Image: Dan Kitwood / Getty Images / Cancer Research UK) (Getty Images)
Cancer treatment has shown amazing results in a small clinical trial. All treated patients, who had a specific form of mid-stage rectal cancer, have since experienced complete remission. Although the findings are based on a sample size of only 18 people, they could have important implications for treating these cancers in particular.
The results of the Phase II trial were published over the weekend in the New England Journal of Medicine. The study was attended by researchers at the Memorial Sloan Kettering Cancer Center and Yale University, and was sponsored by the pharmaceutical company GlaxoSmithKline.
The trial enrolled volunteers diagnosed with stage II or III rectal cancer, meaning their tumors had begun to grow and spread to nearby parts of the body. It was also determined that her cancer was caused by a particular mechanism known as a deficiency in repairing the mismatch.
Cancers can form for many different reasons. But sometimes our cells develop mutations that prevent them from being able to correct the mistakes made when copying the DNA inside them. These errors can eventually lead to cancer cells.
The researchers theorized that its treatment, a laboratory antibody called dostarlimab, could help this subset of patients. It works by inhibiting a protein known as the programmed-death receptor-1 (PD-1) that is found in many cancer cells. This inhibition then allows the immune system to recognize the cancer cells as harmful and direct them to their destruction. The drug was developed by GlaxoSmithKline and last year received accelerated approval from the Food and Drug Administration for endometrial cancer cases related to a mismatched repair deficiency.
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Patients received a dose of dostarlimab every three weeks for six months. After that, according to the original plan, they would be given standard chemoradiotherapy and surgery if their tumors could still be detected. But surprisingly, the treatment alone seemed to completely eradicate her cancer. As of the publication of the study, 18 patients have completed treatment, while 12 have been followed for at least a year, and none of them have shown signs of the return of cancer so far.
Cancers are notoriously resistant to treatment, and few drugs alone have ever shown the kind of success that has been seen here. “I think this is the first time this has happened in the history of cancer,” said study author Luis A. Diaz Jr. from the Memorial Sloan Kettering Cancer Center to the New York Times. According to the New York Times, the first patient to receive the drug remained cancer-free two years later.
That said, the findings are still very early and much more research will be needed with larger-scale studies to confirm the effectiveness of the drug, especially in the long term. Dostarlimab and similar immunotherapy treatments are also not free of side effects and can rarely cause serious complications such as muscle weakness, although no adverse events have been reported in this trial. And the drug is not cheap, as it costs $ 11,000 per dose out of pocket.
But if these findings are further validated, they could very well lead to a new standard of care for this type of cancer. Deficiency repair mismatch is most often associated with colorectal cancer, but it can also help cause breast, thyroid, bladder, and prostate cancers, among others. And the results here suggest that PD-1 inhibitors may help people with these tumors avoid more exhausting treatments, if used early enough in the development of cancer, before it spreads throughout the body.