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A genetically modified poliovirus improved the long-term survival of patients with lethal-type brain tumors, according to the results of an early-stage clinical trial released Tuesday.
Twenty-one percent of patients treated with the virus – all with recurrent disease – were alive after three years, compared with only 4% of those who had undergone standard chemotherapy.
The trial at the Duke Cancer Institute involved patients with glioblastoma, the type of tumor that Sen John McCain, R-Ariz., Is fighting. The findings were published online in the New England Journal of Medicine and presented Tuesday at an international conference on brain tumors in Norway.
Glioblastoma, a difficult-to-treat disease that is the most common of all malignant brain tumors, can cause seizures. , headaches, blurred vision and confusion. Even with aggressive treatment, newly diagnosed individuals usually survive less than 20 months, while those who re-offend usually die in less than a year.
Duke researchers opened the Phase 1 trial in 2012 to test the safety of modified viral treatment. and try to determine the right dose. After the surgeons implanted a catheter in each patient's brain, a small amount of a genetically modified form of the polio virus was infused directly into the tumor. The virus is designed to target tumor cells and trigger an immune system response.
The approach was the focus of general attention in 2015, when it was covered by the "60-minute" CBS program. The first trial participant was a nursing student who married and became a nurse, according to Duke officials.
Tuesday's results were well received by experts who were not involved in the study. Still, these scientists strongly insisted on caution, saying that it was too early, and the number of patients in the trial too little, to find out how effective the approach is for glioblastoma .
The treatment of polio is one of several "oncolytic viruses" studied as anticancer agents. While researchers have long regarded these viruses as potential tools for directly killing cancer, they now suspect that viruses may be more effective at marshaling the immune system against malignant tumors, according to the National Cancer Institute
. the survival of the 61 patients in the trial was 12.5 months, compared to 11.3 months for the "historical control group". The latter is a group of patients, used for comparison, who were treated earlier with standard chemotherapy and met the criteria for testing the polio virus
A subgroup of patients who received the treatment has survived for at least two years.
Debra Puffer, a 61-year-old resident of Rome, New York, was diagnosed with glioblastoma in 2014 and was treated with surgery, chemo and radiotherapy. When the cancer returned, she received treatment for the polio virus in Duke and remained two and a half years without recurrence. When the cancer came back again, she received a booster infusion of the polio virus last August.
She ended up in the hospital with serious side effects. But now, "everything looks a lot better," including her brain scans, she says. "I'm enjoying my summer."
Annick Desjardins, Duke's neurologist, who is one of the main authors of the study, said the treatment for poliovirus resembled that of other immunotherapies, because the majority of treated patients did not respond. However, those who have an "active immune response" have the real possibility of becoming long-term survivors, she said.
To try to increase the percentage of these responders, scientists opened a Phase 2 trial at Duke and three other centers to test the treatment of polio virus plus a chemotherapy drug, against only the virus . Researchers are also planning trials for breast cancer and melanoma.
Deepa Subramaniam, director of the Brain Tumor Center at the Lombardi Cancer Center in Georgetown, described the results as "very interesting, enough reasons to continue." But she noted that it was "a very early test" and that the treatment needed a more in-depth review.
John De Groot, neuro-oncologist at the MD Anderson Cancer Center, described the study as "good science" the effectiveness should be tested in a much larger number of patients and in many medical centers . He and Subramaniam both questioned the use of a "historical control group" rather than a real group. Subramaniam said it was a "suboptimal way of comparing" the results between patients receiving experimental treatment and those receiving standard treatment.
Desjardins stated that the authors of the study decided that a traditional randomized trial would have been unethical. the treatment would have been subjected to fictitious procedures, such as the insertion of catheters that did not deliver the virus, so that they would not know if they were receiving the experimental therapy.
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