Efficacy of erlotinib in patients (pts) with advanced non-small-cell lung cancer (NSCLC) relative to clinical characteristics: Subset analyses from the TRUST study.

8081 Background: Erlotinib is proven to prolong survival, delay symptom progression and improve quality of life for pts with advanced NSCLC (Shepherd et al, N Engl J Med 2005;353:123-32). The global, non-randomized, open-label phase IV TRUST study of erlotinib recruited over 7000 pts across 52 countries.,Pts with stage IIIB/IV NSCLC who had previously failed on or were unsuitable for chemo-/radiotherapy received erlotinib 150mg/d p.o. until disease progression or unacceptable toxicity.,At data cut-off on October 25, 2007, data were available for 7039 pts in the study; these data were analyzed by gender, histology and smoking status. Disease control rate (DCR) and progression-free survival (PFS) are shown in the table for six subgroups. DCR was consistent across 2nd- and 3rd-line pts in all groups; only group 5 showed any statistically significant difference between 2nd-line and 3rd-line pts in terms of PFS: 12.7 wks vs 8.9 wks, respectively (p=0.0048). OS data are mature for groups 1 and 5 only; group 1 had median OS of 5.95 mos while group 5 had median OS of 5.58 mos, i.e. no difference between male and female C/FS with SqCC. Among pts with non-squamous tumors, NS appear to derive a greater clinical benefit than C/FS. Prognostic and predictive value could not be differentiated in this study as there was no control arm.,These data confirm the results of the phase III BR.21 study, i.e. a wide range of pt subgroups can derive a clinical benefit from erlotinib. No differences were found in DCR between pts treated in 2nd and 3rd line but some subgroups may derive a greater survival benefit when receiving erlotinib 2nd line. These data indicate that pts should not be excluded from receiving erlotinib based on clinical characteristics. [Table: see text] [Table: see text].