Ac. Nikolaou et al., TREATMENT OF UNRESECTABLE RECURRENT HEAD AND NECK-CARCINOMA WITH 13-CIS-RETINOIC ACID AND INTERFERON-ALPHA - A PHASE-II STUDY, Journal of Laryngology and Otology, 110(9), 1996, pp. 857-861
Sixteen patients with unresectable recurrent head and neck carcinomas
were treated with 13-cis-retinoic acid and interferon-alpha. All patie
nts had presented with recurrences after having been treated primarily
with surgery and radiotherapy, while two of them had also received in
duction chemotherapy. The site of relapse was strictly locoregional in
all cases (only at the primary site in three cases, at the cervical l
ymph nodes only in four cases and both at the primary site and the nec
k 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 w
as administered subcutaneously at a dose of 3x10(6) IU every second da
y. The dose of retinoids was 40 mg per os every day. The duration of t
reatment was two to 14 months (median seven months). There were two ca
ses of partial response (tumour regression >50 per cent), eight cases
of stable disease lasting for three to seven months (median four month
s) 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 prolon
ged administration of the two agents, allows us to conclude that an in
crease 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 numbe
rs of patients have to be treated and evaluated before definite conclu
sions can be reached.