https://m2.mtmt.hu/ hun 2026-09-22 16:51 JournalArticle 31966288 ADMIN_APPROVED true Funding Agency and Grant Number: PfizerPfizer; MerckMerck & Company Funding text: This trial was sponsored by Pfizer as part of an alliance between Pfizer and Merck. Medical writing assistance was provided by Eleanor Green at ClinicalThinking, funded by Pfizer and Merck. We thank the patients and their families and the investigators, co-investigators, and study teams at each of the participating centres. 0 false 2026-07-16T13:06:06.355+0000 2022-02-08T10:00:07.094+0000 2021-04-15T12:47:19.178+0000 true 10062250 Molnár-Taga Márta /api/admin/10062250 Admin true 10062250 2022-02-08T09:58:13.849+0000 2022-02-08T09:58:13.849+0000 2022-02-08T10:00:07.102+0000 true 10070075 Nádas Orsolya /api/admin/10070075 Admin true true false true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle true 10000059 Article true 24 24 /api/publicationtype/24 PublicationType 1 true 24 JournalArticle /api/subtype/10000059 Szakcikk SubType 101 true 10000059 true 1 /api/category/1 Category true 1 Lee, N.Y. Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial true true /api/journal/10001287 REVIEWED true false 10001287 false 10001287 true 1470-2045 1474-5488 Journal FOREIGN 22 4 450 462 450 13 2021 Background: Chemoradiotherapy is the standard of care for unresected locally advanced squamous cell carcinoma of the head and neck. We aimed to assess if addition of avelumab (anti-PD-L1) to chemoradiotherapy could improve treatment outcomes for this patient population. Methods: In this randomised, double-blind, placebo-controlled, phase 3 study, patients were recruited from 196 hospitals and cancer treatment centres in 22 countries. Patients aged 18 years or older, with histologically confirmed, previously untreated, locally advanced squamous cell carcinoma of the oropharynx, hypopharynx, larynx, or oral cavity (unselected for PD-L1 status), an Eastern Cooperative Oncology Group performance status score of 0 or 1, and who could receive chemoradiotherapy were eligible. Patients were randomly assigned (1:1) centrally by means of stratified block randomisation with block size four (stratified by human papillomavirus status, tumour stage, and nodal stage, and done by an interactive response technology system) to receive 10 mg/kg avelumab intravenously every 2 weeks plus chemoradiotherapy (100 mg/m2 cisplatin every 3 weeks plus intensity-modulated radiotherapy with standard fractionation of 70 Gy [35 fractions during 7 weeks]; avelumab group) or placebo plus chemoradiotherapy (placebo group). This was preceded by a single 10 mg/kg avelumab or placebo lead-in dose given 7 days previously and followed by 10 mg/kg avelumab or placebo every 2 weeks maintenance therapy for up to 12 months. The primary endpoint was progression-free survival by investigator assessment per modified Response Evaluation Criteria in Solid Tumors, version 1.1, in all randomly assigned patients. Adverse events were assessed in patients who received at least one dose of avelumab or placebo. This trial is registered with ClinicalTrials.gov, NCT02952586. Enrolment is no longer ongoing, and the trial has been discontinued. Findings: Between Dec 12, 2016, and Jan 29, 2019, from 907 patients screened, 697 patients were randomly assigned to the avelumab group (n=350) or the placebo group (n=347). Median follow-up for progression-free survival was 14·6 months (IQR 8·5–19·6) in the avelumab group and 14·8 months (11·6–18·8) in the placebo group. Median progression-free survival was not reached (95% CI 16·9 months–not estimable) in the avelumab group and not reached (23·0 months–not estimable) in the placebo group (stratified hazard ratio 1·21 [95% CI 0·93–1·57] favouring the placebo group; one-sided p=0·92). The most common grade 3 or worse treatment-related adverse events were neutropenia (57 [16%] of 348 patients in the avelumab group vs 52 [15%] of 344 patients in the placebo group), mucosal inflammation (50 [14%] vs 45 [13%]), dysphagia (49 [14%] vs 47 [14%]), and anaemia (41 [12%] vs 44 [13%]). Serious treatment-related adverse events occurred in 124 (36%) patients in the avelumab group and in 109 (32%) patients in the placebo group. Treatment-related deaths occurred in two (1%) patients in the avelumab group (due to general disorders and site conditions, and vascular rupture) and one (<1%) in the placebo group (due to acute respiratory failure). Interpretation: The primary objective of prolonging progression-free survival with avelumab plus chemoradiotherapy followed by avelumab maintenance in patients with locally advanced squamous cell carcinoma of the head and neck was not met. These findings may help inform the design of future trials investigating the combination of immune checkpoint inhibitors plus CRT. 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style="float: left" src="/frontend/resources/grid/publication-core-icon.png"> <img title="Idézőközlemény" style="float: left" src="/frontend/resources/grid/publication-citation-icon.png"> <div class="autype autype0"> <span class="author-name" >Lee N.Y. ✉ </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Ferris R.L.<sup>*</sup> </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Psyrri A. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Haddad R.I. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Tahara M. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Bourhis J. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Harrington K. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Chang P.M.-H. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Lin J.-C. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Razaq M.A. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Teixeira M.M. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" mtid="10026872"><a href="/gui2/?type=authors&mode=browse&sel=10026872" target="_blank">Lövey J. (<span class="authorship-author-name">Lövey József</span> <span class="authorAux-mtmt"> Sugárterápia, onkológia</span>) </a> </span> <span class="author-affil">Országos Onkológiai Intézet; <span title="Semmelweis Egyetem">SE</span>/<span title="Általános Orvostudományi Kar">AOK</span>/<span title="Klinikum">K</span>/Onkológiai Tanszék</span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Chamois J. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Rueda A. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Hu C. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Dunn L.A. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Dvorkin M.V. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >De Beukelaer S. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Pavlov D. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Thurm H. </span> ;&nbsp;&nbsp;&nbsp; <span class="author-name" >Cohen E. </span> </div> </div> <div class="title"><a href="/gui2/?mode=browse&params=publication;31966288" target="_blank">Avelumab plus standard-of-care chemoradiotherapy versus chemoradiotherapy alone in patients with locally advanced squamous cell carcinoma of the head and neck: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial</a></div> <div> <span class="journal-title">LANCET ONCOLOGY</span> <span class="journal-issn">(<a target="_blank" href="https://portal.issn.org/resource/ISSN/1470-2045">1470-2045</a> <a target="_blank" href="https://portal.issn.org/resource/ISSN/1474-5488">1474-5488</a>)</span>: <span class="journal-volume">22</span> <span class="journal-issue">4</span> <span class="page"> pp 450-462 </span> <span class="year">(2021)</span> </div> <div class="pub-footer"> <span class="language" xmlns="http://www.w3.org/1999/html">Nyelv: Angol | </span> <span class="identifiers"> <span class="id identifier oa_PAY" title=" Fizetős "> <a style="color:blue" title="10.1016/S1470-2045(20)30737-3" target="_blank" href="https://doi.org/10.1016/S1470-2045%2820%2930737-3"> DOI </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="000637971400022" target="_blank" href="https://www.webofscience.com/wos/woscc/full-record/000637971400022"> WoS </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="85103408951" target="_blank" href="http://www.scopus.com/record/display.url?origin=inward&eid=2-s2.0-85103408951"> Scopus </a> </span> <span class="id identifier oa_none" title="none"> <a style="color:blue" title="33794205" target="_blank" href="http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=33794205&dopt=Abstract"> PubMed </a> </span> </span> <OnlyViewableByAuthor><div class="ratings"> <div class="journal-subject">Folyóirat szakterülete: Scopus - Oncology&nbsp;&nbsp;&nbsp;SJR indikátor:&nbsp;D1</div> </div></OnlyViewableByAuthor> <div class="publication-citation" style="margin-left: 0.5cm;"> <span title="Nyilvános idézőközlemények összesen, említések nélkül" class="citingPub-count">Nyilvános idéző összesen: 559</span> | Független: 510 | Függő: 49 | Nem jelölt: 0 | WoS jelölt: 532 | Scopus jelölt:&nbsp;375 | WoS/Scopus jelölt:&nbsp;559 | DOI jelölt:&nbsp;552 </div> <div class="publication-citation"> <a target="_blank" href="/api/publication?cond=citations.related;eq;31966288&sort=publishedYear,desc&sort=title"> Idézett közlemények száma: 2 </a> </div> <div class="mtid"><span class="long-pub-mtid">Közlemény: 31966288</span> | <span class="status-data status-ADMIN_APPROVED"> Admin láttamozott </span> Forrás Idéző | <span class="type-subtype">Folyóiratcikk ( Szakcikk ) </span> | <span class="pub-category">Tudományos</span> | <span class="publication-sourceOfData">Scopus</span> </div> <div class="lastModified">Utolsó módosítás: 2022.02.08. 11:00 Nádas Orsolya (OOI admin4) </div> <pre class="comment" style="margin-top: 0; margin-bottom: 0;"><u>Megjegyzés</u>: Funding Agency and Grant Number: PfizerPfizer; MerckMerck & Company Funding text: This trial was sponsored by Pfizer as part of an alliance between Pfizer and Merck. Medical writing assistance was provided by Eleanor Green at ClinicalThinking, funded by Pfizer and Merck. We thank the patients and their families and the investigators, co-investigators, and study teams at each of the ...</pre> </div></div>