Cancer is a genetic disease, i.e. it is caused by changes in the DNA that control how cells work, especially how they grow and divide. These changes can be inherited, but most appear randomly during a person's lifetime, either as the result of errors that occur when the cells divide or due to exposure to carcinogens that damage DNA.
Personalised or precision oncology
Each cancer has a unique combination of genetic changes and tumour DNA sequencing is a way to identify these changes. Being aware of a cancer's genetic alterations can help us choose a more precise personalised treatment plan. Some treatments, especially some targeted therapies, are only effective for people whose cancer cells have specific genetic alterations that make cells grow uncontrollably (also called driver mutations).
At INITIA ONCOLOGY, associated with QuironSalud Valencia, we offer our patients the chance to take advantage of precision oncology through the reliability of the FoundationOne test. FoundationOne is a high-quality DNA sequencing test, validated by multiple studies and is the only test approved by the American Food and Drug Administration. This test comprehensively analyses 315 genes involved in cancer, detecting all the types of mutations that can cause tumour growth. It also reports on tumour mutation burden (TMB) and microsatellite instability (MSI), important biomarkers, which may help predict response to immunotherapy. To this end, we obtain a comprehensive genome report of the tumour, which helps us make decisions in complex clinical situations. The FoundationOne test is conducted on a tumour tissue sample, ideally on a recent metastatic lesion. If it were to be difficult to obtain tumour tissue, a "liquid" biopsy can be taken and the blood tested using the FoundationACT test, a blood-based circulating tumour DNA assay that identifies the 62 most important genes involved in cancer.
Who can benefit from the FoundationOne-FoundationACT test?
Personalised oncology is much more than genetic tumour testing. The FoundationOne makes sense and is more efficient when employed in the evolving therapeutic context of each case. At INITIA ONCOLOGY, our multidisciplinary committee assesses the patient's cancer history to determine if they will benefit from the FoundationOne test or if any other oncology therapy or diagnosis would be more convenient. However, we believe that the FoundationOne test is particularly recommended in the following situations:
- Patients with stage 4 aggressive solid tumours who have exhausted all standard treatments, according to treatment guidelines, and required molecular tests, but maintain overall good health.
- Patients with stage 4 non-small cell lung cancer with no known mutations or progressing towards targeted therapies.
- Patients with stage 4 rare solid tumours that have limited systemic treatment options according to clinical guidelines.
- Patients with cancers of unknown primary.
What results can I expect from the FoundationOne-FoundationACT tests?
The sequencing result will be evaluated by our multidisciplinary committee and you will receive a report with the genetic alterations detected in your tumour and the most suitable targeted therapies or clinical tests in line with scientific evidence. Four types of results with therapeutic implications can come from tumour sequencing:
- A driver alteration with a drug that has already been approved for your tumour is detected. This situation is the most favourable and easiest to interpret.
- A driver alteration with a drug that has been approved but not for your tumour is detected. In this case, there is an option to use the unauthorised drug, i.e. prescribe the medication but for a different use than what it was approved for. This is called "off-label drug use" because although the medication is safe, it is being used for an indication that is not described in its directions for use. Research has shown that using unapproved medications is very common when treating cancer.
- A driver alteration with a drug that is being researched in a clinical study is detected. In this case, we will inform you where this clinical study is being conducted and if you meet the criteria to be treated with this drug.
- No driver alteration susceptible to treatment is detected. In this case, we will keep you informed if a future therapy emerges.
What steps must I take for the precision oncology committee to assess my case?
You, your doctor or the institution that is providing your healthcare can do it, and you can do it in person or remotely. You will have to provide your full oncology records, including copies of your radiology exams and pathologic anatomy reports. They will be assessed by the committee to determine if your case would benefit from the FoudationOne test. If you are not eligible, you will receive a report with therapy recommendations or the necessary diagnosis extensions that can help make clinical decisions. If you are eligible or if you decide to take the FoundationOne test, you must provide/take a biopsy of the metastatic disease or provide a blood sample. The samples are sent to the FoundationOne laboratories and we will obtain the results in 2-3 weeks. Then the committee will analyse the current scientific evidence for each of the genetic alterations found and we will contact you to explain the findings and therapeutic recommendations.
· For patients: www.rochepacientes.es
· For healthcare professionals: www.rocheplus.es/foundationmedicine