Dublin, Ireland: Treatment with capivasertib, a drug used to treat a specific gene mutation that occurs with some tumors, shows that it is effective in a study of 35 patients present today (Tuesday) at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Dublin, Ireland.
The Phase 2 study (EAY131-Y) is part of a larger US study called NCI-MATCH (EAY131), which aims to determine whether cancer patients can be successfully treated by selecting treatments for gene abnormalities found in their tumors, rather than type cancer.
Researchers say their results provide further evidence that a treatment-based approach to tumor-based treatment could offer more effective treatment for individual patients in the future. A more traditional approach is to treat patients based on what has previously worked in other patients with the same type of cancer.
The research was introduced by dr. Kevin Kalinsky, Assistant of Medicine, New York, Presbyterian-Columbia University, Irving Medical Center, USA. He explained: "Capivasertib can be taken by mouth and is a type of medicine called an ACE inhibitor, meaning it binds to a molecule called ACT that has changed the role that plays a role in cancer cell cancer." Capivasertib has shown potential in treating aggressive forms of cancer breasts.
"In this study, we wanted to find out if Capivasertib could be used in patients with any type of cancer whose tumors have a mutation that leads to the ACT molecule being overactive and the cancer to grow."
Patients were selected by testing cells from their tumors. Each of the 35 patients in the study carried the AKT mutation in their tumor cells. Although this mutation occurs in several different types of cancer, it is generally rare. Researchers found a mutation in 1.3% of patients (70 out of 5548) tested centrally in the NCI-MATCH clinical trial.
For all patients in the EAY131-Y study, the cancer spread to other parts of the body and most of them already received three or more previous treatments. Patients were treated with capivasertib twice daily, weekly cycles after four days of treatment and for three days without treatment.
Patient tumors were measured by imaging, such as CT, before and after treatment. In the best confirmed reactions, the tumor was reduced to 8 patients (23%), and in 16 patients (46%), the tumor did not increase or even diminished. In three patients (9%), the tumor increased.
Researchers noted the following side effects of the medicine when they said that doctors should carefully manage them in patients taking capivasertib: high blood sugar, fatigue, diarrhea, nausea, vomiting and skin rash.
Dr. Kalinsky said: "Overall, 23% of patients in our clinical trial experienced a positive response that was defined as a tumor shrinkage prior to initiating treatment with kapivasertib.We have previously determined that if 16% of patients experienced this treatment response, it would mean that the drug would be shifted into a larger study, a positive finding in a clinical trial with patients whose cancer, despite their previous treatment, grew. "
Researchers estimate that six months after treatment, the percentage of patients alive and without their tumors was 52%.
"This study is limited but important evidence." Further studies are needed to gain benefits in each type of tumor and understand why some patients did not respond while others had prolonged time without tumor growth. Kalinsky.
Professor Charles Swanton of the Francis Crick Institute, London, UK, is the co-chair of the EORTC-NCI-AACR Symposium and was not involved in the research. He said, "Although more than ever we understand the role of genes in different types of cancer, there is still a lack of evidence that they use this knowledge to guide treatment and improve patient survival.
"This study is small but important evidence and is part of a larger study that will help us move towards a more personalized cancer treatment.
"This trial approach is especially important for those with rarer cancers, where we know less about which treatments are most effective and conducting patient studies is difficult."
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