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,  Clinical Article

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.

Methods

  • 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.

Results
  • 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.

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