BRIDGEWATER, New JerseyThe US Food and Drug Administration (FDA) has
approved Taxotere (docetaxel, Aventis) as first-line therapy, in combination
with cisplatin (Platinol), in patients with unresectable, locally advanced or
metastatic non-small-cell lung cancer (NSCLC).
Taxotere is the only agent indicated both for patients with newly
diagnosed NSCLC, in combination with cisplatin, and for those with previously
treated advanced NSCLC, as a single agent, Aventis said in a news release
announcing the approval.
The FDA approval was based on a randomized controlled international phase
III trial of 1,218 good performance status patients with previously untreated
advanced NSCLC. Patients were randomized to receive Taxotere/cisplatin,
Taxotere/carboplatin (Paraplatin), or a standard regimen of vinorelbine
Patients in the Taxotere/cisplatin arm had a median survival of 10.9
months vs 10 months for vinorelbine/cisplatin (P = .035). The overall
response rates were 31.6% for Taxotere/cisplatin vs 24.4% for vinorelbine/cisplatin.
The Taxotere/carboplatin combination produced survival and response rates
similar to those seen with vinorelbine/cisplatin.
Additional study analysis showed that the benefits from Taxotere/cisplatin
were maintained in patients who were 65 years of age and older. This age
group accounts for 68% of all lung cancer patients, according to data from
the National Cancer Institute. Taxotere/cisplatin also showed clinical
benefits in maintaining body weight, performance status, and pain management,
compared with vinorelbine/cisplatin.