Erlotinib in First-line Therapy for Non-small Cell Lung Cancer: A Prospective Phase II Study

• Published in: Anticancer research Vol. 31; no. 10; pp. 3457 - 3462
• Main Authors: DAE RO CHOI, DAE HO LEE, CHOI, Chang-Min, KIM, Sang-We, SUH, Cheolwon, LEE, Jung-Shin
• Format: Journal Article
• Language: English
• Published: Attiki International Institute of Anticancer Research 01.10.2011
• Subjects: Aged; Antineoplastic agents; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Biological and medical sciences; Carcinoma, Non-Small-Cell Lung - drug therapy; Carcinoma, Non-Small-Cell Lung - pathology; Chemotherapy; Erlotinib Hydrochloride; Female; Humans; Kaplan-Meier Estimate; Lung Neoplasms - drug therapy; Lung Neoplasms - pathology; Male; Medical sciences; Middle Aged; Mutation - genetics; Pharmacology. Drug treatments; Prospective Studies; Quinazolines - adverse effects; Quinazolines - therapeutic use; Receptor, Epidermal Growth Factor - genetics; Treatment Outcome; Tumors; Antineoplastic agent; Gemcitabine; Quinazoline derivatives; Lung cancer; non-small cell lung carcinoma; Epidermal growth factor receptor; Prospective; EGFR mutation; Cancerology; Gene; Phase II trial; Genetics; Bronchus disease; Protein-tyrosine kinase; Pyrimidine nucleoside; Platinum II Complexes; Human; non-small cell lung cancer; Lung disease; Drug combination; Enzyme; Tyrosine kinase inhibitor; Respiratory disease; Transferases; Enzyme inhibitor; Malignant tumor; First line treatment; Chemo-naive; Chemotherapy; platinum doublet; Treatment; Antimetabolic; Erlotinib; Carboplatin; Pyrimidine derivatives; Fluorine Organic compounds; Mutation; Cancer
• ISSN: 0250-7005; 1791-7530

This phase II study evaluated efficacy of first-line erlotinib therapy for chemo-naïve patients with non-small cell lung cancer (NSCLC) by their clinicopathological and/or molecular characteristics. Eligible patients received erlotinib 150 mg daily until disease progression, followed by a gemcitabine/carboplatin doublet. By clinicopathological characteristics, the patients were categorized as squamous cell carcinoma (SQCC group), ever-smoker with adenocarcinoma (ever-smoking ADCC group), or never-smoker with adenocarcinoma (never-smoking ADCC group). Epidermal Growth Factor Receptor (EGFR) mutations were prospectively assessed by a direct sequencing method and confirmed retrospectively by the Scorpion amplified refractory mutation system (ARMS). Seventy-five patients participated in this study. The direct sequencing method detected 18 EGFR mutations while ARMS detected an additional 3 EGFR mutations and 1 second EGFR T790M mutation. The objective response rates (ORR) were 71.7% in never-smoking ADCC, 25.0% in ever-smoking ADCC, but no response in SQCC, while those of the patients with EGFR mutant and wild-type ere 85.7% and 10.0%, respectively. Even in never-smoking ADCC, the EGFR mutants responded better, with ORR of 88.9% and survived longer, with median survival time of 25.4 months, than those with wild-type EGFR with ORR of 25.0% and median survival time of 16.6 months (p<0.05). ORR for gemcitabine and carboplatin was 16.1%. The decision to administer first-line erlotinib should be decided by molecular characteristics, if known, but can be made by clinico-pathological characteristics as second best policy.