This international work initiated by an European country aims to evaluate the effect of chemotherapy on survival in patients with squamous cell head and neck carcinoma by performing a meta-analysis, or synthesis, of all randomized trials, published or not, comparing loco-regional treatment with loco-regional treatment plus chemotherapy.
Head and neck carcinomas (HNC) are frequently occurring tumors with 60 000 new cases (oral cavity, oropharynx, hypopharynx, larynx) per year in the European Community. These diseases have often a locally advanced stage at diagnosis. Despite loco-regional treatment with surgery and/or radiotherapy the prognosis of HNC patients remains poor with less than 30% of patients with locally advanced disease surviving 5 years.
More than 60 trials have been performed between 1965 and 1993, but the question of the efficacy of chemotherapy on survival remains open to debate. Half of the trials have been performed in the European Community. Most of the individual trials have not been large enough to distinguish between an ineffective treatment and a moderate effect on survival. The study will be based on updated individual patients data sent by trialists. Given the incidence of head and neck cancer, a moderate improvement of survival (5-10%) could prolong the life of thousands of patients world-wide each year.
In a second meta-analysis, the role of chemotherapy in the avoidance of mutilating surgery of the larynx will be studied. Larynx preservation is a high priority in clinical research
because of its importance in the quality of life of patients.
These 2 meta-analyses will give a unique opportunity to compare its results with the results of a literature-based meta-analysis. The latter is more rapid and cheaper, but more prone to biases leading to potential overestimation of the treatment effect. The reasons for any difference between the two types of meta-analyses will be investigated.