Nivolumab Plus Cetuximab and Radiotherapy May Be a Safe Treatment Option in Head and Neck Cancer
Researchers sought to determine if the addition of nivolumab to radiotherapy and chemotherapy could improve outcomes among this patient population.
|The following article features coverage from the American Society of Clinical Oncology (ASCO) 2018 meeting. Click here to read more of Cancer Therapy Advisor's conference coverage.|
CHICAGO—Nivolumab in addition to cetuximab plus radiotherapy (RT) is a possible therapeutic option among newly diagnosed patients with intermediate-risk (IR) and high-risk (HR) head and neck squamous cell carcinoma (HNSCC), according to a presentation at the American Society of Clinical Oncology 2018 Annual Meeting on Friday, June 1.
Previous studies have demonstrated that nivolumab improves survival among patients with HNSCC that are refractory to platinum-based chemotherapy regimens. Researchers sought to determine if the addition of nivolumab to RT and chemotherapy could improve outcomes among this patient population.
In this analysis of the phase 1 RTOG 3504 study (ClinicalTrials.gov Identifier: NCT02764593), investigators assessed the safety outcomes of 29 patients among 3 cohorts: nivolumab 240 mg every 2 weeks for 10 cycles, cisplatin 40 mg/m2 weekly for 7 cycles, plus RT for 7 weeks (Cohort 1), nivolumab 240 mg for 2 weeks then 360 mg every 3 weeks for 6 cycles, cisplatin 100 mg/m2 every 3 weeks for 3 cycles, plus RT for 7 weeks (Cohort 2), and nivolumab 240 mg every 2 weeks for 10 cycles, cetuximab 250/400 mg/m2 per week for 7 cycles, and RT for 7 weeks (Cohort 3). The primary endpoint was nivolumab dose-limiting toxicity (DLT): grade 3 or greater adverse effects (AE) that remained unresolved in 4 weeks, RT delay greater than 2 weeks, inability to complete RT, and inability to complete 70% or more of cetuximab therapy. DLT was assessed from day 1 of nivolumab therapy until 28 days post-RT.
The median follow-up was 11.5 months, 10.4 months, and 8.0 months for Cohorts 1, 2, and 3, respectively. There was one death reported in cohort 2 and one instance of disease progression in Cohort 3 (lung metastases at 6 months).
Mucositis was observed in 100% of patients (8), and the only other grade 3 treatment-related AE was lipase increase, which was not considered to be a DLT. While a total of 11 serious AEs were reported in 3 patients, none were considered to be nivolumab-associated.
Of the 8 patients, 7 were able to complete RT and 7 were able to complete cetuximab. Five patients were able to complete 10 concurrent doses of nivolumab; 1 patient was able to complete 6 doses, 1 patient was able to complete 7 doses, and 1 patient is currently on their 8th dose.
Based on the results, the DLT rate for Cohort 3 was found to be acceptable; DLT rates for Cohorts 1 and 2 were also previously reported as acceptable. No new safety concerns were reported for Cohort 3.
Robert L. Ferris, MD, concluded, “nivolumab is safe and feasible to administer concomitantly with a cetuximab-RT regimen for patients with newly diagnosed IR/HR HNSCC.” He added that the “oncologic outcome appears promising at early time points.”
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- Ferris RL, Gillison ML, Harris J, et al. Safety evaluation of nivolumab (Nivo) concomitant with cetuximab-radiotherapy for intermediate (IR) and high-risk (HR) local-regionally advanced head and neck squamous cell carcinoma (HNSCC): RTOG 3504. Oral presentation at: 2018 ASCO Annual Meeting; June 1-5, 2018; Chicago, IL.