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Navelbine Clinical Research Report: NSCLC

Navelbine Flower

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:

Report of a Southwest Oncology
Group Study (SWOG 9308 Phase III)*

Wozniak AJ, Crowley JJ, Balcerzak SP, et al.
(Presented at ASCO; May 18-21, 1996; Philadelphia, Pa.)


A total of 415 eligible patients with stage IV or IIIb (pleural effusions or multiple ipsilateral lung nodules) non-small cell lung cancer (NSCLC) were randomized to receive cisplatin or NAVELBINE plus cisplatin:

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.


A total of 415 patients met eligibility requirements for the study. Selected patient characteristics are shown below:

CDDP (n=209) NAVELBINE/CDDP (n=206)

Median 63 63
Range 37-81 33-83

IV 92% 92%
IIIb 8% 8%
(radiation or surgery)

Yes 36% 32%
No 64% 68%

Administration of NAVELBINE is contraindicated in patients with pretreatment granulocyte counts <1,000 cells/mm3.


This study demonstrated a significant advantage in progression-free survival (P=0.0001) and overall survival (P=0.0018) favoring NAVELBINE plus cisplatin over cisplatin alone.


12 mo
CISPLATIN (CDDP) (n=209) 20%
NAVELBINE/CDDP (n=206) 36%


The most frequent toxicity was hematologic. Eighty-one percent of patients receiving NAVELBINE plus cisplatin developed reversible grade 3 or 4 neutropenia.

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%).


Results of this trial confirm the results of Le Chevalier et al*: NAVELBINE plus cisplatin significantly improves survival over comparators in patients with advanced, unresectable, non­small cell lung cancer.

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.
Please consult Full Prescribing Information.

Glaxo Wellcome
©1997 Glaxo Wellcome Inc. All rights reserved.

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