role in decisions about pursuing or forgoing specific therapies in treatment de-escalation trials.ObjectiveTo evaluate longitudinal patient-reported outcomes (PROs) encompassing decisional comfort and health-related quality of life (HRQOL) among patients who elected to enroll in a clinical trial evaluating radiotherapy alone, without breast surgery, for invasive breast cancers with exceptional response to neoadjuvant systemic therapy (NST).Design, setting, and participantsProspective, single-group, phase 2 clinical trial at 7 US medical centers. Women aged 40 years or older with invasive cT1-2 N0-1 M0 triple-negative or human epidermal growth factor receptor 2 (ERBB2)-positive breast cancer with no pathologic evidence of residual disease following standard NST enrolled from March 6, 2017, to November 9, 2021. Validated PRO measures were administered at baseline and 6, 12, and 36 months post-radiotherapy. Data were analyzed from January to February 2023.InterventionsPRO measures included the Decision Regret Scale (DRS), Functional Assessment of Cancer Therapy-Lymphedema (FACT-B+4), and Breast Cancer Treatment Outcomes Scale (BCTOS).Main outcomes and measuresChanges in PRO measure scores and subscores over time.ResultsAmong 31 patients, the median (IQR) age was 61 (56-66) years, 26 (84%) were White, and 26 (84%) were non-Hispanic. A total of 15 (48%) had triple-negative disease and 16 (52%) had ERBB2-positive disease. Decisional comfort was high at baseline (median [IQR] DRS score 10 [0-25] on a 0-100 scale, with higher scores indicating higher decisional regret) and significantly increased over time (median [IQR] DRS score at 36 months, 0 [0-20]; P < .001). HRQOL was relatively high at baseline (median [IQR] FACT-B composite score 121 [111-134] on a 0-148 scale, with higher scores indicating higher HRQOL) and significantly increased over time (median [IQR] FACT-B score at 36 months, 128 [116-137]; P = .04). Perceived differences between the affected breast and contralateral breast were minimal at baseline (median [IQR] BCTOS score 1.05 [1.00-1.23] on a 1-4 scale, with higher scores indicating greater differences) and increased significantly over time (median [IQR] BCTOS score at 36 months, 1.36 [1.18-1.64]; P < .001). At 36 months postradiotherapy, the cosmetic subscore was 0.45 points higher than baseline (95% CI, 0.16-0.74; P = .001), whereas function, pain, and edema subscores were not significantly different than baseline.Conclusions and relevanceIn this nonrandomized phase 2 clinical trial, analysis of PROs demonstrated an overall positive experience for trial participants, with longitudinal improvements in decisional comfort and overall HRQOL over time and minimal lasting adverse effects of therapy.Trial registrationClinicalTrials.gov Identifier: NCT02945579.

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Outcomes following local therapy for early-stage breast cancer in non-trial populations.

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Outcomes following local therapy for early-stage breast cancer in non-trial populations.

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