IS THERE A NEW ERA OF BREAST CANCER TESTS COMING?

In February the British institute NICE (The National Institute for Health and Clinical Excellence) issued a preliminary recommendation regarding the usage of Oncotype DX® breast cancer assay (Genomic Health; USA) in clinical practise in Great Britain (see the article below). This preliminary recommendation means another important step towards the development of personalized oncological treatment.

Oncotype DX® test is based on profiling of gene expression, following specific tumor markers that help determine how the tumor will develop. Test quantifies the expression of 21 genes in tumor tissue using reverse-transcription polymerase chain reaction (RT-PCR), and predicts the likelihood of cancer recurrence for women of all ages adjuvant treated with newly diagnosed breast cancer of stage I. or II . with estrogen receptor positive (ER+), without lymph node (LN ) or lymph nodes (LN+, up to 3 positive nodes) . Test assigns the value of continuous tumor recurrence (Recurrence Score - RS) and risk categories: low (RS < 18), medium (18 ≤ R ≤ 30), high (RS ≥ 31), and also inform about the status of ER, progesterone receptor (PR) and human epidermal growth factor receptor (HER 2) . Tumor tissue is fixed by formalin in paraffin blocks and tissue samples are evaluated in a central laboratory of the producer in U.S.. The test results are known within 7-10 days.

WHO IS ELIGABLE?

The occurrence of breast cancer has been observed not only in women, but a small portion of patients with this disease are also men. Despite the fact that all clinical evidence is based on studies of the disease done with women we can say that even if there are certain gender-specific phatobiological differences of the tumor tissue, the common subtypes are the same for both men and women. Oncotype DX®, as well as general recommendations and procedures in the treatment of breast cancer, is intended for patients of both genders and all age groups.

Oncotype DX® test should be recommended to patients with ER+, LN-, HER2- breast cancer at an early stage, when it is necessary to decide on the chemotherapy, if the patient is in imminent danger of life, it is unclear whether prescribe chemotherapy, and it is probable that information on the biology of the tumor, obtained through the Oncotype DX®, will help predict disease progression.

WHAT DOES NICE SAY?

Office of NICE stated that on the basis of proven results, Oncotype DX®, in comparison with other relevant tests, is the most sophisticated evaluation, both in terms of validity of the provided data, clinical utility and predictive capacity. NICE recommended Oncotype DX® as the only multi-gene test for breast cancer, suitable for use in clinical practice when deciding on chemotherapy in case of some patients with breast cancer at an early stage, with ER+, LN- and negative HER2. This preliminary recommendation is in line with the international standards for the treatment of breast cancer, including ASCO (2007) NCCN (2008), ESMO (2010) and Wed Gallen (2011). There is an ongoing prospective study TAILORx. It is expected that it will provide more extensive information about the benefits of chemotherapy in case of women that were ranked by Oncotype DX® in the medium-high risk of recurrence. Given that studies TAILORx are being done in North America, respectively with the North American population, NICE supports the collection of all data relating to the testing and the results of Oncotype DX® in the UK.

SITUATION IN GREAT BRITAIN

There are 42,000 patients diagnosed with breast cancer every year in the UK. Approximately in half of the cases it is the early stage of the disease - for this group of patients Oncotype DX® could therefore be very useful. Many of these patients would have been (based on the NICE draft recommendation) already qualified for the use of Oncotype DX® . To this date, the advantage of this test was used in case of more than 1,000 British women and globally in case of more than 335,000 patients in 65 countries. Insurance covers the costs associated with Oncotype DX® testing in case of patients who meet the qualifying conditions. This is valid in many European countries, USA, Israel and major Canadian provinces, because of the proven clinical utility and health-economic benefit of Oncotype DX® test in different health care systems. "The draft of NICE recommendation for the use of Oncotype DX® in clinical practice for UK is the next important step in the development of personalized medicine and in the achieving of better treatment results in case of patients with breast cancer. In the future, we are thus opening the way to an important, clinically relevant genomic tests" says Dr. Christer Svedman, medical director of Genomic Health for Europe.

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