Results from clinical survey of Oncotype DX on patients with node-positive breast cancer announced

Dec 12 2009

Genomic Health, Inc. (Nasdaq: GHDX) today announced results from a clinical survey evaluating the impact of the Oncotype DX® Recurrence Score® result on physicians' adjuvant treatment recommendations for patients with node-positive, hormone receptor-positive breast cancer. The findings, presented as a poster at the 32nd Annual CTRC-AACR San Antonio Breast Cancer Symposium (Abstract # 2031), demonstrated that physicians frequently changed treatment recommendations for breast cancer patients with 1-3 positive nodes after integrating Recurrence Score results.

Oncotype DX is a multi-gene expression test that physicians currently use to predict the likelihood of chemotherapy benefit and recurrence risk for patients with early-stage breast cancer. This survey of 160 medical oncologists about their clinical experience with Oncotype DX in node-positive breast cancer was conducted through a voluntary web-based questionnaire, and found that treatment recommendations changed for half of the patients after obtaining a Recurrence Score result.

Specifically, in the 138 cases where the physician had a specific treatment recommendation before obtaining the Recurrence Score, recommended treatment changed from hormonal therapy plus chemotherapy to hormonal therapy alone in 46 patients (33 percent), and from hormonal therapy alone to hormonal therapy plus chemotherapy in 13 patients (9 percent). Other regimen changes such as treatment intensity were reported in 11 patients (8 percent). In these patients with node-positive disease, 72 (52 percent) of patients analyzed had a low Recurrence Score result (<18), 53 (38 percent) had an intermediate Recurrence Score result (18-30) and 13 (9 percent) had a high Recurrence Score result (greater than or equal to 31). Recommendations based on the Recurrence Score results led to an overall reduction in chemotherapy.

"The clinical experiences of these physicians underscore the value of using Oncotype DX for node-positive breast cancer patients as demonstrated in five previous studies including one published yesterday in the online version of The Lancet Oncology," said Ruth Oratz, M.D., Clinical Associate Professor of Medicine, New York University School of Medicine, and lead author of the study. "As someone who has used Oncotype DX for treatment planning with both node-negative and node-positive breast cancer patients, I believe this test is becoming standard practice for individualizing treatment in early stage breast cancer."

In this survey of 160 patients with node-positive disease, median age was 61 years and 79 percent of patients were postmenopausal. Patients had either stage T1 (62 percent), T2 (35 percent) or T3 (3 percent) disease. One, two, three or four or more positive lymph nodes were reported in 69 percent, 18 percent, 6 percent and 3 percent of patients, respectively. Therefore, physicians reported use of the Oncotype DX Recurrence Score® result to plan treatment for node-positive disease most often in patients with 1-3 positive nodes and stage T1 or T2 disease.

"Results from this survey of current practice patterns indicate that oncologists who order Oncotype DX for patients with node-positive breast cancer use the results in a similar manner as they do for node-negative patients," said Steven Shak, M.D., Chief Medical Officer of Genomic Health.