ADJUVANT AND ADJUNCTIVE CHEMOTHERAPY IN THE MANAGEMENT OF SQUAMOUS-CELL CARCINOMA OF THE HEAD AND NECK REGION - A METAANALYSIS OF PROSPECTIVE AND RANDOMIZED TRIALS

Purpose: Using the technique of meta-analysis, we aim to illustrate th e potential benefit, or lack of it, in adding chemotherapy to locoregi onal definitive treatment in a prospective randomized setting, Patient s and Methods: Mantel-Haenszel summary analyses were used to test 42 p rospective and properly randomized trials for statistically significan t differences in the proportion with side effects and in the proportio n with response to treatment between the experimental treatment arm (i ncluding chemotherapy) and control arm (local definitive treatment onl y) of the study. Summarized estimates of relative risks of side effect s and relative proportions of positive responses were obtained using t he summarizing options in PROC FREQ in the SAS computer package. In 25 of 42 studies, sufficient survival information was available to estim ate the effect of chemotherapy on the rate of dying per person per uni t of rime. Results: Chemotherapy, when added to local definitive treat ment, was found to increase toxicity, This increase is statistically s ignificant. The relative proportion of side effects wets 2.17, with a 95% confidence interval of 1.84 to 2.56 and P less than .001. Addition of chemotherapy to local treatment has reduced the mortality rare for treated patients by 11% in the total group (all 25 studies), with a 9 5% confidence interval of 1% to 19%, This reduction means that at the rime 50% of patients in the control arm were still alive, 54% of patie nts who received chemotherapy would be expected to be alive. Concurren t treatment (11 studies) has reduced the mortality rate by 22%, with a 95% confidence interval of 8% to 33%, which means that at the time 50 % of patients in the control arm were still alive, 58% of patients who received chemotherapy would be expected to be alive, Conclusion: Addi tion of chemotherapy to local definitive treatment has significantly i ncreased the morbidity of treatment as well as the chance of initial t umor response and local control. A statistically significant improveme nt in survival was found for the simultaneous use of chemotherapy and local definitive treatment.