Immunotherapy and Biomarker Testing in Recurrent and Metastatic Head and Neck Cancers

Publication Date: December 14, 2022
Last Updated: March 27, 2023

Treatment

Recommendation 1.1

Programmed death-ligand 1 (PD-L1) immunohistochemistry testing should be performed in patients with recurrent HNSCC. (EB, B, H, S)
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Recommendation 1.2

PD-L1 combined positive score (CPS) ≥1 should be interpreted as positive and correlates with a clinical benefit to PD-1 inhibitors. (EB, B, H, S)
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Recommendation 1.3

Tumor mutational burden (TMB) testing may be performed in patients with recurrent or metastatic HNSCC when CPS is not available or in patients with rare tumors. (EB, B, H, S)
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Recommendation 1.4

TMB ≥10 should be interpreted as high and correlates with a clinical benefit to PD-1 inhibitors. (EB, B, H, S)
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Recommendation 2.1

Pembrolizumab monotherapy or pembrolizumab, platinum, and 5-fluorouracil (5-FU) should be offered as first-line treatment for patients with recurrent or metastatic HNSCC with a CPS ≥1. (EB, B, H, S)
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Recommendation 2.2

Pembrolizumab, platinum, and 5-FU may be offered as first-line treatment for patients with recurrent or metastatic HNSCC with a CPS <1. (EB, B, M, S)
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Recommendation 3.1

Pembrolizumab or nivolumab should be offered to patients with platinum-refractory recurrent or metastatic HNSCC, regardless of CPS status. (EB, B, H, S)
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Recommendation 4.1

Toripalimab, camrelizumab or tislelizumab, with gemcitabine and cisplatin, should be offered as first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer. (EB, B, H, S)
Qualifying statement: Pembrolizumab or nivolumab may be offered with gemcitabine and cisplatin if the immune checkpoint inhibitors in Recommendation 4.1 are unavailable.
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Recommendation 4.2

Programmed cell death protein 1 (PD-1) inhibitors may be offered to patients with recurrent or metastatic nasopharyngeal cancer who have progressed following platinum-based therapy. (IC, B, L, W)
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Recommendation 5.1

For patients with oligometastatic HNSCC, radiation therapy is safe to give concurrently with immunotherapy for the purpose of palliation or local control, but should not be given to enhance response to immunotherapy outside of a clinical trial. (EB, , M, W)
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Recommendation 6.1

Pembrolizumab may be offered to patients with TMB-high recurrent or metastatic rare head and neck cancers. (EB, B, M, W)
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Recommendation 6.2

Pembrolizumab may be offered to patients with PD-L1 positive recurrent or metastatic salivary gland cancer. (EB, B, M, W)
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Recommendation Grading

Disclaimer

The information in this patient summary should not be used as a substitute for professional medical care or advice. Contact a health care provider if you have questions about your health.

Overview

Title

Immunotherapy and Biomarker Testing in Recurrent and Metastatic Head and Neck Cancers

Authoring Organization

American Society of Clinical Oncology

Publication Month/Year

December 14, 2022

Last Updated Month/Year

October 1, 2024

Document Type

Guideline

Country of Publication

US

Document Objectives

To provide evidence-based recommendations for practicing physicians and other health care providers on immunotherapy and biomarker testing for head and neck cancers.

Target Patient Population

Patients with head and neck cancers

Target Provider Population

Medical oncologists, radiation oncologists, surgical oncologists, clinical oncologists, radiologists, nurses, pathologists, oncology pharmacists

PICO Questions

  1. What biomarkers are recommended for selecting head and neck squamous cell carcinoma patients for anti-programmed cell death protein 1 immune checkpoint inhibitor therapy?

  2. What is the optimal first-line treatment regimen for recurrent or metastatic head and neck squamous cell carcinoma patients based on programmed death-ligand 1 status?

  3. What is the effect of immunotherapy compared to other systemic treatments in platinum-refractory recurrent or metastatic head and neck squamous cell carcinoma?

  4. What is the role of immunotherapy for patients with recurrent or metastatic nasopharyngeal carcinoma (NPC)?

  5. What is the effect of radiation therapy in combination with anti–programmed cell death protein 1 or programmed death-ligand 1 immunotherapy compared to immunotherapy alone for the treatment of locoregionally recurrent or oligometastatic head and neck squamous cell carcinoma?

  6. What is the role of immunotherapy for rare head and neck cancers?

Inclusion Criteria

Male, Female, Adult, Older adult

Intended Users

Nurse, nurse practitioner, physician, physician assistant

Scope

Assessment and screening, Treatment

Diseases/Conditions (MeSH)

D007167 - Immunotherapy, D006258 - Head and Neck Neoplasms, D000082082 - Immune Checkpoint Inhibitors

Keywords

immunotherapy, head and neck cancer, Cancer immunotherapy, PD-L1, biomarker, immune-checkpoint inhibitor

Source Citation

Yilmaz E, Ismaila N, Bauman J, et al. Immunotherapy and Biomarker Testing in Recurrent and Metastatic Head and Neck Cancers: ASCO Guideline. J Clin Oncol. 2022 Dec 15. doi: 10.1200/JCO.22.02328

Supplemental Methodology Resources

Data Supplement, Evidence Tables

Methodology

Number of Source Documents
86
Literature Search Start Date
December 31, 1999
Literature Search End Date
January 31, 2022