Research Related Tumour Biopsies in Early-Phase Trials with Simultaneous Molecular Characterisation - a Single Unit Experience.

Early-phase cancer clinical trials are becoming increasingly accessible for patients with advanced cancer who have exhausted standard treatment options and later phase trial options. Many of these trials mandate research tissue biopsies. Research biopsies have been perceived as ethically fraught due to the perception of potential coercion of vulnerable human subjects. We performed an audit of two years of practice to assess the safety of ultrasound (US)-guided research biopsies, and to look at the yield of a simultaneous tumour next-generation sequencing (NGS) and immunohistochemistry (IHC) molecular characterisation programme. We show that in our institution, US-guided research biopsies were safe, produced adequate tumour content and in a selected subset who underwent in-house NGS sequencing, showed a high rate of actionable mutations with 30% having a Tier 1 variant. Nevertheless, these research biopsies may only provide direct benefit for a minority of patients and we conclude with a reflection on the importance of obtaining truly informed consent.

Comparative cost-effectiveness of fine needle aspiration biopsy versus image-guided biopsy, and open surgical biopsy in the evaluation of breast cancer in the era of Affordable Care Act: a changing landscape.

BACKGROUND: Proven as a time challenged and cost-effective sampling procedure, the use of FNAB has still remained controversial among the scientific community. Currently, other minimally invasive sampling procedures such as ultrasound guided fine needle aspiration biopsy (US-FNAB) and image guided core needle biopsy (IG-CNB) have become the preferred sampling procedures for evaluation of breast lesions. However, changes in the medical economy and the current growing emphasis on cost containment in the era of the Affordable Care Act make it necessary to stimulate a renewed interest in the use of FNAB as the initial diagnostic sampling procedure. This study was designed to define the changing trend in the practice of tissue sampling during the last several years, and to assess the comparative effectiveness and appropriateness of the procedure of choice for breast cancer diagnosis. METHODS: After Institutional Review Board (IRB) approval, the computer database of the Pathology Department, University of Florida, College of Medicine-Jacksonville at UF Health was retrospectively searched to identify all breast biopsy pathology reports issued during the period of January 2004 to December 2011. The inclusion criteria were all women that underwent any of the following biopsy types: FNAB, US-FNAB, IG-CNB, and surgical biopsy (SB). Diagnostic procedures were identified using current procedural terminology (CPT) codes recorded on claims from the UF Health Jacksonville patient accounting application files. The data obtained was used to determine which technique has the best cost-effectiveness in the diagnosis of breast cancer. The outcome variable for this project was a positive breast cancer diagnosis resulting from these methodologies. The predictor variable was the biopsy type used for sampling. The rate of cancer detection for each procedure was also determined. RESULTS: Among the four groups of procedures compared, the lower cost was attributed to FNAB, followed by US-FNAB, and SB. IG-CNB was the most costly procedure, even more expensive than SB. The more costs associated with IG-CNB compared to SB is related to the expense involved in the use of localizing devices and also attempts to sample a lesion more than once. More importantly, cancer yield by FNAB was the highest among all the procedures under study. CONCLUSION: This study confirms the comparative effectiveness of FNAB in the evaluation of patients with breast cancer and justifies serious endorsement of this procedure as the initial diagnostic sampling modality for its unique potential in rapid reporting and cost-saving.