1. 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.
- Author
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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, and Bourhis J
- Subjects
- Carcinoma, Squamous Cell mortality, Cause of Death, Chemoradiotherapy, Female, Head and Neck Neoplasms mortality, Humans, Male, Middle Aged, Squamous Cell Carcinoma of Head and Neck, Carcinoma, Squamous Cell therapy, Head and Neck Neoplasms therapy, Methotrexate therapeutic use, Neoplasm Recurrence, Local therapy, Neoplasms, Second Primary therapy, Palliative Care
- Abstract
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., (Copyright © 2011. Published by Elsevier Ireland Ltd.)
- Published
- 2011
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