Phase I trial of oral etoposide in combination with radiotherapy in head and neck squamous cell carcinoma - GORTEC 2004-02.

Details

Serval ID
serval:BIB_7D7AAEA5DD02
Type
Article: article from journal or magazin.
Collection
Publications
Title
Phase I trial of oral etoposide in combination with radiotherapy in head and neck squamous cell carcinoma - GORTEC 2004-02.
Journal
Radiation Oncology
Author(s)
Tao Y., Bardet E., Rosine D., Rolland F., Bompas E., Daly-Schveitzer N., Lusinchi A., Bourhis J.
ISSN
1748-717X (Electronic)
ISSN-L
1748-717X
Publication state
Published
Issued date
2013
Volume
8
Pages
40
Language
english
Notes
Publication types: Clinical Trial, Phase I ; Journal Article ; Multicenter StudyPublication Status: epublish
Abstract
PURPOSE: This study sought to determine the maximum tolerated dose (MTD) of oral etoposide in combination with radiotherapy in head and neck squamous cell carcinoma (HNSCC).
PATIENTS AND METHODS: Phase I, multicenter, open-labelled, non-comparative and dose escalating trial. Patients with locally advanced HNSCC were enrolled onto cohorts of escalating dose of etoposide. Oral etoposide was administered on five consecutive days every week for 7 weeks (7 treatment cycles) in combination with daily radiotherapy (70 Gy /35 fractions). Two dose levels (25 mg/day and 50 mg/day) of etoposide were planned and three to six patients were to be enrolled at each level according to the potential DLTs.
RESULTS: Fourteen patients were allocated to two dose levels: 25 mg/day (3) and 50 mg/day (11). Cisplatin was contra-indicated in all the patients included. Only one patient (50 mg/day) presents a grade 4 neutropenia (DLT), no other DLTs were observed. The most frequently adverse events (AEs) were radiomucositis. Two deaths before 3 months of end of treatment were not related to treatment. Seven patients were still alive with a median follow-up of 30 months (12-58 months). Nine patients had a complete response (CR) at 3 months after the radiotherapy; Among the 9 patients, 3 patients had a local relapse; one patient with local and distant relapse.
CONCLUSION: Due to only one DLT experienced, it is possible to a dose of 50 mg/day for phase II studies, however this should be considered with caution.
Keywords
Administration, Oral, Aged, Antineoplastic Agents, Phytogenic/therapeutic use, Carcinoma, Squamous Cell/drug therapy, Chemoradiotherapy, Dose Fractionation, Etoposide/therapeutic use, Female, Head and Neck Neoplasms/drug therapy, Humans, Male, Maximum Tolerated Dose, Middle Aged, Neoplasm Staging, Prognosis
Pubmed
Web of science
Open Access
Yes
Create date
10/03/2014 14:24
Last modification date
20/08/2019 14:38
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