title: High response rate after intratumoral treatment with interleukin-2: results from a phase 2 study in 51 patients with metastasized melanoma.
abstract: BACKGROUND
  Systemic high-dose interleukin-2 (IL-2) achieved long-term survival in a subset of patients with advanced melanoma. The authors reported previously that intratumorally applied IL-2 induced complete local responses of all metastases in >60% of patients. The objectives of the current study were to confirm those results in a larger cohort and to identify patient or regimen characteristics associated with response.
  
  
  METHODS
  Patients with melanoma who had a median of 12 injectable metastases received intratumoral IL-2 treatments 3 times weekly until they achieved clinical remission. The initial dose of 3 million international units was escalated, depending on the individual patient's tolerance.
  
  
  RESULTS
  Forty-eight of 51 patients were evaluable. Only grade 1/2 toxicity was recorded. A complete response that lasted >/=6 months was documented in 70% of all injected metastases. A complete local response of all treated metastases was achieved in 33 patients (69%), including 11 patients who had between 20 and 100 metastases. Response rates were higher for patients who had stage III disease compared with patients who had stage IV disease. No objective responses of distant untreated metastases were observed. The 2-year survival rate was 77% for patients with stage IIIB/IIIC disease and 53% for patients with stage IV disease. Efficacy and survival did not differ between patients who had >/=20 lesions and patients who had <20 lesions.
  
  
  CONCLUSIONS
  Intratumoral IL-2 treatment elicited complete local responses in a high percentage of patients. Further studies will be required to investigate the mode of action of this treatment and its impact on survival.
authors.affiliation: Department of Dermatology, Center of Dermato-Oncology, University of Tuebingen, Tuebingen, Germany. benjamin.weide@med.uni-tuebingen.de
authors.forename: Benjamin
authors.initials: B
authors.lastname: Weide
authors.forename: Evelyna
authors.initials: E
authors.lastname: Derhovanessian
authors.forename: Annette
authors.initials: A
authors.lastname: Pflugfelder
authors.forename: Thomas K
authors.initials: TK
authors.lastname: Eigentler
authors.forename: Peter
authors.initials: P
authors.lastname: Radny
authors.forename: Henning
authors.initials: H
authors.lastname: Zelba
authors.forename: Claudia
authors.initials: C
authors.lastname: Pföhler
authors.forename: Graham
authors.initials: G
authors.lastname: Pawelec
authors.forename: Claus
authors.initials: C
authors.lastname: Garbe
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D005260:Female; D015332:Gene Rearrangement, alpha-Chain T-Cell Antigen Receptor / Q000276:immunology; D006801:Humans; D015552:Injections, Intralesional; D007376:Interleukin-2 / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000276:immunology / Q000401:mortality / Q000473:pathology; D008875:Middle Aged; D009362:Neoplasm Metastasis
chemical_list: D000970:Antineoplastic Agents; D007376:Interleukin-2