Gene test to determine breast cancer treatment gets approval

A new genetic test that can estimate the risk of breast cancer in women returning after surgery has been approved for use in the NHS. The information it provides could help patients and doctors decide upon the most appropriate course of treatment and identify who would benefit most from chemotherapy.

The National Institute for Health and Care Excellence (NICE) has recommended the Oncotype DX Breast Cancer Assay for NHS patients with certain types of early breast cancers as part of the information presented to them when deciding whether to undergo chemotherapy after surgery.

In the UK around 50,000 women are diagnosed with breast cancer each year. Once a tumour is surgically removed, a course of chemotherapy and drugs may be prescribed to minimise the chances of recurrence. There are a number of common side effects to chemotherapy, however, including fatigue, nausea and hair loss. Other treatment options include hormone therapy and radiotherapy.

'Breast cancer patients face significant emotional and psychological strain when considering chemotherapy', said Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE. 'A test that can help to predict better the risk of the breast cancer spreading, and therefore the potential likely benefit of additional chemotherapy, represents a significant step forward for patients'.

Current methods of assessing the risk of cancer returning include looking at the size and grade of the tumour, as well as whether it has spread to the lymph nodes. The Oncotpye DX works by looking at the activity of 21 genes in the tumour, identified by the developers of the test, US biotech company Genomic Health, as being of significance in the development of breast cancer in women. Using a simple assay to determine the level of gene expression, the test scores the likelihood of recurrence - defined as the possibility of a tumour developing again in the same tissue over the period of ten years.

In addition to these current methods, the information provided by the Oncotype DX can help patients make decisions about their treatment. By covering a wide range of gene functions that are related to tumours, the predictive final score can be more reliable, explain the developers.

The test will not be available for all NHS patients, however. Only patients judged to be at immediate risk with oestrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2−) tumours, and where the cancer has not spread to the lymph nodes, will be eligible for the test.

Last August, NICE recommended for clinical use another test, the RD-100i One Step Nucleic Acid Amplification (OSNA) system, which can detect whether a breast cancer has spread to the lymph nodes (reported in BioNews 717). Genomic Health also released the Oncotype DX Prostate Cancer Assay in May in the USA, which scores the aggressiveness of prostate cancers (reported in BioNews 704).