Abstract P2-03-15: Re-assessment of 21-gene breast cancer assay utilization as a quality indicator by the Florida Initiative for Quality Cancer Care (FIQCC) Consortium
Authors: Laronga Christine , Sun Weihong , Siegel Erin , Lee Ji-Hyun , Fulp William J , Jacobsen Paul B , Gray Jhanelle E 
Published: May 2015

Background: In 2006, the FIQCC conducted a comprehensive review of quality of care indicators specific to breast cancer (BC) based on QOPI/NCCN/ACOS and panel consensus, with feedback provided on indicator performance to encourage quality improvement efforts. In 2009, at re-assessment of adherence to the previous indicators, we introduced a pilot quality indicator from the NCCN treatment guidelines: discussion/recommendation of the 21-gene BC assay for treatment decisions. The current study assesses quality improvement efforts targeting specifically the 21-gene BC assay.

Methods: After disclosure of results in 2012, 5 FIQCC sites agreed to participate in a re-assessment sub-study focused on the 21-gene BC assay. Following IRB approval, each site developed and implemented a site-specific quality improvement plan focused on the discussion/utilization of this assay. Following this intervention, chart reviews were conducted for ER+ BC patients first seen by a medical oncologist in 2013 and eligible for the 21-gene BC assay based on NCCN criteria (n=130). Data collected included: 1) documentation of a discussion with the patient of the 21-gene BC assay; 2) documentation of ordering/performance/results of the 21-gene BC assay; and 3) treatment decisions based on results and/or documentation of reasons for non-compliance. Statistical comparisons of the previously collected 2009 data (n=262) for these 5 FIQCC sites and new 2013 data were performed using the Pearson Chi-Square exact test based on Monte Carlo estimation.

Results: Overall, the mean age of patients was 62 years (range 30-89) for the combined 2009 and 2013 years. More women had her2 negative BC in 2013 compared to 2009 (p=0.003). Since the 2009 dataset was not specific to the 21-gene BC assay eligibility, a smaller proportion of patients had tumor sizes staged as T1c/T2/T3 [80.3% vs. 92.2% for 2009 as compared to 2013, p=0.005] and less were node negative in 2009 [56.8% vs. 96.6%; p&lt;0.001]. Based on NCCN criteria, only 60.9% of eligible patients had a documented discussion or recommendation for the 21-gene assay in 2009 with significant variability among the 5 sites (p=0.011). A significant improvement was seen in 2013 (p&lt;0.001) with 91.4% of eligible patients having documentation of a discussion or recommendation for the 21-gene assay without significant variability amongst the practice sites. Significant improvement in the percentage of patients having the assay ordered from 2009 to 2013 was seen (p&lt;0.001) but variability amongst the sites persisted (2009: p=0.002; 2013: p=0.018). Recurrence Score (RS) results were completely s recorded in both 2009 and 2013. All patients with high-risk RS were referred for chemotherapy. A small fraction of patients with low-risk RS was referred for chemotherapy both years (2009: 5.4%, 2013: 3.8%; p=1.00).

Conclusions: Previously, the FIQCC identified quality improvement needs in multiple aspects of BC care, including recommendation and ordering of the 21-gene BC assay. A dedicated quality improvement effort can significantly increase both the discussion/recommendation and ordering of the 21-gene BC assay among eligible patients. These improvements have the potential to alter treatment recommendations.

Citation Format: Christine Laronga, Weihong Sun, Erin Siegel, Ji-Hyun Lee, William J Fulp, Paul B Jacobsen, Jhanelle E Gray. Re-assessment of 21-gene breast cancer assay utilization as a quality indicator by the Florida Initiative for Quality Cancer Care (FIQCC) Consortium [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P2-03-15.