Long-term survival with gefitinib (ZD 1839) therapy for advanced bronchioloalveolar lung cancer (BAC): Southwest Oncology Group (SWOG) study S0126.

8047 Background: BAC, a non-small cell lung cancer (NSCLC) subtype with distinctive clinical, pathologic, and radiographic characteristics, remains without an accepted standard of care for advanced, multi-focal disease. Outcomes with chemotherapy are reported to be poor, and sensitivity to EGFR inhibitor therapy high. SWOG initiated S0126 to determine the activity and tolerability of gefitinib therapy, and to determine clinical and molecular variables associated with outcomes. We previously reported clinical results with a median follow-up of 22 months (West et al, JCO, 2006) as well as molecular variables of EGFR FISH status and activating mutations in a subset of S0126 patients (Hirsch et al., Ann Oncol 2006).,Here we update long-term results for 135 eligible patients (100 chemo-naive, 35 previously treated) who received gefitinib 500 mg PO daily until progression or prohibitive toxicity.,With a median follow-up of 58 months (minimum 38 mos.), median progression-free survival (PFS) and overall survival (OS) remain at 4/3 and 13/13 months, for treatment-naïve/previously treated cohorts, respectively. Three year survival is 27% for the chemo-naïve stratum and 20% for previously treated. Five-year survival is 12% (14% for pretreated). Patients surviving ≥ 3 years were more likely to be EGFR positive by FISH (50% FISH+ vs 26% for patients surviving < 3yrs, p=.058, N=81 cases with a FISH result). 6 patients remained on treatment without progression > four years; at present 3 patients, all treatment-naïve, remain without evidence of progression at 56-67 months from initiation of treatment; Two are EGFR FISH+, one with an exon 21 mutation.,Long term survival of 27% at 3 years compares favorably to prior SWOG chemotherapy data in advanced BAC. A subset of these patients continue to demonstrate PFS > 4-5 years (CA32102, CA38926) [Table: see text].