Rapid on-site evaluation (ROSE) of image-guided FNA specimens improves subsequent core biopsy adequacy in clinical trial patients: The impact of preanalytical factors and its correlation with survival.

Background: Sufficient tumor collection has become of utmost importance in therapeutic experimental protocols. Rapid on-site evaluation (ROSE) ensures adequate sampling for quantification of biomarkers, molecular analyses, and other ancillary studies. The objectives of this study were to evaluate the role of ROSE in trial-associated fine-needle aspiration (FNA) and to analyze predictors of adequacy and cumulative survival from in-house FNA cases used in clinical trials.

Methods: Clinical trial FNA biopsies performed at a large academic institution were analyzed over 10 months using a comprehensive chart review of the electronic medical records. SPSS version 28 was used for statistical analysis.

Results: Three hundred twenty-five FNAs were collected for 57 clinical trials. In total, 225 individual patients had an average of 1.4 FNA procedures each as a result of a multidepartmental collaborative effort. ROSE was performed for all patients, and adequacy was evaluated by cytotechnologists. Seventy-eight percent of samples were considered adequate, 14% were considered less than optimal, and 8% were considered inadequate, with the latter two categories designated together as less than adequate. The imaging modalities were mainly ultrasound-guided (n = 267; 82%) and computed tomography-guided (n = 58; 18%). There was a statistically significant association between adequate sampling and ultrasound-guided biopsies (83%) compared with computed tomography-guided biopsies (59%; p < .01). The effect of body mass index (BMI) on mortality was also a significant finding. The authors observed a survival benefit in patients who had elevated BMIs (range, 25.0-34.9 kg/m ) compared with those who were underweight (BMI, <18.5 kg/m ) or class III obese (BMI, >35.0 kg/m ; p < .01). Therefore, the best predictors of adequacy and mortality were imaging modality and BMI, respectively.

Conclusions: Ultrasound-guided modalities are recommended for obtaining adequate FNA sampling for clinical trials. In addition, patients with cancer who had slightly elevated BMIs (25.0-34.0 kg/m ) had increased overall survival in this cohort.