Dublin, Ireland: Treatment with capivasertil, a drug designed to fight a specific gene mutation in certain cancers, shows signs of effectiveness in the study of the 35 patients presented today (Tuesday) at the 30th EORTC-NCI-AACR Symposium on Molecular Goals and Cancer Therapy in Dublin , Ireland.
Phase 2 trial (EAY131-Y) is part of a larger US study called NCI-MATCH (EAY131), which aims to determine whether cancer patients can be effectively treated by selecting therapies that target genetic abnormalities in their cancers, instead of according to the type of cancer.
Researchers say their results provide further evidence that the approach of tailoring treatment to cancer genes could in the future offer more effective treatments for individual patients. A more traditional approach is to treat patients based on what worked in the past for other patients with the same type of cancer.
The research was presented by dr. Kevin Kalinsky & # 39; ego, medical adjunct professor at the Presbyterian-Columbia University in New York University Irving Medical Center in the USA. He explained: "Capivasertib can be taken orally and is a type of medicine called an AKT inhibitor, which means it binds to a molecule called AKT, which has mutated the change that plays a role in helping the cancer cells develop." Research, capivasertib has shown potential for treating aggressive form of breast cancer.
"In this trial, we wanted to check whether capivasertib can be used in patients with any type of cancer whose tumors have a mutation that causes the AKT molecule to become too active and cause cancer to grow."
Patients were selected by testing cells from their tumors. Each of the 35 patients in the study had an AKT mutation in the tumor cells. Although this mutation occurs in several different types of cancer, it is rare in general. Researchers found a mutation in 1.3% of patients (70 out of 5548) tested centrally in the NCI-MATCH study.
In all patients in the EAY131-Y study, cancer spread to other parts of the body, and most of them received three or more earlier treatments. Patients were treated with capivasertyb, taken orally twice daily, in weekly cycles of four days of treatment and three days without treatment.
Patient tumors were measured by imaging, such as computed tomography, before and after treatment. In the best-confirmed responses, the tumor decreased in eight patients (23%) and in 16 patients (46%), the tumor did not grow, but did not shrink. In three patients (9%) the tumor was growing.
Researchers observed the following side effects of the drug, saying that doctors should be careful to manage them in patients treated with capivasertyb: high blood sugar, fatigue, diarrhea, nausea, vomiting and skin rash.
Dr Kalinsky said: "A total of 23% of patients in our trial experienced a positive response that was defined as tumor shrinkage prior to treatment with capivasertib. We determined in advance that if 16% of patients experienced this response, it would be a signal to transfer the drug to a higher dose. an attempt, which is a positive finding in a study involving patients whose tumors continued to grow despite previous therapies. "
Researchers estimate that six months after treatment, the proportion of patients who were alive and without their cancer growth was 52%.
"This study is a limited but important proof, more research is needed to understand the benefits of each type of tumor and understand why some patients did not have an answer, while others had a longer time without tumor growth," said Dr. Kalinsky. .
Professor Charles Swanton of the Francis Crick Institute, London, United Kingdom, is the scientific co-chair of the EORTC-NCI-AACR Symposium and has not been involved in research. He said: "Although more than ever we understand the role of genes in various cancers, there is still no evidence to use this knowledge to conduct therapy and improve patients' survival.
"This study is small but important proof and is part of a larger study that will help us move to more personalized cancer treatments.
"This trial approach is especially important for people with rarer cancer, when we know less about which therapies are most effective and it is difficult to conduct patient research."
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