TABLE 7

Completed randomised, placebo controlled trials on (neo) adjuvant chemotherapy

ALPI trial [87]Big Lung Trial [88]IALT trial [85]JBR.10 [89]ANITA [86]
ChemotherapyAdjuvant MVP, three cycles every 3 weeks(Neo)adjuvant MIC, MVP, CV or NP, all three cycles every 3 weeksAdjuvant CV, NP, CE or C + vinblastin, three–four cycles every 3 or 4 weeksAdjuvant NP four cycles every four weeksAdjuvant NP four cycles every four weeks
Cisplatin dose100 mg·m−2 day 1MIC/NVP: 50 mg·m−2 day 1
CV/NP 80 mg·m−2 day 1
80–120 mg·m−250 mg·m−2 days 1 and 8100 mg·m−2 day 1
Eligibility (stage)I, II, IIIAI, II, IIIAI, II, IIIIB, IIIB, II, IIIA
Primary end-pointOSOSOSOSOS
Secondary end-pointsDFS, toxicityDFSDFS, second primary cancer, AEsDFS, toxicity, safetyDFS, safety
Subjects n12093811867482840
Subgroups
 ElderlyNo age limitNo age limitUpper age limit 75 yearsNo age limitNo age limit
 Co-morbidityNot specifiedNot specified “fit to receive chemotherapy”Not specified“Only fit patients”Not specified
 WHO performance statusNot specifiedNot specifiedNot specifiedOnly performance status 0–1Performance status 0–2
  • WHO: World Health Organization; MVP: mitomycin, vindesine, cisplatin; MIC: cisplatin, mitomycin, ifosfamide; CV: cisplatin, vindesine; NP: cisplatin, vinorelbin; CE: cisplatin, etoposide; C: cisplatin; OS: overall survival; DFS: disease-free survival; AE: adverse events.