Personal prognosis of side effects of chemotherapy
As part of a study devoted to the development of a methodology for personalized medicine OnPART (from the English Oncology Preferences and Risk of Toxicity – oncological preferences and risk of toxicity), Inform Genomics scientists identified a complex of single polynucleotide polymorphisms (snips), which allows to predict with an accuracy of more than 90% the individual risk of developing six main side effects of combined protocols in patients chemotherapy.
384 patients with breast, rectal, lung, and ovarian cancer participated in a single-center observational study conducted at the Western Clinic in Memphis, Tennessee, which began in January 2012. According to the prescriptions of the attending physician, patients received standard complex chemotherapy. Doxorubicin, cyclophosphamide and paclitaxel were used for breast cancer, oxaliplatin–based protocols for rectal cancer, and paclitaxel and carboplatin–based protocols for the treatment of lung and ovarian cancer. The condition of the patients was monitored for at least two cycles of chemotherapy.
A saliva sample was taken from each of their participants for DNA analysis. During the analysis, 2.5 million snips were identified for each of the patients. Patients rated the severity of their symptoms on a validated scale from 0 to 10. The study assessed the severity of six side effects: nausea and vomiting, diarrhea, mucositis of the oral mucosa, fatigue, neuropathy and cognitive impairment. For the therapeutic protocols analyzed during the study, OnPART made it possible to predict all the listed side effects with an accuracy above 90%.
According to the president and Chief executive Officer of Inform Genomics, Dr. Ed Rubenstein, the goal of OnPART development is to create a commercial product, which is a microchip, which, based on the identification of approximately 500 snips, would allow for 5-7 days to receive a personal risk profile for the development of side effects of chemotherapy. The laboratory nature of the test eliminates the need to obtain approval from the US Food and Drug Administration, certification in accordance with Clinical Laboratory Improvement Amendments (amendments to the federal standard for optimizing clinical laboratory research) is sufficient to promote it on the market. It is expected that clinicians will receive OnPART at their disposal in the third quarter of 2014.