Results from a small cancer trial that left every patient in remission is being praised as “unprecedented” and “remarkable.”
A paper published on Sunday at The New England Journal of Medicine outlined a study of 18 rectal cancer patients who were given dostarlimab every three weeks for six months and ended up cancer-free, including the first patient who is now two years out from the trial.
“I believe this is the first time this has happened in the history of cancer,” said Dr. Luis A. Diaz Jr. said, an author of the paper, The New York Times reported.
Dr. Andrea Cercek, an oncologist at Memorial Sloan Kettering Cancer Center and another author of the paper, described “a lot of happy tears” at the end of the trial.
While noting the study needs replication, Dr. Kimmie Ng, a colorectal cancer expert from the Dana-Farber Cancer Institute and an associate professor at Harvard University, called the trial results “remarkable” and “unprecedented.”
“We initiated a prospective phase 2 study in which single-agent dostarlimab, an anti–PD-1 monoclonal antibody, was administered every 3 weeks for 6 months in patients with mismatch repair–deficient stage II or III rectal adenocarcinoma,” the study said. “This treatment was to be followed by standard chemoradiotherapy and surgery.”
Those who took the drug, which “unmasks cancer cells, allowing the immune system to identify and destroy them,” according to the Times, did not have to move on to further cancer treatments.
All the patients “had a clinical complete response, with no evidence of tumor on magnetic resonance imaging,” the paper explained. “At the time of this report, no patients had received chemoradiotherapy or undergone surgery, and no cases of progression or recurrence had been reported during follow-up (range, 6 to 25 months). No adverse events of grade 3 or higher have been reported.”
UNC Lineberger Comprehensive Cancer Center’s Hanna K. Sanoff, MD, MPH, advised caution but said the findings were “very encouraging,” according to Science Daily.
“These initial findings of the remarkable benefit with the use of dostarlimab are very encouraging but also need to be viewed with caution until the results can be replicated in a larger and more diverse population,” Sanoff said.
“The responses in these first 12 of a planned-for 30 patients in the trial were remarkable and exceed what we would expect with the standard chemotherapy plus radiation,” she continued. “Although quality of life measures have not been reported yet, it’s encouraging that some of the most difficult symptoms, such as pain and bleeding, all resolved with the use of dostarlimab.”
This post has been updated to note that Dr. Kimmie Ng is a colorectal cancer expert from the Dana-Farber Cancer Institute, as well as an associate professor at Harvard University
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