Introduction

Advanced non-small cell lung cancer (NSCLC) is a serious disease with a poor prognosis. The overall 5-year survival rate for patients with regional lung cancer is 14%; this rate drops to 2% for patients with metastatic disease.^[1]

The best treatment for patients with advanced NSCLC has yet to be established. Although some combination chemotherapy regimens have been shown to result in a survival advantage compared to best supportive care, these regimens are often accompanied by significant toxicities including nausea, vomiting, alopecia, neurotoxicity, and nephrotoxicity. Thus, patients are faced with the dilemma of choosing between longer survival and acceptable quality of life.

Efficacy Summary

NAVELBINE (vinorelbine tartrate) Injection is a semisynthetic vinca alkaloid that has been extensively tested in clinical trials conducted in North America and Europe. The survival durations produced by the combination of NAVELBINE plus cisplatin are significantly longer than those obtained by another vinca alkaloid plus cisplatin chemotherapy regimen (40 weeks median survival time [MST] vs 32 weeks, p=0.03).^[2]

Single-agent therapy with NAVELBINE has been shown to result in consistent MSTs of 30-31 weeks, which is similar to those reported with combination regimens.

Safety Summary

Hematologic: Granulocytopenia, the major dose-limiting toxicity of NAVELBINE (vinorelbine tartrate) Injection, resolves spontaneously, is noncumulative and does not routinely require growth factor support; it is manageable by dose modification or delay and careful patient monitoring. Hospitalizations for complications related to granulocytopenia occurred in less than 1 in 10 patients treated with single-agent NAVELBINE. Granulocytopenia is more frequent in patients receiving the combination of NAVELBINE and cisplatin but remains manageable.

Nonhematologic: 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 greater than 2% of patients. Severe dyspnea was observed in 2% of patients. In combination with cisplatin, NAVELBINE does not add to the nonhematologic toxicities commonly associated with cisplatin.

Whether used in combination with cisplatin or as single-agent therapy, NAVELBINE broadens the treatment options for patients with advanced NSCLC. This Practical Guide discusses safe dosing and administration of NAVELBINE and offers important information on optimal clinical use.

[ Top | Lung Library Index | Navelbine Index | Practical Guide Index | Next ]