Adjuvant chemotherapy in head and neck cancer

Abstract An overview was presented of all the 28 trials of adjuvant chemotherapy for squamous cell carcinoma of the head and neck that were published in the English language. These were reviewed from the point of view of design of the trial, analysis of survival, response rates, meta-analysis, site of failure, and toxicity. The minimal increase in survival that could be detected ranged from 11% to 51%, with a median of 25%. No trial was big enough to detect the likely increase of survival, which is 5%. Many trials excluded some eligible patients before randomization, and some treated patients from analysis, the total being 16%. If cancer mortality was analyzed, the treated arm had a survival rate of 1% better, whereas overall the mortality rate was 7% worse for the treated arms. The response rate in 5 induction studies was 47%, but the death rate was 1% higher in the treated arms. Meta-analysis showed an insignificant overall reduction in cancer mortality of 2.8%. Inducation chemotherapy and induction/maintenance chemotherapy did not affect cancer mortality, whereas both synchronous and synchronous/maintenance therapy significantly reduced mortality, by 6% and 23%, respectively. Cisplatin, methotrexate, bleomycin, and a variety of other regimens did not affect the death rate from cancer, 5-FU decreased it significantly, but the combination of VBM significantly increased it. Single agents significantly reduced mortality by 4% whereas the mortality rate was similar in both arms in trials of multiple agents. The death rate for mouth tumors was 11% lower, and for hypopharyngeal tumors 8% lower, both significant differences, but there was no significant effect at other sites. The rate of locoregional failure was lower by 5% in the treated arms ( P = .056), whereas the metastatic rate was reduced by 1.5%. Neither difference was significantly. The mortality rate from chemotherapy in 11 series averaged 6%. It appears that a multicenter trial of synchronous/ maintenance chemotherapy using single-agent 5-FU for mouth cancer would be worthwhile. The use of chemoradiotherapy to achieve organ preservation has been subjected to only one trial so that an analysis of the outstanding questions is not yet possible.