ASCO Publishes New Guideline on Immunotherapy, Biomarker Testing in Advanced Head and Neck Cancer
A new ASCO guideline is available on the use of immunotherapy and biomarker testing for patients with recurrent or metastatic head and neck squamous cell carcinoma. The guideline provides recommendations related to PD-L1 and tumor mutational burden (TMB) testing, selection of therapy in the first-line and platinum-refractory settings, management of nasopharyngeal cancer, use of radiation therapy in oligometastatic head and neck squamous cell carcinoma, and use of immunotherapy in specific scenarios.1
“Since this is a complex disease with a lot of advances in the field in the last few years, there was a need to put together an evidence-based guideline,” said Co-Chair of the Guideline Expert Panel Emrullah Yilmaz, MD, PhD, of the Cleveland Clinic. Co-Chair of the Guideline Expert Panel Loren K. Mell, MD, of the University of California, San Diego, added that given the number of recent clinical trials, there has been uncertainty about how to apply results into practice. “To be able to assimilate the data into a practice guideline fills an unmet need for the medical community,” he said.
Emrullah Yilmaz, MD, PhD
Loren K. Mell, MD
The guideline provides a centralized resource for clinicians caring for patients with recurrent or metastatic head and neck squamous cell carcinoma. “Sometimes, there might be more than one treatment approach; for example, in one setting, both immunotherapy and chemotherapy or immunotherapy alone might be an option,” Dr. Yilmaz said. “A guideline that is agreed upon within an expert panel might be helpful for physicians to guide their treatment approaches.”
Effective head and neck squamous cell carcinoma management requires collaboration among a multidisciplinary treatment team that includes clinicians from radiation oncology, medical oncology, surgery, and other specialties to ensure the best treatment. Accordingly, the panel that developed the guideline included members with expertise in medical oncology, radiation oncology, pathology, surgical oncology, and radiology/nuclear medicine, in addition to patient representation, to establish a multidisciplinary consensus.
Overview of Guideline
The first recommendations in the guideline address use of biomarker testing. PD-L1 immunohistochemistry testing is recommended in all patients with recurrent or metastatic head and neck squamous cell carcinoma. PD-L1 combined positive score (CPS) ≥ 1 is considered positive and correlates with a benefit from PD-1 inhibitors. TMB testing may be performed when CPS is not available or in patients with rare tumors; TMB ≥ 10 is considered high and correlates with clinical benefit from PD-1 inhibitors.
The second set of recommendations addresses treatment selection for patients with recurrent or metastatic head and neck squamous cell carcinoma. First-line therapy options for patients with a CPS ≥ 1 include pembrolizumab as either monotherapy or in combination with platinum and fluorouracil. First-line options for patients with a CPS < 1 include pembrolizumab, platinum, and fluorouracil. For patients with platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma, pembrolizumab or nivolumab may be considered, regardless of CPS status.
For patients with recurrent or metastatic nasopharyngeal cancer, recommended first-line options include toripalimab, camrelizumab, and tislelizu-mab, each with gemcitabine and cisplatin. If those immune checkpoint inhibitors are not available, pembrolizumab or nivolumab may be used with gemcitabine and cisplatin. PD-1 inhibitors may be offered for patients with disease progression following platinum-based therapy, although this is a weak recommendation based on informal consensus.
The guideline next addresses the use of radiation therapy, noting that for patients with oligometastatic head and neck squamous cell carcinoma, radiation therapy is safe to give concurrently with immunotherapy but should be done for palliation or local tumor control, not to enhance response to immunotherapy.
Finally, recommendations are given regarding the use of pembrolizumab in patients with TMB-high recurrent or metastatic rare head and neck cancers and in patients with PD-L1–positive recurrent or metastatic salivary gland cancer. Both of those recommendations are weak, based on moderate evidence.
The guideline also addresses the importance of patient and clinician communication in head and neck squamous cell carcinoma, which is particularly important given the variety of treatment options available and their potential effects on quality of life. “It’s really important for [these patients] … to know all the options available and also to know the [expected] outcomes from their treatments,” Dr. Yilmaz said. “There should be an open communication with the clinician.”
Clinical trials are continuing to evaluate new strategies to improve outcomes for patients with head and neck squamous cell carcinoma. Dr. Mell noted that in contrast to the recurrent or metastatic setting, in which immune checkpoint inhibitors have demonstrated a clear benefit, there is currently no established role for immune checkpoint inhibitors in patients with locoregionally advanced disease. Thus far, clinical trials have not shown a clear benefit, though efforts are ongoing to explore potential approaches involving immune checkpoint inhibitors in the treatment of locally advanced head and neck squamous cell carcinoma. In the recurrent or metastatic setting, trials are underway evaluating new approaches to improve upon the efficacy of current therapies. “A lot of combination studies are ongoing in this setting, so the field may be evolving in the near future,” Dr. Yilmaz concluded.
Originally published in ASCO Daily News. © American Society of Clinical Oncology. ASCO Daily News, December 16, 2022. All rights reserved.