Abstract
BackgroundWe sought to examine the detection rate of cancer cells in peripheral blood (PBL) and in bone marrow (BM) using an established 7-gene marker panel and evaluated whether there were any definable associations of any individual gene with traditional predictors of prognosis.MethodsPatients with T1-T3 primary breast cancer were enrolled into a prospective, multi-institutional cohort study. In this interim analysis 215 PBL and 177 BM samples were analyzed by multimarker, real-time RT-PCR analysis designed to detect circulating and disseminated breast cancer cells.ResultsAt a threshold of three standard deviations from the mean expression level of normal controls, 63% (136/215) of PBL and 11% (19/177) of BM samples were positive for at least one cancer-associated marker. Marker positivity in PBL demonstrated a statistically significant association with grade II-III (vs. grade I; p = 0.0083). Overexpression of the mammaglobin (mam) gene alone had a statistically significant association with high tumor grade (p = 0.0315), and showed a trend towards ER-negative tumors and a high risk category. There was no association between marker positivity in PBL and the pathologic (H&E) and/or molecular (RT-PCR) status of the axillary lymph nodes (ALN).ConclusionThis study suggests that molecular detection of circulating cancer cells in PBL detected by RT-PCR is associated with high tumor grade and specifically that overexpression of the mam gene in PBL may be a poor prognostic indicator. There was no statistically significant association between overexpression of cancer-associated genes in PBL and ALN status, supporting the concept of two potentially separate metastatic pathways.
Highlights
We sought to examine the detection rate of cancer cells in peripheral blood (PBL) and in bone marrow (BM) using an established 7-gene marker panel and evaluated whether there were any definable associations of any individual gene with traditional predictors of prognosis
There is a significant amount of ongoing work aimed at defining the role of circulating tumor cells (CTC) in peripheral blood (PBL) and disseminated tumor cells (DTC) in bone marrow (BM) of breast cancer patients
The primary objective of the study was to determine whether the molecular detection of occult breast cancer by multimarker real-time RT-PCR in patients with pathology-negative axillary lymph nodes (ALN) is a clinically relevant predictor of disease recurrence
Summary
We sought to examine the detection rate of cancer cells in peripheral blood (PBL) and in bone marrow (BM) using an established 7-gene marker panel and evaluated whether there were any definable associations of any individual gene with traditional predictors of prognosis. The primary objective of the study was to determine whether the molecular detection of occult breast cancer by multimarker real-time RT-PCR in patients with pathology-negative axillary lymph nodes (ALN) is a clinically relevant predictor of disease recurrence. An interim analysis of 489 patients enrolled in the study showed a statistically significant association between molecular detection of occult breast cancer in the ALN and traditional predictors of poor prognosis in subjects with pathology-negative ALN [33]. In a separate publication we show that the sensitivity of sentinel lymph node (SLN) analysis to predict pathologic status of ALN was significantly increased by the addition of molecular analysis [34]
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