Postoperative Chemoradiotherapy and Cetuximab for High-Risk Squamous Cell Carcinoma of the Head and Neck: Radiation Therapy Oncology Group RTOG-0234
Identifieur interne : 002677 ( Main/Exploration ); précédent : 002676; suivant : 002678Postoperative Chemoradiotherapy and Cetuximab for High-Risk Squamous Cell Carcinoma of the Head and Neck: Radiation Therapy Oncology Group RTOG-0234
Auteurs : Paul M. Harari ; Jonathan Harris ; Merrill S. Kies ; Jeffrey N. Myers ; Richard C. Jordan ; Maura L. Gillison ; Robert L. Foote ; Mitchell Machtay ; Marvin Rotman ; Deepak Khuntia ; William Straube ; Qiang Zhang ; Kian AngSource :
- Journal of Clinical Oncology [ 0732-183X ] ; 2014.
Abstract
To report results of a randomized phase II trial (Radiation Therapy Oncology Group RTOG-0234) examining concurrent chemoradiotherapy and cetuximab in the postoperative treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) with high-risk pathologic features.
Eligibility required pathologic stage III to IV SCCHN with gross total resection showing positive margins and/or extracapsular nodal extension and/or two or more nodal metastases. Patients were randomly assigned to 60 Gy radiation with cetuximab once per week plus either cisplatin 30 mg/m2 or docetaxel 15 mg/m2 once per week.
Between April 2004 and December 2006, 238 patients were enrolled. With a median follow-up of 4.4 years, 2-year overall survival (OS) was 69% for the cisplatin arm and 79% for the docetaxel arm; 2-year disease-free survival (DFS) was 57% and 66%, respectively. Patients with p16-positive oropharynx tumors showed markedly improved survival outcome relative to patients with p16-negative oropharynx tumors. Grade 3 to 4 myelosuppression was observed in 28% of patients in the cisplatin arm and 14% in the docetaxel arm; mucositis was observed in 56% and 54%, respectively. DFS in this study was compared with that in the chemoradiotherapy arm of the RTOG-9501 trial (Phase III Intergroup Trial of Surgery Followed by Radiotherapy Versus Radiochemotherapy for Resectable High Risk Squamous Cell Carcinoma of the Head and Neck), which had a hazard ratio of 0.76 for the cisplatin arm versus control (
The delivery of postoperative chemoradiotherapy and cetuximab to patients with SCCHN is feasible and tolerated with predictable toxicity. The docetaxel regimen shows favorable outcome with improved DFS and OS relative to historical controls and has commenced formal testing in a phase II/III trial.
Url:
DOI: 10.1200/JCO.2013.53.9163
PubMed: 25002723
PubMed Central: 4121506
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Postoperative Chemoradiotherapy and Cetuximab for High-Risk Squamous Cell Carcinoma of the Head and Neck: Radiation Therapy Oncology Group RTOG-0234</title><author><name sortKey="Harari, Paul M" sort="Harari, Paul M" uniqKey="Harari P" first="Paul M." last="Harari">Paul M. Harari</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Harris, Jonathan" sort="Harris, Jonathan" uniqKey="Harris J" first="Jonathan" last="Harris">Jonathan Harris</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Kies, Merrill S" sort="Kies, Merrill S" uniqKey="Kies M" first="Merrill S." last="Kies">Merrill S. Kies</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Myers, Jeffrey N" sort="Myers, Jeffrey N" uniqKey="Myers J" first="Jeffrey N." last="Myers">Jeffrey N. Myers</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Jordan, Richard C" sort="Jordan, Richard C" uniqKey="Jordan R" first="Richard C." last="Jordan">Richard C. Jordan</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Gillison, Maura L" sort="Gillison, Maura L" uniqKey="Gillison M" first="Maura L." last="Gillison">Maura L. Gillison</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Foote, Robert L" sort="Foote, Robert L" uniqKey="Foote R" first="Robert L." last="Foote">Robert L. Foote</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Machtay, Mitchell" sort="Machtay, Mitchell" uniqKey="Machtay M" first="Mitchell" last="Machtay">Mitchell Machtay</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Rotman, Marvin" sort="Rotman, Marvin" uniqKey="Rotman M" first="Marvin" last="Rotman">Marvin Rotman</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Khuntia, Deepak" sort="Khuntia, Deepak" uniqKey="Khuntia D" first="Deepak" last="Khuntia">Deepak Khuntia</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Straube, William" sort="Straube, William" uniqKey="Straube W" first="William" last="Straube">William Straube</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Zhang, Qiang" sort="Zhang, Qiang" uniqKey="Zhang Q" first="Qiang" last="Zhang">Qiang Zhang</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Ang, Kian" sort="Ang, Kian" uniqKey="Ang K" first="Kian" last="Ang">Kian Ang</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">25002723</idno><idno type="pmc">4121506</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4121506</idno><idno type="RBID">PMC:4121506</idno><idno type="doi">10.1200/JCO.2013.53.9163</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">002F47</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">002F47</idno><idno type="wicri:Area/Pmc/Curation">002F46</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">002F46</idno><idno type="wicri:Area/Pmc/Checkpoint">001886</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">001886</idno><idno type="wicri:Area/Ncbi/Merge">006825</idno><idno type="wicri:Area/Ncbi/Curation">006825</idno><idno type="wicri:Area/Ncbi/Checkpoint">006825</idno><idno type="wicri:doubleKey">0732-183X:2014:Harari P:postoperative:chemoradiotherapy:and</idno><idno type="wicri:Area/Main/Merge">002681</idno><idno type="wicri:Area/Main/Curation">002677</idno><idno type="wicri:Area/Main/Exploration">002677</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Postoperative Chemoradiotherapy and Cetuximab for High-Risk Squamous Cell Carcinoma of the Head and Neck: Radiation Therapy Oncology Group RTOG-0234</title><author><name sortKey="Harari, Paul M" sort="Harari, Paul M" uniqKey="Harari P" first="Paul M." last="Harari">Paul M. Harari</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Harris, Jonathan" sort="Harris, Jonathan" uniqKey="Harris J" first="Jonathan" last="Harris">Jonathan Harris</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Kies, Merrill S" sort="Kies, Merrill S" uniqKey="Kies M" first="Merrill S." last="Kies">Merrill S. Kies</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Myers, Jeffrey N" sort="Myers, Jeffrey N" uniqKey="Myers J" first="Jeffrey N." last="Myers">Jeffrey N. Myers</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Jordan, Richard C" sort="Jordan, Richard C" uniqKey="Jordan R" first="Richard C." last="Jordan">Richard C. Jordan</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Gillison, Maura L" sort="Gillison, Maura L" uniqKey="Gillison M" first="Maura L." last="Gillison">Maura L. Gillison</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Foote, Robert L" sort="Foote, Robert L" uniqKey="Foote R" first="Robert L." last="Foote">Robert L. Foote</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Machtay, Mitchell" sort="Machtay, Mitchell" uniqKey="Machtay M" first="Mitchell" last="Machtay">Mitchell Machtay</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Rotman, Marvin" sort="Rotman, Marvin" uniqKey="Rotman M" first="Marvin" last="Rotman">Marvin Rotman</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Khuntia, Deepak" sort="Khuntia, Deepak" uniqKey="Khuntia D" first="Deepak" last="Khuntia">Deepak Khuntia</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Straube, William" sort="Straube, William" uniqKey="Straube W" first="William" last="Straube">William Straube</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Zhang, Qiang" sort="Zhang, Qiang" uniqKey="Zhang Q" first="Qiang" last="Zhang">Qiang Zhang</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author><author><name sortKey="Ang, Kian" sort="Ang, Kian" uniqKey="Ang K" first="Kian" last="Ang">Kian Ang</name><affiliation><nlm:aff id="aff1">Paul M. Harari, University of Wisconsin Hospital, Madison, WI; Jonathan Harris and Qiang Zhang, Radiation Therapy Oncology Group Statistical Center, Philadelphia, PA; Merrill S. Kies, Jeffrey N. Myers, and Kian Ang, MD Anderson Cancer Center, Houston, TX; Richard C. Jordan, University of California San Francisco, San Francisco; Deepak Khuntia, Varian Medical Systems, Palo Alto, CA; Maura L. Gillison, The Ohio State University, Columbus; Mitchell Machtay, Case Western Reserve University, Cleveland, OH; Robert L. Foote, Mayo Clinic, Rochester, MN; Marvin Rotman, State University of New York Downstate Medical Center, Brooklyn, NY; and William Straube, Washington University, St. Louis, MO.</nlm:aff><wicri:noCountry code="subfield">MO.</wicri:noCountry></affiliation></author></analytic><series><title level="j">Journal of Clinical Oncology</title><idno type="ISSN">0732-183X</idno><idno type="eISSN">1527-7755</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Purpose</title><p>To report results of a randomized phase II trial (Radiation Therapy Oncology Group RTOG-0234) examining concurrent chemoradiotherapy and cetuximab in the postoperative treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) with high-risk pathologic features.</p></sec><sec><title>Patients and Methods</title><p>Eligibility required pathologic stage III to IV SCCHN with gross total resection showing positive margins and/or extracapsular nodal extension and/or two or more nodal metastases. Patients were randomly assigned to 60 Gy radiation with cetuximab once per week plus either cisplatin 30 mg/m<sup>2</sup> or docetaxel 15 mg/m<sup>2</sup> once per week.</p></sec><sec><title>Results</title><p>Between April 2004 and December 2006, 238 patients were enrolled. With a median follow-up of 4.4 years, 2-year overall survival (OS) was 69% for the cisplatin arm and 79% for the docetaxel arm; 2-year disease-free survival (DFS) was 57% and 66%, respectively. Patients with p16-positive oropharynx tumors showed markedly improved survival outcome relative to patients with p16-negative oropharynx tumors. Grade 3 to 4 myelosuppression was observed in 28% of patients in the cisplatin arm and 14% in the docetaxel arm; mucositis was observed in 56% and 54%, respectively. DFS in this study was compared with that in the chemoradiotherapy arm of the RTOG-9501 trial (Phase III Intergroup Trial of Surgery Followed by Radiotherapy Versus Radiochemotherapy for Resectable High Risk Squamous Cell Carcinoma of the Head and Neck), which had a hazard ratio of 0.76 for the cisplatin arm versus control (<italic>P</italic> = .05) and 0.69 for the docetaxel arm versus control (<italic>P</italic> = .01), reflecting absolute improvement in 2-year DFS of 2.5% and 11.1%, respectively.</p></sec><sec><title>Conclusion</title><p>The delivery of postoperative chemoradiotherapy and cetuximab to patients with SCCHN is feasible and tolerated with predictable toxicity. The docetaxel regimen shows favorable outcome with improved DFS and OS relative to historical controls and has commenced formal testing in a phase II/III trial.</p></sec></div></front></TEI><affiliations><list></list><tree><noCountry><name sortKey="Ang, Kian" sort="Ang, Kian" uniqKey="Ang K" first="Kian" last="Ang">Kian Ang</name><name sortKey="Foote, Robert L" sort="Foote, Robert L" uniqKey="Foote R" first="Robert L." last="Foote">Robert L. Foote</name><name sortKey="Gillison, Maura L" sort="Gillison, Maura L" uniqKey="Gillison M" first="Maura L." last="Gillison">Maura L. Gillison</name><name sortKey="Harari, Paul M" sort="Harari, Paul M" uniqKey="Harari P" first="Paul M." last="Harari">Paul M. Harari</name><name sortKey="Harris, Jonathan" sort="Harris, Jonathan" uniqKey="Harris J" first="Jonathan" last="Harris">Jonathan Harris</name><name sortKey="Jordan, Richard C" sort="Jordan, Richard C" uniqKey="Jordan R" first="Richard C." last="Jordan">Richard C. Jordan</name><name sortKey="Khuntia, Deepak" sort="Khuntia, Deepak" uniqKey="Khuntia D" first="Deepak" last="Khuntia">Deepak Khuntia</name><name sortKey="Kies, Merrill S" sort="Kies, Merrill S" uniqKey="Kies M" first="Merrill S." last="Kies">Merrill S. Kies</name><name sortKey="Machtay, Mitchell" sort="Machtay, Mitchell" uniqKey="Machtay M" first="Mitchell" last="Machtay">Mitchell Machtay</name><name sortKey="Myers, Jeffrey N" sort="Myers, Jeffrey N" uniqKey="Myers J" first="Jeffrey N." last="Myers">Jeffrey N. Myers</name><name sortKey="Rotman, Marvin" sort="Rotman, Marvin" uniqKey="Rotman M" first="Marvin" last="Rotman">Marvin Rotman</name><name sortKey="Straube, William" sort="Straube, William" uniqKey="Straube W" first="William" last="Straube">William Straube</name><name sortKey="Zhang, Qiang" sort="Zhang, Qiang" uniqKey="Zhang Q" first="Qiang" last="Zhang">Qiang Zhang</name></noCountry></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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