title: Intermediate dose recombinant interferon-alpha as second-line treatment for patients with recurrent cutaneous melanoma who were pretreated with low dose interferon.
abstract: BACKGROUND
  Interferon (IFN) is widely considered the most effective agent in the adjuvant therapy of patients with cutaneous melanoma (CM). However, little is known about the effect of IFN on pretreated CM patients who experience disease recurrence. The authors conducted a Phase II study to determine whether intermediate doses of IFN could be beneficial for these patients.
  
  
  METHODS
  A series of 24 consecutive CM patients who had undergone surgery for local, in-transit, or lymph node disease recurrence during adjuvant therapy with low dose IFN (IFNalpha-2b, 3 million units [MU] per day, three times per week) were enrolled for second-line therapy with intermediate dose IFN (IFNalpha-2b, 10 MU per day) for one year.
  
  
  RESULTS
  IFN was discontinued in 7 patients (29.2%) because of toxicity. Several patients complained of impairment in their daily activities. Progression of disease was registered in 17 patients (70. 8%), with a median disease free survival of 5.5 months (95% confidence interval, 3.4-14.2). The median follow-up for the 7 patients who did not experience disease recurrence was 15 months (range, 13-22 months).
  
  
  CONCLUSIONS
  An increased dose of IFN as second-line adjuvant treatment was poorly tolerated and produced negative clinical outcomes in patients with CM. However, these patients probably were unresponsive to IFN regardless of the dosage level. In fact, the first adjuvant IFN treatment was ineffective in all patients. Thus, the key factor in the treatment of CM seems to be patient responsiveness to IFN rather than the total dosage achieved.
authors.affiliation: Department of Clinical Immunology, National Cancer Institute, Naples, Italy. pasciert@tin.it
authors.forename: P A
authors.initials: PA
authors.lastname: Ascierto
authors.forename: A
authors.initials: A
authors.lastname: Daponte
authors.forename: R
authors.initials: R
authors.lastname: Parasole
authors.forename: F
authors.initials: F
authors.lastname: Perrone
authors.forename: C
authors.initials: C
authors.lastname: Caracò
authors.forename: M
authors.initials: M
authors.lastname: Melucci
authors.forename: G
authors.initials: G
authors.lastname: Palmieri
authors.forename: M
authors.initials: M
authors.lastname: Napolitano
authors.forename: N
authors.initials: N
authors.lastname: Mozzillo
authors.forename: G
authors.initials: G
authors.lastname: Castello
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008545:Melanoma / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy; D012878:Skin Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D016898:Interferon-alpha