A Phase II Study of Erlotinib as a First-Line Therapy for Patients with Non—Small-Cell Lung Cancer with Favorable Clinical Predictors

BackgroundMany studies of epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors suggest positive and negative predictors for response and survival. We conducted the study to evaluate the efficacy of erlotinib as a first-line therapy for patients with non—small-cell lung cancer who have favorable clinical predictors, such as never having smoked, adenocarcinoma, or female sex.Patients and MethodsThe eligible patients should have ≥ 2 of 3 favorable clinical predictors, including female sex, adenocarcinoma, and never-smoker status. Additional inclusion criteria were as follows: stage IIIB or IV disease, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0–2, adequate organ function, and measurable lesions. Neither previous chemotherapy nor targeted therapy nor radiation therapy for measurable disease was allowed. Treatment consisted of erlotinib 100–150 mg orally given once daily till disease progression, unacceptable toxicity, or patient's refusal. Objective tumor responses were assessed 1 month after the commencement of erlotinib and then every 2 months.ResultsBetween October 2006 and June 2007, all 38 patients enrolled (median age, 54 years; male/female, 1/37; ECOG PS 0/1/2, 2/29/7; stage IIIB/IV disease, 3/35; never/current smoker 36/2) were evaluable for response. Among them, 26 reached a partial response (PR), 6 had stable disease (SD), and 6 had progressive disease (PD), giving an overall response rate of 68.4% (95% CI, 52.5%–81%) and a disease control rate of 84.2% (95%CI, 69.2%–92.9%). Out of 6 patients identified to have an EGFR gene mutation before initiating treatment, 5 reached a PR, and 1 had PD, while out of 6 patients with wild-type of EGFR, there were 2 PRs, 1 SD, and 3 PDs. After a median follow-up of 7.9 months, the expected median progression-free survival is 10.7 months, with an expected 1-year survival rate of 91.2%. The most common toxicity was skin rash, which was manageable.ConclusionErlotinib showed promising response rates as a first-line therapy for patients who have favorable predictors and could be a treatment of choice in this clinical setting.