Impact of Recording of Pre-Analytical Specimen Handling Conditions for ER and PR Testing in Women with Breast Cancer.

Background : Hormone receptor testing is important in the management of women with breast cancer. We previously reported potential adverse effects of variable specimen and prolonged specimen handling conditions on ER (estrogen receptor) test results (2005 SABCS, abstract#5107). Objective : To compare prevalence of ER and PR (progesterone receptor) negative test results following standardization of pre-analytical specimen handling conditions at Intermountain facilities. Methods : Prospective, quasi-experimental study design of 6 Intermountain facilities. Facilities were separated into 2 categories: experimental (2 facilities) and control (4 facilities) groups. Pre-analytical specimen handling conditions (including recording of time to fixative and duration of fixation in neutral buffered formalin) were standardized at experimental facilities but not at control facilities. Standardization consisted of educating operating and grossing room staff about appropriate specimen handling and the value of recording time to fixation and fixative duration as a way to improve pre-analytic standardization. OR staff was called in any cases where times were not recorded. Study population includes women undergoing breast cancer surgery and who were tested for ER/PR status between January 2008 and January 2009. Specimen handling conditions and ER/PR test results were collected manually. Covariates were retrieved from cancer registry and included age, grade, positive lymph nodes, specimen type, and tumor stage. Multivariate logistic regression was used to compare prevalence of ER and PR negativity between experimental and control facilities after controlling for covariates. Results : 1054 women with breast cancer were tested for ER/PR status during the study period. The average age was 60.2 years (59.2 years for control cases and 61.1 years for the experimental group). The overall prevalence of ER and PR negative tests was respectively 18.5% and 27.3%. Average time to fixative at experimental facilities was 18.4 minutes (SE=3.1; 95% CI, 12.2-25.6) and average time in fixative was 18.0 hours (SE=0.4; 95% CI, 17.2-18.8). Compared to experimental facilities, both the prevalence of ER and PR negativity was higher (16.9% vs 19.7%) and (23.9% vs 30.0%) at control facilities. After controlling for covariates there was no difference in prevalence of ER negativity (p=0.13) between the two groups. However, the prevalence of PR negativity remains significantly higher (p Conclusions: The prevalence of ER and PR negative results was lower following staff education and recording of pre-analytical specimen handling conditions. Our data suggest that staff education and recording of pre-analytical specimen handling conditions has the potential to optimize hormone receptor test results. It also shows the feasibility of fixing tissue routinely after less than an hour interval between time of breast cancer tissue removal and fixation and underscores the value of standardization of pre-analytic handling as a method to improve ER and PR testing on breast cancer specimens. Citation Information: Cancer Res 2009;69(24 Suppl):Abstract nr 4154.