landmark trials in head and neck cancer ppt

Kandoth C, McLellan MD, Vandin F, Ye K, Niu B, Lu C, et al. He has authored or co-authored over 120 scientific papers in Polish and international journals (with an impact factor of above 1200, index-H: 32, citation index>4000), and is co-author of national and international recommendations for sarcoma and melanoma. In addition to this design, immunotherapy is being integrated in several neoadjuvant combinations with radiation or chemotherapy prior to surgery. In another phase II neoadjuvant pembrolizumab clinical trial, we reported no severe grade 3/4 AEs and no surgical delays in a total of 36 treated HNSCC patients (54). Hillmen P, Robak T, Janssens A, Babu KG, Kloczko J, Grosicki S, Doubek M, Panagiotidis P, Kimby E, Schuh A, Pettitt AR, Boyd T, Montillo M, Gupta IV, Wright O, Dixon I, Carey JL, Chang CN, Lisby S, McKeown A, Offner F, COMPLEMENT 1 Study Investigators. 2004;350:246170. doi: 10.1200/JCO.2017.76.2591, 26. Haddad R, et al. This material is provided for educational purposes only and with the goal of encouraging further study about the landmark trials that have impacted oncology. Turner NC, Ro J, Andr F, Loi S, Verma S, Iwata H, Harbeck N, Loibl S, Huang Bartlett C, Zhang K, Giorgetti C, Randolph S, Koehler M, Cristofanilli M, PALOMA3 Study Group. The Department of Veterans Affairs Laryngeal Cancer Study Group. CrossRef These studies with previously untreated tumors may enable establishment of predictive biomarkers to select appropriate patients and also define mechanistic pathways. However, negative Phase III trials (19, 20) in this setting have reduced enthusiasm for these approaches. doi: 10.1080/2162402X.2019.1581530, 34. J Clin Oncol (2021) 39(15_suppl):60533. Tumour Regression in Non-Small-Cell Lung Cancer Following Neoadjuvant Therapy. Study 19 [28, 29] used olaparib against placebo and demonstrated a PFS of 11.2months in BRCA-mutated patients compared with 4.3months for wild-type patients (hazard ratio, 0.18; P<0.0001). J Clin Oncol. doi: 10.1056/NEJMoa031317, 24. 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. Merlino etal. 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. Goodman AM, Kato S, Bazhenova L, Patel SP, Frampton GM, Miller V, et al. doi: 10.1038/nature12634, 50. 2011;1(1):4453. 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). Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial. 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. In a spontaneous mouse metastatic breast cancer model, neoadjuvant checkpoint inhibitors showed an enhanced survival compared to the adjuvant setting by suppressing metastatic lesions (37). doi: 10.1126/science.aax0902, 10. J Clin Oncol (2017) 35(14):15429. In ER-positive, HER2-negative metastatic disease, the landmark trial (PALOMA 3) uses the CDK 4/6 inhibitor, palbociclib [26, 27]. Platinum-Based Chemotherapy Plus Cetuximab in Head and Neck Cancer. Blood. For example, in a phase II trial, platinum combined with immunotherapy (nivolumab) followed by transoral robotic surgery (TORS) or RT/CRT is being examined in oropharyngeal cancer patients (NCT03107182). Both trials demonstrated significant benefit for maintenance PARP inhibitors in all subgroups of platinum-sensitive relapsed high-grade serous ovarian cancer. Avelumab Maintenance Therapy for Advanced or Metastatic Urothelial Carcinoma. JClin Oncol (2018) 36(31):307783. All authors read and approved the final manuscript. Cristofanilli M, Turner NC, Bondarenko I, Ro J, Im SA, Masuda N, Colleoni M, DeMichele A, Loi S, Verma S, Iwata H, Harbeck N, Zhang K, Theall KP, Jiang Y, Bartlett CH, Koehler M, Slamon D. Fulvestrant plus palbociclib versus fulvestrant plus placebo for treatment of hormone-receptor-positive, HER2-negative metastatic breast cancer that progressed on previous endocrine therapy (PALOMA-3): final analysis of the multicentre, double-blind, phase 3 randomised controlled trial. Head Neck. Key pathological findings after neoadjuvant immunotherapy include 1) keratinous debris, 2) giant cells, histiocytic reaction and 3) tumor necrosis. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. Leidner R, Crittenden M, Young K, Xiao H, Wu Y, Couey MA, et al. Forastiere A, et al. Uppaluri R, Lee NY, Westra W, Cohen EEW, Haddad RI, Temam S, et al. 2015;372(4):32030. Gubin MM, Zhang X, Schuster H, Caron E, Ward JP, Noguchi T, et al. In conclusion, the RESONATE-2 trial demonstrates that ibrutinib is a new important player in the treatment of elderly unfit patients and in those with high-risk disease. The significant impact of checkpoint inhibitor therapy for R/M HNSCC has proven the existence of anti-cancer immunity in HNSCC (1214). Another meta-analysis showed that HPV positive HNSCC patients display significant improved outcomes with PD-1/PD-L1 axis blockage treatment compared to HPV negative HNSCC patients (46). Lancet. N Engl J Med. Oliva M, Spreafico A, Taberna M, Alemany L, Coburn B, Mesia R, et al. Phase III Randomized Trial of Induction Chemotherapy in Patients With N2 or N3 Locally Advanced Head and Neck Cancer. In support of this, neoadjuvant anti-PD-1 treatment in a mouse HNSCC model resulted in conversion of functional immune-dominance and induced robust anti-cancer responses, supporting the application of neoadjuvant immunotherapy for HNSCC (38). doi: 10.1136/jitc-2021-002568corr1, 68. Haddad R, ONeill A, Rabinowits G, Tishler R, Khuri F, Adkins D, et al. There was an 86% MPR rate and a 67% pCR rate. Xu Y, Zhu G, Maroun CA, Wu IXY, Huang D, Seiwert TY, et al. In this editorial, we discuss the special article collection entitled Spotlight on landmark oncology trials recently published in BMC Medicine, which focuses on the core clinical trials of selected solid tumours (lung cancer [2], melanoma [3, 4], STS [5], head and neck cancer [6]). Oncol. Harrington JA, Wheeler GM, Sweeting MJ, Mander AP, Jodrell DI. His current research is focused on investigating the impact of novel laboratory parameters for assessing prognosis of CLL. N Engl J Med. Delay to Surgery After Neoadjuvant Chemotherapy in Head and Neck Squamous Cell Carcinoma Affects Oncologic Outcomes. We also highlight selected and recent practice-changing trials in chronic lymphocytic leu-kaemia as well as breast and gynaecological cancers, and review the advances offered by the development of novel clinical trial designs. reported on findings from a clinical trial where neoadjuvant nivolumab (240 mg on days 1 and 15) with or without tadalafil was tested. In a phase II neoadjuvant immunotherapy clinical trial for oral cavity cancer patients which treated with nivolumab (N, n=14) or nivolumab and ipilimumab (N+I, n=15), two (N) and five (N+I) patients showed grade 3/4 AEs. doi: 10.1016/S0140-6736(18)31999-8, 14. A total of 28 patients were eligible, and 24 (86%) of patients were HPV positive. Front. Major pathological responses were seen in 1 HPV-positive tumor with none in the HPV-negative tumors. Hanna GJ, Lizotte P, Cavanaugh M, Kuo FC, Shivdasani P, Frieden A, et al. Subsequently the Keynote-048 study, a randomized multi-center phase III study from 37 countries, examined pembrolizumab alone or with chemotherapy (platinum plus fluorouracil) versus cetuximab with chemotherapy (the EXTREME regimen (32)) for first-line treatment of R/M HNSCC (14). Nature (2013) 502(7471):3339. Lawrence MS, Sougnez C, Lichtenstein L, Cibulskis K, Lander E, Gabriel SB, et al. 2014;32:273543. However, cancer research also faces challenges in the effective development and assessment of targeted therapeutics [1], including the need for early evaluation of potential biomarkers by translational and correlative studies. NEngl J Med (2016) 375(19):185667. Following this, the phase III KEYNOTE-048 trial established a new paradigm for first-line R/M HNSCC patients (14). HPV infection might also be a clinical biomarker to predict the response to CPIs. Completed and ongoing trials have focused on a diverse group of HNSCC patients including early and advanced stage and HPV-positive and negative patients. Pathological Response After Neoadjuvant Chemotherapy in Resectable Non-Small-Cell Lung Cancers: Proposal for the Use of Major Pathological Response as a Surrogate Endpoint. There were no delays to surgery and 3/28 patients had Grade 3 AEs. Finally, considering the ease of biopsies in the head and neck region, compared to adjuvant immunotherapy, neoadjuvant immunotherapy has the benefit to enable translational efforts such as TCR analysis, gene-expression profiling, and cytokine evaluation in the primary tumor which is not affected by other treatments including chemotherapeutics or radiation. Long term results of TAX324, a randomized phase III trial of sequential therapy with TPF versus PF in locally advanced squamous cell cancer of the head and neck. HE has received research funding from Cancer Research UK and the NIHR HTA, and is funded by the NIHR Cambridge Biomedical Research Centre. This trial aims to enroll 600 patients. 2014;32(12):123641. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. doi: 10.1073/pnas.0915174107, 72. 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. HE has provided clinical advice at Advisory Board meetings for Roche, Pfizer and Astra Zeneca. Burger JA, Tedeschi A, Barr PM, Robak T, Owen C, Ghia P, Bairey O, Hillmen P, Bartlett NL, Li J, Simpson D, Grosicki S, Devereux S, McCarthy H, Coutre S, Quach H, Gaidano G, Maslyak Z, Stevens DA, Janssens A, Offner F, Mayer J, ODwyer M, Hellmann A, Schuh A, Siddiqi T, Polliack A, Tam CS, Suri D, Cheng M, Clow F, Styles L, James DF, Kipps TJ, RESONATE-2 Investigators. On the other hand, MPR represents 10% of residual viable tumor (63). doi: 10.1002/hed.20279, 7. JCI Insight (2018) 3(4):113. She has been an expert advisor for NHS NICE Health Technology Assessments. This enhanced function acts to destroy micro-metastasis in clinically advanced tumors, decreasing loco-regional or distant metastasis after primary therapies. Head and Neck Cancer Clinical Trials | Center for Cancer Research Google Scholar. RU is funded by NIH/NIDCR R01DE024403, R01DE027736, and NIH/NCI/NIDCR U01DE029188. doi: 10.1093/annonc/mdy495, 49. The landmark Docetaxel-Based Chemotherapy Plus or Minus Induction Chemotherapy to Decrease Events in Head and Neck Cancer (DECIDE) trial randomized 285 patients between 2004 and 2009 to concurrent chemoradiation plus or minus induction chemotherapy.

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