Abstract
BACKGROUND
The current randomized, multicenter, Phase III trial was conducted to determine whether the disease free interval and overall survival of patients with T2βT4,N0βN3,M0 squamous cell carcinoma (SCC) of the oral cavity or oropharynx could be extended through the combination of surgery (and radiotherapy, if required) with perilymphatic recombinant ILβ2 (rILβ2).
METHODS
Patients with a resectable T2βT4,N0βN3,M0 SCC of the oral cavity and oropharynx were assigned randomly to receive surgery and radiotherapy or to receive ILβ2, surgery, and radiotherapy. Five thousand units of rILβ2 were injected around the ipsilateral cervical lymph node chain daily for 10 days before surgery. After surgery, contralateral 5βday rILβ2 courses were administered monthly for 1 year. The differences in disease free and overall survival between the two groups of patients were evaluated statistically.
RESULTS
Two hundred two patients finished the study. No significant complications related to rILβ2 were encountered, and surgery and radiotherapy were not hampered by its prior administration. Multivariate analysis conducted to determine the extent to which survival was influenced by rILβ2 and the other variables showed that rILβ2 significantly lengthened disease free survival (P < 0.01) and that this resulted in longer overall survival (P < 0.03).
CONCLUSIONS
The data emerging from this trial indicate that perilymphatic administration of low, nontoxic doses of rILβ2 is a simple and manageable way to delay recurrences of SCC. Cancer 2002;95:90β7. Β© 2002 American Cancer Society.
DOI 10.1002/cncr.10654