Meta-Analysis Shows Benefits of Docetaxel in Patients With Advanced NSCLC

Sanofi-Aventis announced that a meta-analysis performed on seven clinical trials in patients with advanced non-small-cell lung cancer (NSCLC) showed that patients receiving docetaxel (Taxotere) had demonstrated overall survival and less febrile neutropenia than those treated with vinca alkaloid (vinorelbine or vindesine) regimens. The trials used docetaxel and vinca alkaloids alone or in combination as first-line therapy for advanced NSCLC. Six of the trials compared docetaxel to vinorelbine regimens and one to a vindesine regimen. The results of the meta-analysis were presented at the 42nd annual meeting of the American Society of Clinical Oncology (ASCO), in Atlanta.

Survival Improved

The pooled results of the seven trials conducted on a total of 2,867 patients show that docetaxel regimens significantly improved overall survival (hazard ratio [HR] = 0.89; 95% confidence interval [CI] = 0.82-0.96; P = .03) compared to vinca alkaloid regimens in this patient population. The comparison was done on a total of 1,638 patients who received docetaxel regimens and 1,229 who received vinca alkaloid regimens.

The meta-analysis also demonstrated that the benefit derived from docetaxel therapy persisted after exclusion of the vindesine study (HR = 0.90; 95% CI = 0.83-0.98) and also when monotherapy regimens were excluded from the analysis (HR = 0.89; 95% CI = 0.82-0.97).

Less Toxicity

While neutropenia was a common adverse event in the trials, it was significantly less frequent with docetaxel (odds ratio [OR] = 0.60; 95%CI = 0.39-0.92, P = .019]) than with vinca alkoloid regimens, as was febrile neutropenia (OR = 0.60; 95% CI = 0.39-0.96, P = .034).

"This is the first meta-analysis that demonstrated significant benefits in both survival and in toxicity for patients receiving Taxotere-based chemotherapy compared to compared to vinca alkaloid-based regimens in first-line advanced NSCLC," said Jean-Yves Douillard, professor and head of the department of medical oncology at the Centre R. Gauducheau in Saint Herblain, France, and principal investigator of the meta-analysis.

The findings of the meta-analysis are in line with the results of the pivotal TAX 326 study, which provided the basis for the approval of docetaxel in the first-line treatment of NSCLC.