Noninferiority trials in second-line treatments of nonsmall cell lung cancer: A systematic review of literature with meta-analysis of phase III randomized clinical trials

Davide Tassinari, Emanuela Scarpi, Sergio Sartori, Fabrizio Drudi, Cinzia Castellani, Federica Carloni, Paola Tombesi, Luigi Lazzari-Agli

Research output: Contribution to journalArticle


BACKGROUND:: To assess the role of the novel second-line treatments in nonsmall cell lung cancer (NSCLC). METHODS:: A systematic review of the literature with meta-analysis of phase III randomized clinical trials (RCTs) was independently performed by 3 authors. All the trials comparing any novel treatment with every-3-weeks docetaxel (3WD) and designed as noninferiority trial were included in the analysis. One-year survival rate (SR) was the primary end point, and quality of life and safety represented the secondary end points. RESULTS:: Four RCTs met the selection criteria. The outcomes of 3355 patients were analyzed in the pooled analysis. No heterogeneity was documented in the primary analysis either including all the trials or analyzing separately gefitinib and the chemotherapeutic alternatives to 3WD. The cumulative odds ratio was 0.927 (P=0.313) for 1-year SR, 0.889 (P=0.323) for the chemotherapeutic alternatives to 3WD and 0.953 (P=0.616) for gefitinib. The experimental arms showed a significant advantage in quality of life in the cumulative analysis (odds ratio=1.623, P=0.01) and in the subgroup of patients treated with gefitinib (odds ratio=1.962, P

Original languageEnglish
Pages (from-to)593-599
Number of pages7
JournalAmerican Journal of Clinical Oncology: Cancer Clinical Trials
Issue number6
Publication statusPublished - Dec 2012



  • docetaxel
  • erlotinib
  • gefitinib
  • lung cancer
  • pemetrexed
  • second-line treatments
  • topotecan

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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