Background: Patients with advanced squamous cell carcinoma of the head and
neck (SCC) have a depressed immune system whose function is worsened by che
motherapy. In a pilot phase II study in order to improve the immune functio
n during chemotherapy, we combined to cisplatin (CDDP) and 5-fluorouracil (
5-FU) two biological response modifiers, retinyl palmitate (R) and Thymopen
tin (TP-5) for the treatment of SCC. Patients and methods: Fifty patients w
ith recurrent or metastatic SCC of the head and neck were treated with Cisp
latin 24 mg/m(2) from day I to 5 and 5-FU 1,000 mg/m(2) by a 120 hour conti
nuous infusion. Retinyl palmitate was administer ed orally 50,000 lu b.i.d
and Thymopentin 50 mg subcutaneously 3 times a week. Results: Chemotherapy
treatment was well tolerated with G3 hematological toxicity in 30% of patie
nts and G2 gastrointestinal toxicity in 20% of patients. 16 patients (32%)
had a complete response (CR), 13 patients had partial response (PR) (26%),
(response rate 58%, 95% c.i. 43%-72%); stable disease (SD) was observed in
7 patients (14%), while 14 patients progressed (PD) (28%). Median time to p
rogression was 12 months (range 2.8-94.5), Median overall survival was 13.5
months (range 2-104). Conclusions: The association of CDDP and 5-FU with R
etinyl Palmitate and TP5 has a major activity in the treatment of advanced
head and neck cancer and a relatively well tolerated toxicity.