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Opdivo — even when given in a low dose — was shown to improve outcomes in patients with advanced head and neck squamous cell carcinoma, highlighting a new option for patients who cannot receive the full dose.
Adding a low dose of the immunotherapy drug, Opdivo (nivolumab) to chemotherapy improved survival in patients with advanced head and neck squamous cell carcinoma — offering patients who cannot undergo the full dose of Opdivo another option, according to findings from a phase 3 study that were recently published in the Journal of Clinical Oncology.
The study authors noted in low- and middle-income countries, only 1-3% of patients are able to receive the standard-of-care treatment for advanced head and neck cancer (Opdivo plus chemotherapy) because of the high cost.
Of note, Opdivo was approved in 2016 for patients with metastatic or recurrent squamous cell carcinoma of the head and neck whose disease worsened on platinum-based chemotherapy.
“Retrospective data suggest that a low dose of (Opdivo) may be efficacious,” the authors wrote. “Hence, we aimed to assess whether the addition of low-dose (Opdivo) to triple metronomic chemotherapy improved overall survival.”
The study involved 151 patients who were randomly assigned to one of two groups: 75 patients received a chemotherapy regimen (methotrexate, celecoxib and erlotinib), while 76 received the same chemotherapy regimen plus Opdivo.
At one year after treatment, 16.3% of patients were alive in the chemotherapy-only group, compared to 43.4% for those who received chemotherapy plus Opdivo. On average, patients lived for 6.7 months and 10.1 months after treatment in the chemotherapy-only and Opdivo-containing groups, respectively.
The researchers also found that compared to chemotherapy alone, adding low-dose Opdivo improved progression-free survival (time from treatment until disease worsens), response rate (the percentage of patients whose disease shrinks as a result of treatment) and some measures of quality of life — all of which occurred without an increased rate of side effects in the Opdivo group.
READ MORE: Immunotherapy Offers Survival and Quality-of-Life Benefits in Head and Neck Cancer
“To our knowledge, this is the first-ever randomized study to demonstrate that the addition of low-dose (Opdivo) to metronomic chemotherapy improved (overall survival) and is an alternative standard of care for those who cannot access full-dose checkpoint inhibitors,” the researchers wrote.
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