Affiliation:
1. Department of Pathology Johns Hopkins University School of Medicine Baltimore Maryland USA
2. Department of Pathology University of Maryland School of Medicine Baltimore Maryland USA
3. Department of Radiology Johns Hopkins University School of Medicine Baltimore Maryland USA
Abstract
AbstractBackgroundSufficient 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.MethodsClinical 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.ResultsThree 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/m2) compared with those who were underweight (BMI, <18.5 kg/m2) or class III obese (BMI, >35.0 kg/m2; p < .01). Therefore, the best predictors of adequacy and mortality were imaging modality and BMI, respectively.ConclusionsUltrasound‐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/m2) had increased overall survival in this cohort.