Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. strategies for preserving the quality of life during and after treatment. In this trial, pembrolizumab monotherapy significantly improved the OS of PD-L1 positive (CPS 20 or CPS 1) HNSCC. Neoadjuvant chemotherapy has a long history in HNSCC where induction chemotherapy (IC) prior to conventional platinum-based chemotherapy has been tested in numerous studies HNSCC (18). Landmark Trials. doi: 10.1158/1078-0432.CCR-19-3977, 71. The Head and Neck Cancer Immune Landscape and Its Immunotherapeutic Implications. Per standard of care, postoperative RT or CCRT were performed, and adjuvant pembrolizumab treatment was used in high-risk patients with positive surgical margins or extra-nodal extension. CrossRef 2023 Springer Nature Switzerland AG. The three-planar views are crucial to understanding the malignant gradient. In addition, in the KEYNOTE-040 phase III study, the correlation of clinical outcome and PD-L1 expression on tumor (PD-L1 tumor proportion score 50%) was evident (13). For example, radiological tumor examination is widely used in Response Evaluation Criteria In Solid Tumors (RECIST) after organ preservation therapy including radiotherapy and chemotherapy. Harrington JA, Wheeler GM, Sweeting MJ, Mander AP, Jodrell DI. The published and ongoing trials described above focused on single agent checkpoint blockade immunotherapy prior to surgery. doi:10.1080/17474086.2017.1313108. Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crin L, Blumenschein Jr GR, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus docetaxel in advanced nonsquamous non-small-cell lung cancer. PubMed A study by Lin et al. 2017;15(4):50435. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomized trials and 17,346 patients. Concurrent Chemotherapy and Radiotherapy for Organ Preservation in Advanced Laryngeal Cancer. 11:727433. doi: 10.3389/fonc.2021.727433. 2016;388(10043):48897. doi: 10.1016/j.cllc.2019.11.003, 62. There are several distinct mechanisms of how radiation and/or chemotherapy can work with immunotherapy and other have covered these topics. doi: 10.1056/NEJMoa031317, 24. The primary cancer (oral cavity) invades in various directions, which are color-coded vectors (arrows) representing stage of progression: Tis, yellow; T1, green; T2, blue; T3, purple; T4A, red; and T4B, black. Ettinger DS, Wood DE, Aisner DL, Akerley W, Bauman J, Chirieac LR, DAmico TA, DeCamp MM, Dilling TJ, Dobelbower M, Doebele RC, Govindan R, Gubens MA, Hennon M, Horn L, Komaki R, Lackner RP, Lanuti M, Leal TA, Leisch LJ, Lilenbaum R, Lin J, Loo Jr BW, Martins R, Otterson GA, Reckamp K, Riely GJ, Schild SE, Shapiro TA, Stevenson J, Swanson SJ, Tauer K, Yang SC, Gregory K, Hughes M. Non-Small Cell Lung Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology. 2017;15:55. JCI Insight (2018) 3(4):113. PubMedGoogle Scholar. Radiother Oncol. Head and Neck Cancer Center - Clinical trials - Mayo Clinic BMC Med. Eur J Cancer. A special article collection in BMC Medicine, Spotlight on landmark oncology trials, features articles from invited experts on recent clinical practice-changing trials. evaluated the role of measuring plasma EBV DNA and is included. HPV-related oropharyngeal HNSCC shows better survival related to HPV-negative oropharyngeal HNSCCs. Ferrarotto R, Bell D, Rubin ML, Hutcheson KA, Johnson JM, Goepfert RP, et al. An important consideration in neoadjuvant immunotherapy approaches is appropriate patient selection. on behalf of the MAC-NPC Collaborative Group. The head and neck region is anatomically complex and serves essential functions such as eating, speaking, and breathing. 2016;53:12534. Liu J, Blake SJ, Yong MC, Harjunp H, Ngiow SF, Takeda K, et al. Menzies AM, Amaria RN, Rozeman EA, Huang AC, Tetzlaff MT, van de Wiel BA, et al. Bertrand Baujat et al. Immunotherapy in head and neck cancer: aiming at EXTREME precision. Goodman AM, Kato S, Bazhenova L, Patel SP, Frampton GM, Miller V, et al. Clinical Trials - Head and Neck Cancer Alliance Despite optimal local treatment, approximately 50% of adult patients with localised STS develop distant metastases and die of metastatic disease. N Engl J Med. Randomized Phase III Trial of Induction Chemotherapy With Docetaxel, Cisplatin, and Fluorouracil Followed by Surgery Versus Up-Front Surgery in Locally Advanced Resectable Oral Squamous Cell Carcinoma. Neoadjuvant Immunoradiotherapy Results in High Rate of Complete Pathological Response and Clinical to Pathological Downstaging in Locally Advanced Head and Neck Squamous Cell Carcinoma. N Engl J Med (2013) 369(2):13444. This trial aims to enroll 600 patients. doi: 10.1200/JCO.2016.70.1524, 45. A clinical trial studying the side effects of chemotherapy for patients with locally recurrent head and neck squamous cell carcinoma. Understanding Patterns of Pathologic Response Following Neoadjuvant Immunotherapy for Solid Tumors. 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. Rutkowski P, Kozak K. News from the melanoma sessions of the European Cancer Congress 2017. Although only 15-20% of patients benefit, immunotherapies have been approved and widely used for recurrent and metastatic HNSCC. Lancet Oncol (2013) 14(3):25764. Lancet Oncol. Clin Cancer Res (2020) 26(3):67989. 2016;17(6):791800. Ther Adv Med Oncol (2021) 13:1758835920984061. doi: 10.1177/1758835920984061, 40. 2013;10(5):27788. Moreover, recent trials of immune checkpoint inhibitors in melanoma, non-small cell lung carcinoma, and head and neck cancers have significantly influenced the therapeutic landscape by providing promising evidence for immunotherapy efficacy in the adjuvant setting in high-risk locoregional disease. He is the current Head of the Department of Soft Tissue/Bone Sarcoma and Melanoma, the Plenipotentiary Director of Institute for Clinical Trials at the Maria Sklodowska-Curie Memorial Cancer Center as well as the President of the Scientific Council of Maria Sklodowska-Curie Memorial Cancer Center. N Engl J Med (2004) 350(19):194552. Gianni L, Pienkowski T, Im YH, Tseng LM, Liu MC, Lluch A, Starosawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi GV, Magazz D, McNally V, Douthwaite H, Ross G, Valagussa P. 5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial. Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial. Induction Chemotherapy Plus Radiation Compared With Surgery Plus Radiation in Patients With Advanced Laryngeal Cancer. quantification of plasma epstein-barr virus DNA in patients with advanced nasopharyngeal carcinoma. To be eligible, patients had to have N2 or N3 adenopathy. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomized controlled trial. Schoenfeld JD, Hanna GJ, Jo VY, Rawal B, Chen YH, Catalano PS, et al. elective versus therapeutic neck dissection in node-negative oral cancer. Earl, H., Molica, S. & Rutkowski, P. Spotlight on landmark oncology trials: the latest evidence and novel trial designs. University of Cambridge Department of Oncology, NIHR Cambridge Biomedical Research Centre, and Hon Consultant in Medical Oncology, Cambridge University Hospital NHS Foundation Trust, Cambridge, UK, Department Hematology-Oncology, Azienda Ospedaliera Pugliese-Ciaccio, 88100, Catanzaro, Italy, Department of Soft Tissue/Bone Sarcoma and Melanoma, Maria Sklodowska-Curie Institute - Oncology Center, Roentgena 5, 02-781, Warsaw, Poland, You can also search for this author in Huang SH, Xu W, Waldron J, Siu L, Shen X, Tong L, et al. doi: 10.1158/2159-8290.CD-16-0577, 38. For example, a phase II/III trial in patients with early-stage HPV-positive HNSCC is testing whether RT plus chemotherapy (cisplatin) or immunotherapy (nivolumab or durvalumab) can be used for de-intensification (NCT03952585, NCT03410615). doi: 10.1056/NEJMoa0802656, 33. Indeed, ibrutinib demonstrated a survival advantage over chlorambucil despite the studys crossover design. Ann Oncol (2014) 25(1):21625. Junker K, Thomas M, Schulmann K, Klinke F, Bosse U, Mller KM. There were excellent clinical outcomes and only one patient required adjuvant chemoradiation. HNSCC patients with high CD8+ T cells infiltration showed better anti-PD-1 response in the adjuvant setting (52, 54). Ann Oncol (2018) 29(8):16302. A study in over 300 patients across 22 solid tumor types from four KEYNOTE trials and an observational study of 126 HNSCC patients revealed HNSCC patients with high TMB showed significantly better anti-PD-1 response (51, 52). Google Scholar. Hitt R, Grau JJ, Lpez-Pousa A, Berrocal A, Garca-Girn C, Irigoyen A, et al. cancer [2], melanoma [3, 4], STS [5], head and neck cancer [6]). Haddad R, et al. Licitra L, Grandi C, Guzzo M, Mariani L, Lo Vullo S, Valvo F, et al. Frezza AM, Stacchiotti S, Gronchi A. Refining American Joint Committee on Cancer/Union for International Cancer Control TNM Stage and Prognostic Groups for Human Papillomavirus-Related Oropharyngeal Carcinomas. PR is an active member of the EORTC Soft Tissue and Bone Sarcoma Group, where he chaired the Local Treatment Subcommittee and the Membership Committee of the EORTC Board. Larkin J, Chiarion-Sileni V, Gonzalez R, et al. Pembrolizumab versus ipilimumab in advanced melanoma. Herbst RS, Baas P, Kim DW, Felip E, Prez-Gracia JL, Han JY, Molina J, Kim JH, Arvis CD, Ahn MJ, Majem M, Fidler MJ, de Castro Jr G, Garrido M, Lubiniecki GM, Shentu Y, Im E, Dolled-Filhart M, Garon EB. Sci Rep (2019) 9(1):13404. doi: 10.1038/s41598-019-49771-0, 46. doi: 10.1093/annonc/mdy218, 59. von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, et al. Considering the TME will be dramatically changed after therapeutic treatment, neoadjuvant immunotherapy for HNSCC can provide an opportunity to establish immune markers to predict efficacy of subsequent immunotherapy. doi: 10.1093/annonc/mdt461, 25. J Clin Oncol (2015) 33(8):83645. Sholl LM. Historically, surgery and radiotherapy with/without conventional chemotherapy including platinum, taxanes or fluorouracil, were applied to treat HNSCC. N Engl J Med. Xiong Y, Neskey DM, Horton JD, Paulos CM, Knochelmann HM, Armeson KE, et al. doi: 10.1001/jamaoncol.2020.2955, 69. This enhanced function acts to destroy micro-metastasis in clinically advanced tumors, decreasing loco-regional or distant metastasis after primary therapies. As described by ASO Editor-in-Chief, Kelly M. McMasters, MD, PhD, "The Landmark Series is designed to trace the origins of current multidisciplinary therapy for each type of solid tumor, and demonstrate the logical progression of clinical trials and other key evidence. Induction Chemotherapy Followed by Cetuximab Radiotherapy Is Not Superior to Concurrent Chemoradiotherapy for Head and Neck Carcinomas: Results of the GORTEC 2007-02 Phase III Randomized Trial. Bernier J, et al. Differences in T-Cell Infiltrates and Survival Between HPV+ and HPV- Oropharyngeal Squamous Cell Carcinoma. The BATTLE-2 Study: a biomarker-integrated targeted therapy study in previously treated patients with advanced nonsmall-cell lung cancer. 2012;366(15):138292. With the advent of novel oral agents that are well tolerated and highly efficacious, the therapeutic landscape of CLL underwent radical changes [31]. 2016;128(24):27703. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Hanna GJ, ONeill AM, Jo VY, Wong K, Lizotte PH, Annino DJ, et al. Neoadjuvant Checkpoint Blockade for Cancer Immunotherapy. Springer, Cham. Cancer Discov (2016) 6(12):138299. Notably, the timing of immune checkpoint inhibitors may influence the outcome of cancer treatment (33). NEngl J Med (2016) 375(19):185667. The first articles in the special article collection focus on landmark clinical trials in selected advanced solid tumours, with special attention on the most studied tumours with regards to immunotherapy development, namely melanoma [3, 4], NSCLC [], and head and neck cancer [].Recent developments and approvals in immunotherapy have significantly changed the landscape of melanoma and NSCLC . doi: 10.1172/jci.insight.89829, 18. Cooper JS. doi: 10.1080/2162402X.2019.1581530, 34. Landmark Trials | Division of Cancer Prevention Liu J, ODonnell JS, Yan J, Madore J, Allen S, Smyth MJ, et al. Matlung SE, Wilhelmina van Kempen PM, Bovenschen N, van Baarle D, Willems SM. A meta-analysis by Pignon et al. Improved Efficacy of Neoadjuvant Compared to Adjuvant Immunotherapy to Eradicate Metastatic Disease. Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefbvre JL, Greiner RH, et al. First published on Mon 11 Oct 2021 07.19 EDT. doi: 10.1158/1078-0432.CCR-19-2209, 39. Article Landmark Trials in Selected Head and Neck Cancers - ResearchGate Our doctors are running clinical trials testing: new drug therapies for head and neck cancer, including immunotherapies and targeted therapies, that can boost the effectiveness of your care. Kwok M, Rawstron AC, Varghese A, Evans PA, OConnor SJ, Doughty C, Newton DJ, Moreton P, Hillmen P. Minimal residual disease is an independent predictor for 10-year survival in CLL. Below are current clinical trials. They used pathological response (PR) criteria which was defined tumor necrosis and/or histiocytic inflammation and giant cell reaction to keratinaceous debris (74). Additionally, R/M HNSCC patients treated with pembrolizumab plus chemotherapy had significantly prolonged OS compared to the cetuximab with chemotherapy group. Head And Neck Cancer - SlideShare McGrail DJ, Pili PG, Rashid NU, Voorwerk L, Slagter M, Kok M, et al. Finally, we recently reported a second cohort of our neoadjuvant pembrolizumab trial where instead of one dose, patients received two doses of drug similar to the neoadjuvant phase of the KEYNOTE-689 Phase II trial (75). doi: 10.1158/1078-0432.CCR-16-1761, 43. Laramore GE, Scott CB, al-Sarraf M, Haselow RE, Ervin TJ, Wheeler R, et al. Note, there are institution specific protocols where induction chemotherapy prior to surgery is still used for larger tumors to achieve more rapid control (21). CAS There were no treatment related delays thus achieving the primary safety endpoint. Vermorken JB, Mesia R, Rivera F, Remenar E, Kawecki A, Rottey S, et al. doi: 10.1172/jci.insight.98811, 53. Nature (2014) 515(7528):57781. J Clin Oncol. Ann Oncol (2019) 30(1):5767. A Randomized Phase III Trial Comparing Induction Chemotherapy Followed by Chemoradiotherapy Versus Chemoradiotherapy Alone as Treatment of Unresectable Head and Neck Cancer. Bachaud JM, Cohen-Jonathan E, Alzieu C, David JM, Serrano E, Daly-Schveitzer N. Combined Postoperative Radiotherapy and Weekly Cisplatin Infusion for Locally Advanced Head and Neck Carcinoma: Final Report of a Randomized Trial. Lancet. doi: 10.1038/nature12634, 50. Based on this study and depending on the programmed death-ligand 1 (PD-L1) combined positive score (CPS) either pembrolizumab alone or with chemotherapy represents the first choice for these patients (14). 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]. The expression level of PD-L1 in the tumor does not necessarily correlate withthe response to CPIs. The Department of Veterans Affairs Laryngeal Cancer Study Group. Then, we focus on the rationale and clinical trials of neoadjuvant immunotherapy and its potential impact on HNSCC treatment. Ang KK, et al. doi: 10.1158/1078-0432.CCR-20-1695, 55. Landmark Trials in Selected Head and Neck Cancers We also highlight selected and recent practice-changing trials in chronic lymphocytic leukaemia as well as breast and gynaecological cancers, and review the advances offered by the development of novel clinical trial designs. HPV infection might also be a clinical biomarker to predict the response to CPIs. Immunological Effects of Nivolumab Immunotherapy in Patients With Oral Cavity Squamous Cell Carcinoma. A new cancer treatment can wipe out tumours in terminally ill head and neck cancer patients, scientists have discovered. Park JW, Liu MC, Yee D, Yau C, van t Veer LJ, Symmans WF, Paoloni M, Perlmutter J, Hylton NM, Hogarth M, DeMichele A, Buxton MB, Chien AJ, Wallace AM, Boughey JC, Haddad TC, Chui SY, Kemmer KA, Kaplan HG, Isaacs C, Nanda R, Tripathy D, Albain KS, Edmiston KK, Elias AD, Northfelt DW, Pusztai L, Moulder SL, Lang JE, Viscusi RK, Euhus DM, Haley BB, Khan QJ, Wood WC, Melisko M, Schwab R, Helsten T, Lyandres J, Davis SE, Hirst GL, Sanil A, Esserman LJ, Berry DA, I-SPY 2 Investigators. More effective and cost-efficient phase II trial designs would rapidly lead to landmark trials and practice-changing results. Lorch J, et al. 2016;35:4907. HE has provided clinical advice at Advisory Board meetings for Roche, Pfizer and Astra Zeneca. Front Immunol (2021) 12:645170. doi: 10.3389/fimmu.2021.645170, 47. Neoadjuvant Nivolumab for Patients With Resectable HPV-Positive and HPV-Negative Squamous Cell Carcinomas of the Head and Neck in the CheckMate 358 Trial. Induction Chemotherapy Followed by Concurrent Chemoradiotherapy (Sequential Chemoradiotherapy) Versus Concurrent Chemoradiotherapy Alone in Locally Advanced Head and Neck Cancer (PARADIGM): A Randomised Phase 3 Trial. PD-L1 expression in tumor cells and immune cells remains the most widely used biomarker in HNSCC and other cancers (40, 41). NEngl J Med (2008) 359(11):111627. van der Graaf WT, Blay JY, Chawla SP, Kim DW, Bui-Nguyen B, Casali PG, Schffski P, Aglietta M, Staddon AP, Beppu Y, Le Cesne A, Gelderblom H, Judson IR, Araki N, Ouali M, Marreaud S, Hodge R, Dewji MR, Coens C, Demetri GD, Fletcher CD, Dei Tos AP, Hohenberger P, EORTC Soft Tissue and Bone Sarcoma Group; PALETTE study group. Three HPV-positive tumors and one HPV-negative tumor had partial pathologic responses. Ann Oncol (2021) 32(5):66172. Key pathological findings after neoadjuvant immunotherapy include 1) keratinous debris, 2) giant cells, histiocytic reaction and 3) tumor necrosis. 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