Radiotherapy with concomitant weekly docetaxel for Stages III/IV oropharynx carcinoma. Results of the 98-02 GORTEC Phase II trial

Autor: Gilles Calais, Etienne Bardet, Jacques Tortochaux, Marc Alfonsi, Jean Bourhis, H. Auvray, B. Rhein, Yooye Tao Kong Man, Christian Sire, Pascal Garaud
Rok vydání: 2004
Předmět:
Zdroj: International Journal of Radiation Oncology*Biology*Physics. 58:161-166
ISSN: 0360-3016
Popis: Purpose 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/m 2 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%. Conclusion 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.
Databáze: OpenAIRE