14 Articles, This article is part of the Research Topic, Rationale of Neoadjuvant Immunotherapy for HNSCC, Patient Selection for Neoadjuvant Immunotherapy, Biomarker Candidates for Neoadjuvant Immunotherapy, Pathologic Response Criteria for Neoadjuvant Immunotherapy, Clinical Studies of Neoadjuvant Immunotherapy for HNSCC, Immune Related Adverse Events in Neoadjuvant Immunotherapy Treated Patients, Creative Commons Attribution License (CC BY). Recent developments and approvals in immunotherapy have significantly changed the landscape of melanoma and NSCLC therapy in the metastatic setting, and open various possibilities for adjuvant treatment in high-risk locoregional disease [7,8,9,10]. Lancet Oncol. Epidemiology. J Natl Compr Canc Netw. PD-1 and CTLA-4 Combination Blockade Expands Infiltrating T Cells and Reduces Regulatory T and Myeloid Cells Within B16 Melanoma Tumors. Mutational Landscape and Significance Across 12 Major Cancer Types. doi: 10.1016/S1470-2045(13)70334-6, 64. 20 studies in Head and Neck Cancer Center (open studies only). Table2 Ongoing neoadjuvant immunotherapy clinical trials. Recent clinical trials of neoadjuvant immunotherapy show promising results and this methodology has the potential to change the treatment algorithm of HNSCC. N Engl J Med. cancer [2], melanoma [3, 4], STS [5], head and neck cancer [6]). Privacy 2023 Springer Nature Switzerland AG. Prolonged survival in stage III melanoma with ipilimumab adjuvant therapy. Neoadjuvant and Adjuvant Nivolumab and Lirilumab in Patients With Recurrent, Resectable Squamous Cell Carcinoma of the Head and Neck. This was followed by BATTLE-2 [42], testing combination treatments in the same disease. Historically, surgery and radiotherapy with/without conventional chemotherapy including platinum, taxanes or fluorouracil, were applied to treat HNSCC. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. doi: 10.1200/JCO.2019.37.15_suppl.2575, 73. Three trials are discussed that studied various forms of treatment de-intensification in patients with HPV-positive oropharyngeal carcinoma, including a phase 2 study by ECOG, RTOG 1016, and the De-ESCALaTE trial. doi: 10.1200/EDBK_280687, Keywords: head and neck squamous cell carcinoma, neoadjuvant immunotherapy, clinical trial, biomarker, pathological tumor response, Citation: Shibata H, Saito S and Uppaluri R (2021) Immunotherapy for Head and Neck Cancer: A Paradigm Shift From Induction Chemotherapy to Neoadjuvant Immunotherapy. Forastiere A, et al. KEYNOTE-689: Phase 3 Study of Adjuvant and Neoadjuvant Pembrolizumab Combined With Standard of Care (SOC) in Patients With Resectable, Locally Advanced Head and Neck Squamous Cell Carcinoma. doi: 10.1016/0360-3016(92)90027-F, 19. Ann Oncol (2019) 30(1):5767. In fact, meta-analysis of melanoma neoadjuvant immunotherapy trials has shown that any degree of pathologic response and not just MPR/pCR, was correlated with better clinical outcomes (64). Head Neck. Intriguingly, in preclinical mouse models, a specific interval between neoadjuvant immunotherapy and subsequent surgery was important to establish potent systemic T cell response (33), suggesting that it will be important to establish the optimal duration in the clinical setting. In a landmark trial, a cocktail of immunotherapy medications harnessed patients' immune systems to kill their own cancer cells and prompted "a positive trend in survival . BMC Med. Twenty-nine HNSCC patients with locoregionally recurrent disease who were surgically resectable were treated with neoadjuvant nivolumab and lirilumab, an anti-KIR blocking antibody focused on NK cell checkpoint inhibition. 2014;89(1):1320. doi: 10.1056/NEJMoa031317, 24. In a landmark trial, a . HE is an academic clinician in Medical Oncology and currently Professor of Clinical Cancer Medicine at the University of Cambridge, Department of Oncology and a Principal Investigator of the NIHR Cambridge Biomedical Research Centre and Cambridge Experimental Cancer Medicine Centre. Wason JMS, Abraham JE, Baird RD, Gounaris I, Vallier A-V, Brenton JD, Earl HM, Mander AP. A total of 28 patients were eligible, and 24 (86%) of patients were HPV positive. Final results of local-regional control and late toxicity of RTOG 90-03; a randomized trial of altered fractionation radiation for locally advanced head and neck cancer. Liu J, ODonnell JS, Yan J, Madore J, Allen S, Smyth MJ, et al. He is also an active member of the EORTC Melanoma Group and the Global Melanoma Task Force. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. 1. In addition to this design, immunotherapy is being integrated in several neoadjuvant combinations with radiation or chemotherapy prior to surgery. However, although IC may help with surgical management, Phase III trial results showed no improvements in survival. Landmark Trials. 2016;375(1):1122. She has been an expert advisor for NHS NICE Health Technology Assessments. More effective and cost-efficient phase II trial designs would rapidly lead to landmark trials and practice-changing results. 2016;388(10043):48897. Robert C, Long GV, Brady B, Dutriaux C, Maio M, Mortier L, Hassel JC, Rutkowski P, McNeil C, Kalinka-Warzocha E, Savage KJ, Hernberg MM, Lebb C, Charles J, Mihalcioiu C, Chiarion-Sileni V, Mauch C, Cognetti F, Arance A, Schmidt H, Schadendorf D, Gogas H, Lundgren-Eriksson L, Horak C, Sharkey B, Waxman IM, Atkinson V, Ascierto PA. Nivolumab in previously untreated melanoma without BRAF mutation. Hodi FS, Ballinger M, Lyons B, Soria JC, Nishino M, Tabernero J, et al. IC continues to be used at some centers with defined indications including advanced or borderline resectable tumors. 2023 BioMed Central Ltd unless otherwise stated. From a clinical standpoint, he is actively involved in the management and treatment of patients with hematological malignancies and, particularly, those suffering from lymphoproliferative disorders. Moreover, three anti-PD-1/anti-PD-L1 agents, pembrolizumab, nivolumab and atezolizumab, have been approved for second-line therapy of NSCLC [16,17,18]; however, contrary to melanoma, patient selection to therapy should be based on PD-L1 expression level of tumour cells. Post-operative adjuvant treatments for locally advanced HNSCC have been studied for many years as historically surgery alone for locally advanced disease had very poor outcomes. examined neoadjuvant 1) nivolumab (N) or 2) nivolumab plus ipilimumab (N+I) in untreated 29 oral cavity cancer patients in a phase II trial (eligible for T2 or node positive) (NCT02919683) (68). Treatment intensification with neoadjuvant (induction) chemotherapies with platinum drugs are insufficient to significantly prolong overall survival.
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