title: A three-arm phase III randomised trial assessing, in patients with extensive-disease small-cell lung cancer, accelerated chemotherapy with support of haematological growth factor or oral antibiotics.
abstract: The European Lung Cancer Working Party (ELCWP) designed a 3-arm phase III randomised trial to determine the role of accelerated chemotherapy in extensive-disease (ED) small-cell lung cancer (SCLC). Eligible patients were randomised between the 3 following arms: (A) Standard chemotherapy with 6 courses of EVI (epirubicin 60 mg m(-2), vindesine 3 mg m(-2), ifosfamide 5 g m(-2); all drugs given on day 1 repeated every three weeks. (B) Accelerated chemotherapy with EVI administered every 2 weeks and GM-CSF support. (C) Accelerated chemotherapy with EVI and oral antibiotics (cotrimoxazole). Primary endpoint was survival. 233 eligible patients were randomised. Chemotherapy could be significantly accelerated in arm B with increased absolute dose-intensity. Best response rates, in the population of evaluable patients, were, respectively for arm A, B and C, 59%, 76% and 70%. The response rate was significantly higher in arm B in comparison to arm A (P = 0.04). There was, however, no survival difference with respective median duration and 2-year rate of 286 days and 5% for arm A, 264 days and 6% for arm B and 264 days and 6% for arm C. Severe thrombopenia occurred more frequently in arm B but without an increased rate of bleeding. Non-severe infections were more frequent in arm B and severe infections were less frequent in arm C. Our trial failed to demonstrate, in ED-SCLC, a survival benefit of chemotherapy acceleration by using GM-CSF support.
authors.affiliation: Department of Medicine, Institut Jules Bordet, 1rue Héger-Bordet, B-1000 Bruxelles, Belgium.
authors.forename: J P
authors.initials: JP
authors.lastname: Sculier
authors.forename: M
authors.initials: M
authors.lastname: Paesmans
authors.forename: J
authors.initials: J
authors.lastname: Lecomte
authors.forename: O
authors.initials: O
authors.lastname: Van Cutsem
authors.forename: J J
authors.initials: JJ
authors.lastname: Lafitte
authors.forename: T
authors.initials: T
authors.lastname: Berghmans
authors.forename: G
authors.initials: G
authors.lastname: Koumakis
authors.forename: M C
authors.initials: MC
authors.lastname: Florin
authors.forename: J
authors.initials: J
authors.lastname: Thiriaux
authors.forename: J
authors.initials: J
authors.lastname: Michel
authors.forename: V
authors.initials: V
authors.lastname: Giner
authors.forename: M C
authors.initials: MC
authors.lastname: Berchier
authors.forename: P
authors.initials: P
authors.lastname: Mommen
authors.forename: V
authors.initials: V
authors.lastname: Ninane
authors.forename: J
authors.initials: J
authors.lastname: Klastersky
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000401:mortality; D023381:Endpoint Determination; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D015662:Trimethoprim, Sulfamethoxazole Drug Combination / Q000008:administration & dosage; D014751:Vindesine / Q000008:administration & dosage
chemical_list: D000900:Anti-Bacterial Agents; D005047:Etoposide; D015662:Trimethoprim, Sulfamethoxazole Drug Combination; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D014751:Vindesine; D007069:Ifosfamide