PMID- 23445779
OWN - NLM
STAT- MEDLINE
DCOM- 20130903
LR  - 20211021
IS  - 1748-717X (Electronic)
IS  - 1748-717X (Linking)
VI  - 8
DP  - 2013 Feb 27
TI  - Phase I trial of oral etoposide in combination with radiotherapy in head and neck 
      squamous cell carcinoma - GORTEC 2004-02.
PG  - 40
LID - 10.1186/1748-717X-8-40 [doi]
AB  - 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.
FAU - Tao, Yungan
AU  - Tao Y
AD  - Institute Gustave-Roussy, Villejuif, France.
FAU - Bardet, Etienne
AU  - Bardet E
FAU - Rosine, Dominique
AU  - Rosine D
FAU - Rolland, Frederic
AU  - Rolland F
FAU - Bompas, Emmanuelle
AU  - Bompas E
FAU - Daly-Schveitzer, Nicolas
AU  - Daly-Schveitzer N
FAU - Lusinchi, Antoine
AU  - Lusinchi A
FAU - Bourhis, Jean
AU  - Bourhis J
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Multicenter Study
DEP - 20130227
PL  - England
TA  - Radiat Oncol
JT  - Radiation oncology (London, England)
JID - 101265111
RN  - 0 (Antineoplastic Agents, Phytogenic)
RN  - 6PLQ3CP4P3 (Etoposide)
SB  - IM
MH  - Administration, Oral
MH  - Aged
MH  - Antineoplastic Agents, Phytogenic/*therapeutic use
MH  - Carcinoma, Squamous Cell/*drug therapy
MH  - *Chemoradiotherapy
MH  - Dose Fractionation, Radiation
MH  - Etoposide/*therapeutic use
MH  - Female
MH  - Head and Neck Neoplasms/*drug therapy
MH  - Humans
MH  - Male
MH  - Maximum Tolerated Dose
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Prognosis
PMC - PMC3606353
EDAT- 2013/03/01 06:00
MHDA- 2013/09/04 06:00
PMCR- 2013/02/27
CRDT- 2013/03/01 06:00
PHST- 2012/07/21 00:00 [received]
PHST- 2013/01/27 00:00 [accepted]
PHST- 2013/03/01 06:00 [entrez]
PHST- 2013/03/01 06:00 [pubmed]
PHST- 2013/09/04 06:00 [medline]
PHST- 2013/02/27 00:00 [pmc-release]
AID - 1748-717X-8-40 [pii]
AID - 10.1186/1748-717X-8-40 [doi]
PST - epublish
SO  - Radiat Oncol. 2013 Feb 27;8:40. doi: 10.1186/1748-717X-8-40.