Radiotherapy with concomitant weekly docetaxel for Stages III/IV oropharynx carcinoma. Results of the 98-02 GORTEC Phase II trial.
OBJECTIVE
We designed a prospective Phase II clinical trial to evaluate the addition of weekly chemotherapy using Docetaxel during standard radiation therapy in patients with Stages III and IV oropharynx carcinoma.


METHODS
A total of 63 patients have been entered in a Phase II multicenter trial. Radiotherapy delivered, with conventional fractionation, 70 Gy in 35 fractions. Patients received during the period of radiotherapy seven cycles of Docetaxel (20 mg/m2 each week).


RESULTS
Radiotherapy compliance was good in respect to total dose, treatment duration, and treatment interruption. The rate of Grade 3 and 4 mucositis was 84%. Grade 3 and 4 skin toxicity occurred in 53% of the patients. Hematologic toxicity was infrequent, with only a 5% rate of Grade 3 or 4 neutropenia. Three-year overall actuarial survival and disease-free survival rates were, respectively, 47% (95% CI = 39-68%) and 39% (95% CI = 30-57%). The local and regional control rate was 64%.


CONCLUSIONS
The adjunction of weekly Docetaxel to conventional radiotherapy is feasible. Mucositis and skin toxicity were the major acute toxic effects. Therapeutic results were similar to those observed with concomitant chemotherapy using platinum and/or 5-FU. Further trials using Docetaxel in combination with other cytotoxic agents are needed.
Calais
Gilles
G
Centre Hospitalier Universitaire, Tours, France. calais@med.univ-tours.fr
Bardet
Etienne
E
Sire
Christian
C
Alfonsi
Marc
M
Bourhis
Jean
J
Rhein
Béatrix
B
Tortochaux
Jacques
J
Man
Yooye Tao Kong
YT
Auvray
Hugues
H
Garaud
Pascal
P
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D003131:Combined Modality Therapy; D000077143:Docetaxel; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D009959:Oropharyngeal Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy*; D011446:Prospective Studies; D011838:Radiation-Sensitizing Agents / Q000627:therapeutic use*; D016019:Survival Analysis; D043823:Taxoids / Q000627:therapeutic use*
D000972:Antineoplastic Agents, Phytogenic; D011838:Radiation-Sensitizing Agents; D043823:Taxoids; D000077143:Docetaxel