NEWS FROM ESMO

Targeted Therapy Better Than Chemotherapy for NSCLC?

In Asia, a high proportion of non-smokers develop NSCLC with adenocarcinoma histology. Fifty to sixty percent of them have tumors with mutations in the epidermal growth factor receptor (EGFR) that are responsive to therapy with EGFR tyrosine kinase inhibitors (TKIs). Investigators designed a phase III randomized trial of 1,217 Asian non-smokers with stage IIIB/IV adenocarcinoma of the lung, chemo-naive, to receive oral gefitinib (Iressa™) (G) 250 mg daily or carboplatin + paclitaxel (C/P) chemotherapy. Primary endpoint was to assess non-inferiority of G vs C/P for PFS. Results: G demonstrated superior PFS compared with C/P (HR 0.74; p<0.001), exceeding the primary endpoint. Treatment effect was not constant over time, favoring C/P for the first 6 months and G for the remaining 16 months, probably driven by differences in PFS outcomes for patients with EGFR mutation M(+) and M(-) tumors. ORR was significantly higher with G than C/P (43% vs 32.2%, odds ratio [OR] 1.59; p=0.0001). QoL and tolerability profiles were significantly higher for G. PFS was longer for G than C/P in M(-) patients. The authors conclude that this study has demonstrated superior treatment outcomes for G over standard chemoRx as first-line treatment for this clinically selected population. They believe that gefitinib should be one of the standard first-line therapies for such patients.

Comment: Gefitinib and other EGFR TKIs are now considered as second-line therapy after failure of chemoRx, but in this special patient population they should be considered for use as initial treatment.

Mok T, et al. LBA2 Annals of Oncology 19 (Supplement 8) 2008.

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