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| |  Gene Test Included in Breast Cancer Treatment Guidelines: Presented at NCCN By Ed Susman HOLLYWOOD, Fla -- March 16, 2008 -- The National Comprehensive Cancer Network has, for the first time, included a recommendation for limited use of a multigene assay test to assist doctors in making treatment choices for patients. The guidelines divide women with breast cancer into several different groups -- reflecting the concept that breast cancer is not one disease, but several different forms of a disease that occurs in the breast, which must be treated individually. The system that has been incorporated into the guidelines is the 21-gene reverse-transcription polymerase chain reaction (RT-PCR) assay, said Robert W. Carlson, MD, Professor of Medicine, Stanford University Medical School, and Stanford Comprehensive Cancer Centre, Stanford, California. The assay uses various genes and complex equations to determine levels of gene expression in the tumour tissue sample and calculates a disease recurrence score (range 0-100) to indicate the woman's risk of cancer recurrence, Dr. Carlson said in a presentation here on March 8 at the National Comprehensive Cancer Network (NCCN) 13th Annual Conference: Clinical Practice Guidelines and Quality Cancer Care. A score under 18 indicates a low risk; 18 to 30 denotes intermediate risk; above 31 indicates a high risk. The NCCN guidelines separate individuals with breast cancer according to oestrogen-receptor positive or negative, progesterone-receptor positive or negative, and HER2 oncogene positive or negative. "The recurrence score appears to be fairly good at sorting out the risk categories," Dr. Carlson said. A previous study demonstrated that after 16 years, more than 90% of women predicted by the assay to be at low risk of recurrence were disease free, about 80% of those predicted to be at intermediate risk were disease free, and of those predicted to be at high risk, 70% were disease free. However, Dr. Carlson said the test has a number of limitations, in particular that it is validated only in cases in which women received tamoxifen and first-generation chemotherapy regimens. He said it appears to be most useful in predicting outcomes among women who were oestrogen-receptor positive and/or progesterone-receptor positive, or HER2 negative, and who also have no detectable cancer in the lymph nodes. The guidelines recommend the use of adjuvant endocrine therapy with or without adjuvant chemotherapy for tumours that are not evaluated using the RT-PCR assay. If the assay is utilised, a low score would lead to the recommendation of adjuvant endocrine therapy alone. An intermediate score would suggest endocrine therapy with or without chemotherapy. A high score would lead to treatment with both endocrine and chemotherapy. However, evidence for these recommendations is limited, and Dr. Carlson said the opinion of the breast cancer panel on these suggestions was not uniform.
[Presentation title: Update: Breast Cancer Guidelines.]
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