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Randomized, placebo-controlled, phase II study of sequential erlotinib and chemotherapy as first-line treatment for advanced non-small-cell lung cancer
Journal of Clinical Oncology, 09/11/09
Mok TSK et al. – Sequential administration of erlotinib following gemcitabine/platinum chemotherapy led to a significant improvement in PFS.
Methods- Previously untreated patients (n = 154) with stage IIIB or IV NSCLC and ECOG PS of 0 or 1 were randomly assigned to receive erlotinib (150 mg/d) or placebo on d 15-28 of a 4-w cycle that included gemcitabine (1,250 mg/m2 d 1 and 8) and either cisplatin (75 mg/m2 d 1) or carboplatin (5 x area under the serum concentration-time curve, d 1)
- The NPR at 8 weeks was 80.3% in the gemcitabine plus cisplatin or carboplatin (GC) -erlotinib arm (n = 76) and 76.9% in the GC-placebo arm (n = 78)
- At 16 w, the NPR was 64.5% for GC-erlotinib versus 53.8% for GC-placebo
- The response rate was 35.5% for GC-erlotinib versus 24.4% for GC-placebo
- PFS was significantly longer with GC-erlotinib than with GC-placebo (adjusted HR, 0.47; median, 29.4 v 23.4 w)
- There was no significant difference in OS
- The addition of erlotinib to chemotherapy was well tolerated, with no increase in hematologic toxicity, and no treatment-related interstitial lung disease
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