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Randomized double-blind placebo-controlled trial of thalidomide in combination with gemcitabine and carboplatin in advanced non-small-cell lung cancer
Journal of Clinical Oncology, 09/28/09

Lee SM et al. – In this large trial of patients with NSCLC, thalidomide in combination with chemotherapy did not improve survival overall, but increased the risk of thrombotic events. Unexpectedly, survival was significantly worse in patients with nonsquamous histology.

Methods

722 patients randomly assigned to receive placebo or thalidomide capsules 100 to 200 mg daily for up to 2 years
All received gemcitabine and carboplatin every 3 weeks for up to four cycles
End points were OS, PFS, response rate, grade 3/4 toxicity, and QoL

Results

Median OS rates were 8.9 months (placebo) and 8.5 months (thalidomide)
HR was 1.13 (95% CI, 0.97 to 1.32)
2-year survival rate was 16% and 12% in the placebo and thalidomide
PFS results consistent with those for OS
Risk of thrombotic event increased by 74% in the thalidomide group: HR of 1.74 (95% CI, 1.20 to 2.52)
No differences in hematologic toxicities, but slight excess of rash and neuropathy in the thalidomide group
QoL scores similar but thalidomide associated with less insomnia, and more constipation and peripheral neuropathy
In retrospective analysis, patients with nonsquamous histology in the thalidomide group had poorer survival: 2-year risk difference of 10% (95% CI, 4% to 16%)

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