Assessment of HER-2/neu status in breast cancer. Automated Cellular Imaging System (ACIS)-assisted quantitation of immunohistochemical assay achieves high accuracy in comparison with fluorescence in situ hybridization assay as the standard.

This retrospective study of formalin-fixed infiltrating breast cancer specimens compared manual immunohistochemical assay with a new image analyzer-assisted immunohistochemical quantitation method, using fluorescence in situ hybridization assay (FISH) as the standard. Following the manual immunohistochemical assay, 189 cases, including most manual immunohistochemically positive and some random negative cases, were analyzed by FISH assay for Her-2/neu gene amplification and by the Automated Cellular Imaging System (ACIS) for immunohistochemical staining. Using the FISH standard, the ACIS immunohistochemical assay attained a higher concordance rate and sensitivity than the manual immunohistochemical assay (91.0% and 88% vs 85.7% and 71%, respectively), with only a slight decrease in specificity (93% vs 96%, respectively). In particular, the ACIS immunohistochemical assay resulted in a higher correlation with the FISH assay in the manual immunohistochemical assay 2+ cases. The ACIS immunohistochemical assay achieved higher accuracy than the manual method according to receiver operating characteristic curve analysis. The ACIS method represents a substantial improvement over the manual method for objective evaluation of the HER-2/neu status.

Treatment of "poor risk" acute nonlymphocytic leukemia with continuously infused low-dose cytosine arabinoside.

There is currently little experience using a continuous intravenous infusion of low-dose cytosine arabinoside (LDARA-C) in the treatment of acute nonlymphocytic leukemia (ANLL). We report the results in 12 patients with ANLL described as either relapsed ANLL, ANLL with a preceding myelodysplastic phase, or ANLL in the elderly treated with 14 days of continuous intravenous LDARA-C (20 mg/m2/day). Complete responses (CR) were seen in five patients (42%) and partial responses (PR) in three patients (25%). Treatment resulted in overall and clonal cytoreduction, which was evident by serial bone marrow exams and bone marrow cytogenetic analysis. The ability to obtain a CR correlated with the finding of a low initial marrow cellularity (P less than .05). This study finds that continuous intravenous infusion of LDARA-C for ANLL can achieve response rates comparable to standard induction programs in a subset of patients traditionally defined as having a poor prognosis.