Prevalence, treatment patterns, and prognosis of low estrogen receptor-positive (1% to 10%) breast cancer: a single institution's experience in Korea.

PURPOSE: To determine prevalence, clinicopathological characteristics, initial treatments, and outcomes associated with low estrogen receptor (ER)-expressing invasive breast cancer. METHODS: This retrospective, non-interventional database study included patients undergoing surgery with curative intent for invasive ductal or lobular breast cancer. Patients were treated between January 2003-December 2012. Demographics, clinicopathological characteristics, initial treatments, and outcomes were abstracted from patient records. Patients were categorized using immunohistochemistry to determine ER, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) levels. ER-positive patients were subclassified as ER-low (1% to 10%) and ER-high (> 10%) according to the Allred Proportion Score. Disease-free survival (DFS) and overall survival (OS) were estimated by the Kaplan-Meier method and compared among groups by log-rank test. RESULTS: 5930 patients were included (median follow-up, 80.9 months). Of all patients included, 117 (2.0%) had ER-low tumors: 63 (53.8%) of whom had HER2- tumors and 54 (46.2%) HER2+ tumors. Five-year DFS and OS were highest in the ER-high/HER2- cohort (94.0% and 98.6%, respectively) and lowest in the triple-negative breast cancer (TNBC; 81.3% and 90.1%) and ER-low/HER2- (85.7% and 92.1%) cohorts. Menopausal status, elevated Ki-67, higher nuclear grade, higher tumor stage, presence of lymphovascular invasion, greater regional lymph node involvement, and larger tumor size were all potential prognostic factors for shorter DFS and OS. CONCLUSION: Patients with ER-low/HER2- breast cancer had similar clinicopathological characteristics, treatments, and outcomes as patients with TNBC irrespective of disease setting. Further research is needed to understand predictive and prognostic factors associated with ER-low/HER2- disease.

Outcomes among pediatric patients with cancer who are treated on trial versus off trial: A matched cohort study.

BACKGROUND: Approximately 50% of children with cancer in the United States who are aged <15 years receive primary treatment on a therapeutic clinical trial. To the authors' knowledge, it remains unknown whether trial enrollment has a clinical benefit compared with the best alternative standard therapy and/or off trial (ie, clinical trial effect). The authors conducted a retrospective matched cohort study to compare the morbidity and mortality of pediatric patients with cancer who are treated on a phase 3 clinical trial compared with those receiving standard therapy and/or off trial. METHODS: Subjects were aged birth to 19 years; were diagnosed between 2000 and 2010 with acute lymphocytic leukemia (ALL), acute myeloid leukemia (AML), rhabdomyosarcoma, or neuroblastoma; and had received initial treatment at the Children's Hospital of Philadelphia. On-trial and off-trial subjects were matched based on age, race, ethnicity, a diagnosis of Down syndrome (for patients with ALL or AML), prognostic risk level, date of diagnosis, and tumor type. RESULTS: A total of 428 participants were matched in 214 pairs (152 pairs for ALL, 24 pairs for AML, 32 pairs for rhabdomyosarcoma, and 6 pairs for neuroblastoma). The 5-year survival rate did not differ between those treated on trial versus those treated with standard therapy and/or off trial (86.9% vs 82.2%; P = .093). On-trial patients had a 32% lower odds of having worse (higher) mortality-morbidity composite scores, although this did not reach statistical significance (odds ratio, 0.68; 95% confidence interval, 0.45-1.03 [P = .070]). CONCLUSIONS: There was no statistically significant difference in outcomes noted between those patients treated on trial and those treated with standard therapy and/or off trial. However, in partial support of the clinical trial effect, the results of the current study indicate a trend toward more favorable outcomes in children treated on trial compared with those treated with standard therapy and/or off trial. These findings can support decision making regarding enrollment in pediatric phase 3 clinical trials.

Practice Style Variation in Medicaid and Non-Medicaid Children With Complex Chronic Conditions Undergoing Surgery.

OBJECTIVES: With differential payment between Medicaid and Non-Medicaid services, we asked whether style-of-practice differs between similar Medicaid and Non-Medicaid children with complex chronic conditions (CCCs) undergoing surgery. SUMMARY OF BACKGROUND DATA: Surgery in children with CCCs accounts for a disproportionately large percentage of resource utilization at major children's hospitals. METHODS: A matched cohort design, studying 23,582 pairs of children with CCCs undergoing surgery (Medicaid matched to Non-Medicaid within the same hospital) from 2009 to 2013 in 41 Children's Hospitals. Patients were matched on age, sex, principal procedure, CCCs, and other characteristics. RESULTS: Median cost in Medicaid patients was $21,547 versus $20,527 in Non-Medicaid patients (5.0% higher, P < 0.001). Median paired difference in cost (Medicaid minus Non-Medicaid) was $320 [95% confidence interval (CI): $208, $445], (1.6% higher, P < 0.001). 90th percentile costs were $133,640 versus $127,523, (4.8% higher, P < 0.001). Mean paired difference in length of stay (LOS) was 0.50 days (95% CI: 0.36, 0.65), (P < 0.001). ICU utilization was 2.8% higher (36.7% vs 35.7%, P < 0.001). Finally, in-hospital mortality pooled across all pairs was higher in Medicaid patients (0.38% vs 0.22%, P = 0.002). After adjusting for multiple testing, no individual hospital displayed significant differences in cost between groups, only 1 hospital displayed significant differences in LOS and 1 in ICU utilization. CONCLUSIONS: Treatment style differences between Medicaid and Non-Medicaid children were small, suggesting little disparity with in-hospital surgical care for patients with CCCs operated on within Children's Hospitals. However, in-hospital mortality, although rare, was slightly higher in Medicaid patients and merits further investigation.

Outcomes, ICU Use, and Length of Stay in Chronically Ill Black and White Children on Medicaid and Hospitalized for Surgery.

BACKGROUND: With increasing Medicaid coverage, it has become especially important to determine whether racial differences exist within the Medicaid system. We asked whether disparities exist in hospital practice and patient outcomes between matched black and white Medicaid children with chronic conditions undergoing surgery. STUDY DESIGN: We conducted a matched cohort study, matching 6,398 pairs within states on detailed patient characteristics using data from 25 states contributing adequate Medicaid Analytic eXtract claims for admissions of children with chronic conditions undergoing the same surgical procedures between January 1, 2009 and November 30, 2010 for ages 1 to 18 years. RESULTS: The black patient 30-day revisit rate was 19.3% vs 19.8% in matched white patients (p = 0.61), 30-day readmission rates were 7.0% vs 6.9% (p = 0.43), and 30-day mortality rates were 0.38% vs 0.19% (p = 0.06), respectively. A higher percentage of black patients exceeded their own state's individual median length of stay (44.0% vs 39.6%; p < 0.001) and median ICU length of stay (25.9% vs 23.8%; p < 0.001). Intensive care unit use was higher in black patients (25.9% vs 23.8%; p < 0.001). After adjusting for multiple testing, only 2 states were found to differ significantly by race (New York for length of stay and New Jersey for ICU use). CONCLUSIONS: We did not observe disparities in 30-day revisits and readmissions for chronically ill children in Medicaid undergoing surgery, and only slight differences in length of stay, ICU length of stay, and use of the ICU, where blacks displayed somewhat elevated rates compared with white controls.