Gefitinib versus placebo as maintenance therapy in patients with locally advanced or metastatic non-small-cell lung cancer (INFORM; C-TONG 0804): a multicentre, double-blind randomised phase 3 trial
The Lancet Oncology, 04/20/2012
Zhang L et al. – Maintenance treatment with gefitinib significantly prolonged progression-free survival compared with placebo in patients from east Asia with advanced NSCLC who achieved disease control after first-line chemotherapy.
Patients were aged 18 years or older, were of east Asian ethnic origin, had a life expectancy of more than 12 weeks, histologically or cytologically confirmed stage IIIb or IV NSCLC, a WHO performance status of 0—2, and had completed four cycles of first-line platinum-based doublet chemotherapy without disease progression or unacceptable toxic effects.
Between Sept 28, 2008 and Aug 11, 2009, 296 patients were randomly assigned 1:1 to receive either gefitinib (250 mg per day orally) or placebo (orally) within 3—6 weeks after chemotherapy until progression or unacceptable toxic effects.
Randomisation was done via an interactive web response system with computer-generated randomisation codes.
Our primary endpoint was progression-free survival assessed in the intention-to-treat population.
Progression-free survival was significantly longer with gefitinib (n=148) than with placebo (148) (median progression-free survival 4·8 months [95% CI 3·2—8·5] vs 2·6 months [1·6—2·8]; hazard ratio [HR] 0·42, 95% CI 0·33—0·55; p<0·0001).
Adverse events occurred more frequently with gefitinib than with placebo; the most common adverse events of any grade were rash (73 [50%] of 147 in the gefitinib group vs 14 [9%] of 148 in the placebo group), diarrhoea (37 [25%] vs 13 [9%]), and alanine aminotransferase increase (31 [21%] vs 12 [8%]).
The most commonly reported grade 3 or 4 adverse event was alanine aminotransferase increase (3 [2%] of 147 in the gefitinib group, none of 148 in the placebo group).
Ten of 147 (7%) patients given gefitinib and five of 148 (3%) patients given placebo had serious adverse events.
Three deaths were thought to be related to treatment with gefitinib: one from interstitial lung disease; one from lung infection; and one from pneumonia.
MDLinx connects healthcare professionals and patients to tomorrow's important medical news, while providing the pharmaceutical and healthcare industries with highly targeted interactive marketing, education, content, and medical research solutions.