Improved survival with perilymphatic interleukin 2 in patients with resectable squamous cell carcinoma of the oral cavity and oropharynx.

Abstract

BACKGROUND:

The current randomized, multicenter, Phase III trial was conducted to determine whether the disease free interval and overall survival of patients with T2-T4,N0-N3,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 IL-2 (rIL-2).

METHODS:

Patients with a resectable T2-T4,N0-N3,M0 SCC of the oral cavity and oropharynx were assigned randomly to receive surgery and radiotherapy or to receive IL-2, surgery, and radiotherapy. Five thousand units of rIL-2 were injected around the ipsilateral cervical lymph node chain daily for 10 days before surgery. After surgery, contralateral 5-day rIL-2 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 rIL-2 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 rIL-2 and the other variables showed that rIL-2 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 rIL-2 is a simple and manageable way to delay recurrences of SCC.

• Authors: Antonella De Stefani, Guido Forni, Riccardo Ragona, Giovanni Cavallo, Mario Bussi, Antonio Usai, Fausto Badellino, Giorgio Cortesina
• Journal: Cancer (Cancer) Vol. 95 Issue 1 Pg. 90-7 (Jul 01 2002) ISSN: 0008-543X [Print] United States
• PMID: 12115321 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright 2002 American Cancer Society.

Chemical References

• Interleukin-2
• Recombinant Proteins

Topics

• Adult
• Aged
• Carcinoma, Squamous Cell (drug therapy, mortality)
• Humans
• Interleukin-2 (administration & dosage)
• Middle Aged
• Mouth Neoplasms (drug therapy, mortality)
• Oropharyngeal Neoplasms (drug therapy, mortality)
• Recombinant Proteins (administration & dosage)
• Survival Rate