title: Interferon alpha-2a and combined chemotherapy as first line treatment in SCLC patients: a randomized trial.
abstract: BACKGROUND
  Interferons (IFNs) are known to act synergistically with antineoplastic agents when applied to SCLC cell cultures. This study was conducted in order to detect the clinical benefits, if any, of the addition of IFN-alpha in the induction chemotherapy (CT) of SCLC patients.
  
  
  METHODS
  Ninety previously untreated patients with SCLC were randomly assigned to receive either CT alone (arm A) or CT plus IFN alpha-2a in a dose of 3 MU/m2 twice weekly (arm B). CT for both arms consisted of carboplatin 420 mg/m2, etoposide 200 mg/m2 and ifosfamide 3.5 g/m2 or epirubicin 80 mg/m2 every 28 days for a total of eight cycles. Responding patients received primary site and prophylactic cranial irradiation and then had maintenance CT with cyclophosphamide 100 mg/m2/day for 20 days every month. Patients in arm B received IFN throughout these treatments.
  
  
  RESULTS
  Eighty-one patients were evaluable for response, 39 in arm A and 42 in arm B. Both arms were comparable in terms of age, performance status and extent of disease. Overall response rates were not significantly different between the two arms (90% vs. 86%), although complete response rate was higher in arm B (38% vs. 28%). More importantly, Kaplan-Meier analysis disclosed a clear survival benefit in the arm receiving IFN-alpha (P < 0.05). For limited disease the difference was even more significant (P < 0.0067), while for extensive disease no significant difference was found (P < 0.35). Fever, fatigue and anorexia were more frequent in arm B (P < 0.001), as also leukopenia (P < 0.01).
  
  
  CONCLUSIONS
  The addition of IFN-alpha to induction CT appears to confer a survival benefit to SCLC patients but optimal dosing schedule has yet to be defined.
authors.affiliation: Aristotelion University Pulmonary Department, G. Papanicolaou Hospital, Thessaloniki, Greece.
authors.forename: K
authors.initials: K
authors.lastname: Zarogoulidis
authors.forename: E
authors.initials: E
authors.lastname: Ziogas
authors.forename: A
authors.initials: A
authors.lastname: Papagiannis
authors.forename: K
authors.initials: K
authors.lastname: Charitopoulos
authors.forename: K
authors.initials: K
authors.lastname: Dimitriadis
authors.forename: D
authors.initials: D
authors.lastname: Economides
authors.forename: N
authors.initials: N
authors.lastname: Maglaveras
authors.forename: C
authors.initials: C
authors.lastname: Vamvalis
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D018288:Carcinoma, Small Cell / Q000188:drug therapy*; D003131:Combined Modality Therapy; D004334:Drug Administration Schedule; D004357:Drug Synergism; D015251:Epirubicin / Q000008:administration & dosage; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D000077190:Interferon alpha-2; D016898:Interferon-alpha / Q000627:therapeutic use*; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011994:Recombinant Proteins; D012074:Remission Induction
chemical_list: D000077190:Interferon alpha-2; D016898:Interferon-alpha; D011994:Recombinant Proteins; D015251:Epirubicin; D005047:Etoposide; D016190:Carboplatin; D007069:Ifosfamide