title: Intratumoral PEG-interleukin-2 therapy in patients with locoregionally recurrent head and neck squamous-cell carcinoma.
abstract: BACKGROUND
  An enhanced efficacy of local as compared to systemic administration of interleukin-2 (IL-2) has been demonstrated in several experimental tumors. We previously reported that guinea pigs with palpable tumors and regional micrometastases could be cured by intratumoral injections of polyethylene glycol-modified IL-2 (PEG-IL-2). In the present study this treatment schedule was applied in a clinical situation.
  
  
  METHODS
  Nineteen patients with 11 local and 11 regional recurrences of head and neck squamous cell carcinoma (HNSCC) were treated with intratumoral injections of 200,000 U of PEG-IL-2 3 times weekly in courses of 4 weeks.
  
  
  RESULTS
  Treatment was given on an out-patient basis, and was well tolerated. Temporary regional swelling and redness developed in 10 patients, and in 9 of them systemic eosinophilia was documented. Median duration of treatment was 4 weeks (range 2-14 weeks). Seventeen patients were evaluable for response. One complete response (CR; 6%; duration 91 weeks), and 6 stable diseases (SDs; duration 8-57+ weeks) were recorded. The CR and the 3 best SDs (23, 40, 57+ weeks) occurred in patients with a single regional tumor recurrence of relatively small size. During treatment, all 4 developed locoregional edema and redness, and high levels of circulating eosinophils. Median survival was 23 weeks for all patients, and 45+ weeks for the patients with SD.
  
  
  CONCLUSIONS
  Intratumoral injection of PEG-IL-2 in patients with HNSCC is feasible. This treatment appears beneficial for highly selected patients. The objective response rate is insufficient to justify wide clinical application.
authors.affiliation: Department of Medical Oncology, University Hospital, Nijmegen, The Netherlands.
authors.forename: V
authors.initials: V
authors.lastname: Mattijssen
authors.forename: P H
authors.initials: PH
authors.lastname: De Mulder
authors.forename: A
authors.initials: A
authors.lastname: De Graeff
authors.forename: P S
authors.initials: PS
authors.lastname: Hupperets
authors.forename: F
authors.initials: F
authors.lastname: Joosten
authors.forename: D J
authors.initials: DJ
authors.lastname: Ruiter
authors.forename: H
authors.initials: H
authors.lastname: Bier
authors.forename: P A
authors.initials: PA
authors.lastname: Palmer
authors.forename: P
authors.initials: P
authors.lastname: Van den Broek
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000628:therapy*; D005240:Feasibility Studies; D005260:Female; D006258:Head and Neck Neoplasms / Q000628:therapy*; D006801:Humans; D015552:Injections, Intralesional; D007376:Interleukin-2 / Q000008:administration & dosage / Q000031:analogs & derivatives*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000628:therapy*; D011092:Polyethylene Glycols; D012074:Remission Induction
chemical_list: D007376:Interleukin-2; C067245:interleukin-2, polyethylene glycol-modified; D011092:Polyethylene Glycols