Abstract
Systematic collection of fresh tissues for research at the time of diagnostic image-guided breast biopsy has the potential to fuel a wide variety of innovative studies. Here we report the initial experience, including safety, feasibility, and laboratory proof-of-principle, with the collection and analysis of research specimens obtained via breast core needle biopsy immediately following routine clinical biopsy at a single institution over a 14-month period. Patients underwent one or two additional core biopsies following collection of all necessary clinical specimens. In total, 395 patients were approached and 270 consented to the research study, yielding a 68.4% consent rate. Among consenting patients, 238 lesions were biopsied for research, resulting in 446 research specimens collected. No immediate complications were observed. Representative research core specimens showed high diagnostic concordance with clinical core biopsies. Flow cytometry demonstrated consistent recovery of hundreds to thousands of viable cells per research core. Among a group of HER2 + tumor research specimens, HER2 assessment by flow cytometry correlated highly with immunohistochemistry (IHC) staining, and in addition revealed extensive inter- and intra-tumoral variation in HER2 levels of potential clinical relevance. Suitability for single-cell transcriptomic analysis was demonstrated for a triple-negative tumor core biopsy, revealing substantial cellular diversity in the tumor immune microenvironment, including a prognostically relevant T cell subpopulation. Thus, collection of fresh tissues for research purposes at the time of diagnostic breast biopsy is safe, feasible and efficient, and may provide a high-yield mechanism to generate a rich tissue repository for a wide variety of cross-disciplinary research.
Highlights
Emerging research on the dynamic and complex nature of breast cancer and its precursors has propelled precision medicine to the forefront of breast cancer care
Among the lesions biopsied for research revealing invasive breast carcinoma (N = 98), the majority were hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2 –) breast cancer (71.5%), followed by HER2 + breast cancer (16.3%), and triple-negative breast cancer (TNBC) (12.2%)
Among consenting the patients with research core biopsy specimen collection that were diagnosed with invasive breast carcinoma (N = 94), 55 patients (58.5%) subsequently underwent upfront surgery, 31 patients (33.0%) received neoadjuvant therapy, seven patients (7.4%) received systemic therapy only due to metastatic disease, concurrent cancer, or comorbidities, and one patient (1.1%) received subsequent care outside the system with outcomes unknown
Summary
Emerging research on the dynamic and complex nature of breast cancer and its precursors has propelled precision medicine to the forefront of breast cancer care. Cancerpositive biopsies allow assessment of molecular features associated with treatment response in patients destined to undergo neoadjuvant therapy The analysis of such specimens can inform the entire spectrum of questions regarding mechanisms of breast cancer risk, pathogenesis, disease progression, treatment response, and disease outcomes. We describe the initial experience with the collection of more than 400 core biopsy breast tissue research specimens obtained immediately following routine clinical image-guided breast biopsy at a single institution over a 14-month period. A total of 1622 clinical breast biopsy procedures (ultrasound-guided or mammographic-guided) were performed at our institution between January 2019 and March 2020 Among those undergoing a clinical core needle breast biopsy, 395 patients were approached and 270 consented to the study for the research core collection, yielding a 68.4% consent rate. Zero complications were reported among the nonresearch procedures (1622 breast biopsy procedures, ultrasound (US)-guided or mammographic-guided)
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