Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase III trial

The Lancet - Early Online Publication, 08/09/2011

Quoix E et al. – Despite increased toxic effects, platinum-based doublet chemotherapy was associated with survival benefits compared with vinorelbine or gemcitabine monotherapy in elderly patients with NSCLC. The authors feel that the current treatment paradigm for these patients should be reconsidered.

Methods

  • Multicentre, open-label, phase 3, randomised trial
  • Recruited patients aged 70—89 years with locally advanced or metastatic NSCLC and WHO performance status scores of 0—2
  • Patients received either 4 cycles (3 weeks on treatment, 1 week off treatment) of carboplatin (on day 1) plus paclitaxel (on days 1, 8, and 15) or 5 cycles (2 weeks on treatment, 1 week off treatment) of vinorelbine or gemcitabine monotherapy
  • Randomisation was done centrally with minimisation method
  • Primary endpoint was OS, and analysis was done by intention to treat

Results

  • 451 patients enrolled
  • 226 were randomly assigned monotherapy and 225 doublet chemotherapy
  • Median age was 77 years and median follow-up was 30·3 months (range 8·6—45·2)
  • Median OS was 10·3 months for doublet chemotherapy and 6·2 months for monotherapy (HR 0·64, 95% CI 0·52—0·78; p<0·0001); 1-year survival 44·5% (95% CI 37·9—50·9) and 25·4% (19·9—31·3)
  • Toxic effects more frequent in doublet chemotherapy group than in the monotherapy group (most frequent, decreased neutrophil count (108 [48·4%] vs 28 [12·4%]; asthenia 23 [10·3%] vs 13 [5·8%])

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