{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,26]],"date-time":"2026-06-26T15:38:25Z","timestamp":1782488305793,"version":"3.54.5"},"reference-count":29,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"20","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2011,7,10]]},"abstract":"<jats:sec><jats:title>Purpose<\/jats:title><jats:p> Radiochemotherapy of head and neck cancer causes severe mucositis in most patients. We investigated whether palifermin reduces this debilitating sequela. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p> We conducted a multicenter, double-blind, randomized, placebo-controlled trial in 186 patients with stages II to IVB carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx. Patients received 60 or 66 Gy after complete (R0) or incomplete resection (R1), respectively, at 2 Gy\/fraction and five fractions per week. Cisplatin 100 mg\/m<jats:sup>2<\/jats:sup> was administered on days 1 and 22 (and on day 43 with R1). Patients were randomly assigned to receive weekly palifermin 120 \u03bcg\/kg or placebo from 3 days before and continuing throughout radiochemotherapy. Trained evaluators performed oral assessments twice weekly. The primary end point was the incidence of severe oral mucositis (WHO grades 3 to 4). Overall survival and time to locoregional progression were also assessed. Analysis was by intention to treat. <\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p> Severe oral mucositis was seen in 47 (51%) of 92 patients administered palifermin and 63 (67%) of 94 administered placebo (P = .027). Palifermin decreased the duration (median, 4.5 v 22.0 days) and prolonged the time to develop (median, 45 v 32 days) severe mucositis. Neither patient-reported mouth and throat soreness scores nor treatment breaks differed between treatment arms. After median follow-up of 32.8 months, 23 deaths (25%) had occurred in both treatment arms, and disease had recurred in 25 (27%) and 22 (24%) of palifermin- and placebo-treated patients, respectively. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p> Palifermin reduced the occurrence of severe oral mucositis in patients with head and neck cancer undergoing postoperative radiochemotherapy. Additional clinical exploration of palifermin with postoperative radiochemotherapy would be useful. <\/jats:p><\/jats:sec>","DOI":"10.1200\/jco.2010.32.4103","type":"journal-article","created":{"date-parts":[[2011,6,14]],"date-time":"2011-06-14T18:17:49Z","timestamp":1308075469000},"page":"2815-2820","source":"Crossref","is-referenced-by-count":145,"title":["Palifermin Decreases Severe Oral Mucositis of Patients Undergoing Postoperative Radiochemotherapy for Head and Neck Cancer: A Randomized, Placebo-Controlled Trial"],"prefix":"10.1200","volume":"29","author":[{"given":"Michael","family":"Henke","sequence":"first","affiliation":[{"name":"From the University Clinic Freiburg, Germany; Institut Sainte Catherine Service de Radioth\u00e9rapie, Avignon; and Centre R\u00e8gional de Lutte Contre le Cancer Nantes-Atlantiques, Nantes, France; San Paolo Hospital and University of Milan, Milan, Italy; Vall d'Hebron University Hospital, Barcelona; and Hospital Universitario de la Princesa, Madrid, Spain; Ear, Nose, and Throat University Hospital Graz, Medical University Graz, Austria; Amgen, Thousand Oaks, CA; and Amgen, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marc","family":"Alfonsi","sequence":"additional","affiliation":[{"name":"From the University Clinic Freiburg, Germany; Institut Sainte Catherine Service de Radioth\u00e9rapie, Avignon; and Centre R\u00e8gional de Lutte Contre le Cancer Nantes-Atlantiques, Nantes, France; San Paolo Hospital and University of Milan, Milan, Italy; Vall d'Hebron University Hospital, Barcelona; and Hospital Universitario de la Princesa, Madrid, Spain; Ear, Nose, and Throat University Hospital Graz, Medical University Graz, Austria; Amgen, Thousand Oaks, CA; and Amgen, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paolo","family":"Foa","sequence":"additional","affiliation":[{"name":"From the University Clinic Freiburg, Germany; Institut Sainte Catherine Service de Radioth\u00e9rapie, Avignon; and Centre R\u00e8gional de Lutte Contre le Cancer Nantes-Atlantiques, Nantes, France; San Paolo Hospital and University of Milan, Milan, Italy; Vall d'Hebron University Hospital, Barcelona; and Hospital Universitario de la Princesa, Madrid, Spain; Ear, Nose, and Throat University Hospital Graz, Medical University Graz, Austria; Amgen, Thousand Oaks, CA; and Amgen, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jordi","family":"Giralt","sequence":"additional","affiliation":[{"name":"From the University Clinic Freiburg, Germany; Institut Sainte Catherine Service de Radioth\u00e9rapie, Avignon; and Centre R\u00e8gional de Lutte Contre le Cancer Nantes-Atlantiques, Nantes, France; San Paolo Hospital and University of Milan, Milan, Italy; Vall d'Hebron University Hospital, Barcelona; and Hospital Universitario de la Princesa, Madrid, Spain; Ear, Nose, and Throat University Hospital Graz, Medical University Graz, Austria; Amgen, Thousand Oaks, CA; and Amgen, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Etienne","family":"Bardet","sequence":"additional","affiliation":[{"name":"From the University Clinic Freiburg, Germany; Institut Sainte Catherine Service de Radioth\u00e9rapie, Avignon; and Centre R\u00e8gional de Lutte Contre le Cancer Nantes-Atlantiques, Nantes, France; San Paolo Hospital and University of Milan, Milan, Italy; Vall d'Hebron University Hospital, Barcelona; and Hospital Universitario de la Princesa, Madrid, Spain; Ear, Nose, and Throat University Hospital Graz, Medical University Graz, Austria; Amgen, Thousand Oaks, CA; and Amgen, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laura","family":"Cerezo","sequence":"additional","affiliation":[{"name":"From the University Clinic Freiburg, Germany; Institut Sainte Catherine Service de Radioth\u00e9rapie, Avignon; and Centre R\u00e8gional de Lutte Contre le Cancer Nantes-Atlantiques, Nantes, France; San Paolo Hospital and University of Milan, Milan, Italy; Vall d'Hebron University Hospital, Barcelona; and Hospital Universitario de la Princesa, Madrid, Spain; Ear, Nose, and Throat University Hospital Graz, Medical University Graz, Austria; Amgen, Thousand Oaks, CA; and Amgen, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michaela","family":"Salzwimmer","sequence":"additional","affiliation":[{"name":"From the University Clinic Freiburg, Germany; Institut Sainte Catherine Service de Radioth\u00e9rapie, Avignon; and Centre R\u00e8gional de Lutte Contre le Cancer Nantes-Atlantiques, Nantes, France; San Paolo Hospital and University of Milan, Milan, Italy; Vall d'Hebron University Hospital, Barcelona; and Hospital Universitario de la Princesa, Madrid, Spain; Ear, Nose, and Throat University Hospital Graz, Medical University Graz, Austria; Amgen, Thousand Oaks, CA; and Amgen, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Lizambri","sequence":"additional","affiliation":[{"name":"From the University Clinic Freiburg, Germany; Institut Sainte Catherine Service de Radioth\u00e9rapie, Avignon; and Centre R\u00e8gional de Lutte Contre le Cancer Nantes-Atlantiques, Nantes, France; San Paolo Hospital and University of Milan, Milan, Italy; Vall d'Hebron University Hospital, Barcelona; and Hospital Universitario de la Princesa, Madrid, Spain; Ear, Nose, and Throat University Hospital Graz, Medical University Graz, Austria; Amgen, Thousand Oaks, CA; and Amgen, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lara","family":"Emmerson","sequence":"additional","affiliation":[{"name":"From the University Clinic Freiburg, Germany; Institut Sainte Catherine Service de Radioth\u00e9rapie, Avignon; and Centre R\u00e8gional de Lutte Contre le Cancer Nantes-Atlantiques, Nantes, France; San Paolo Hospital and University of Milan, Milan, Italy; Vall d'Hebron University Hospital, Barcelona; and Hospital Universitario de la Princesa, Madrid, Spain; Ear, Nose, and Throat University Hospital Graz, Medical University Graz, Austria; 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San Paolo Hospital and University of Milan, Milan, Italy; Vall d'Hebron University Hospital, Barcelona; and Hospital Universitario de la Princesa, Madrid, Spain; Ear, Nose, and Throat University Hospital Graz, Medical University Graz, Austria; Amgen, Thousand Oaks, CA; and Amgen, Cambridge, United Kingdom."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"B1","unstructured":"Head and Neck Cancers NCCN Clinical Practice Guidelines in Ocology Version 2.2008. http:\/\/www.nccn.org"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa032641"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa032646"},{"key":"B4","first-page":"23","volume":"5","author":"Rosenthal DI","year":"2007","journal-title":"J Support Oncol"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.20162"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.11671"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.21622"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.22484"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.1093\/annonc\/mdp165"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejca.2007.09.014"},{"key":"B11","doi-asserted-by":"publisher","DOI":"10.1073\/pnas.86.3.802"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1016\/S0065-230X(04)91003-2"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa040125"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.13.7349"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(03)14567-9"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.22620"},{"key":"B17","first-page":"719","volume":"22","author":"Mantel N","year":"1959","journal-title":"J Natl Cancer Inst"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.2307\/3001616"},{"key":"B19","first-page":"351","volume":"37","author":"van Elteren PH","year":"1960","journal-title":"Bulletin Intl Stat Inst"},{"key":"B20","first-page":"351","volume":"18","author":"Lachenbruch PA","year":"1976","journal-title":"Biometr Z"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/75.4.800"},{"key":"B22","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1958.10501452"},{"key":"B23","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.32.4095"},{"key":"B24","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.04.1152"},{"key":"B25","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.02.8340"},{"key":"B26","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2000.18.19.3339"},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1016\/j.radonc.2004.12.006"},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2004.05.050"},{"key":"B29","doi-asserted-by":"publisher","DOI":"10.1186\/1748-717X-5-37"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.2010.32.4103","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T22:51:13Z","timestamp":1653519073000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2010.32.4103"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,7,10]]},"references-count":29,"journal-issue":{"issue":"20","published-print":{"date-parts":[[2011,7,10]]}},"alternative-id":["10.1200\/JCO.2010.32.4103"],"URL":"https:\/\/doi.org\/10.1200\/jco.2010.32.4103","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,7,10]]}}}