Treatment of unresectable recurrent head and neck carcinoma with 13-cis-retinoic acid and interferon-alpha. A phase II study

Sixteen patients with unresectable recurrent head and neck carcinomas were treated with 13-cis-retinoic acid and interferon-alpha. All patients had presented with recurrences after having been treated primarily with surgery and radiotherapy, while two of them had also received induction chemotherapy. The site of relapse was strictly locoregional in all cases (only at the primary site in three cases, at the cervical lymph nodes only in four cases and both at the primary site and the neck in the remaining nine cases. Two patients were female, and 14 male, with an age range of 47-72 years (median 61 years). Interferon-alpha was administered subcutaneously at a dose of 3x10(6) IU every second day. The dose of retinoids was 40 mg per os every day. The duration of treatment was two to 14 months (median seven months). There were two cases of partial response (tumour regression >50 per cent), eight cases of stable disease lasting for three to seven months (median four months) and six cases presented with progressive disease. All patients died after a survival of three to 17 months (median 9.5 months). Toxicity was generally minimal. We believe that the results are not encouraging, but also not disappointing. The fact that toxicity was indeed mild, with not a single case of life-threatening sequellae even after prolonged administration of the two agents, allows us to conclude that an increase of the dose of IFN-alpha might be more beneficial. Selection of patients with more 'favourable' recurrences will give a better chance to the treatment combination to prove its real efficacy. Larger numbers of patients have to be treated and evaluated before definite conclusions can be reached.