Survival in patients with recurrent squamous cell head and neck carcinoma treated with bio-chemotherapy

Background. We have shown that rIL-2 administration in recurrent head and n eck cancers induces a tumor-specific T-lymphocyte reactivity and tumor regr ession; in a pilot study we have shown a safe and effective administration of rIL2 after cisplatin + 5-fluorouracil. Long-term results are not known. Methods. Thirty patients with recurrent/persistent head and neck cancer wer e treated with cisplatin (100 mg/m(2)) d.1,5-fluorouracil (1 gr/m(2)/d c.i. 96 h), and SQ rIL-2 (4.5 M IU day 8 to 12 and 15 to 19) every 3 weeks. Results. The overall response rate was 53.3% (95% CI; 34.4-72.3%): 26.6% co mplete response (CR) (8 patients) and 26.6% partial response (PR) (8 patien ts); 6 patients had SD (20%), 8 had PD (26.6%). The median follow-up was 36 months (range, 28-44). The median CR duration is 16.2 months (8.5-39+); th e median survival duration of this group has not been reached. The median P R duration was 7.2 months (3-10); the median survival was 13.3 months (10-2 6). The median overall survival was 14 months. Conclusions. The most impressive finding is the very long survival of CRs p atients. This outcome has been reported in other cancer patients with a CR after IL-2 therapy. (C) 2001 John Wiley 8 Sons, Inc.