Phase II study of erlotinib for chemotherapy-naïve patients with advanced or metastatic non-small cell lung cancer who are ineligible for platinum doublets.

Purpose: This phase II study evaluated efficacy of single-agent erlotinib for chemotherapy-naïve patients with advanced/metastatic NSCLC who were ineligible for platinum doublets.

Methods: Chemotherapy-naive patients but ineligible for platinum doublets (aged 18-75 with an ECOG performance status [PS] 2-3; or aged 76 or older with an ECOG PS 1-3) were enrolled and treated with erlotinib 100 mg once daily till disease progression, unacceptable toxicity or patient's refusal.

Results: Out of 24 patients enrolled, 5 reached a PR, giving an overall response rate of 21%, but all responders were never-smokers with adenocarcinoma. According to EGFR mutation status, PR was observed in two of three patients having mutant EGFR (67%) but in one of nine having wild-type EGFR (11%). With a median follow-up of 22.6 months, the median progression-free and overall survival was 1.5 months and 3.2 months, respectively. All responders to post-erlotinib chemotherapy had responded to prior erlotinib.

Conclusions: For unselected chemotherapy-naïve Asian patients with NSCLC but ineligible for platinum doublets, empirical use of upfront erlotinib could not be recommended because of poor survival outcome. However, this can be given to selected subsets based on molecular or clinical predictors.