Diagnostic accuracy and safety of coaxial core-needle biopsy (CNB) system in Oncology patients treated in a specialist cancer centre with prospective validation within clinical trial data

Abstract

Background

Image guided tissue biopsies are critically important in diagnosis and management of cancer patients. High yield samples are also vital for biomarker and resistance mechanism discovery through molecular/genomic analyses.

Patients and methods

All consecutive patients who underwent plugged image-guided biopsy at Royal Marsden from June 2013 until September 2016 were included in the analysis. In second step, a second cohort of patients prospectively treated within two clinical trials (PROSPECT-C and R), were assessed for the DNA yield from biopsies assessed for complex genomic analysis.

Results

A total of 522 plugged core biopsies were performed in 457 patients [52% men; median age 63 years (range 17-93)]. Histological diagnosis was achieved in 501/522 (96%) of performed biopsies. Age, gender, modality, metastatic site and seniority of the interventionist were not found to be significant factors associated with odds of failure on a logistic regression. Seventeen (3.3%) were admitted due to biopsy-related complications; 9, 3, 2, 1, 1,1 were admitted for grade I/II pain control, sepsis, vasovagal syncope, thrombosis, haematuria and deranged liver functions respectively; 2 patients with right upper quadrant pain after liver biopsy were found to have radiologically confirmed subcapsular haematoma requiring conservative treatment. One patient (0.2%) developed grade III haemorrhage following biopsy of a gastric GIST tumour. Overall molecular analysis was successful in 89% (197/222 biopsies). Prospective validation in 62 biopsies gave success rates of 92.06% and 79.03% for DNA extraction of >1microgram and tumour content of >20% respectively.

Conclusion

The probability of diagnostic success for complex molecular analysis is increased with plugged large co-axial needle biopsy technique, which also minimises complications and reduces hospital stay. High yield DNA acquisition allows genomic molecular characterisation for personalised medicine.

Statement of significance

Cancer diagnosis and personalised management is largely dependent on safe acquisition of tumour tissue required for histological diagnosis, and sometimes genomic characterisation. This poses significant challenge to treating physicians, when deliberating risk-benefit ratio of invasive procedures, especially within the context of clinical trials. In this largest examination of safety and efficacy of biopsies in more than 500 patients, we show that diagnostic success for complex molecular analysis is increased with CNB technique that minimises complications and reduces hospital stay. Moreover, we provide validation of our findings with a group of patients treated within prospective clinical trials.