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.
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
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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