Head and neck cancer patients who received pembrolizumab had a higher response rate to treatment than those who received standard chemotherapy.
Treating patients with chemotherapy-resistant head and neck cancer with the immunotherapy pembrolizumab is more effective and less toxic than 2nd-line chemotherapy, reports an international team of researchers in The Lancet. The clinical trial involved 97 medical centers from 20 countries.
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Previous research has shown pembrolizumab to be safe and effective in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck whose disease has progressed during or after standard chemotherapy. Data from this clinical trial, called KEYNOTE-040, goes further by comparing the immunotherapy drug to three chemotherapy drugs currently used as standard treatment: methotrexate, docetaxel and cetuximab.
“We compared pembrolizumab to the standard of care to see if it lived up to the promise of early data on patients who are unlikely to have good outcomes with standard treatment,” said Ezra Cohen, professor of medicine at the San Diego School of Medicine in California and study director. “In this trial, patients who received only pembrolizumab achieved a higher treatment response rate than those who received standard chemotherapy, and did so for an average of one and a half years. In addition, survival median at one year was significantly better. I think it’s safe to say that these types of therapies should be the new normal for people with cancer that comes back and is resistant to standard treatments.” -he.
8.4 month survival
Over a period of 17 months, 247 patients were randomized to receive pembrolizumab and 248 patients were randomly selected by their physician to receive one of three standard treatments. Patients were treated until their cancer progressed, they developed intolerable toxicity, they withdrew, or their physician removed them from the experiment.
Median overall survival for patients receiving immunotherapy was 8.4 months and 6.9 months for patients treated with standard care. The median duration of treatment response was 18.4 months in the pembrolizumab group, compared to five months in the standard treatment group. Twelve months into the trial, 37% of patients receiving pembrolizumab were alive, compared to 26.5% of patients receiving standard therapy. Head and neck cancers account for 4% of cancers worldwide.
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