Randomized trial of postoperative reirradiation combined with chemotherapy after salvage surgery compared with salvage surgery alone in head and neck carcinoma.

Details

Serval ID
serval:BIB_7B0F38DD4120
Type
Article: article from journal or magazin.
Collection
Publications
Title
Randomized trial of postoperative reirradiation combined with chemotherapy after salvage surgery compared with salvage surgery alone in head and neck carcinoma.
Journal
Journal of Clinical Oncology
Author(s)
Janot F., de Raucourt D., Benhamou E., Ferron C., Dolivet G., Bensadoun R.J., Hamoir M., Géry B., Julieron M., Castaing M., Bardet E., Grégoire V., Bourhis J.
ISSN
1527-7755 (Electronic)
ISSN-L
0732-183X
Publication state
Published
Issued date
2008
Peer-reviewed
Oui
Volume
26
Number
34
Pages
5518-5523
Language
english
Notes
Publication types: Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't Publication Status: ppublish
Abstract
PURPOSE: Full-dose reirradiation combined with chemotherapy has been shown to be feasible after salvage surgery with acceptable toxicity. The Groupe d'Etude des Tumeurs de la Tête et du Cou and Groupe d'Oncologie Radiothérapie Tête Et Cou groups performed a randomized study to assess its efficacy.
PATIENTS AND METHODS: Between 1999 and 2005, 130 patients with head and neck cancer were treated with salvage surgery and randomly assigned to full-dose reirradiation combined with chemotherapy (RT arm) or to observation (a "wait and see" approach; WS arm). Eligibility criteria were recurrence or a second primary tumor in a previously irradiated area, no major sequelae resulting from the first radiotherapy, good general condition, no distant metastasis, and salvage surgery with macroscopic complete resection. Patients in the RT arm received 60 Gy over 11 weeks combined with concomitant fluorouracil and hydroxyurea.
RESULTS: Sixty-five patients were randomly assigned to each arm. There was no imbalance in the distribution of the main tumor and patients characteristics. The most serious acute toxicity in the RT arm was mucositis, attaining grade 3 or 4 in 28% of patients. At 2 years, 39% of patients in the RT arm and 10% in the WS arm experienced grade 3 or 4 late toxicity according to Radiation Therapy Oncology Group criteria (P = .06). Disease-free survival (DFS) was significantly improved in the RT arm, with a hazard ratio of 1.68 (95% CI, 1.13 to 2.50; P = .01), but overall survival (OS) was not statistically different.
CONCLUSION: Full-dose reirradiation combined with chemotherapy after salvage surgery significantly improved DFS, but had no significant impact on OS. An increase in both acute and late toxicity was observed.
Keywords
Antineoplastic Agents/therapeutic use, Carcinoma, Squamous Cell/drug therapy, Carcinoma, Squamous Cell/radiotherapy, Combined Modality Therapy, Disease Progression, Female, Fluorouracil/pharmacology, Head and Neck Neoplasms/drug therapy, Head and Neck Neoplasms/radiotherapy, Humans, Hydroxyurea/pharmacology, Male, Neoplasm Metastasis, Postoperative Period, Recurrence, Salvage Therapy, Treatment Outcome
Pubmed
Web of science
Create date
01/12/2014 17:24
Last modification date
20/08/2019 14:37
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