Randomized phase III trial (GORTEC 98-03) comparing re-irradiation plus chemotherapy versus methotrexate in patients with recurrent or a second primary head and neck squamous cell carcinoma, treated with a palliative intent.

Détails

ID Serval
serval:BIB_6084BE15DE85
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
Randomized phase III trial (GORTEC 98-03) comparing re-irradiation plus chemotherapy versus methotrexate in patients with recurrent or a second primary head and neck squamous cell carcinoma, treated with a palliative intent.
Périodique
Radiotherapy and Oncology
Auteur⸱e⸱s
Tortochaux J., Tao Y., Tournay E., Lapeyre M., Lesaunier F., Bardet E., Janot F., Lusinchi A., Benhamou E., Bontemps P., Maingon P., Calais G., Daly-Schveitzer N., Verrelle P., Bourhis J.
ISSN
1879-0887 (Electronic)
ISSN-L
0167-8140
Statut éditorial
Publié
Date de publication
2011
Peer-reviewed
Oui
Volume
100
Numéro
1
Pages
70-75
Langue
anglais
Notes
Publication types: Clinical Trial, Phase III ; Comparative Study ; Journal Article ; Randomized Controlled TrialPublication Status: ppublish
Résumé
PURPOSE: This randomized phase III trial investigated the potential benefit of concurrent re-irradiation, fluorouracil and hydroxyurea versus methotrexate for patients treated with palliative intent for recurrent or second primary head and neck squamous cell carcinoma (HNSCC) in previously irradiated area.
PATIENTS AND METHODS: Patients with recurrent HNSCC or a second primary not amenable to curative-intent treatment were randomized to the R-RT arm (concurrent re-irradiation, fluorouracil and hydroxyurea) or to the Ch-T arm (methotrexate). The primary endpoint was overall survival (OS). Due to a very slow accrual, the trial was closed after inclusion of 57 patients.
RESULTS: Fifty-seven patients were included. All patients died in the two arms with a maximal follow-up of 5years. Although four complete responses were achieved in R-RT arm, (none in Ch-T arm) re-irradiation did not improve OS compared with methotrexate (23% versus 22% at 1year, NS). Sixteen patients experienced clinical grade ⩾3 late toxicities (>6months), 11 in R-RT arm and five in Ch-T arm.
CONCLUSIONS: Premature discontinuation of the trial did not allow us to draw firm conclusions. However, there was no suggestion that concurrent re-irradiation, fluorouracil and hydroxyurea improved OS compared to methotrexate alone in patients treated with palliative intent for a recurrent or second primary HNSCC.
Mots-clé
Carcinoma, Squamous Cell/mortality, Carcinoma, Squamous Cell/therapy, Cause of Death, Chemoradiotherapy, Female, Head and Neck Neoplasms/mortality, Head and Neck Neoplasms/therapy, Humans, Male, Methotrexate/therapeutic use, Middle Aged, Neoplasm Recurrence, Local/therapy, Neoplasms, Second Primary/therapy, Palliative Care
Pubmed
Web of science
Création de la notice
01/12/2014 17:02
Dernière modification de la notice
20/08/2019 14:17
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