Genomic Health: Analysis shows Oncotype DX score also predictor of cancer recurrence in tamoxifen-treated patients

By E. Janene Geiss

Philadelphia, Dec. 12 - Genomic Health, Inc. announced Monday positive results from a new analysis demonstrating that the same Oncotype DX Recurrence Score that quantifies distant recurrence for a large portion of early-stage breast cancer patients also is a significant predictor of local or regional recurrence in tamoxifen-treated patients.

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 scores as identified by Oncotype DX and risk for loco-regional recurrence, according to a company news release.

Specifically, the study found the recurrence score to be a significant predictor of loco-regional recurrence among the 895 tamoxifen-treated patients with lymph node-negative, estrogen receptor-positive breast cancer, independent of age, clinical tumor size and tumor grade, officials said.

Significant associations of the recurrence score and loco-regional recurrence also were observed in the placebo-treated and chemotherapy plus tamoxifen-treated patients, officials said.

"Our analysis suggests an important correlation between an individual patient's recurrence score and time to first local or regional recurrence," Terry Mamounas, medical director of Aultman Cancer Center and lead author of the study, said in the release. "These results expand the predictive value of Oncotype DX and could have clinical implications for the individualizing of loco-regional therapy decisions."

This study, conducted by researchers from the National Surgical Adjuvant Breast and Bowel Project (NSABP), a National Cancer Institute-funded cooperative group, Genomic Health and the Aultman Health Foundation, was presented at the annual San Antonio Breast Cancer Symposium.

Separately, researchers from Genomic Health and the Royal Marsden Hospital in London also reported that successful gene expression analysis from very small fixed paraffin-embedded tumor specimens was feasible using the Oncotype DX 21-gene panel.

In this study the standard Oncotype DX 21-gene test was performed on tumor specimens using both unamplified RNA and amplified RNA, officials said.

Overall, gene expression profiles and recurrence scores obtained using amplified RNA were similar to those obtained with unamplified RNA. These results indicate that Genomic Health can perform quantitative gene expression analysis for clinical studies by amplifying RNA with 50- to 100-fold less tissue than typically used in the standard test, officials said.

The company also presented findings at the conference from a 68-patient independent community-based study demonstrating that the Oncotype DX breast cancer test changed the choice of adjuvant therapy in 25% of patients with early-stage breast cancer.

Genomic Health is a Redwood City, Calif., life science company focused on development and commercialization of genomic-based clinical diagnostic tests for cancer that allow physicians and patients to make individualized treatment decisions.

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