title: Chemo-immunotherapy in advanced head and neck cancer.
abstract: BACKGROUND
  Patients with advanced squamous cell carcinoma of the head and neck (SCC) have a depressed immune system whose function is worsened by chemotherapy. In a pilot phase II study, in order to improve the immune function during chemotherapy, we combined to cisplatin (CDDP) and 5-fluorouracil (5-FU) two biological response modifiers, retinyl palmitate (R) and Thymopentin (TP-5) for the treatment of SCC.
  
  
  METHODS
  Fifty patients with recurrent or metastatic SCC of the head and neck were treated with Cisplatin 24 mg/m2 from day 1 to 5 and 5-FU 1,000 mg/m2 by a 120 hour continuous infusion. Retinyl palmitate was administered orally 50,000 i.u. 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 patients 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 progression 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 Retinyl Palmitate and TP5 has a major activity in the treatment of advanced head and neck cancer and a relatively well tolerated toxicity.
authors.affiliation: Division di Oncologia, Ospedale Civile, Avezzano, Italy. franre@flashnet.it
authors.forename: F
authors.initials: F
authors.lastname: Recchia
authors.forename: G
authors.initials: G
authors.lastname: Sica
authors.forename: S
authors.initials: S
authors.lastname: De Filippis
authors.forename: M
authors.initials: M
authors.lastname: Rosselli
authors.forename: P
authors.initials: P
authors.lastname: Pompili
authors.forename: G
authors.initials: G
authors.lastname: Saggio
authors.forename: S
authors.initials: S
authors.lastname: Rea
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D002945:Cisplatin / Q000008:administration & dosage; D004224:Diterpenes; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000401:mortality / Q000628:therapy*; D006801:Humans; D007167:Immunotherapy; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D012074:Remission Induction; D000084562:Retinyl Esters; D015996:Survival Rate; D016305:Thymopentin / Q000008:administration & dosage; D016896:Treatment Outcome; D014801:Vitamin A / Q000008:administration & dosage / Q000031:analogs & derivatives
chemical_list: D000276:Adjuvants, Immunologic; D004224:Diterpenes; D000084562:Retinyl Esters; D014801:Vitamin A; C014794:retinol palmitate; D016305:Thymopentin; D002945:Cisplatin; D005472:Fluorouracil