Final results of a trial comparing two neoadjuvant chemotherapy (CT) regimens followed by surgery in patients with resectable non-small cell lung cancer (NSCLC): A phase II randomized study by the European Lung Cancer Working Party.

Authors:
  • TBT. Berghmans
    T. Berghmans
  • JLJ. Lafitte
    J. Lafitte
  • VGV. Giner
    V. Giner
  • MBM. Berchier
    M. Berchier
  • MPM. Paesmans
    M. Paesmans
  • AMA. Meert
    A. Meert
  • TBT. Bosschaerts
    T. Bosschaerts
  • NLN. Leclercq
    N. Leclercq
  • JSJ. P. Sculier
    J. P. Sculier
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Abstract
7055 Background: (Neo)adjuvant cisplatin-based CT demonstrated its activity in improving survival in resectable NSCLC. We aimed to determine if a combination of cisplatin with second-generation drugs (GNP) and a standard neoadjuvant chemotherapy with first-generation drugs (MIP) can be performed in patients with initially resectable stage I-IIIA NSCLC, without reducing the resectability rate. Final results are presented. Methods: Patients with previously untreated pathologically proven stage I-IIIA resectable NSCLC, Karnofsky performance status ≥ 60, adequate haematological, hepatic, renal, lung and cardiac functions were eligible. After central randomisation, patients received three courses of MIP (ifosfamide 3g/m2, mitomycine 6 mg/m2, cisplatin 50 mg/m2) or GNP (gemcitabine 1g/m2 D1-8, vinorelbine 25 mg/m2 D1-8, cisplatin 50 mg/m2). The conclusion of feasibility of each regimen will be drawn if, at least, 50 patients per arm within a sample size of 67 can be completely resected (α 5%, β 20%). Results: From 2001 to 2007, 140 eligible patients were randomized, without any significant imbalance between both arms. The main characteristics were: stage I/II/III in 52, 37 and 51 pts, squamous histology in 82 pts, male 114 pts, median PS 90. All patients alive had at least a 5-years follow-up. No difference in postoperative complications was noted (p = 0.18). There were more thrombopenia with GNP (p = 0.03) and more nausea/vomiting with MIP (p = 0.03). Conclusions: The final results of this randomized study in resectable stage I-III NSCLC showed that both MIP and GNP are efficient neoadjuvant CT regimens but with different toxicity patterns.