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Adding Pembrolizumab to Chemoradiotherapy Safe for Locally Advanced HNSCC
Study findings show that combining pembrolizumab with weekly cisplatin-based chemoradiotherapy is safe for patients with head and neck squamous cell carcinoma (HNSCC; J Clin Oncol. 2020;38[21]:2427-2437).
“Although pembrolizumab is approved for recurrent/metastatic [HNSCC], its role in the management of locally advanced…disease is not defined,” wrote Steven F. Powell, MD, Sioux Falls, South Dakota, and colleagues.
Therefore, they conducted a phase IB study examining the safety and efficacy of adding pembrolizumab to cisplatin-based chemoradiotherapy in patients with locally advanced HNSCC.
A total of 59 patients with oral cavity, oropharyngeal, hypopharyngeal, or laryngeal stage III to IVB HNSCC eligible to receive cisplatin-based, standard-dose (70 Gy) chemoradiotherapy were enrolled in the study between November 2015 and October 2018. Thirty-four patients had human papillomavirus (HPV), whereas 25 did not.
All patients were given pembrolizumab concurrently with and after chemoradiotherapy with weekly cisplatin.
The primary end point was safety, determined by incidence of chemoradiotherapy adverse events (AEs) and immune-related AEs (irAEs), and efficacy was defined as complete response (CR) rate at 100 days postradiotherapy completion.
Ultimately, 5 (8.8%) patients had to discontinue pembrolizumab therapy because of irAEs; 98.3% completed the full planned treatment dose (70 Gy) of radiotherapy without any delays ≥5 days; and 88.1% of patients completed the goal cisplatin dose of ≥200 mg/m2.
Among patients who were HPV-positive and HPV-negative, CR rates were 85.3% and 78.3%, respectively.
“Pembrolizumab in combination with weekly cisplatin-based chemoradiotherapy is safe and does not impair delivery of curative radiotherapy or chemotherapy in HNSCC. Early efficacy data support further investigation of this approach,” Dr Powell and co-investigators concluded.—Hina M. Porcelli
