Bernier J, Domenge C, Ozsahin M, Matuszewska K, Lefbvre JL, Greiner RH, et al. Gutirrez Caldern V, Cantero Gonzlez A, Glvez Carvajal L, Aguilar Lizarralde Y, Rueda Domnguez A. Neoadjuvant Immunotherapy in Resectable Head and Neck Cancer: Oral Cavity Carcinoma as a Potential Research Model. Oliva M, Spreafico A, Taberna M, Alemany L, Coburn B, Mesia R, et al. Ledermann J, Harter P, Gourley C, Friedlander M, Vergote I, Rustin G, Scott C, Meier W, Shapira-Frommer R, Safra T, Matei D, Macpherson E, Watkins C, Carmichael J, Matulonis U. Olaparib maintenance therapy in platinum-sensitive relapsed ovarian cancer. In ER-positive, HER2-negative metastatic disease, the landmark trial (PALOMA 3) uses the CDK 4/6 inhibitor, palbociclib [26, 27]. B Cell Signatures and Tertiary Lymphoid Structures Contribute to Outcome in Head and Neck Squamous Cell Carcinoma. The data and subsequent meta-analysis showed the superiority of CCRT to preserve the larynx in advanced laryngeal cancer patients (8, 23). Several landmark trials established the clinical benefit of using cisplatin-based chemoradiotherapy after surgery for locally advanced, high-risk HNSCC patients (3, 4). Epidemiology. Both trials did not show a significant extension of OS and DFS, consistent with the subsequent studies (24, 25). doi: 10.1093/annonc/mdy495, 49. 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 [2], and head and neck cancer [6]. Hitt R, Grau JJ, Lpez-Pousa A, Berrocal A, Garca-Girn C, Irigoyen A, et al. Lancet Oncol. The RTOG 90-03 trial . Gubin MM, Zhang X, Schuster H, Caron E, Ward JP, Noguchi T, et al. ID: NCT03803774. As opposed to the CIAO and IMCISION trials where some patients enrolled were undergoing salvage surgery, a third trial recently presented at ASCO 2021 focused exclusively on challenging recurrent, surgically resectable HNSCC patients (NCT03341936) (73). N Engl J Med. Induction Chemotherapy in Advanced Head and Neck Tumors. Understanding Patterns of Pathologic Response Following Neoadjuvant Immunotherapy for Solid Tumors. 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. Zuur CL, Elbers JBW, Vos JL, Avd L, Qiao X, Karakullukcu B, et al. In addition, there was evidence of response in both arms. 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. In this trial, primary endpoints are rate of major pathological response (10% tumor cells in resected primary and lymph nodes on central review) and event-free survival (EFS). This was nearly double what we saw with one dose of pembrolizumab. Friedman J, Moore EC, Zolkind P, Robbins Y, Clavijo PE, Sun L, et al. It is meant to be an educational resource . She is co-lead for the Breast Cancer Programme at the Cancer Research UK Cambridge Cancer Centre and significantly contributes to the translational endeavour in precision medicine and the development of personalised treatment pathways in breast cancer. doi: 10.1158/2159-8290.CD-16-0577, 38. a landmark trial conducted by Bonner and colleagues evaluating the role of cetuximab plus radiation vs radiation alone, and several induction trials evaluating TPF vs cisplatin . N Engl J Med (2004) 350(19):193744. As further investigation of these intriguing results is needed, the SITC HNSCC immunotherapy guidelines does not recommend using HPV status for anti-PD1 treatments in R/M HNSCC (31). J Clin Oncol (2014) 32(25):273543. The November 3, 2021 "Clinical Trial Endpoint Development" (12pm - 5:00 pm ET) will address Locally Advanced Head and Neck Squamous Cell Carcinoma (HNSCC) Systemic treatment in advanced soft tissue sarcoma: what is standard, what is new. He is also Coordinator of the Polish Clinical GIST Registry, and a reviewer for several international scientific journals, as well as a member of the Editorial Board of Annals of Surgical Oncology, BMC Medicine and European Journal of Surgical Oncology. His current research is focused on investigating the impact of novel laboratory parameters for assessing prognosis of CLL. Definition and Impact of Pathologic Complete Response on Prognosis After Neoadjuvant Chemotherapy in Various Intrinsic Breast Cancer Subtypes. Clinical Trial Endpoint Development for Locally Advanced Head and Neck A total of 36 patients (T3/T4; 80%, stage IV; 92%) were enrolled and received one time dose of neoadjuvant pembrolizumab (200 mg) followed by surgery two or three weeks after the immunotherapy. 2011;12(2):1539. Ann Oncol (2014) 25(2):4626. Furthermore, the one-year relapse rate in high-risk patients was 16.7%, which was lower than historical data. Lancet Oncol (2014) 15(1):e4250. 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). The radiographic volumetric response (RVR) and PTE were evaluated, and the results of RVR and PTE was significantly correlated in primary tumor and lymph nodes. Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. J Immunother Cancer (2021) 9(5):115. These data suggest the reactivity of neoadjuvant immunotherapy is related to immunogenic phenotype before treatment and highlights the future possibility to select patients for neoadjuvant immunotherapy before surgery. Schffski P, Chawla S, Maki RG, Italiano A, Gelderblom H, Choy E, Grignani G, Camargo V, Bauer S, Rha SY, Blay JY, Hohenberger P, DAdamo D, Guo M, Chmielowski B, Le Cesne A, Demetri GD, Patel SR. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. A pooled analysis of data from these two postoperative trials is included, which was designed to analyze the selection criteria, clinical and pathologic risk factors, and outcomes and to establish precisely which patients benefit from the addition of cisplatin to postoperative radiation therapy. Being a member of the American Society Clinical Oncology (ASCO), American Society Hematology (ASH), European Society Hematology, he is actively involved in the GIMEMA (Gruppo Italiano Malattie Ematologiche Adulto) lymphoproliferative working group as a member of the working party. Mol Cancer Ther (2017) 16(11):2598608. 20 studies in Head and Neck Cancer Center (open studies only). Terms and Conditions, A trial done by Tata Memorial Centre is included that randomized patients with mostly oral tongue carcinoma to elective neck dissection at the time of primary cancer surgery or watchful waiting with therapeutic neck dissection for nodal relapse. Despite these efforts to improve clinical prognosis, the five-year survival rate of locally advanced stage III/IV HNSCC patients is still sub-optimal [53% in postoperative CCRT treated patients (7)], and half of advanced patients show recurrence within three years (8). Article 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). volume15, Articlenumber:111 (2017) In this trial, pembrolizumab monotherapy significantly improved the OS of PD-L1 positive (CPS 20 or CPS 1) HNSCC. It remains the fifth leading cause of cancer in the United States and constitutes 10% or more of all cancers worldwide. doi: 10.1016/S0140-6736(18)31999-8, 14. How to accurately evaluate the effect of neoadjuvant immunotherapy is an evolving area. He is a member of several Polish and international scientific societies (Board member and Past-President of Polish Society Surgical Oncology and Ex-member of the Board of Directors of the Connective Tissue Oncology Society). Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. Liu J, Blake SJ, Yong MC, Harjunp H, Ngiow SF, Takeda K, et al. 2013;31(36):45628. Hellmann MD, Chaft JE, William WN Jr, Rusch V, Pisters KM, Kalhor N, et al. Immune Biomarkers of Response to Immune-Checkpoint Inhibitors in Head and Neck Squamous Cell Carcinoma. Lancet. elective versus therapeutic neck dissection in node-negative oral cancer. J Immunother Cancer (2021) 9(6):111. J Natl Compr Canc Netw. Springer Nature. Notably, the treatments were safe and 16/26 patients (61.5%) had pathologic responses (>20%) and 8/26 (31%) of patients experienced complete response (72). cancer [2], melanoma [3, 4], STS [5], head and neck cancer [6]). J Clin Oncol. 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). All authors read and approved the final manuscript. Historically, surgery and radiotherapy with/without conventional chemotherapy including platinum, taxanes or fluorouracil, were applied to treat HNSCC. PR is Professor of Surgical Oncology at the Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology in Warsaw, Poland. Bayesian adaptive designs for biomarker trials with biomarker discovery. Landmark Trials in Selected Head and Neck Cancers. Landmark Trials in Oncology pp 217239Cite as. Lancet Oncol. Ferris RL, Blumenschein G Jr., Fayette J, Guigay J, Colevas AD, Licitra L, et al. Table2 Ongoing neoadjuvant immunotherapy clinical trials. Mutational Landscape and Significance Across 12 Major Cancer Types. In the era of precision cancer medicine, innovative trial designs will also require the matching of novel drugs with putative targets. Int J Radiat Oncol Biol Phys (1996) 36(5):9991004. Pathological Response After Neoadjuvant Chemotherapy in Resectable Non-Small-Cell Lung Cancers: Proposal for the Use of Major Pathological Response as a Surrogate Endpoint. 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). 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. Kandoth C, McLellan MD, Vandin F, Ye K, Niu B, Lu C, et al. Part of Springer Nature. Head and neck cancer was the seventh most common cancer worldwide in 2018 (890,000 new cases and 450,000 deaths), 1 accounting for 3% of all cancers (51,540 new cases) and just over . There was an 86% MPR rate and a 67% pCR rate. Pathologic responses were evaluated in 34 patients (17 HPV+ and 17 HPV-negative). Any pTR was seen in 44% and pTR-2 was seen in 22% of patients. Bertrand Baujat et al. Lin J-C, et al. Neoadjuvant PD-1 Immune Checkpoint Blockade Reverses Functional Immunodominance Among Tumor Antigen-Specific T Cells. No new safety signals were observed and there were no surgical delays. Gianni L, Pienkowski T, Im YH, Roman L, Tseng LM, Liu MC, Lluch A, Staroslawska E, de la Haba-Rodriguez J, Im SA, Pedrini JL, Poirier B, Morandi P, Semiglazov V, Srimuninnimit V, Bianchi G, Szado T, Ratnayake J, Ross G, Valagussa P. Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial. 2016;375(19):184555. J Clin Oncol (2015) 33(8):83645. Barker AD, Sigman CC, Kelloff GJ, Hylton NM, Berry DA, Esserman LJ. 2015;372(4):32030. However, the five-year survival rate is still below 50% in advanced HPV-negative HNSCC patients (8), and many patients suffer from severe impact on essential functions. PDF Spotlight on landmark oncology trials: the latest evidence and novel A meta-analysis which examined the results of clinical trials including Checkmate 141, KEYNOTE-012, KEYNOTE-055 showed that HPV infection status was associated with the response rate to anti-PD-1 treatment independently of PD-L1 expression and TMB in HNSCC (45). Cookies policy. 2014;32(12):123641. J Clin Oncol. The Annals of Surgical Oncology (ASO) is pleased to announce, The Landmark Series. Bossi P, Lo Vullo S, Guzzo M, Mariani L, Granata R, Orlandi E, et al. HNSCC patients with high CD8+ T cells infiltration showed better anti-PD-1 response in the adjuvant setting (52, 54). Although neither baseline CD8+ T cell infiltration status nor PD-L1 expression level correlated with overall response, there was a trend in which greater CD8+ T cells infiltrated patients tended to show MPR. Google Scholar. JCI Insight (2016) 1(17):e89829. Radiother Oncol. Schoenfeld JD, Hanna GJ, Jo VY, Rawal B, Chen YH, Catalano PS, et al. For larynx cancer, this approach was initially focused on reducing metastases, and preserving laryngeal function including speech and swallowing. However, a potential setback is represented by the control arm since chlorambucil is no longer regarded an adequate therapy in CLL [26]. PubMed We classified pTR into pTR-0 (10%), pTR-1 (10-49%), and pTR-2 (50%) (54). In Checkmate-141 phase III trial, there wasno correlation of survival extension and PD-L1 expression on tumors (PD-L1+ >1%, 5% and 10%) (12). 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). Chan TA, Yarchoan M, Jaffee E, Swanton C, Quezada SA, Stenzinger A, et al. Abstract CT075. https://doi.org/10.1007/978-3-030-14405-0_7, DOI: https://doi.org/10.1007/978-3-030-14405-0_7. J Clin Oncol (2021) 39(15_suppl):60066. PubMedGoogle Scholar. These early studies led to two randomized Phase III trials, which provided Level 1 evidence supporting the use of concurrent chemoradiotherapy in high-risk HNSCC patients (57). Part of 2017;5(10):42532. Positive results from this study established the application of anti-PD-1 for R/M HNSCC treatment, and proved the existence of actionable, efficient anti-cancer immunity in HNSCC tumors.
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