Adding Bristol-Myers-Squibb‘s Opdivo (nivolumab) to a regimen of radiation therapy and chemotherapy is safe in patients with newly diagnosed advanced head and neck cancer, a Phase 1 clinical trial shows.
Researchers presented the results at the Multidisciplinary Head and Neck Cancers Symposium in Scottsdale, Arizona, Feb. 15-17. The title of the presentation was “Safety evaluation of nivolumab (Nivo) concomitant with platinum-based chemoradiotherapy (CRT) for intermediate (IR) and high-risk (HR) local-regionally advanced head and neck squamous cell carcinoma (HNSCC): RTOG Foundation 3504.”
“Patients diagnosed with cancers in the mouth and throat often are diagnosed at advanced stages of disease and relapse within two years,” Dr. Maura Gillison, the study’s lead author, said in a press release.
The research team had previously discovered that Opdivo improves the survival of head and neck cancer patients whose disease returned after platinum chemotherapy, Gillison said. “Thus, we are compelled to evaluate whether adding immunotherapy to the initial treatment of head and neck cancer could prevent these relapses from happening.”
The RTOG Foundation 3504 study (NCT02764593) assessed the safety and feasibility of adding Opdivo to a regimen of radiation and Platinol (cisplatin) chemotherapy — “a treatment that is already quite taxing for patients due to side effects,” Gillison said.
The trial covered 20 patients with newly diagnosed head and neck squamous cell carcinoma, or HNSCC. Their median age was 56 years. Sixty-five percent had an intermediate-risk disease, and 35 percent a high-risk form.
Eighty percent of the participants had an advanced stage of the disease, and 55 percent were former smokers. Patients took Opdivo and radiation therapy with either high-dose Platinol or weekly administrations of it.
“We found that it is possible to add [Opdivo] immunotherapy to cisplatin treatment without compromising radiation delivery, and patients were also able to tolerate continuing immunotherapy for up to a year,” the researchers wrote.
All patients were able to complete radiation therapy. In addition, 15 of the 17 patients whom researchers were able to evaluate took at least 70 percent of their prescribed dose of platinum chemotherapy. Most patients were able to continue on Opdivo after their first-line treatment.
Patients tolerated Opdivo well, with none experiencing dose-limiting toxicities. Two patients had to discontinue Platinol for reasons unrelated to Opdivo. In addition, three patients had to discontinue their immunotherapy due to blurred vision, diarrhea, and joint pain, which are known side effects of Opdivo.
Some of the patients who were taking Platinol weekly experienced severe, but not life-threatening events due to Opdivo. They included decreased white blood cell count, loss of appetite, fatigue, and adrenal insufficiency, or the adrenal glands failing to produce enough hormones.
In the high-dose Platinol group, severe events associated with Opdivo included one case each of diarrhea, an elevated level of the enzyme amylase, and an elevated level of the enzyme lipase.