A Rapid, Fully Automated, Molecular-Based Assay Accurately Analyzes Sentinel Lymph Nodes for the Presence of Metastatic Breast Cancer

摘要: In breast cancer and other malignancies, involvement of regional lymph nodes is a strong prognostic indicator greatly influences staging clinical management.1–4 One benefit from the implementation sentinel node biopsy (SLNB) techniques identification metastatic foci in 10% to 15% patients that would have been previously staged as node-negative (pN0) by conventional methods.5,6 This improved sensitivity attributed both addition immunohistochemical staining (IHC) an increase sampling volume.5,6 Many these additional positive contain only micrometastatic tumor. However, significance disease identified SLNB highly controversial.7–11 Nonetheless, are now widely used melanoma being applied with increasing frequency tumors, including colorectal, oropharyngeal, prostate, lung, solid organ cancers.12–15 Another clear advantage technique majority patients, safely avoids axillary dissection (ALND) associated morbidity when SLN negative for disease.16 rapid, frozen-section analysis metastasis 50% 70% sensitive detection compared permanent histologic sections IHC same node,17,18 complete specimen currently requires extensive preparation time-consuming review.8 Even experienced hands, specimens later found metastases.19 As result, required second surgical procedure ALND. clearly undesirable algorithm patient, healthcare provider, payer, this dilemma has contributed new controversy; if positive, does completion ALND confer therapeutic or patient? Until ongoing multicenter trials determine whether completing benefits it time accurately evaluate significant implications.20 It must also be recognized that, even adequate time, accurate challenging, discordance interpretation materials well-known problem. Indeed, recent study alarming disparity among pathologists specimens.21 Furthermore, protocols vary between centers.22 Thus, current methods lack standardization, dependent part on subjective criteria, subject human error. We others shown real-time, quantitative RT-PCR (QRT-PCR) can more than predicting prognosis malignancies,23,24 we reported our development rapid QRT-PCR completed (including RNA isolation) less 25 minutes.25 Importantly, revolutionary tool molecular-based assays called GeneXpert (Cepheid, Sunnyvale, CA) final stages development. instrument fully automates sample preparation, isolation purification, single-use, cartridge-based format removes major obstacles limiting routine use assays. aimed automated, internally controlled assay performed prototype could produce equivalent results analysis, IHC. providers definitively analyzing using objective criteria frame allows intraoperative use, reduces patient psychologic distress, improves standardization centers.