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Experimental and Molecular Therapeutics 43: Conventional and Novel Therapeutic Approaches |
St. Mary Medical Center, Langhorne, PA, University of Pittsburgh, Pittsburgh, PA, Precision Therapeutics, Pittsburgh, PA
Background: Multiple chemotherapy options exist for the treatment of primary breast cancer. Treatment is typically based on clinical and histological features, as well as historical population response rates. Although response rates are good, many patients are treated with unnecessary or ineffective chemotherapy. Inadequate treatments are partly due to the lack of accurate predictors of response in individual patients. To predict an individual patient’s clinical response to therapy, ex vivo chemosensitivity and resistance assays (CSRAs) have long been evaluated, but have historically been limited by the need for large (1-2 gm) amounts of fresh tissue and other technical difficulties. However, these problems have largely been overcome with new technology. Novel methods used in Precision Therapeutics’ ChemoFx® Assay allow for testing smaller amounts of tissue (35 mg). This reduced tissue requirement is crucial in the breast cancer setting, as the diagnosis is often made by biopsy. The goal of this study was to determine the success rate of culturing cells from patient biopsies obtained through use of the MAMMOTOME® device and to determine the feasibility of testing these cells with the ChemoFx® Assay. Methods: This was a prospective study of women with primary breast cancer whose tissue was obtained using the MAMMOTOME® Breast Biopsy System. This ultrasound guided, vacuum-assisted biopsy device used an 11-gauge probe (estimated yield 80-100 mg) to extract tissue. The specimens were then submitted to Precision Therapeutics, Inc. A primary culture of each specimen was established, and the ex vivo chemoresponse profiles of each culture were evaluated. Success was defined as the ability to grow enough cells to test at least two chemotherapy drugs per specimen using the ChemoFx® Assay. Results: 14 out of 14 [95% CI: 0.77-1.00] consecutively received specimens grew successfully and all specimens were tested for chemoresponsiveness using the ChemoFx® Assay. Chemotherapy drugs tested included cyclophosphamide, docetaxel, doxorubicin, 5-fluorouracil, gemcitabine, irinotecan, methotrexate, and paclitaxel. The average number of drugs tested for each specimen was 4.5 (range: 2-6). The average amount of time needed to provide an assay result was 23.1 days (range: 11-38). Conclusions: It is feasible to culture breast cancer cells from MAMMOTOME® biopsies and perform the ChemoFx® Assay on them. Demonstrating that sufficient cells can be cultured for ex vivo chemoresponse testing from biopsies greatly increases the utility of the assay in adjuvant or neoadjuvant primary breast cancer settings.
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