Vandetanib delays disease progression in elderly NSCLC patients
medwireNews: Vandetanib used in combination with gemcitabine significantly improves progression-free survival (PFS) compared with gemcitabine alone when used as a first-line treatment for elderly patients with advanced non-small-cell lung cancer (NSCLC), Italian researchers report.
Cesare Gridelli (“SG Moscati” Hospital, Avellino) compared the efficacy and tolerability of oral vandetanib (100 mg daily) plus gemcitabine (1200 mg/m2 intravenously on days 1, 8 and 21 of each 21-day cycle) with that of placebo plus gemcitabine in 124 patients aged 70 years or older. All patients had treatment-naïve stage IIIB/IV NSCLC.
The researchers report in the Journal of Thoracic Oncology that PFS was significantly longer in the vandetanib/gemcitabine arm compared with the gemcitabine alone arm at a median of 183 versus 169 days.
Furthermore, a planned subgroup analysis showed that PFS was significantly longer with vandetanib plusgemcitabine than gemcitabine alone for patients with all types of histological tumours except squamous cell carcinoma, as well as in never and past smokers and in female patients.
The researchers note that the improvement in PFS in the vandetanib arm did not, however, translate into an improvement in overall survival or any other secondary endpoint investigated, namely objective response rate, duration of response, disease control rate and time to deterioration of performance status.
Pyrexia, dyspnoea and neutropaenia were the most common adverse events and were observed at comparable rates in the two groups. Overall 96.7% of patients in the vandetanib arm and 98.4% of those in the gemcitabine only arm experienced at least one adverse event. Serious adverse events were reported by 42.6% and 32.7%, respectively.
Gridelli and co-authors comment that QT interval prolongation has been reported in previous clinical trials with vandetanib. In the current study, a QTc interval prolongation was reported in five (8.2%) patients treated with vandetanib and in two (3.2%) in the gemcitabine only group.
The researchers conclude: “Taking into account the results of this phase II study in terms of efficacy and safety, further research is of interest to better identify the group of patients who might benefit from vandetanib treatment.”
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By Laura Cowen, medwireNews Reporter