Article 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. Beitler J, et al. Lancet. PubMed Chlorambucil plus ofatumumab versus chlorambucil alone in previously untreated patients with chronic lymphocytic leukaemia (COMPLEMENT 1): a randomised, multicentre, open-label phase 3 trial. Article This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). Therapeutically, HPV-positive HNSCC demonstrates sensitivity to chemoradiotherapy, and offers a better prognosis (2). This was nearly double what we saw with one dose of pembrolizumab. However, a potential setback is represented by the control arm since chlorambucil is no longer regarded an adequate therapy in CLL [26]. 2016;17(6):791800. 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. N Engl J Med (2013) 369(2):13444. Sholl LM. J Natl Compr Canc Netw. Histological Assessment. This trial included both definitive and salvage surgery patients. Larkin J, Chiarion-Sileni V, Gonzalez R, Grob JJ, Cowey CL, Lao CD, Schadendorf D, Dummer R, Smylie M, Rutkowski P, Ferrucci PF, Hill A, Wagstaff J, Carlino MS, Haanen JB, Maio M, Marquez-Rodas I, McArthur GA, Ascierto PA, Long GV, Callahan MK, Postow MA, Grossmann K, Sznol M, Dreno B, Bastholt L, Yang A, Rollin LM, Horak C, Hodi FS, Wolchok JD. doi: 10.1016/S0140-6736(18)31999-8, 14. PubMed Central 2017;15(4):50435. 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. doi: 10.1016/j.cllc.2019.11.003, 62. These trials will test the important topic of whether there is synergy in combination approaches with RT, immunotherapy and/or chemotherapy. Google Scholar. Tumors with both PD-L1 and PD-L2 expression responded better than tumors with only PD-L1 expression, indicating that combinatorial scoring may be an attractive approach. Of eighty evaluated patients, 32 patients (40%) showed a PR [26 partial PR ( 20% and <90%) and 6 with major PR (>90%)]. I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. (NCT03021993), in which a total of 10 locally advanced OSCC patients were treated with neoadjuvant nivolumab (3 mg/kg on days 1, 14 and 28) (69). The three-planar views are crucial to understanding the malignant gradient. Proc Natl Acad Sci USA (2010) 107(9):427580. Wason JMS, Abraham JE, Baird RD, Gounaris I, Vallier A-V, Brenton JD, Earl HM, Mander AP. The goal of cytotoxic chemotherapy in this setting is to directly attack tumor cells to reduce tumor burden. IC continues to be used at some centers with defined indications including advanced or borderline resectable tumors. J Cancer Res Clin Oncol (1997) 123(9):46977. Using a primary radiation based approach, several ongoing clinical trials aim to de-intensify the treatment impact by adding immunotherapy (77). Papadimitrakopoulou V, Lee JJ, Wistuba II, Tsao AS, Fossella FV, Kalhor N, Gupta S, Byers LA, Izzo JG, Gettinger SN, Goldberg SB, Tang X, Miller VA, Skoulidis F, Gibbons DL, Shen L, Wei C, Diao L, Peng SA, Wang J, Tam AL, Coombes KR, Koo JS, Mauro DJ, Rubin EH, Heymach JV, Hong WK, Herbst RS. Lancet. Quantitative Assessment of the Heterogeneity of PD-L1 Expression in Non-Small-Cell Lung Cancer. Pathological complete response (pCR) and major pathologic response (MPR) are widely used as surrogate clinical endpoints for long-term survival (5962). The RTOG 90-03 trial compared four radiation therapy fractionation schemes for locoregionally advanced patients undergoing radiation therapy alone and is discussed. 2015;373:5219. I. HPV-Positive Status Associated With Inflamed Immune Microenvironment and Improved Response to Anti-PD-1 Therapy in Head and Neck Squamous Cell Carcinoma. The Mutational Landscape of Head and Neck Squamous Cell Carcinoma. Clinical outcomes were better than historical with 70% 1-year disease free survival and 85% 1-year overall survival. Several landmark trials established the clinical benefit of using cisplatin-based chemoradiotherapy after surgery for locally advanced, . 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. 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. A meta-analysis by Pignon et al. Note that MPR was observed in 8 (29%) patients in either the primary tumor or lymph node metastasis. Rochester, Minn., Jacksonville, Fla. The Head and Neck Cancer Immune Landscape and Its Immunotherapeutic Implications. doi: 10.1056/NEJMoa0802656, 33. Nat Commun (2021) 12(1):3349. doi: 10.1038/s41467-021-23355-x, 56. Powles T, Park SH, Voog E, Caserta C, Valderrama BP, Gurney H, et al. Completed and ongoing trials have focused on a diverse group of HNSCC patients including early and advanced stage and HPV-positive and negative patients. 2017;15:57. 2016;387(10030):183746. Rituximab plus chlorambucil as first-line treatment for chronic lymphocytic leukemia: Final analysis of an open-label phase II study. Anyone you share the following link with will be able to read this content: Sorry, a shareable link is not currently available for this article. 1998;16:13107. He has participated in several investigator-driven trials in melanoma and sarcoma. doi: 10.1158/1078-0432.CCR-19-3977, 71. The FOCUS 4 trial in metastatic colorectal cancer uses group-sequential multi-arm, multi-stage methodology [46] to achieve similar matching of novel therapy and biomarker groups. National Cancer Center Hospital East, Japan, University General Hospital Attikon, Greece. He is also an active member of the EORTC Melanoma Group and the Global Melanoma Task Force. This was followed by BATTLE-2 [42], testing combination treatments in the same disease. Pignon J-P, et al. doi: 10.1200/JCO.2021.39.15_suppl.6053, 74. 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. Lancet Oncol. Fehrenbacher L, Spira A, Ballinger M, Kowanetz M, Vansteenkiste J, Mazieres J, Park K, Smith D, Artal-Cortes A, Lewanski C, Braiteh F, Waterkamp D, He P, Zou W, Chen DS, Yi J, Sandler A, Rittmeyer A, POPLAR Study Group. Article Phase III randomized trial of induction chemotherapy in patients with N2 or N3 locally advanced head and neck cancer. 2016;53:12534. Following this, the phase III KEYNOTE-048 trial established a new paradigm for first-line R/M HNSCC patients (14). Ruffin AT, Cillo AR, Tabib T, Liu A, Onkar S, Kunning SR, et al. JCI Insight (2016) 1(17):e89829. 2018. Nat Rev Clin Oncol. 2014;370(12):110110. Notably, grade 3/4 serious adverse events or delay of surgery didnt occur, underscoring the safety of neoadjuvant immunotherapy. The pTR rate is calculated as the area of regions 1-3/(1-3)+area of any remaining tumor. Laramore GE, Scott CB, al-Sarraf M, Haselow RE, Ervin TJ, Wheeler R, et al. RU: editing and supervising the manuscript, tables and figure. Postoperative Irradiation With or Without Concomitant Chemotherapy for Locally Advanced Head and Neck Cancer. Schoenfeld JD, Hanna GJ, Jo VY, Rawal B, Chen YH, Catalano PS, et al. safer and more-effective approaches to head and neck radiation therapy. 2016;34(Suppl; abstr 9504). Piotr Rutkowski. Wise-Draper TM, Takiar V, Mierzwa ML, Casper K, Palackdharry S, Worden FP, et al. Lancet. These results clearly demonstrate the superiority of dual HER2-directed therapy. Saad ED, Paoletti X, Burzykowski T, Buyse M. Precision medicine needs randomized clinical trials. HPV infection might also be a clinical biomarker to predict the response to CPIs. 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). J Clin Oncol (2019) 37(15_suppl):25755. 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. doi: 10.1007/BF01192200, 63. doi: 10.1016/S0140-6736(13)62422-8, 61. Considering the treatment nave situation and the absence of treatment-resistant cells compared with the R/M setting, neoadjuvant immunotherapy is hypothetically likely able to result in a strong and durable therapeutic effect. Landmark Trials in Selected Head and Neck Cancers. Table2 Ongoing neoadjuvant immunotherapy clinical trials. Cottrell TR, Thompson ED, Forde PM, Stein JE, Duffield AS, Anagnostou V, et al. Median PFS was 9.5months in the fulvestrant plus palbociclib group and 4.6months in the fulvestrant plus placebo group with a hazard ratio of 0.46, which was highly statistically significant. Pathological Response After Neoadjuvant Chemotherapy in Resectable Non-Small-Cell Lung Cancers: Proposal for the Use of Major Pathological Response as a Surrogate Endpoint. BMC Med. J Clin Oncol. 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. Immune Biomarkers of Response to Immune-Checkpoint Inhibitors in Head and Neck Squamous Cell Carcinoma. We defined pathological tumor response (pTR) as one such approach which is quantified as the proportion of the resection bed with tumor necrosis, keratinous debris, and giant cell/histiocytic reaction were distinct from growing tumor and only seen after therapy (Figure1). doi: 10.1126/science.aar3593, 52. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomized controlled trial. In the era of precision cancer medicine, innovative trial designs will also require the matching of novel drugs with putative targets. The premise of neoadjuvant immunotherapy is to use the existing tumor mass as an in-situ source of tumor-specific antigens to enhance systemic immunity via dendritic cell antigen presentation to rejuvenate T cells and priming especially for cytotoxic T cells (34). 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. 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. Uppaluri R, Chernock R, Mansour M, Jackson R, Rich J, Pipkorn P, et al. In fact, a study evaluating 20 resected non-small cell lung cancer (NSCLC) tumors after neoadjuvant anti-PD-1 treatment showed a discrepancy between radiological and pathological evaluation (58). It is meant to be an educational resource . N Engl J Med (2004) 350(19):193744. Provided by the Springer Nature SharedIt content-sharing initiative. Nature (2014) 515(7528):57781. Nivolumab Plus Ipilimumab in Lung Cancer With a High Tumor Mutational Burden. N Engl J Med (2018) 378(22):2093104. A new cancer treatment can wipe out tumours in terminally ill head and neck cancer patients, scientists have discovered. 2016;32(18):28668. High Tumor Mutation Burden Fails to Predict Immune Checkpoint Blockade Response Across All Cancer Types. B Cell Signatures and Tertiary Lymphoid Structures Contribute to Outcome in Head and Neck Squamous Cell Carcinoma. The studies listed below represent the first major clinical trials to evaluate risk reduction for people at high risk of breast, prostate, lung, colorectal, ovarian, cervical, and lung cancer. Privacy Ann Oncol (2014) 25(1):21625. Neoadjuvant and Adjuvant Pembrolizumab in Resectable Locally Advanced, Human Papillomavirus-Unrelated Head and Neck Cancer: A Multicenter, Phase II Trial. 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. Lancet (2014) 384(9938):16472. She has also received unrestricted educational grants to support investigator initiated clinical trials from Lilly, Roche and Sanofi Aventis, and has received free gemcitabine from Lilly and free bevacizumab from Roche for clinical trials. To test the sequencing of these therapies in the laryngeal cancer setting, RTOG 91-11 compared the clinical efficacy of 1) IC followed by RT, 2) CCRT and 3) RT alone for advanced laryngeal cancer patients (23). 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). There are several questions about how this approach would integrate with current SOC including whether this treatment intensification is necessary especially in good prognosis HPV+ disease and the role of nivolumab as SBRT alone conferred a high rate of pathologic responses. quantification of plasma epstein-barr virus DNA in patients with advanced nasopharyngeal carcinoma. The current mainstay of advanced head and neck squamous cell carcinoma (HNSCC) treatment remains surgery and radiotherapy with/without conventional chemotherapy. Neoadjuvant Immunoradiotherapy Results in High Rate of Complete Pathological Response and Clinical to Pathological Downstaging in Locally Advanced Head and Neck Squamous Cell Carcinoma. Enhanced Pathologic Tumor Response With Two Cycles of Neoadjuvant Pembrolizumab in Surgically Resectable, Locally Advanced HPV-Negative Head and Neck Squamous Cell Carcinoma (HNSCC). Adaptive randomization of veliparib-carboplatin treatment in breast cancer. 2011;1(1):4453. Leidner R, Crittenden M, Young K, Xiao H, Wu Y, Couey MA, et al. N Engl J Med. Alexandrov LB, Nik-Zainal S, Wedge DC, Aparicio SA, Behjati S, Biankin AV, et al. These designs would allow recruitment of biomarker-negative patients, often not included in other trials, and have the potential for perpetual designs, in which successful matching of novel drugs and biomarkers would result in graduation of the pair to a phase III trial, along with the rapid rejection of novel drugs that did not work. Liu J, Blake SJ, Yong MC, Harjunp H, Ngiow SF, Takeda K, et al. The study is aimed at establishing the purpose of tumour markers, their application, classification, diagnostic and therapeutic roles in the management of head and neck cancer. N Engl J Med. Front Oncol (2020) 10:566315. doi: 10.3389/fonc.2020.566315, 66. 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). To speed up the introduction of targeted therapy for cancer patients, novel phase II trials are being designed, and may likely form the basis for the landmark trials of the future. Curran MA, Montalvo W, Yagita H, Allison JP. Lancet Oncol (2010) 11(8):7819. The strength of the study also relies on the good tolerance profile of ibrutinib, which allows it to be administered continuously and provide indefinite disease suppression even in elderly or unfit CLL patients. doi: 10.1200/JCO.2003.06.146, 27. 2016;14:20. 2016;375(1):2334. Price KAR, Nichols AC, Shen CJ, Rammal A, Lang P, Palma DA, et al. Nature (2013) 502(7471):3339. Correspondence to Palbociclib in hormone-receptor-positive advanced breast cancer. Landmark results include those in triple negative breast cancer for the combination of velaparib and carboplatin [44] and neratinib in HER2-positive breast cancer [45]. J Clin Oncol (2003) 21(2):32733. J Clin Oncol. The expression level of PD-L1 in the tumor does not necessarily correlate withthe response to CPIs. A Study to Evaluate Fractionated Radiation Therapy Utilizing GRID Therapy for Locally-advanced Bulky Tumors. Cristescu R, Mogg R, Ayers M, Albright A, Murphy E, Yearley J, et al. Rugo HS, Olopade OI, DeMichele A, Yau C, van t Veer LJ, Buxton MB, Hogarth M, Hylton NM, Paoloni M, Perlmutter J, Symmans WF, Yee D, Chien AJ, Wallace AM, Kaplan HG, Boughey JC, Haddad TC, Albain KS, Liu MC, Isaacs C, Khan QJ, Lang JE, Viscusi RK, Pusztai L, Moulder SL, Chui SY, Kemmer KA, Elias AD, Edmiston KK, Euhus DM, Haley BB, Nanda R, Northfelt DW, Tripathy D, Wood WC, Ewing C, Schwab R, Lyandres J, Davis SE, Hirst GL, Sanil A, Berry DA, Esserman LJ, I-SPY 2 Investigators. Am Soc Clin Oncol Educ Book (2020) 40:113. The landmark oncology trials highlighted in the BMC Medicine series Spotlight on landmark oncology trials and this editorial are recent trials that have produced practice-changing results for patients. chemoradiotherapy versus radiotherapy in patients with advanced nasopharyngeal cancer: phase III randomized intergroup study 0099. Schoenfeld etal. Cite this article. 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. 2016;34(30):363847. 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.
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