Erlotinib as first-line treatment for untreated advance stage NSCLC with good prognosis

Abstract

7178 Background: Erlotinib demonstrated improved survival in previously treated NSCLC, but did not affect survival in untreated NSCLC when used with concurrent chemotherapy. A potential hypothesis for this paradox is erlotinib may be more effective for patients with less aggressive tumors (i.e. those still surviving after multiple chemotherapy treatments). The current trial was designed to evaluate erlotinib before initial chemotherapy in a population of patients with less aggressive tumors based on clinical criteria. Methods: Eligibility criteria included stage IIIB/IV or recurrent NSCLC, no prior chemotherapy for systemic disease, PS = 0–1, weight loss less than 10%, and no urgent symptoms. Patients received erlotinib 150 mg po/day until objective or symptomatic progression before they were switched to chemotherapy. The 10 endpoint was time-to-progression after 1st chemotherapy. Results: 40 patients have been accrued. The median age was 65, 35 had PS = 1, 8 were never-smoker, and 23 were former smokers. Histologies were: Adeno 20, BAC 2, Sq 6, NSCLC 11, Other 1. The major toxicity was rash (Gr0 in 4, Gr1in 15, Gr2 in 14, Gr3 in 3, 4 too early. Other toxicity included liver (Gr 1 in 2, Gr2 in 1), mucositis (Gr1 in 1, Gr2 in 1) and diarrhea (liver (Gr1 in 10, Gr2 in 1, Gr3 in 2). 34 have been followed long enough for response evaluation, which identified 4 (12%) with PR (median 37 wks), 8 with stable (median 20 wk) and 22 with progression. At progression only 2 patients were too ill to start chemotherapy due to inadequate performance status. The median time on erlotinib was 8 wks overall: for rash Gr 0–1 8 wks, Gr 2–3=43 wks (p = 0.03). The median and 6-month PFS for chemotherapy are 22 wks and 45% with17 still on treatment. The median and 1-yr survivals are 50 wks and 47% with 24 pts still alive. Conclusions: Mid-term safety analyses exceeded expectations. Rash predicts duration of erlotinib effectiveness. Preliminary results suggest single agent, erlotinib may be as effective (PFS and survival) as initial chemotherapy with less toxicity and merits randomized testing as first treatment for advanced lung cancer. No significant financial relationships to disclose.