Vinorelbine is a semisynthetic vinca
alkaloid that is effective as monotherapy in elderly patients with advanced
non-small cell lung cancer (NSCLC). In the large comparative Elderly
Lung Cancer Vinorelbine Italian Study (
ELVIS), patients receiving
vinorelbine monotherapy achieved an objective response rate of 19.7%. The median survival time and the 1-year survival rate were significantly higher in recipients of
vinorelbine plus best supportive care than in recipients of best supportive care alone.
Vinorelbine recipients generally scored better than recipients of best supportive care on quality-of-life (QOL) functioning scales and experienced significantly fewer
lung cancer-related symptoms; however, QOL scores were worse with
vinorelbine for parameters relating to
drug tolerability. Comparative phase III trials investigating the efficacy of combination
therapy with
vinorelbine and other agents specifically in elderly patients with advanced NSCLC have been conducted only for the combination of
vinorelbine and
gemcitabine [the Southern Italy Cooperative Oncology Group (SICOG) trial and the Multicenter Italian
Lung Cancer in the Elderly Study (MILES)]. Objective response rates for
vinorelbine/
gemcitabine combination
therapy in these phase III trials were 22 and 20%, respectively. The SICOG trial was closed early when an interim analysis demonstrated a significant survival advantage for combination
therapy with
vinorelbine plus
gemcitabine over
vinorelbine monotherapy. However, a survival advantage for combination
therapy versus
vinorelbine monotherapy was not demonstrated in the larger MILES trial. The main adverse effect of
vinorelbine monotherapy in the elderly is myelosuppression. Adverse events associated with most
antineoplastic agents, such as mild
alopecia,
nausea,
vomiting and
mucositis, were reported in clinical trials; however, these events were rarely severe. Mild-to-moderate neurotoxicity, including
constipation (presumably from autonomic neuropathy), was also reported. The addition of
gemcitabine to
vinorelbine increased the incidence of both haematological and nonhaematological adverse events. However, there was no significant increase in the incidence of life-threatening toxicity.
Vinorelbine as a single agent is effective in elderly patients with NSCLC and is associated with improved survival and at least a trend towards improved QOL parameters compared with best supportive care alone.
Vinorelbine was associated with a generally manageable tolerability profile. The benefit of adding
gemcitabine to
vinorelbine for the treatment of NSCLC in the elderly is equivocal; improved survival was reported in one comparative trial, but not in another larger one.
Vinorelbine is an effective and well tolerated
palliative treatment option for elderly patients with advanced NSCLC.