Randomized Trial of Radiation Therapy Versus Concomitant Chemotherapy and RadiationTherapy for Advanced-Stage Oropharynx Carcinoma
Identifieur interne : 001A86 ( Main/Exploration ); précédent : 001A85; suivant : 001A87Randomized Trial of Radiation Therapy Versus Concomitant Chemotherapy and RadiationTherapy for Advanced-Stage Oropharynx Carcinoma
Auteurs : Gilles Calais ; Marc Alfonsi ; Etienne Bardet ; Christian Sire ; Thierry Germain ; Philippe Bergerot ; Be Atrix Rhein ; Jacques Tortochaux ; Patrick Oudinot ; Philippe Bertrand [France]Source :
- Journal of the National Cancer Institute [ 0027-8874 ] ; 1999-12-15.
Abstract
BACKGROUND: We designed a randomized clinical trial to test whether the addition of three cycles of chemotherapy during standard radiation therapy would improve disease-free survival in patients with stages III and IV (i.e., advanced oropharynx carcinoma). METHODS: A total of 226 patients have been entered in a phase III multicenter, randomized trial comparing radiotherapy alone (arm A) with radiotherapy with concomitant chemotherapy (arm B). Radiotherapy was identical in the two arms, delivering, with conventional fractionation, 70 Gy in 35 fractions. In arm B, patients received during the period of radiotherapy three cycles of a 4-day regimen containing carboplatin (70 mg/m2 per day) and 5-fluorouracil (600 mg/m2 per day) by continuous infusion. The two arms were equally balanced with regard to age, sex, stage, performance status, histology, and primary tumor site. RESULTS: Radiotherapy compliance was similar in the two arms with respect to total dose, treatment duration, and treatment interruption. The rate of grades 3 and 4 mucositis was statistically significantly higher in arm B (71%; 95% confidence interval [CI] = 54%-85%) than in arm A (39%; 95% CI = 29%-56%). Skin toxicity was not different between the two arms. Hematologic toxicity was higher in arm B as measured by neutrophil count and hemoglobin level. Three-year overall actuarial survival and disease-free survival rates were, respectively, 51% (95% CI = 39%-68%) versus 31% (95% CI = 18%-49%) and 42% (95% CI = 30%-57%) versus 20% (95% CI = 10%-33%) for patients treated with combined modality versus radiation therapy alone (P = .02 and .04, respectively). The locoregional control rate was improved in arm B (66%; 95% CI = 51%-78%) versus arm A (42%; 95% CI = 31%-56%). CONCLUSION: The statistically significant improvement in overall survival that was obtained supports the use of concomitant chemotherapy as an adjunct to radiotherapy in the management of carcinoma of the oropharynx.
Url:
DOI: 10.1093/jnci/91.24.2081
Affiliations:
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<record><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Randomized Trial of Radiation Therapy Versus Concomitant Chemotherapy and RadiationTherapy for Advanced-Stage Oropharynx Carcinoma</title><author><name sortKey="Calais, Gilles" sort="Calais, Gilles" uniqKey="Calais G" first="Gilles" last="Calais">Gilles Calais</name></author><author><name sortKey="Alfonsi, Marc" sort="Alfonsi, Marc" uniqKey="Alfonsi M" first="Marc" last="Alfonsi">Marc Alfonsi</name></author><author><name sortKey="Bardet, Etienne" sort="Bardet, Etienne" uniqKey="Bardet E" first="Etienne" last="Bardet">Etienne Bardet</name></author><author><name sortKey="Sire, Christian" sort="Sire, Christian" uniqKey="Sire C" first="Christian" last="Sire">Christian Sire</name></author><author><name sortKey="Germain, Thierry" sort="Germain, Thierry" uniqKey="Germain T" first="Thierry" last="Germain">Thierry Germain</name></author><author><name sortKey="Bergerot, Philippe" sort="Bergerot, Philippe" uniqKey="Bergerot P" first="Philippe" last="Bergerot">Philippe Bergerot</name></author><author><name sortKey="Rhein, Be Atrix" sort="Rhein, Be Atrix" uniqKey="Rhein B" first="Be Atrix" last="Rhein">Be Atrix Rhein</name></author><author><name sortKey="Tortochaux, Jacques" sort="Tortochaux, Jacques" uniqKey="Tortochaux J" first="Jacques" last="Tortochaux">Jacques Tortochaux</name></author><author><name sortKey="Oudinot, Patrick" sort="Oudinot, Patrick" uniqKey="Oudinot P" first="Patrick" last="Oudinot">Patrick Oudinot</name></author><author><name sortKey="Bertrand, Philippe" sort="Bertrand, Philippe" uniqKey="Bertrand P" first="Philippe" last="Bertrand">Philippe Bertrand</name></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:BE1221179EF9EA9EBCFE221B01353BEA247E783C</idno><date when="1999" year="1999">1999</date><idno type="doi">10.1093/jnci/91.24.2081</idno><idno type="url">https://api.istex.fr/document/BE1221179EF9EA9EBCFE221B01353BEA247E783C/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000E91</idno><idno type="wicri:Area/Istex/Curation">000E91</idno><idno type="wicri:Area/Istex/Checkpoint">000A95</idno><idno type="wicri:doubleKey">0027-8874:1999:Calais G:randomized:trial:of</idno><idno type="wicri:Area/Main/Merge">001B35</idno><idno type="wicri:Area/Main/Curation">001A86</idno><idno type="wicri:Area/Main/Exploration">001A86</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Randomized Trial of Radiation Therapy Versus Concomitant Chemotherapy and RadiationTherapy for Advanced-Stage Oropharynx Carcinoma</title><author><name sortKey="Calais, Gilles" sort="Calais, Gilles" uniqKey="Calais G" first="Gilles" last="Calais">Gilles Calais</name></author><author><name sortKey="Alfonsi, Marc" sort="Alfonsi, Marc" uniqKey="Alfonsi M" first="Marc" last="Alfonsi">Marc Alfonsi</name></author><author><name sortKey="Bardet, Etienne" sort="Bardet, Etienne" uniqKey="Bardet E" first="Etienne" last="Bardet">Etienne Bardet</name></author><author><name sortKey="Sire, Christian" sort="Sire, Christian" uniqKey="Sire C" first="Christian" last="Sire">Christian Sire</name></author><author><name sortKey="Germain, Thierry" sort="Germain, Thierry" uniqKey="Germain T" first="Thierry" last="Germain">Thierry Germain</name></author><author><name sortKey="Bergerot, Philippe" sort="Bergerot, Philippe" uniqKey="Bergerot P" first="Philippe" last="Bergerot">Philippe Bergerot</name></author><author><name sortKey="Rhein, Be Atrix" sort="Rhein, Be Atrix" uniqKey="Rhein B" first="Be Atrix" last="Rhein">Be Atrix Rhein</name></author><author><name sortKey="Tortochaux, Jacques" sort="Tortochaux, Jacques" uniqKey="Tortochaux J" first="Jacques" last="Tortochaux">Jacques Tortochaux</name></author><author><name sortKey="Oudinot, Patrick" sort="Oudinot, Patrick" uniqKey="Oudinot P" first="Patrick" last="Oudinot">Patrick Oudinot</name></author><author><name sortKey="Bertrand, Philippe" sort="Bertrand, Philippe" uniqKey="Bertrand P" first="Philippe" last="Bertrand">Philippe Bertrand</name><affiliation wicri:level="1"><country xml:lang="fr" wicri:curation="lc">France</country><wicri:regionArea>Affiliations of authors: G. Calais, Centre HospitalierUniversitaire Tours, France; M. Alfonsi, Clinique Sainte CatherineAvignon, France; E. Bardet, Centre René Gauducheau, Nantes,France; C. Sire, Centre Hospitalier, Lorient, France; T. Germain,Centre Hospitalier Universitaire, Poitiers, France; P. Bergerot, CentreEtienne Dolet, Saint Nazaire, France; B. Rhein, Centre HospitalierUniversitaire, Limoges, France; J. Tortochaux, Centre Jean Perrin, Clermont-Ferrand, France; P. Oudinot, Centre Guillaume LeConquérant, Le Havre, France; P. Bertrand, Département deBiostatistiques, Université de Tours, France.Other authors included the following: P. Maillard (Centre PaulPapin, Angers, France); A. Favre (Centre Hospitalier Régional,Orléans, France); P. Desprez (Centre Saint Yves, Vannes, France);J. M. Ardiet (Centre Hospitalier Universitaire, Lyon Sud, France); S.Chaib-Rassou (Centre Hospitalier, Metz, France); C. Alavena (Centre C.de Sienne, Nantes, France); A. Delpon (Centre J Bernard, Le Mans,France); P. Gesta (Centre Hospitalier, Niort, France); J. J. Auregan(Centre G de Varye, Saint Doulchard, France); P. E. Cailleux (CliniqueFleming, Tours, France); Y. Raoul (Centre de Radiothérapie, SaintGregoire</wicri:regionArea><wicri:noRegion>SaintGregoire</wicri:noRegion><wicri:noRegion>SaintGregoire</wicri:noRegion></affiliation></author></analytic><monogr></monogr><series><title level="j">Journal of the National Cancer Institute</title><title level="j" type="abbrev">JNCI J Natl Cancer Inst</title><idno type="ISSN">0027-8874</idno><idno type="eISSN">1460-2105</idno><imprint><publisher>Oxford University Press</publisher><date type="published" when="1999-12-15">1999-12-15</date><biblScope unit="volume">91</biblScope><biblScope unit="issue">24</biblScope><biblScope unit="page" from="2081">2081</biblScope><biblScope unit="page" to="2086">2086</biblScope></imprint><idno type="ISSN">0027-8874</idno></series><idno type="istex">BE1221179EF9EA9EBCFE221B01353BEA247E783C</idno><idno type="DOI">10.1093/jnci/91.24.2081</idno><idno type="PII">1460-2105</idno><idno type="local">2081.sgm</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0027-8874</idno></seriesStmt></fileDesc><profileDesc><textClass></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">BACKGROUND: We designed a randomized clinical trial to test whether the addition of three cycles of chemotherapy during standard radiation therapy would improve disease-free survival in patients with stages III and IV (i.e., advanced oropharynx carcinoma). METHODS: A total of 226 patients have been entered in a phase III multicenter, randomized trial comparing radiotherapy alone (arm A) with radiotherapy with concomitant chemotherapy (arm B). Radiotherapy was identical in the two arms, delivering, with conventional fractionation, 70 Gy in 35 fractions. In arm B, patients received during the period of radiotherapy three cycles of a 4-day regimen containing carboplatin (70 mg/m2 per day) and 5-fluorouracil (600 mg/m2 per day) by continuous infusion. The two arms were equally balanced with regard to age, sex, stage, performance status, histology, and primary tumor site. RESULTS: Radiotherapy compliance was similar in the two arms with respect to total dose, treatment duration, and treatment interruption. The rate of grades 3 and 4 mucositis was statistically significantly higher in arm B (71%; 95% confidence interval [CI] = 54%-85%) than in arm A (39%; 95% CI = 29%-56%). Skin toxicity was not different between the two arms. Hematologic toxicity was higher in arm B as measured by neutrophil count and hemoglobin level. Three-year overall actuarial survival and disease-free survival rates were, respectively, 51% (95% CI = 39%-68%) versus 31% (95% CI = 18%-49%) and 42% (95% CI = 30%-57%) versus 20% (95% CI = 10%-33%) for patients treated with combined modality versus radiation therapy alone (P = .02 and .04, respectively). The locoregional control rate was improved in arm B (66%; 95% CI = 51%-78%) versus arm A (42%; 95% CI = 31%-56%). CONCLUSION: The statistically significant improvement in overall survival that was obtained supports the use of concomitant chemotherapy as an adjunct to radiotherapy in the management of carcinoma of the oropharynx.</div></front></TEI><affiliations><list><country><li>France</li></country></list><tree><noCountry><name sortKey="Alfonsi, Marc" sort="Alfonsi, Marc" uniqKey="Alfonsi M" first="Marc" last="Alfonsi">Marc Alfonsi</name><name sortKey="Bardet, Etienne" sort="Bardet, Etienne" uniqKey="Bardet E" first="Etienne" last="Bardet">Etienne Bardet</name><name sortKey="Bergerot, Philippe" sort="Bergerot, Philippe" uniqKey="Bergerot P" first="Philippe" last="Bergerot">Philippe Bergerot</name><name sortKey="Calais, Gilles" sort="Calais, Gilles" uniqKey="Calais G" first="Gilles" last="Calais">Gilles Calais</name><name sortKey="Germain, Thierry" sort="Germain, Thierry" uniqKey="Germain T" first="Thierry" last="Germain">Thierry Germain</name><name sortKey="Oudinot, Patrick" sort="Oudinot, Patrick" uniqKey="Oudinot P" first="Patrick" last="Oudinot">Patrick Oudinot</name><name sortKey="Rhein, Be Atrix" sort="Rhein, Be Atrix" uniqKey="Rhein B" first="Be Atrix" last="Rhein">Be Atrix Rhein</name><name sortKey="Sire, Christian" sort="Sire, Christian" uniqKey="Sire C" first="Christian" last="Sire">Christian Sire</name><name sortKey="Tortochaux, Jacques" sort="Tortochaux, Jacques" uniqKey="Tortochaux J" first="Jacques" last="Tortochaux">Jacques Tortochaux</name></noCountry><country name="France"><noRegion><name sortKey="Bertrand, Philippe" sort="Bertrand, Philippe" uniqKey="Bertrand P" first="Philippe" last="Bertrand">Philippe Bertrand</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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