An early phase trial found that it is feasible to combine nivolumab immunotherapy with radiation therapy and chemotherapy in patients with newly diagnosed local-regionally advanced head and neck cancers.
“Patients diagnosed with cancers in the mouth and throat often are diagnosed at advanced stages of disease and relapse within 2 years,” said Maura Gillison, MD, PhD, of the University of Texas MD Anderson Cancer Center in Houston, in a press release. Previous research found that nivolumab can improve survival in patients who relapse after platinum chemotherapy, so the new study aimed to include the immunotherapy in initial treatment and potentially stave off those relapses. She presented results of the RTOG Foundation 3504 trial at the 2018 Multidisciplinary Head and Neck Cancers Symposium, held February 15–17 in Scottsdale, Arizona.
The investigators enrolled 20 patients, and this analysis of early safety results included 17 patients, divided between two cohorts. Arm 1 (eight patients) received nivolumab along with weekly cisplatin and radiation therapy (70 Gy in 35 fractions); arm 2 (nine patients) received nivolumab along with high-dose cisplatin and the same radiation therapy regimen. Most patients were male (70%), and the median age was 56 years.
In arm 1, five of the enrolled patients were intermediate risk and five were high risk. In arm 2, eight patients were intermediate risk and two were high-risk. Five and eight patients in the two arms had positive human papillomavirus status.
“The most important aspect of the trial was that the addition of nivolumab to standard therapy raised no new safety concerns,” Gillison said during a press conference. All evaluable patients completed the radiation therapy, which Gillison highlighted because delays can compromise the outcome of the treatment. Also, 15 of the 17 patients analyzed received a cisplatin dose at or above the effective dose.
Three patients discontinued therapy due to known side effects of nivolumab. These included one case each of blurred vision, diarrhea, and joint pain. Six of eight evaluable patients completed a full year of nivolumab therapy, continuing after the completion of the chemoradiotherapy regimen.
“The addition of nivolumab to standard of care cisplatin and radiation therapy was feasible and no new safety concerns were identified,” Gillison concluded during the press conference. “Importantly, standard of care therapy was not compromised by the addition of nivolumab.” She noted that phase III evaluations of the clinical benefit of this combination are now ongoing.
Danielle Margalit, MD, of the Dana-Farber Cancer Institute in Boston, offered some expert perspective during the press conference. She said that there is now substantial interest in moving immune checkpoint inhibition from the advanced setting into the realm of initial therapy in many malignancies. “This trial really provides data that serves as a foundation in terms of the safety of bringing these agents into the upfront setting,” she said.