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Lawrence J. Solin, MD, FACR, FASTRO, Chair of the Departmentof Radiation Oncology at Einstein Medical Center in Philadelphia, presentedstudy results that represent a significant advance for patients with ductalcarcinoma in situ (DCIS).
The study, presented at the 2011 San Antonio Breast Cancer Symposium (SABCS), held Dec. 6-10, detailed that researchers have developed and prospectively validated a multigene test to identify the risk for recurrence of ductal carcinoma in situ (DCIS) of the breast.“We have successfully identified patients at higher risk for recurrence and patients at lower risk,” said Solin. “This is an important advance for women with newly-diagnosed DCIS of the breast. By predicting individual risk, physicians can provide a more tailored treatment program for each patient.”The test, which determines the gene profile of a patient’s individual DCIS tumor, may spare some patients with DCIS the necessity of undergoing radiation after surgery. It is the first time that a multigene test has been used to differentiate between more aggressive and lower-risk forms of DCIS. Numerous studies, including the current one, have shown that routine microscopic pathology grading is not a reliable indicator of the risk for recurrence.“The DCIS score will help the physician understand the underlying biology of DCIS for an individual patient and accurately gauge the risk for that person,” said Solin. “As a result, the patient and physician can decide on the appropriate course of treatment based on a more complete understanding of the risk involved.”The validation study of the DCIS score was a collaboration among the Eastern Cooperative Oncology Group (ECOG), North Central Cancer Treatment Group (NCCTG) and Genomic Health, Inc. The validation utilized patient tumor samples from E5194, an ECOG-led, multi-institutional study of patients with low-, intermediate- or high-grade DCIS who had been treated with surgical excision, but had not received radiation. E5194 was a prospective study of local excision alone for DCIS. Researchers tested and scored tumors from 327 patients to determine their individual risk for recurrence. The DCIS validation study team used the Oncotype DX breast cancer assay platform, which has been available for invasive breast cancer since 2004, and a DCIS score algorithm to study these tumor samples. The test uses reverse transcriptase-polymerase chain reaction technology, which quantitates the level of RNA in the individual tumor sample to reveal its underlying biology. The level of RNA is then used by a prespecified algorithm to calculate a DCIS score, which predicts the likelihood of local recurrence, defined as either the development of a new invasive breast cancer or the recurrence of DCIS in the treated breast. Solin also reported 10-year results of E5194, in which 46 patients had an ipsilateral breast event (IBE; defined as ipsilateral local recurrence of DCIS or invasive cancer) at a median follow-up of 8.8 years. Continuous DCIS score was significantly associated with IBE when adjusted for tamoxifen use and provided value beyond the traditional measures of tumor size, tumor grade and margin status.