Compassionate Use Programs or Phase IV Trials of Innovative Molecular Targeted Drugs in Lung Cancer: Deal or No Deal?

Efficacy of this EGF-R acting drug erlotinib in South-East Asian patients is confirmed by the high percentage of 27% objective responses among the 1118

Wilfried Eberhardt

2010

Scholarcy highlights

  • Specific interactions with significant comorbidities of the patients with lung cancer may be revealed in such a large phase IV population
  • Efficacy of this EGF-R acting drug erlotinib in South-East Asian patients is confirmed by the high percentage of 27% objective responses among the 1118
  • No data on EGF-R mutation status are provided for this large group of patients included into the phase IV study
  • With activating EGF-R mutations proven to be a predictive biomarker for progression-free survival under first-line EGF-R treatment, gathering of such datasets is of considerable importance, especially in those with multiple prior therapies
  • Open-labeled phase IV trials/compassionate use programs with new agents in thoracic cancers such as the one reported in this study by Mok et al and Reck et al. for advanced non-small cell lung cancer represent an important part of the clinical drug research and development program necessary to safely and effectively introduce innovative agents later into the standard of care management for these individual cancers

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