Randomized trial comparing cisplatin with cisplatin plus intravenous Navelbine® (vinorelbine tartrate) in the treatment of previously untreated, stage IV and selected stage IIIb nonsmall cell lung cancer patients:
|Arm I: (n=209)||Arm II: (n=206)|
|Cisplatin (CDDP) 100 mg/m2 IV every 4 weeks||
NAVELBINE 25 mg/m2 IV weekly*
CDDP 100 mg/m2 IV every 4 weeks
G-CSF (granulocyte colony stimulating factor) was allowed after the first course of treatment for grade 3 or 4 neutropenia.
*The usual initial dose of NAVELBINE is 30 mg/m2 administered weekly.
In controlled clinical trials, NAVELBINE was used in combination with 120 mg/m2 of cisplatin, given on days 1 and 29, then every 6 weeks.
|CDDP (n=209)||NAVELBINE/CDDP (n=206)|
(radiation or surgery)
Administration of NAVELBINE is contraindicated in patients with pretreatment granulocyte counts <1,000 cells/mm3.
|CISPLATIN (CDDP) (n=209)||20%|
In controlled clinical trials, granulocytopenia was the major dose-limiting toxicity with NAVELBINE; it was generally reversible and not cumulative over time.
In the North American clinical trials with single-agent NAVELBINE, nonhematologic toxicities were usually mild or moderate and included injection site reactions (38%), nausea (34%), vomiting (15%), constipation (29%), fatigue (27%), peripheral neuropathy (20%), diarrhea (13%), and alopecia (12%).
NAVELBINE is indicated as a single agent or in combination with cisplatin for first-line treatment of patients with advanced, unresectable NSCLC.
*Le Chevalier et al. J Clin Oncol. 1994; 12:360-367.
For additional information, please contact your Glaxo Wellcome Oncology/HIV representative.
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