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Worldwide Availability of the Oncotype DX® Colon Cancer Test
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FAQ About Genomic Health Oncotype DX® Colon Cancer Assay
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Overview of Oncotype DX® Data at the 2009 San Antonio Breast Cancer Symposium
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New Data Presented at ASCO Symposium
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Three New Data Publications Highlight the Key Role of Oncotype DX® in Breast Cancer
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Three New Data Publications Highlight the Key Role of Oncotype DX® in Breast Cancer
- On January 12, 2010 the Journal of Clinical Oncology published online a prospective, multi-center study showing that the Oncotype DX breast cancer test had a significant impact on breast cancer treatment decisions for early-stage breast cancer patients, while also increasing patient satisfaction and physician confidence in those decisions. The study, led by Shelly S. Lo, M.D., Assistant Professor of Medicine, Division of Hematology/Oncology, Department of Medicine, Loyola University Chicago Stritch School of Medicine, Cardinal Bernardin Cancer Center, Loyola Universi ty Health System, Maywood, Il, found that knowledge of a patient's Recurrence Score changed oncologists' treatment recommendations in 31.5 percent of cases and changed 27 percent of breast cancer patients' treatment decisions.
The study evaluated 89 breast cancer patients treated by 17 medical oncologists from three academic centers and one community practice. The most common change in treatment plan occurred among breast cancer patients who received a low Recurrence Score result - switching from an initial pre-Recurrence Score plan of chemotherapy plus hormonal therapy, to a treatment plan of hormonal therapy alone.
Researchers also assessed physicians' and patients' experience in using the Oncotype DX breast cancer test and the impact it had on their confidence levels about breast cancer treatment decisions. The study found that in 76 percent of the cases, oncologists reported increased confidence in their treatment decision. Additionally, 95 percent of patients said that they were glad they received a Recurrence Score result to individualize their treatment, and 83 percent of patients felt the Oncotype DX breast cancer test influenced their treatment choice, regardless of whether it changed or reinforced their original decision.
- A study led by Terry Mamounas, M.D., chair of the NSABP Breast Committee, medical director, Aultman Cancer Center, Canton, Ohio, was also published online on January 12, 2010 in the Journal of Clinical Oncology. This study demonstrated that the Oncotype DX Recurrence Score, which quantifies the risk of distant recurrence for a large portion of early-stage breast cancer patients, also significantly predicts local or regional recurrence, which is when breast cancer returns to the breast, chest wall, or axillary lymph nodes. This is the first study to show such an association based on a sizeable population of tamoxifen and chemotherapy-treated patients from randomized clinical trials.
This analysis of 1,674 patients from previous NSABP B-14 and B-20 randomized clinical trials (895 tamoxifen-treated patients, 355 placebo-treated patients and 424 chemotherapy plus tamoxifen-treated patients) demonstrated a clear association between the Recurrence Score results as identified by Oncotype DX and risk for loco-regional recurrence (LRR). Specifically, the study found the Recurrence Score to be a significant predictor of LRR among the 895 tamoxifen-treated patients with lymph node-negative (N-), estrogen receptor-positive (ER+) breast cancer (p-value < 0.001), independent of age, clinical tumor size and tumor grade. Significant associations of the Recurrence Score and LRR were also observed in the placebo-treated and chemotherapy plus tamoxifen-treated patients (p-value < 0.05).
- On December 10, 2009 The Lancet Oncology published positive results from a study of Oncotype DX in postmenopausal women with node-positive, estrogen receptor-positive breast cancer conducted by the Southwest Oncology Group (SWOG), a National Cancer Institute-supported clinical trials cooperative group. The Lancet Oncology published these results online as an "early release" to coincide with additional data analyses that were presented the same day as a late-breaking poster during a discussion on multigene assays at the 2009 San Antonio Breast Cancer Symposium (Abstract 112).
For this study, researchers analyzed 367 tumor samples from node-positive, estrogen receptor-positive breast cancer patients who participated in the SWOG/Breast Cancer Intergroup of North America trial that evaluated CAF chemotherapy followed by tamoxifen versus tamoxifen-alone, to determine the prognostic and predictive effects of the Oncotype DX Recurrence Score.
The Recurrence Score was highly prognostic in the tamoxifen-alone arm (p=0.006) and demonstrated predictive ability in those patients treated with chemotherapy followed by tamoxifen. Specifically the study found no chemotherapy benefit in the low Recurrence Score group (log-rank p=0.97; HR=1.02); however, there was significant disease-free survival improvement for the high Recurrence Score group (log-rank p=0.03; HR=0.59).
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