title: A randomised phase III trial comparing consolidation treatment with further chemotherapy to chest irradiation in patients with initially unresectable locoregional non-small-cell lung cancer responding to induction chemotherapy. European Lung Cancer Working Party.
abstract: OBJECTIVE
  A phase III randomised trial was conducted in patients with non-metastatic unresectable non-small-cell lung cancer in order to compare, in responders to induction chemotherapy, consolidation treatment by further chemotherapy to chest irradiation.
  
  
  METHODS
  A total of 462 untreated NSCLC patients were eligible for three courses of induction chemotherapy (MIP) consisting of cisplatin (50 mg/m2), ifosfamide (3 g/m2) and mitomycin C (6 mg/m2). It was proposed that objective responders be randomised to either three further courses of MIP or to chest irradiation (60 Gy; 2 Gy per fraction given over six weeks).
  
  
  RESULTS
  An objective response rate of 35% was achieved; 115 patients (including 52% with initial stage IIIA and 44% with initial stage IIIB) were randomised to consolidation treatment, 60 of them to further chemotherapy and 55 to chest radiotherapy. There was no significant difference in survival between the two arms, with a respective median and two-year survival of 42 weeks (95% confidence intervals (95% CI: 35-51) and 18% (95% CI: 8-28) for chemotherapy and 54 weeks (95% CI: 43-73) and 22% (95% CI: 11-33) for irradiation. There was also no statistical difference for response duration between the two arms but chest irradiation was associated with a significantly greater duration of local control than chemotherapy (median duration times: 158 vs. 31 weeks, P = 0.0007).
  
  
  CONCLUSIONS
  For non-metastatic unresectable NSCLC treated by an induction chemotherapy regimen containing cisplatin and ifosfamide, if an objective response is obtained, consolidation treatments by further chemotherapy or by chest irradiation result in non-statistically different survival distributions, although a better local control duration is observed with radiotherapy.
authors.affiliation: Service de Médecine, Institut Jules Bordet, Brussels, Belgium. 101473.1044@compuserve.com
authors.forename: J P
authors.initials: JP
authors.lastname: Sculier
authors.forename: M
authors.initials: M
authors.lastname: Paesmans
authors.forename: J J
authors.initials: JJ
authors.lastname: Lafitte
authors.forename: J
authors.initials: J
authors.lastname: Baumöhl
authors.forename: J
authors.initials: J
authors.lastname: Thiriaux
authors.forename: O
authors.initials: O
authors.lastname: van Cutsem
authors.forename: P
authors.initials: P
authors.lastname: Recloux
authors.forename: G
authors.initials: G
authors.lastname: Bureau
authors.forename: M C
authors.initials: MC
authors.lastname: Berchier
authors.forename: C
authors.initials: C
authors.lastname: Zacharias
authors.forename: P
authors.initials: P
authors.lastname: Mommen
authors.forename: T
authors.initials: T
authors.lastname: Bosschaerts
authors.forename: T
authors.initials: T
authors.lastname: Berghmans
authors.forename: P
authors.initials: P
authors.lastname: van Houtte
authors.forename: V
authors.initials: V
authors.lastname: Ninane
authors.forename: J
authors.initials: J
authors.lastname: Klastersky
mesh_terms: D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage; D018906:Antineoplastic Agents, Alkylating / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D002945:Cisplatin / Q000008:administration & dosage; D016001:Confidence Intervals; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000532:radiotherapy*; D008297:Male; D008875:Middle Aged; D008937:Mitomycins / Q000008:administration & dosage; D009367:Neoplasm Staging; D011379:Prognosis; D018714:Radiotherapy, Adjuvant; D012074:Remission Induction; D016879:Salvage Therapy; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000903:Antibiotics, Antineoplastic; D018906:Antineoplastic Agents, Alkylating; D008937:Mitomycins; D002945:Cisplatin; D007069:Ifosfamide