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Navelbine

Appropriate Use: Contents


Appropriate use with cisplatin

Patient selection

NAVELBINE plus cisplatin may be used in ambulatory patients with advanced, unresectable NSCLC. NAVELBINE should not be used in patients with granulocyte counts less than 1000 cells/mm3.

Dosage

NAVELBINE: 30 mg/m2 weekly as a 6- to 10-minute intravenous injection.
Cisplatin: Standard dosage.
Dosage of NAVELBINE must be reduced if granulocytopenia and/or hepatic insufficiency are present.

Length of trial

Allow adequate time for response to occur. Responses have been seen as late as the third month of therapy in clinical studies.[1]

Reasonable expectations

In a randomized clinical study, 206 patients who received NAVELBINE plus cisplatin showed a median survival time of approximately 40 weeks and a 1-year survival rate of 35%.[2] Dose limiting side effects Dose-limiting toxicity is granulocytopenia, which is generally reversible and noncumulative over time. Granulocytopenia resulting in hospitalizations for fever and/or sepsis was reported in 8% of patients. Septic deaths occurred in approximately 1% of patients.

Other side effects

Nonhematologic adverse effects are usually mild or moderate and include injection site reactions, nausea/vomiting, constipation, fatigue, peripheral neuropathy, diarrhea, and alopecia. Fatigue (5%) and injection site reactions (5%) were the only nonhematologic events that were of Grade 3-4 intensity in less than 2% of patients. Severe dyspnea was observed in 2% of patients. Since NAVELBINE is a moderate vesicant, proper administration technique is important to avoid potential extravasation.

How to order NAVELBINE

NAVELBINE can be ordered through your wholesaler. Offices and free-standing clinics also can order NAVELBINE directly from Glaxo Wellcome Inc. by calling 1-800-252-9566.

Please see accompanying full prescribing information.


Appropriate use as monotherapy

Patient selection

NAVELBINE may be used as a single agent for the first-line treatment of ambulatory patients with stage IV NSCLC. NAVELBINE should not be used in patients with granulocyte counts less than 1000 cells/mm3.

Dosage

30 mg/m2 weekly in a 6- to 10-minute intravenous injection. Dosage must be reduced if granulocytopenia and/or hepatic insufficiency are present.

Length of trial

Allow adequate time for response to occur. Responses have been seen as late as the third month of therapy in clinical studies.[1]

Reasonable expectations

In a randomized clinical study, 206 patients who received NAVELBINE showed a median survival time of approximately 31 weeks and a 1-year survival rate of 30%.[2]

Dose limiting side effects

Dose-limiting toxicity is granulocytopenia, which is generally reversible and noncumulative over time. Granulocytopenia resulting in hospitalizations for fever and/or sepsis was reported in 8% of patients. Septic deaths occurred in approximately 1% of patients.

Other side effects

Nonhematologic adverse effects are usually mild or moderate and include injection site reactions, nausea/vomiting, constipation, fatigue, peripheral neuropathy, diarrhea, and alopecia. Fatigue (5%) and injection site reactions (5%) were the only nonhematologic events that were of Grade 3-4 intensity in less than 2% of patients. Severe dyspnea was observed in 2% of patients. Since NAVELBINE is a moderate vesicant, proper administration technique is important to avoid potential extravasation.

How to order NAVELBINE

NAVELBINE can be ordered through your wholesaler. Offices and free-standing clinics also can order NAVELBINE directly from Glaxo Wellcome Inc. by calling 1-800-252-9566.

Please see accompanying full prescribing information.


References:

1. Depierre A, Lemarie E, Dabouis G, Garnier G, Jacoulet P, Dalphin JC. A phase II study of Navelbine (vinorelbine) in the treatment of non-small-cell lung cancer. Am J Clin Oncol. 1991;14(2):115-119.

2. Le Chevalier T, Brisgand D, Douillard J-Y, et al. Randomized study of vinorelbine and cisplatin versus vindesine and cisplatin versus vinorelbine alone in advanced non-small-cell lung cancer: Results of a European multicenter trial including 612 patients. J Clin Oncol. 1994;12(2):360-367.


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