> More evidences of the genomic test, Oncotype Dx, that may avoid chemotherapy.
The test helps to decide whether an hormonal therapy would be enough to cope with a breast cancer or not.
Studies say it is an effective test. A simple genomic test, with no additional inconvenience for the patient, that may avoid chemotherapy to one third of the patients of a particular breast cancer subgroup. This has been shown in the 13th St Gallen International Breast Cancer Conference, held in Switzerland, through an European Study which combines results from four different European countries, including Spain. But the fact is that the Oncotype DX test is offered routinely only in four of the Spanish Regions and only in few countries in the European Community.
The Director of the Medical Oncology Service at the Hospital del Mar, Dr. Joan Albanell, is a strong supporter of the application of this test and, as he says, it is only indicated for a specific subgroup of patients. In particular, it is indicated for women with early breast cancer, with unaffected axillary nodes, and hormone receptor positive and HER 2 Neu negative. This constitutes the 20% of all patients with a first diagnosis of breast cancer.
The ones living in Madrid, Valencia, Cataluña or País Vasco will have the opportunity to have this test, which will help to determine whether a woman should proceed with chemotherapy in addition to hormone therapy. Avoiding chemotherapy assures a better quality of life for patients and avoids them unwanted side effects traditionally associated to chemo, such as hair loss or fatigue. However, those women living in the other 13 regions of Spain must pay 3.200€ if they want to have the test. The private insurances do not include this test in their benefits.
Its price is, without doubt, one of the main reasons for which health authorities are reluctant to give the green light to the test. Though it is an important amount of money, it is still less than most of the medicines used in oncology, as Albanell recognizes. “It is not just about price; this initiative takes time to be implemented, it is something very innovative”. Criteria used to decide whether to include or not a medicine into the health system benefits is very defined, but not enough to include something that is voluntary and intended for a specific patient profile.
In any case, the high price of the test is justified, in contrast to other tests, by the fact that it has to be done in specific laboratories that the company has in California (USA). Samples of tumors extracted through surgery from patients have to be sent to those laboratories by messenger service, and after looking at a group of 21 genes, the sample will be sent back to the hospital 10-14 days after with a score between 0 and 100 that correlates with the likelihood of a woman’s chances of having her cancer return in 10 years, and the likelihood that she will benefit from adding chemotherapy to her hormonal therapy. Obviously it would be less costly if the laboratories were placed closer, an idea that the company is considering for the future.
To demonstrate test effectiveness, they used a simple method: tumor samples from patients who participated in clinical trials were analyzed and classified basing on the results of the test, and then contrasted with what actually happened to the patients. In the vast majority of cases, the prognosis given by the test matched with the reality, which has made the test to be approved and included in the clinical practice guidelines.