New Decision Impact Study regarding OncotypeDX for DCIS test

Journal of Surgical Oncology published results from a multi-center study of the Oncotype DX® DCIS Score™, demonstrating the test has significant impact on the treatment recommendations for patients with ductal carcinoma in situ (DCIS), also referred to as stage 0 or pre-invasive breast cancer. These study results underscore the practice-changing clinical utility of the test for many of the women diagnosed with DCIS each year.

"Most patients with DCIS are treated with surgery followed by radiation, yet only about 20 percent of them are likely to experience a recurrence or develop an invasive form of the disease," said Michael Alvarado, M.D., associate professor of surgery, the University of California, San Francisco Helen Diller Family Comprehensive Cancer Center. "These results highlight the need to optimize treatment of this non-invasive, indolent form of breast disease, and the importance of Oncotype DX in helping physicians reduce over- and under-treatment of DCIS."

DCIS affects approximately one out of every five women diagnosed with breast cancer, and is often treated with surgery followed by radiation therapy and/or hormonal therapy. The Oncotype DX DCIS Score result provides patients with an individualized estimate of local (in the same breast) recurrence, which could be either invasive breast cancer or DCIS. This information helps physicians and patients personalize treatment decisions to potentially spare women with low risk of recurrence additional treatment they may not need, while identifying women with a higher risk of recurrence who may need additional treatment after surgery.

Conducted in collaboration with Partnership for Health Analytic Research, this prospective study analyzed 115 patients from 10 cancer centers in the United States. The results showed that physician treatment recommendations changed for 31 percent of patients after receiving the DCIS Score result, reducing the number of patients receiving a radiotherapy recommendation by approximately one-third. Importantly, of the patients initially recommended not to receive radiotherapy, 32 percent were identified as having a high risk of recurrence and recommended to have radiotherapy. Physicians in this study rated the DCIS Score as the most important factor in planning treatment compared with pathologic features, patient preference, patient age, comorbidities or consultation with other physicians.

"The Oncotype DX DCIS Score result was validated in two studies including nearly 900 patients and is the only genomic test for patients with pre-invasive breast cancer," said Phil Febbo, M.D., chief medical officer, Genomic Health. "The publication of this clinical utility study clearly demonstrates that the Oncotype DX DCIS Score can play a key role in enhancing cancer care for patients with DCIS, and we believe that these results will support expanded adoption of and access to the DCIS Score."

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