Pembrolizumab as an immunotherapy drug in the treatment of a patient with recurrent (unresectable) cancer of the lower lip

Authors

  • L. Y. Markulan Bogomolets National Medical University, Kyiv , Ukraine https://orcid.org/0000-0003-2879-5012
  • L. M. Makarevych Regional Clinical Oncology Center of the Kirovohrad Regional Council, Kropyvnytskyi, Ukraine

DOI:

https://doi.org/10.30978/GS-2022-2-75

Keywords:

recurrent and/or metastatic squamous cell cancer of the head and neck, immunotherapy, pembrolizumab

Abstract

Advances in immunotherapy have changed approaches to the treatment of recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC). The US Food and Drug Administration (the FDA) has approved both pembrolizumab monotherapy for first‑line treatment of the tumours expressing the programmed cell death receptor‑1 (PD‑L1; combined positive score of ≥ 1) in patients with R/M HNSCC and pembrolizumab administration in combination with platinum and fluorouracil regardless of the level of PD‑L1 expression. Pembrolizumab is a humanized monoclonal antibody class drug that activates the anti‑tumour immune response.

Objective — to present treatment outcomes for recurrent (unresectable) cancer of the lower lip that was treated using a pembrolizumab monotherapy regimen.

Patient H., born in 1968, received a 20‑month combined therapy for cancer of the lower lip. He had radical surgical removal of the primary tumour and two surgical resections of metastases, as well as courses of both remote gamma‑therapy and polychemotherapy. Nevertheless, the disease progressed from T2N0M0 to T4N1M0. In the area of the chin and right cheek, the patient developed a defect of the skin and subcutaneous tissue measuring 18 ´ 10 cm with purulent‑necrotic margins and an external fistula of the oral cavity. He was also bothered by unbearable pain in the area of the tumour and an unpleasant odour from the mouth and from the tumour. The patient was prescribed immunotherapy with pembrolizumab since an immunohistochemical examination revealed an RD‑L1‑positive tumour. One year after the start of immunotherapy, which included 17 courses of cancer treatment, the wound healed and the patient’s quality of life significantly improved. No adverse reactions were observed during immunotherapy. Computed tomography revealed a 25 x 15 mm nodule at the level of the lower jaw on the right and a lymph node of about 10 mm in diameter in the area of the lower parts of the right parotid salivary gland. Distant metastases were not detected. Currently, immunotherapy is ongoing. The issue of surgical removal of pathological formations is under consideration.

This case demonstrates the positive outcomes of a pembrolizumab monotherapy regimen in a patient with R/M HNSCC.

 

References

Argiris A, Karamouzis MV, Raben D, Ferris RL. Head and neck cancer. Lancet. 2008;371:1695-1709.doi: 10.1016/S0140-6736(08)60728-X.

Bauml JM, Aggarwal C, Cohen RB. Immunotherapy for head and neck cancer: where are we now and where are we going? Ann Transl Med. 2019;7:S75.

Bauml J, Seiwert TY, Pfister DG, et al. Pembrolizumab for platinum- and cetuximab-refractory head and neck cancer: results from a Single-Arm, Phase II Study. J Clin Oncol 2017;35:1542-9.

Bernier J, Cooper JS, Pajak TF, et al. Defining risk levels in locally advanced head and neck cancers: A comparative analysis of concurrent postoperative radiation plus chemotherapy trials of the EORTC (#22931) and RTOG (# 9501) Head Neck. 2005;27:843-50. doi: 10.1002/hed.20279.

Blanchard P, Landais C, Petit C, et al. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): An update on 100 randomized trials and 19,248 patients, on behalf of MACH-NC group. Ann. Oncol. 2016;27 doi: 10.1093/annonc/mdw376.02.

Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J. Clin. 2018;68:394-424. doi: 10.3322/caac.21492.

Burtness B, Harrington KJ, Greil R, et al. Pembrolizumab alone or with chemotherapy versus cetuximab with chemotherapy for recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-048): A randomised, open-label, phase 3 study. Lancet. 2019;394:1915-28. doi: 10.1016/S0140-6736(19)32591-7.

Chow LQM, Haddad R, Gupta S, et al. Antitumor activity of pembrolizumab in biomarker-unselected patients with recurrent and/or metastatic head and neck squamous cell carcinoma: Results from the phase Ib KEYNOTE-012 expansion cohort. J. Clin. Oncol. 2016;34:3838-45. doi: 10.1200/JCO.2016.68.1478.

Cohen EEW, Soulières D, Le Tourneau C, et al. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. Lancet. 2019;393:156-67.

Cohen EEW, Soulieres D, Tourneau CL, et al. Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs standard of care (SOC) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in KEYNOTE-040. J Clin Oncol 2018;36:6013.

Concha-Benavente F, Srivastava RM, Trivedi S, et al. Identification of the cell-intrinsic and -extrinsic pathways downstream of EGFR and IFNgamma that induce PD-L1 expression in head and neck cancer. Cancer Res. 2016;76:1031-43.

Cooper JS, Pajak TF, Forastiere AA, et al. Postoperative concurrent radiotherapy and chemotherapy for high-risk squamous-cell carcinoma of the head and neck. N. Engl. J. Med. 2004;350:1937-44. doi: 10.1056/NEJMoa032646.

Economopoulou P, Agelaki S, Perisanidis C, et al. The promise of immunotherapy in head and neck squamous cell carcinoma. Ann Oncol. 2016;27:1675-85.

Gauduchon T, Reverdy T, Gau M, Karabajakian A, Collet L, Neidhardt EM, Fayette J. Head and neck cancer and immunotherapy: current knowledge and perspective. J Cancer Metastasis Treat. 2019;5:72.

Harrington KJ, Soulières D, Le Tourneau C, et al. Quality of life with pembrolizumab for recurrent and/or metastatic head and neck squamous cell carcinoma: KEYNOTE-040. J Natl Cancer Inst. 2021;113:171-81.

Jacob LA, Chaudhuri T, Lakshmaiah KC, et al. Current status of systemic therapy for recurrent and/or metastatic squamous cell carcinoma of the head and neck. Indian J Cancer. 2016;53:471-7.

Kwok G, Yau TC, Chiu JW, Tse E, Kwong YL. Pembrolizumab (Keytruda). Hum Vaccin Immunother. 2016 Nov;12(11):2777-89. doi: 10.1080/21645515.2016.1199310. Epub 2016 Jul 11.

Lau A, Yang WF, Li KY, Su YX. Systemic therapy in recurrent or metastatic head and neck squamous cell carcinoma- a systematic review and meta-analysis. Crit Rev Oncol Hematol. 2020;153:102984.

León X, Hitt R, Constenla M, et al. A retrospective analysis of the outcome of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck refractory to a platinum-based chemotherapy. Clin Oncol (R Coll Radiol). 2005;17:418-24.

Moy JD, Moskovitz JM, Ferris RL. Biological mechanisms of immune escape and implications for immunotherapy in head and neck squamous cell carcinoma. Eur J Cancer. 2017;76:152-66.

Muzaffar J, Bari S, Kirtane K, Chung CH. Recent Advances and Future Directions in Clinical Management of Head and Neck Squamous Cell Carcinoma. Cancers (Basel). 2021 Jan 18;13(2):338. doi: 10.3390/cancers13020338.

Pfister DG, Spencer S, Brizel DM, et al. Head and neck cancers, Version 2.2014. Clinical practice guidelines in oncology. J. Natl. Compr. Cancer Netw. 2014;12:1454-87.doi: 10.6004/jnccn.2014.0142.

Poulose JV, Kainickal CT. Immune checkpoint inhibitors in head and neck squamous cell carcinoma: A systematic review of phase-3 clinical trials. World J Clin Oncol. 2022 May 24;13(5):388-411. doi: 10.5306/wjco.v13.i5.388.

Rischin D, Harrington KJ, Greil R, et al. Protocol-specified final analysis of the phase 3 KEYNOTE-048 trial of pembrolizumab (pembro) as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). J Clin Oncol 2019;37:6000-6000.

Seiwert TY, Burtness B, Mehra R, et al. Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): An open-label, multicentre, phase 1b trial. Lancet Oncol. 2016;17:956-65. doi: 10.1016/S1470-2045(16)30066-3.

Sharon S, Bell RB. Immunotherapy in head and neck squamous cell carcinoma: a narrative review. Front Oral Maxillofac Med. 2022 Sep;4:28. doi: 10.21037/fomm-21-48.

Siegel RL, Miller KD, Jemal A. Cancer statistics. CA Cancer J. Clin. 2018;68:7-30. doi: 10.3322/caac.21442.

Yang Y. Cancer immunotherapy: harnessing the immune system to battle cancer. J Clin Invest. 2015;125:3335-7.

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Published

2022-12-30

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Clinical Case