Elderly patients with advanced non-small-cell lung cancer (NSCLC) treated with vinorelbine tartrate(Drug information on vinorelbine tartrate) (Navelbine) injection enjoy improved survival over those receiving best supportive care, according to a study published in the February issue of the Journal of the National Cancer Institute.
The multicenter, phase III study conducted in Italy compared best supportive care to vinorelbine in 161 NSCLC patients ³ 70 years old. In patients who received vinorelbine, the median survival duration was 28 weeks, vs 21 weeks in those who received best supportive care. Survival rates at 6 and 12 months were 55% and 32%, respectively, among those in the vinorelbine arm, compared to 41% and 14%, respectively, in those who received only best supportive care.
Trial Stopped Early
The trial was stopped early because the investigators’ hesitancy to continue to enroll patients in the best supportive care arm resulted in a low enrollment rate.
Quality of life measures, which were also an endpoint in the study, should be interpreted with caution state the authors of the study due to the decline in completed questionnaires over the study period.
“How to effectively treat elderly cancer patients is a growing concern because most elderly patients have difficulty tolerating the toxicity of chemotherapy agents,” said Judy Bryson, pharmd, director, Glaxo Wellcome US Medical Affairs, Oncology. “That these results show that Navelbine offers a survival benefit without adversely affecting their quality of life gives them a viable treatment option.”
Vinorelbine is a semisynthetic vinca approved as a single agent or in combination with cisplatin(Drug information on cisplatin) (Platinol) for first-line treatment of ambulatory patients with unresectable, advanced NSCLC. The approved dose of vinorelbine as a single agent or combined with cisplatin is 30 mg/m²/wk.
Vinorelbine is contraindicated in patients with pretreatment granulocyte counts of < 1,000 cells/mm³. The major dose-limiting adverse events, leukopenia and granulocytopenia, occur 7 to 10 days after the dose and usually recover within the following 7 to 10 days.
Clinical Experience With Vinorelbine in the Elderly
Of the total number of patients in North American clinical studies evaluating IV vinorelbine, approximately one-third were ³ 65 years of age. No overall differences in effectiveness or safety were observed between these patients and younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
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