Multiple studies presented at 2014 ASCO® annual meeting reinforce unique, practice-changing value of Oncotype DX® breast cancer test

  • Demonstrate importance of consistent results from multiple validation studies
  • Highlight substantial differences between multi-gene tests
  • Reinforce Genomic Health’s commitment to improving the quality of treatment decisions for cancer patients

Business Wire

GENEVA, Switzerland--(BUSINESS WIRE)--

Genomic Health, Inc. (GHDX) announced results of three studies with the Oncotype DX breast cancer test at the recent 2014 American Society of Clinical Oncology® (ASCO®) Annual Meeting.

1. Oncotype DX test predicts risk of recurrence and survival in patients treated with adjuvant taxane containing chemotherapy – Results from PACS01 trial

The PACS01 trial was a large study conducted in France which compared six cycles of fluorouracil, epirubicin, and cyclophosphamide (FEC) with three cycles of FEC followed by three cycles of docetaxel (FEC-D) in 1,999 node positive breast cancer patients1. The study presented at ASCO2 included 530 patients from the original PACS01 trial and assessed the association of the Oncotype DX Recurrence Score® results with distant recurrence in hormone-receptor-positive, node positive patients treated with either FEC or FEC-D.

Results were consistent with those of a similar study3 conducted previously, and showed that the Recurrence Score was a significant predictor of distant recurrence and disease free survival in both treatment arms (p-value

These results emphasise the need to optimise treatment for each individual patient. A tool such as Oncotype DX, which has been validated with consistent results across multiple studies, can help us better understand the individual tumour biology and make more informed treatment decisions about chemotherapy.” said Prof. Frederique Penault-Llorca, lead investigator of the PACS01 study and Director Centre Jean Perrin, Clermont-Ferrand, France.

2. Head-to-head comparison confirms Oncotype DX results are different from other genomic tests – reinforces Oncotype DX test’s unique value as predictive of chemotherapy benefit

A comparison study4 in collaboration with University of California, San Francisco (UCSF), Marin Medical Laboratories in California, and investigators from the Athens University Medical School in Greece, evaluated if the information provided by Oncotype DX and the Risk of Recurrence (ROR) scores are equivalent. Specifically, results in 52 node negative, estrogen receptor-positive (ER+), post-menopausal, tamoxifen-treated invasive breast cancer patients revealed a very low concordance between Oncotype DX and ROR results (correlation = 0.08, 95% CI -0.19, 0.35). The high level of discordance between the Oncotype DX Recurrence Score and ROR results seen in this study provides additional evidence to support the findings from an independent, previously conducted 1,017-patient comparison study, which showed that Oncotype DX Recurrence Score and ROR classified patients differently (correlation = 0.39)5.

“The results are consistent with previous comparisons between different genomic tests demonstrating that these tests provide different information and that they are not interchangeable. If the question is, besides estimating prognosis, whether or not to use chemotherapy, Oncotype DX is the only test that has been appropriately studied and validated so far,” said Prof. Christos Markopoulos, Director Breast Unit at Athens Medical Center, Athens, Greece.

3. Oncotype DX predicts late recurrence five to 15 years out

Results of a large, positive study6 confirm that the Oncotype DX Recurrence Score results and quantitative ER expression predict late distant recurrence risk in certain early-stage invasive breast cancer patients after initial tamoxifen therapy. These results suggest that the Oncotype DX test may help identify which patients have greater potential to benefit from extended hormonal treatment beyond five years.

This new study analysed 668 and 1,065 patients from the original NSABP B-147 and B-288 trials, respectively. Median follow-up of 13.9 years (B-14) and 11.2 years (B-28) determined that the Oncotype DX Recurrence Score results were significantly associated with distant recurrence after five years in patients whose tumours had high ER expression. Specifically, in the NSABP B-14 patients, the association of the continuous Recurrence Score with distant recurrence after five years in the higher ER patients was significant (p=0.004) after adjustment for age, grade and tumour size. The results suggest that extending tamoxifen beyond five years may be most beneficial in patients with high and intermediate Recurrence Score results with higher quantitative ER expression. Conversely, patients with low Recurrence Score results would be expected to have limited benefit from extended tamoxifen beyond five years due to much lower risk for late distant recurrence.

“The new data presented at ASCO address important clinical questions and provide practice-changing results which emphasise the value of Oncotype DX and reinforce our commitment to improving the quality of treatment decisions for cancer patients around the world”, said Christer Svedman, M.D., Director of Medical Affairs Europe at Genomic Health.

About Genomic Health

Genomic Health, Inc. (GHDX) is a world's leading provider of genomic-based diagnostic tests that inform treatment decisions and help to ensure each patient receives appropriate treatment for early stage cancer. The company is applying its state-of-the-art scientific and commercial expertise and infrastructure to translate significant amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patient's journey, from screening and surveillance, through diagnosis and treatment selection.

The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, To learn more about Oncotype DX, visit:

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the company's expectations regarding reporting study results; the attributes and focus of the company's product pipeline; the applicability of clinical study results to actual outcomes; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies; the applicability of clinical study results to actual outcomes; our ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; the company's ability to obtain capital when needed and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's quarterly report on Form 10-Q for the period ended March 31, 2014. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.

NOTE: The Genomic Health logo, Oncotype, Oncotype DX and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.

1 Coudert B et al, Oncologist. 2012;17(7):900-9
2 Penault-Llorca F. et al., Abstract #11052 presented at ASCO 2014
3 Mamounas EP, Tang G, Paik S, et al: 2012 ASCO Breast Cancer Symposium
4 Prasad C. et al., Abstract #11003 presented at ASCO 2014
5 Dowsett M. et al, J Clin Oncol, 2013; 31(22):2783-90
6 Wolmark N. et al., Abstract #11024 presented at ASCO 2014
7 Paik et al.,N Engl J Med, 2004; 351:2817-26
8 Mamounas EP, Tang G, Paik S, et al, 2012 ASCO Breast Cancer Symposium

Federico Maiardi
Genomic Health
+41 79 138 1326
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