Tirapazamine, Cisplatin, and Radiation Versus Cisplatin and Radiation for Advanced Squamous Cell Carcinoma of the Head and Neck (TROG 02.02, HeadSTART): A Phase III Trial of the Trans-Tasman Radiation Oncology Group
Identifieur interne : 007440 ( Main/Exploration ); précédent : 007439; suivant : 007441Tirapazamine, Cisplatin, and Radiation Versus Cisplatin and Radiation for Advanced Squamous Cell Carcinoma of the Head and Neck (TROG 02.02, HeadSTART): A Phase III Trial of the Trans-Tasman Radiation Oncology Group
Auteurs : Danny Rischin [Australie, Canada, Espagne, Suisse, France, Allemagne, États-Unis] ; Lester Peters ; Brian O'Sullivan ; Jordi Giralt ; Richard Fisher ; Kally Yuen ; Andy Trotti ; Jacques Bernier ; Jean Bourhis ; Jolie Ringash ; Michael Henke ; Lizbeth KennySource :
- Journal of clinical oncology [ 0732-183X ] ; 2010.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
Purpose Promising results in a randomized phase II trial with the hypoxic cytotoxin tirapazamine (TPZ) combined with cisplatin (CIS) and radiation led to this phase III trial. Patients and Methods Patients with previously untreated stage III or IV (excluding T1-2N1 and M1) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx were randomly assigned to receive definitive radiotherapy (70 Gy in 7 weeks) concurrently with either CIS (100 mg/m2) on day 1 of weeks 1, 4, and 7 or CIS (75 mg/m2) plus TPZ (290 mg/m2/d) on day 1 of weeks 1, 4, and 7 and TPZ alone (160 mg/m2/d) on days 1, 3, and 5 of weeks 2 and 3 (TPZ/CIS). The primary end point was overall survival (OS). The planned sample size was 850, estimated to result in 334 deaths, which would provide 90% power to detect a difference in 2-year survival rates of 60% v 70% for CIS versus TPZ/CIS, respectively (hazard ratio = 0.69). Results Eight hundred sixty-one patients were accrued from 89 sites in 16 countries. In an intent-to-treat analysis, the 2-year OS rates were 65.7% for CIS and 66.2% for TPZ/CIS (TPZ/CIS - CIS: 95% CI, -5.9% to 6.9%). There were no significant differences in failure-free survival, time to locoregional failure, or quality of life as measured by Functional Assessment of Cancer Therapy- Head and Neck. Conclusions We found no evidence that the addition of TPZ to chemoradiotherapy, in patients with advanced head and neck cancer not selected for the presence of hypoxia, improves OS.
Affiliations:
- Allemagne, Australie, Canada, Espagne, France, Suisse, États-Unis
- Bade-Wurtemberg, Catalogne, District de Fribourg-en-Brisgau, Ontario, Victoria (État)
- Barcelone, Fribourg-en-Brisgau, Melbourne, Toronto
- Université de Melbourne, Université de Toronto
Links toward previous steps (curation, corpus...)
- to stream PascalFrancis, to step Corpus: 002582
- to stream PascalFrancis, to step Curation: 003A04
- to stream PascalFrancis, to step Checkpoint: 001F14
- to stream Main, to step Merge: 007982
- to stream Main, to step Curation: 007440
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Tirapazamine, Cisplatin, and Radiation Versus Cisplatin and Radiation for Advanced Squamous Cell Carcinoma of the Head and Neck (TROG 02.02, HeadSTART): A Phase III Trial of the Trans-Tasman Radiation Oncology Group</title><author><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Department of Medical Oncology, Department of Radiation Oncology, and Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre; University of Melbourne</s1><s2>Melbourne, Victoria</s2><s3>AUS</s3></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Radiation Oncology, ORI-Royal Brisbane Hospital</s1><s2>Brisbane, Queensland</s2><s3>AUS</s3></inist:fA14><country>Australie</country><wicri:noRegion>Brisbane, Queensland</wicri:noRegion></affiliation><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Department of Radiation Oncology, Princess Margaret Hospital and the University of Toronto</s1><s2>Toronto, Ontario</s2><s3>CAN</s3></inist:fA14><country>Canada</country><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName><orgName type="university">Université de Toronto</orgName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Radiation Oncology, Vall d'Hebron University Hospital</s1><s2>Barcelona</s2><s3>ESP</s3></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Genolier Swiss Medical Network Department of Radiation Oncology</s1><s2>Geneva</s2><s3>CHE</s3></inist:fA14><country>Suisse</country><wicri:noRegion>Genolier Swiss Medical Network Department of Radiation Oncology</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Radiation Oncology, Institut Gustave Roussy</s1><s2>Villejuif</s2><s3>FRA</s3></inist:fA14><country>France</country><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Institut Gustave Roussy</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>University Hospital of Freiberg</s1><s2>Freiburg</s2><s3>DEU</s3></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Fribourg-en-Brisgau</region><settlement type="city">Fribourg-en-Brisgau</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Department of Radiation Oncology, H. Lee Moffitt Cancer Center</s1><s2>Tampa, FL</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>Tampa, FL</wicri:noRegion></affiliation></author><author><name sortKey="Peters, Lester" sort="Peters, Lester" uniqKey="Peters L" first="Lester" last="Peters">Lester Peters</name></author><author><name sortKey="O Sullivan, Brian" sort="O Sullivan, Brian" uniqKey="O Sullivan B" first="Brian" last="O'Sullivan">Brian O'Sullivan</name></author><author><name sortKey="Giralt, Jordi" sort="Giralt, Jordi" uniqKey="Giralt J" first="Jordi" last="Giralt">Jordi Giralt</name></author><author><name sortKey="Fisher, Richard" sort="Fisher, Richard" uniqKey="Fisher R" first="Richard" last="Fisher">Richard Fisher</name></author><author><name sortKey="Yuen, Kally" sort="Yuen, Kally" uniqKey="Yuen K" first="Kally" last="Yuen">Kally Yuen</name></author><author><name sortKey="Trotti, Andy" sort="Trotti, Andy" uniqKey="Trotti A" first="Andy" last="Trotti">Andy Trotti</name></author><author><name sortKey="Bernier, Jacques" sort="Bernier, Jacques" uniqKey="Bernier J" first="Jacques" last="Bernier">Jacques Bernier</name></author><author><name sortKey="Bourhis, Jean" sort="Bourhis, Jean" uniqKey="Bourhis J" first="Jean" last="Bourhis">Jean Bourhis</name></author><author><name sortKey="Ringash, Jolie" sort="Ringash, Jolie" uniqKey="Ringash J" first="Jolie" last="Ringash">Jolie Ringash</name></author><author><name sortKey="Henke, Michael" sort="Henke, Michael" uniqKey="Henke M" first="Michael" last="Henke">Michael Henke</name></author><author><name sortKey="Kenny, Lizbeth" sort="Kenny, Lizbeth" uniqKey="Kenny L" first="Lizbeth" last="Kenny">Lizbeth Kenny</name></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">10-0316164</idno><date when="2010">2010</date><idno type="stanalyst">PASCAL 10-0316164 INIST</idno><idno type="RBID">Pascal:10-0316164</idno><idno type="wicri:Area/PascalFrancis/Corpus">002582</idno><idno type="wicri:Area/PascalFrancis/Curation">003A04</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">001F14</idno><idno type="wicri:explorRef" wicri:stream="PascalFrancis" wicri:step="Checkpoint">001F14</idno><idno type="wicri:doubleKey">0732-183X:2010:Rischin D:tirapazamine:cisplatin:and</idno><idno type="wicri:Area/Main/Merge">007982</idno><idno type="wicri:Area/Main/Curation">007440</idno><idno type="wicri:Area/Main/Exploration">007440</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Tirapazamine, Cisplatin, and Radiation Versus Cisplatin and Radiation for Advanced Squamous Cell Carcinoma of the Head and Neck (TROG 02.02, HeadSTART): A Phase III Trial of the Trans-Tasman Radiation Oncology Group</title><author><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name><affiliation wicri:level="4"><inist:fA14 i1="01"><s1>Department of Medical Oncology, Department of Radiation Oncology, and Centre for Biostatistics and Clinical Trials, Peter MacCallum Cancer Centre; University of Melbourne</s1><s2>Melbourne, Victoria</s2><s3>AUS</s3></inist:fA14><country>Australie</country><placeName><settlement type="city">Melbourne</settlement><region type="état">Victoria (État)</region></placeName><orgName type="university">Université de Melbourne</orgName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Department of Radiation Oncology, ORI-Royal Brisbane Hospital</s1><s2>Brisbane, Queensland</s2><s3>AUS</s3></inist:fA14><country>Australie</country><wicri:noRegion>Brisbane, Queensland</wicri:noRegion></affiliation><affiliation wicri:level="4"><inist:fA14 i1="03"><s1>Department of Radiation Oncology, Princess Margaret Hospital and the University of Toronto</s1><s2>Toronto, Ontario</s2><s3>CAN</s3></inist:fA14><country>Canada</country><placeName><settlement type="city">Toronto</settlement><region type="state">Ontario</region></placeName><orgName type="university">Université de Toronto</orgName></affiliation><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Radiation Oncology, Vall d'Hebron University Hospital</s1><s2>Barcelona</s2><s3>ESP</s3></inist:fA14><country>Espagne</country><placeName><settlement type="city">Barcelone</settlement><region nuts="2" type="region">Catalogne</region></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Genolier Swiss Medical Network Department of Radiation Oncology</s1><s2>Geneva</s2><s3>CHE</s3></inist:fA14><country>Suisse</country><wicri:noRegion>Genolier Swiss Medical Network Department of Radiation Oncology</wicri:noRegion></affiliation><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Radiation Oncology, Institut Gustave Roussy</s1><s2>Villejuif</s2><s3>FRA</s3></inist:fA14><country>France</country><wicri:noRegion>Villejuif</wicri:noRegion><wicri:noRegion>Institut Gustave Roussy</wicri:noRegion><wicri:noRegion>Villejuif</wicri:noRegion></affiliation><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>University Hospital of Freiberg</s1><s2>Freiburg</s2><s3>DEU</s3></inist:fA14><country>Allemagne</country><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Fribourg-en-Brisgau</region><settlement type="city">Fribourg-en-Brisgau</settlement></placeName></affiliation><affiliation wicri:level="1"><inist:fA14 i1="08"><s1>Department of Radiation Oncology, H. Lee Moffitt Cancer Center</s1><s2>Tampa, FL</s2><s3>USA</s3></inist:fA14><country>États-Unis</country><wicri:noRegion>Tampa, FL</wicri:noRegion></affiliation></author><author><name sortKey="Peters, Lester" sort="Peters, Lester" uniqKey="Peters L" first="Lester" last="Peters">Lester Peters</name></author><author><name sortKey="O Sullivan, Brian" sort="O Sullivan, Brian" uniqKey="O Sullivan B" first="Brian" last="O'Sullivan">Brian O'Sullivan</name></author><author><name sortKey="Giralt, Jordi" sort="Giralt, Jordi" uniqKey="Giralt J" first="Jordi" last="Giralt">Jordi Giralt</name></author><author><name sortKey="Fisher, Richard" sort="Fisher, Richard" uniqKey="Fisher R" first="Richard" last="Fisher">Richard Fisher</name></author><author><name sortKey="Yuen, Kally" sort="Yuen, Kally" uniqKey="Yuen K" first="Kally" last="Yuen">Kally Yuen</name></author><author><name sortKey="Trotti, Andy" sort="Trotti, Andy" uniqKey="Trotti A" first="Andy" last="Trotti">Andy Trotti</name></author><author><name sortKey="Bernier, Jacques" sort="Bernier, Jacques" uniqKey="Bernier J" first="Jacques" last="Bernier">Jacques Bernier</name></author><author><name sortKey="Bourhis, Jean" sort="Bourhis, Jean" uniqKey="Bourhis J" first="Jean" last="Bourhis">Jean Bourhis</name></author><author><name sortKey="Ringash, Jolie" sort="Ringash, Jolie" uniqKey="Ringash J" first="Jolie" last="Ringash">Jolie Ringash</name></author><author><name sortKey="Henke, Michael" sort="Henke, Michael" uniqKey="Henke M" first="Michael" last="Henke">Michael Henke</name></author><author><name sortKey="Kenny, Lizbeth" sort="Kenny, Lizbeth" uniqKey="Kenny L" first="Lizbeth" last="Kenny">Lizbeth Kenny</name></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Antineoplastic agent</term><term>Cancerology</term><term>Chemotherapy</term><term>Cisplatin</term><term>Comparative study</term><term>Head and neck cancer</term><term>Head and neck squamous cell carcinoma</term><term>Malignant tumor</term><term>Phase III trial</term><term>Tirapazamine</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Tirapazamine</term><term>Etude comparative</term><term>Stade avancé</term><term>Cisplatine</term><term>Chimiothérapie</term><term>Cancérologie</term><term>Carcinome épidermoïde de la tête et du cou</term><term>Tumeur maligne</term><term>Cancer de la tête et du cou</term><term>Essai clinique phase III</term><term>Anticancéreux</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose Promising results in a randomized phase II trial with the hypoxic cytotoxin tirapazamine (TPZ) combined with cisplatin (CIS) and radiation led to this phase III trial. Patients and Methods Patients with previously untreated stage III or IV (excluding T1-2N1 and M1) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx were randomly assigned to receive definitive radiotherapy (70 Gy in 7 weeks) concurrently with either CIS (100 mg/m<sup>2</sup>) on day 1 of weeks 1, 4, and 7 or CIS (75 mg/m<sup>2</sup>) plus TPZ (290 mg/m<sup>2</sup>/d) on day 1 of weeks 1, 4, and 7 and TPZ alone (160 mg/m<sup>2</sup>/d) on days 1, 3, and 5 of weeks 2 and 3 (TPZ/CIS). The primary end point was overall survival (OS). The planned sample size was 850, estimated to result in 334 deaths, which would provide 90% power to detect a difference in 2-year survival rates of 60% v 70% for CIS versus TPZ/CIS, respectively (hazard ratio = 0.69). Results Eight hundred sixty-one patients were accrued from 89 sites in 16 countries. In an intent-to-treat analysis, the 2-year OS rates were 65.7% for CIS and 66.2% for TPZ/CIS (TPZ/CIS - CIS: 95% CI, -5.9% to 6.9%). There were no significant differences in failure-free survival, time to locoregional failure, or quality of life as measured by Functional Assessment of Cancer Therapy- Head and Neck. Conclusions We found no evidence that the addition of TPZ to chemoradiotherapy, in patients with advanced head and neck cancer not selected for the presence of hypoxia, improves OS.</div></front></TEI><affiliations><list><country><li>Allemagne</li><li>Australie</li><li>Canada</li><li>Espagne</li><li>France</li><li>Suisse</li><li>États-Unis</li></country><region><li>Bade-Wurtemberg</li><li>Catalogne</li><li>District de Fribourg-en-Brisgau</li><li>Ontario</li><li>Victoria (État)</li></region><settlement><li>Barcelone</li><li>Fribourg-en-Brisgau</li><li>Melbourne</li><li>Toronto</li></settlement><orgName><li>Université de Melbourne</li><li>Université de Toronto</li></orgName></list><tree><noCountry><name sortKey="Bernier, Jacques" sort="Bernier, Jacques" uniqKey="Bernier J" first="Jacques" last="Bernier">Jacques Bernier</name><name sortKey="Bourhis, Jean" sort="Bourhis, Jean" uniqKey="Bourhis J" first="Jean" last="Bourhis">Jean Bourhis</name><name sortKey="Fisher, Richard" sort="Fisher, Richard" uniqKey="Fisher R" first="Richard" last="Fisher">Richard Fisher</name><name sortKey="Giralt, Jordi" sort="Giralt, Jordi" uniqKey="Giralt J" first="Jordi" last="Giralt">Jordi Giralt</name><name sortKey="Henke, Michael" sort="Henke, Michael" uniqKey="Henke M" first="Michael" last="Henke">Michael Henke</name><name sortKey="Kenny, Lizbeth" sort="Kenny, Lizbeth" uniqKey="Kenny L" first="Lizbeth" last="Kenny">Lizbeth Kenny</name><name sortKey="O Sullivan, Brian" sort="O Sullivan, Brian" uniqKey="O Sullivan B" first="Brian" last="O'Sullivan">Brian O'Sullivan</name><name sortKey="Peters, Lester" sort="Peters, Lester" uniqKey="Peters L" first="Lester" last="Peters">Lester Peters</name><name sortKey="Ringash, Jolie" sort="Ringash, Jolie" uniqKey="Ringash J" first="Jolie" last="Ringash">Jolie Ringash</name><name sortKey="Trotti, Andy" sort="Trotti, Andy" uniqKey="Trotti A" first="Andy" last="Trotti">Andy Trotti</name><name sortKey="Yuen, Kally" sort="Yuen, Kally" uniqKey="Yuen K" first="Kally" last="Yuen">Kally Yuen</name></noCountry><country name="Australie"><region name="Victoria (État)"><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name></region><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name></country><country name="Canada"><region name="Ontario"><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name></region></country><country name="Espagne"><region name="Catalogne"><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name></region></country><country name="Suisse"><noRegion><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name></noRegion></country><country name="France"><noRegion><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name></noRegion></country><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name></region></country><country name="États-Unis"><noRegion><name sortKey="Rischin, Danny" sort="Rischin, Danny" uniqKey="Rischin D" first="Danny" last="Rischin">Danny Rischin</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Asie/explor/AustralieFrV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 007440 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 007440 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Asie
|area= AustralieFrV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= Pascal:10-0316164
|texte= Tirapazamine, Cisplatin, and Radiation Versus Cisplatin and Radiation for Advanced Squamous Cell Carcinoma of the Head and Neck (TROG 02.02, HeadSTART): A Phase III Trial of the Trans-Tasman Radiation Oncology Group
}}
| This area was generated with Dilib version V0.6.33. |  |