A Reappraisal of the Comparative Effectiveness of Lumpectomy Versus Mastectomy on Breast Cancer Survival: A Propensity Score-Matched Update From the National Cancer Data Base (NCDB).

BACKGROUND: Recent observational studies are concerning because they document rising mastectomy rates coinciding with more than a dozen reports that lumpectomy has better overall survival (OS) than mastectomy. Our aim was to determine if there were differences in OS of matched breast cancer patients undergoing lumpectomy versus mastectomy in the National Cancer Database (NCDB). PATIENTS AND METHODS: A retrospective cohort of patients with stage I-III breast cancer in the NCDB (2004-2013) was identified. Propensity score matching (PSM), Kaplan-Meier, and multivariate Cox proportional hazards models were used to examine OS by type of surgery. RESULTS: Of 845,136 patients, 464,052 (54.9%) underwent lumpectomy and 381,084 (45.1%) underwent mastectomy. After PSM, the hazard ratio (HR) and confidence interval (CI) for OS in all patients comparing lumpectomy with mastectomy was 1.02 (CI, 1.00-1.04; P = .002). In patients with stage I, II, and III, they were HR 1.27 (CI, 1.23-1.36; P < .001), HR 0.98 (CI, 0.95-1.01; P = .21), and HR 0.83 (CI, 0.80-0.86; P < .001), respectively. In subgroup analyses of all patients by estrogen receptor (ER) status, they were HR 1.05 (CI, 1.03-1.07; P < .001) and HR 1.00 (CI, 0.96-1.03; P = .65) in ER+ and ER- patients. CONCLUSION: In our primary model of all stage I-III matched patients, using the most recent NCDB data and the largest observational sample size to date, the OS after mastectomy was not inferior to lumpectomy. This finding can be reassuring to patients and providers. In subgroup analyses, the association between type of surgery and OS differed by cancer stage and hormone receptor status.

A US Registry-Based Assessment of Use and Impact of Chemotherapy in Stage I HER2-Positive Breast Cancer.

Background: Despite the paucity of evidence supporting chemotherapy in the treatment of node-negative, HER2-positive breast cancer measuring <2 cm, use of trastuzumab-based chemotherapy has increased over the past decade. Therefore, we used the National Cancer Database to evaluate the use and impact of chemotherapy on survival in this population. Methods: We identified female patients aged 18 to 70 years with node-negative, HER2-positive breast cancer measuring <2 cm. A propensity-matched cohort model was used to control for risk factors known to influence survival. Primary end points assessed were receipt of chemotherapy and overall survival (OS). Results: In our propensity-matched cohort model (n=8,222), adjuvant chemotherapy (ACT) was associated with a lower 5-year OS rate in T1mi breast cancer (n=626; 89.1% [95% CI, 81.8%-93.5%] vs 99.1% [96.6%-99.8%]), no significant effect in T1a disease (n=2,901; 95.4% [93.2%-96.9%] vs 96.9% [94.1%-98.3%]), and improved 5-year OS in T1b (n=2,340; 97.1% [95.1%-98.4%] vs 92.3% [88.5%-94.9%]) and T1c tumors (n=2,355; 95.9% [93.5%-97.5%] vs 91.5% [88.4%-93.9%]). In the entire cohort of 21,148 patients who met the inclusion criteria, ACT was associated with lower 5-year OS in T1mi (89.6% [83.7%-93.4%] vs 98.1% [96.6%-98.9%]) and T1a tumors (94.9% [92.9%-96.3%] vs 96.5% [94.6%-97.7%]), and improved 5-year OS in T1b (96.8% [95.6%-97.7%] vs 92.3% [88.7%-94.8%]) and T1c tumors (95.8% [94.9%-96.5%] vs 91.6% [88.5%-93.9%]). Increased use of ACT was observed over the study period. From 2010 to 2013, annual treatment rates were 71.5%, 72.4%, 73.3%, and 74.4%, respectively (trend test, P<.0001). Conclusions: Our data support the use of ACT for HER2-positive, node-negative T1b and T1c breast cancer, whereas no benefit was observed for ACT in T1mi and T1a HER2-positive, node-negative breast cancer. Although use of ACT is increasing in node-negative, HER2-positive breast cancer <2 cm, our findings caution against its use in the smallest of these tumors (T1mi and T1a) due to lack of survival benefit.

A Strategy for Changing Adherence to National Guidelines for Decreasing Laboratory Testing for Early Breast Cancer Patients.

INTRODUCTION: Past studies indicate delays in adoption of consensus-based guideline updates. In June 2016, the National Comprehensive Cancer Network changed its guidelines from routine testing to omission of ordering complete blood cell count (CBC) and liver function tests (LFT) in patients with early breast cancer. In response, we developed an implementation strategy to discontinue our historical practice of routine ordering of these tests in asymptomatic patients. METHODS: The ordering of CBC and LFT for clinical stage I-IIIA breast cancer patients was audited in 2016. In June 2016, we utilized the levers of the National Quality Strategy implementation methodology to enact a system-wide change to omit routine ordering. To measure the plan's effectiveness, guideline compliance for ordering was tracked continually. RESULTS: Of 92 patients with early stage cancer in 2016, the overall rate of compliance with guidelines for ordering a CBC and LFT was 82% (88/107) and 87% (93/107), respectively. Segregated by the pre- and post-guideline change time period, the compliance rates for ordering a CBC and LFT were 78% and 87% (P = 0.076). CONCLUSION: In contrast to historical reports of delays in adoption of new evidence-based guideline changes, we were able to quickly change provider practice during the transition from routine ordering to omission of ordering screening blood tests in newly diagnosed patients with early breast cancer.

Fewer Reoperations After Lumpectomy for Breast Cancer with Neoadjuvant Rather than Adjuvant Chemotherapy: A Report from the National Cancer Database.

BACKGROUND: Reoperations occur frequently after initial lumpectomy for breast cancer. The authors hypothesized that the receipt of neoadjuvant chemotherapy (NAC) is associated with fewer reoperations. METHODS: The association between timing of chemotherapy and reoperation rates (ROR) after lumpectomy was investigated for patients with stages 1-3 breast cancer in the National Cancer Database (NCDB) from 2010 to 2013 by multivariable logistic regression modeling. Then propensity score-matching was performed. RESULTS: The unadjusted ROR for 71,627 stages 1-3 patients was 11.4% for those who had NAC compared with 20.3% for those who had postoperative chemotherapy (p < 0.001) (odds ratio [OR] 0.53; 95% confidence interval [CI] 0.49-0.57; p < 0.001). The ORs for the reoperations performed for patients with stages 1, 2, and 3 cancers who received NAC were respectively 0.65 (95% CI 0.56-0.75), 0.50 (95% CI 0.45-0.56), and 0.27 (95% CI 0.19-0.38) The p values for all were lower than 0.001. CONCLUSION: For a population of patients receiving chemotherapy, the receipt of chemotherapy before instead of after surgery was associated with fewer reoperations after initial lumpectomy for breast cancer.

21-Gene recurrence score decreases receipt of chemotherapy in ER+ early-stage breast cancer: an analysis of the NCDB 2010-2013.

The purpose of this study was to determine if receipt of chemotherapy was associated with utilization of the 21-gene recurrence score assay (RS assay) or with recurrence score (RS) in eligible patients. Using the National Cancer Data Base (NCDB), we identified female patients eligible for RS assay based on National Comprehensive Cancer Network (NCCN) guidelines: age 18-70, ER-positive and HER2-negative early-stage breast cancer diagnosed during 2010-2013. We excluded patients not meeting testing guidelines. Inclusion required result of RS in patients who underwent RS assay and status for receipt of chemotherapy. Multivariable logistic regression models and propensity matched analysis were used to determine associations between RS assay and RS with receipt of chemotherapy. Among 129,765 patients who were eligible, 74,778 underwent RS assay and had results available. Of these, 59.5 % (44,505) had low-risk, 32.0 % (23,920) had intermediate-risk, and 8.5 % (6353) had high-risk RS. Patients with intermediate- and high-risk RS were more likely to receive chemotherapy [OR 12.9 (CI 12.2-13.6), p <0.001 and OR 87.2 (CI 79.6-95.6), p <0.0001], respectively. In both low- and intermediate-risk groups, increasing RS score was significantly associated with increasing odds of receiving chemotherapy [OR 1.10 (CI 1.09-1.12), p <0.0001 and OR 1.26 (CI 1.25-1.27), p <0.0001, respectively, for each point increase in RS]. Receipt of chemotherapy was more likely in patients who did not undergo RS assay compared to those who did, OR 1.21 (CI 1.175-1.249) p <0.0001. The utilization of RS assay and the RS were both strongly associated with chemotherapy receipt. Patients eligible for chemotherapy, based on NCCN criteria, were more likely to receive chemotherapy if they did not undergo RS assay or they had a high RS.

Institutional review of compliance with NCCN guidelines for breast cancer: lessons learned from real-time multidimensional synoptic reporting.

BACKGROUND: Variations exist in compliance with NCCN Guidelines. Prior reports of adherence to NCCN Guidelines contain limitations because of lack of contemporary review and incomplete listing of reasons for noncompliance. PURPOSE: To assess institutional compliance and assist national quality improvement strategies through identifying valid reasons for noncompliance. METHODS: Compliance with NCCN Guidelines was recorded prospectively using electronic synoptic templates for patients with newly diagnosed breast cancer treated at a single institution between January 2010 and December 2011. Compliance with NCCN Guidelines was recorded. The accuracy of real-time synoptic auditing methods compared with retrospective chart review and reasons for noncompliance was assessed. SAS 9.3 software was used for data analysis. RESULTS: Compliance with NCCN Guidelines among 395 patients was 94% for initial staging evaluation, 97% for surgery, 91% for chemotherapy, 89% for hormone therapy, 91% for radiation therapy, 85% for follow-up, and 100% for determination of estrogen receptor/progesterone receptor and HER2 status. Age, comorbidities, and stage influenced guideline compliance. The most common reasons for noncompliance were patient refusal, patient choice after shared decision-making, and overuse of testing. Synoptic templated reporting was accurate in 97% patients. CONCLUSIONS: High compliance with NCCN Guidelines was demonstrated. Reasons for noncompliance were identifiable. Compliance and nonadherence can be evaluated quickly with electronic synoptic reporting. This allows real-time action plans to address quality concerns and aids national risk adjustment for comparison and benchmarking.

A community breast center report card determined by participation in the national quality measures for breast centers program.

Measurement of quality indicators and peer comparison has been demonstrated to improve quality of care. The goal of this study was to determine whether a community breast center, in collaboration with the National Consortium of Breast Centers (NCBC), could voluntarily audit the quality of breast cancer care, confidentially transmit quality information to the NCBC, and receive peer performance comparisons. Quality indicator metrics from consecutive breast cancer patients undergoing care at a community interdisciplinary breast center were entered into a prospective database of quality measures that were defined by the NCBC. Retrospective review of patients from 2004 to 2006 was performed and subsequent quality indicator data was submitted electronically to the NCBC National Quality Measures for Breast Centers (NQMBC(TM) ) program. The percentage of new cancer diagnoses made by needle biopsy techniques was 94%, 95% and 96% from 2004 to 2006. Sentinel lymph node utilization in eligible patients was 93%, 96% and 91% from 2004 to 2006 and the immediate intraoperative pathologic frozen section false negative rate of the sentinel lymph node was 6.5%, 4.7% and 4%. Chart documentation of "patient participation in shared decision making for breast conserving therapy versus mastectomy" improved from 74% to 99% (p<0.05) from 2004 to 2006. Adjuvant systemic treatment for stage 2 breast cancer occurred in 76%, 89% and 77% of patients from 2004 to 2006. Neutropenia requiring hospital admission occurred in no patients in 2004 but in 4.8% and 2.9% in 2005 and 2006. The re-excision lumpectomy rates for stage 0, 1, 2, and 3 breast cancer patients from 2004 to 2006 was 14.2%, 22% and 24.8%. Quality indicator data was submitted to the NQMBC(TM) with successful confidential receipt of peer performance comparisons. Voluntary interdisciplinary institutional audits of breast cancer quality can be successfully submitted to the NQMBC(TM) with confidential peer performance comparison.

A breast center review of compliance with National Comprehensive Cancer Network Breast Cancer guidelines.

BACKGROUND: National Comprehensive Cancer Network (NCCN) guideline compliance for breast cancer was determined in a breast center. METHODS: A retrospective study of 200 new breast cancer patients seen in 2004 was performed. RESULTS: NCCN guideline compliance rates for preoperative evaluation, breast surgery, lymph node surgery, radiation treatment, and systemic adjuvant therapy were 87%, 97%, 97%, 77%, and 63%, respectively. The most common reasons for noncompliance were partial breast radiation, no radiation, limited life expectancy, and patient choice to defer systemic treatment. CONCLUSIONS: The investigation of quality of breast cancer care requires measurement of compliance and reasons for noncompliance with established guidelines. A review that focuses only on percentage compliance has the potential to penalize institutions that (1) practice informed consent detailing absolute risks of survival with and without systemic therapy, (2) practice evidence-based medicine before the standardized guideline is changed to reflect it, and (3) serve populations with limited life expectancy.