Oncotype DX Recurrence Score provides consistent results across varied patient populations

Sep 22 2009

Genomic Health, Inc. (NASDAQ: GHDX) today, announced results from the first study to compare the distribution of Oncotype DX® Recurrence Score® results between European, Middle Eastern and United States patient populations. The findings (Abstract 194), confirming that the distribution of Recurrence Scores in EME (Europe and the Middle East) breast cancer patients is consistent with those observed in the U.S., were presented today in a poster at the joint ECCO 15 - 34th ESMO Multidisciplinary Congress in Berlin, Germany.

Oncotype DX measures the expression of 21 genes of an individual tumor to generate a Recurrence Score (RS) result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage breast cancer patients. More than 8,000 physicians have used Oncotype DX for more than 100,000 patients in over 40 countries, including Germany, the United Kingdom, France, Spain, Italy, Israel and Greece. Oncotype DX was launched in the U.S. in 2004 where it has since been widely adopted for treating early-stage breast cancer.

"Oncotype DX represents an important step forward in personalized medicine by providing individual information about the benefit of adjuvant chemotherapy for early-stage breast cancer patients," said Professor Nadia Harbeck, MD, Head of Breast Center, University Cologne, Cologne, Germany. "With this test, we can save some patients from unnecessary treatments, while offering chemotherapy to others who will benefit from it."

For this study, researchers at Genomic Health's CLIA certified, CAP accredited laboratory analyzed samples from over 2,676 EME patients, submitted by physicians between January 2004 and April 2009. The distribution of EME scores, when compared to U.S. scores, showed that the recurrence levels were consistent across the low (51 percent EME, versus 52 percent U.S.), intermediate (37 percent EME, versus 35 percent U.S.) and high (12 percent EME, versus 13 percent U.S.) ranges of recurrence. The fact that greater than fifty percent of the patients in the EME samples had low scores is significant as this group of patients has been shown to have little or no benefit from chemotherapy(1).

The table below illustrates the distribution of low, intermediate and high risk between these two regions:

EME> "Using Oncotype DX allows me to provide my patients with important additional information related to their individual risk of recurrence and whether they are likely to benefit from chemotherapy," said Paul Dyson, MBBS, BSc, PhD, FRCR, Consultant Clinical Oncologist, Carlisle, U.K. "This data supports the use of Oncotype DX in Europe and I believe we will start to see additional physicians incorporating the test into clinical practice."

"As more physicians outside of the U.S. begin to use Oncotype DX, they can feel confident that the Recurrence Score provides consistent results across varied patient populations," said Gary Palmer, M.D., Vice President, Medical Affairs, Genomic Health. "This study, in combination with the recently published St. Gallen guidelines, which recommend for the first time that validated multigene assays be considered as an adjunct to standard measures in helping determine chemotherapy benefit, further establishes Oncotype DX as an essential component to personalized breast cancer treatment planning."