{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,23]],"date-time":"2026-08-23T18:41:38Z","timestamp":1787510498500,"version":"build-2736575974"},"reference-count":30,"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>\n                    <jats:title>Purpose<\/jats:title>\n                    <jats:p>Oral mucositis (OM) is a debilitating toxicity of chemoradiotherapy for head and neck cancer (HNC). This randomized, placebo-controlled, double-blind study evaluated the efficacy and safety of palifermin to reduce OM associated with definitive chemoradiotherapy for locally advanced HNC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods<\/jats:title>\n                    <jats:p>\n                      Patients receiving conventionally fractionated radiotherapy (2.0 Gy\/d, 5 days\/wk to 70 Gy) with cisplatin (100 mg\/m\n                      <jats:sup>2<\/jats:sup>\n                      on days 1, 22, and 43) received palifermin (180 \u03bcg\/kg) or placebo before starting chemoradiotherapy and then once weekly for 7 weeks. The primary end point was the incidence of severe, observable, and functional OM (WHO grade 3 to 4).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The palifermin (n = 94) and placebo (n = 94) arms were well balanced. The incidence of severe OM was significantly lower for palifermin than for placebo (54% v 69%; P = .041). In the palifermin arm, median time to severe OM was delayed (47 v 35 days), median duration of severe OM was shortened (5 v 26 days), and the incidence of xerostomia grade \u2265 2 was lower (67% v 80%), favoring palifermin; however, the differences were not significant after multiplicity adjustment. Opioid analgesic use, average mouth and throat soreness scores, and chemoradiotherapy compliance were not significantly different between treatment arms. Adverse events were similar between arms (98%, palifermin; 93%, placebo). The most common study drug\u2013related adverse events were rash, flushing, and dysgeusia. After median follow-up of 25.8 months, overall survival and progression-free survival were similar between treatment arms.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Although palifermin reduced severe functional OM, its role in the management of locally advanced HNC during chemoradiotherapy remains to be elucidated.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1200\/jco.2010.32.4095","type":"journal-article","created":{"date-parts":[[2011,6,14]],"date-time":"2011-06-14T14:17:49Z","timestamp":1308061069000},"page":"2808-2814","source":"Crossref","is-referenced-by-count":158,"title":["Palifermin Reduces Severe Mucositis in Definitive Chemoradiotherapy of Locally Advanced Head and Neck Cancer: A Randomized, Placebo-Controlled Study"],"prefix":"10.1200","volume":"29","author":[{"given":"Quynh-Thu","family":"Le","sequence":"first","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harold E.","family":"Kim","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles J.","family":"Schneider","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gy\u00f6rgyi","family":"Murak\u00f6zy","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Krzysztof","family":"Skladowski","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sabine","family":"Reinisch","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuhchyau","family":"Chen","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Hickey","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"May","family":"Mo","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mon-Gy","family":"Chen","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dietmar","family":"Berger","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Lizambri","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Henke","sequence":"additional","affiliation":[{"name":"Quynh-Thu Le, Stanford University, Stanford; Michael Hickey, May Mo, Mon-Gy Chen, Dietmar Berger, and Richard Lizambri, Amgen, Thousand Oaks, CA; Harold E. Kim, Karmanos Cancer Center, Wayne State University Medical School, Detroit, MI; Charles J. Schneider, Helen F. Graham Cancer Center, Christiana Care Health Systems, Newark, DE; Gy\u00f6rgyi Murak\u00f6zy, Szt Imre Hospotal, Budapest, Hungary; Krzysztof Skladowski, Center of Oncology-Maria Sklodowska-Curie Memorial Institute, Gliwice, Poland; Sabine Reinisch,..."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(00)90011-4"},{"key":"B2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2004.09.034"},{"key":"B3","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2007.04.088"},{"key":"B4","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa031317"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa032641"},{"key":"B6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa032646"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1093\/oxfordjournals.jncimonographs.a003440"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijrobp.2007.01.053"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.1634\/theoncologist.2008-0024"},{"key":"B10","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.21622"},{"key":"B11","first-page":"13","volume":"5","author":"Murphy BA","year":"2007","journal-title":"J Support Oncol"},{"key":"B12","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.22484"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa040125"},{"key":"B14","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2005.02.8340"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2007.13.7349"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.1016\/j.clpt.2006.02.011"},{"key":"B17","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19810101)47:1<207::AID-CNCR2820470134>3.0.CO;2-6"},{"key":"B18","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.22620"},{"key":"B19","doi-asserted-by":"publisher","DOI":"10.2307\/1402373"},{"key":"B20","volume-title":"Nonparametrics: Statistical Methods Based on Ranks","author":"Lehman EL","year":"1975"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.1093\/biomet\/75.4.800"},{"key":"B22","volume-title":"The statistical analysis of failure time data","author":"Kalbfleisch JD","year":"1980"},{"key":"B23","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2010.32.4103"},{"key":"B24","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bmt.1705846"},{"key":"B25","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.27.4498"},{"key":"B26","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-153-6-201009210-00003"},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.2009.27.4449"},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa071028"},{"key":"B29","doi-asserted-by":"publisher","DOI":"10.1158\/1541-7786.MCR-07-2131"},{"key":"B30","doi-asserted-by":"publisher","DOI":"10.1007\/s00411-010-0271-7"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.2010.32.4095","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T18:51:07Z","timestamp":1653504667000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2010.32.4095"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,7,10]]},"references-count":30,"journal-issue":{"issue":"20","published-print":{"date-parts":[[2011,7,10]]}},"alternative-id":["10.1200\/JCO.2010.32.4095"],"URL":"https:\/\/doi.org\/10.1200\/jco.2010.32.4095","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]]}}}