Originally published as JCO Early Release 10.1200/JCO.2004.08.021 on December 2 2003

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Final Results of the 94–01 French Head and Neck Oncology and Radiotherapy Group Randomized Trial Comparing Radiotherapy Alone With Concomitant Radiochemotherapy in Advanced-Stage Oropharynx Carcinoma

From the Clinique d'Oncologie et de Radiothérapie, Centre Hospitalier Universitaire, Tours; Centre René Gauducheau, Nantes; Clinique Sainte Catherine, Avignon; Centre Hospitalier, Lorient; Centre Hospitalier Universitaire, Poitiers; Centre Etienne Dolet, Saint-Nazaire; Centre Hospitalier Universitaire, Limoges; Centre Jean Perrin, Clermont-Ferrand, France

Address reprint requests to Fabrice Denis, MD, MSc, Clinique d'Oncologie et Radiothérapie, Hôpital Bretonneau, 2 Blvd Tonnelé, 37044 Tours, France; e-mail: fcdenis{at}club-internet.fr

PURPOSE: We report the 5-year survival and late toxicity results of a randomized clinical trial, which showed a 3-year improvement in overall survival and locoregional control of stage III or IV oropharynx carcinoma, using concomitant radiochemotherapy (arm B), compared with standard radiotherapy (arm A).

PATIENTS AND METHODS: A total of 226 patients were entered onto a phase III multicenter randomized trial comparing radiotherapy alone (70 Gy in 35 fractions; arm A) with concomitant radiochemotherapy (70 Gy in 35 fractions with three cycles of a 4-day regimen comprising carboplatin and fluorouracil; arm B). Prognostic factors were evaluated by univariate and multivariate analysis. Five-year late toxicity was evaluated using National Cancer Institute Common Toxicity Criteria for neurological toxicity, hearing, taste, mandibula, and teeth damage, and Radiation Therapy Oncology Group toxicity criteria for skin, salivary gland, and mucosa.

RESULTS: Five-year overall survival, specific disease-free survival, and locoregional control rates were 22% and 16% (log-rank P = .05), 27% and 15% (P = .01), and 48% and 25% (P = .002), in arm B and arm A, respectively. Stage IV, hemoglobin level lower than 125 g/L, and standard treatment were independent prognostic factors of short survival and locoregional failure by univariate and multivariate analysis. One or more grade 3 to 4 complications occurred in 56% of the patients in arm B, compared with 30% in arm A (P was not significant).

CONCLUSION: Concomitant radiochemotherapy improved overall survival and locoregional control rates and does not statistically increase severe late morbidity. Anemia was the most important prognostic factor for survival in both arms.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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