Targeted and Cytotoxic Therapy in Coordinated Sequence (TACTICS): Erlotinib, Bevacizumab, and Standard Chemotherapy for Non-Small-Cell Lung Cancer, A Phase II Trial

The aim of this phase II study (ClinicalTrials.gov ID: NCT00607165) was to effectively combine existing targeted and cytotoxic chemotherapy in unselected patients with non small-cell lung cancer (NSCLC). The study achieved it primary endpoint, with a nonprogression rate of 46%, and the combination of erlotinib and bevacizumab was well tolerated. Given the modest benefit and the fact that frontline treatment with erlotinib is primarily indicated in patients with activating epidermal growth factor receptor (EGFR) tyrosine kinase (TK) mutations, we do not feel that this regimen requires further evaluation in unselected patients with NSCLC. Background: This trial focused on optimally combining existing targeted therapies and cytotoxic chemotherapy in the treatment of unselected patients with advanced non-small-cell lung cancer (NSCLC). Methods: Patients with previously untreated advanced-stage nonsquamous NSCLC were eligible for this trial. In module A, patients received up to 4 cycles of erlotinib 150 mg daily and bevacizumab 15 mg/kg every 3 weeks. Patients then received carboplatin (AUC = 6), paclitaxel 200 mg/m2, and bevacizumab 15 mg/kg for 4 cycles in module B. Patients who did not have progressive disease in module A received maintenance erlotinib 150 mg daily and bevacizumab 15 mg/kg every 3 weeks in module C. Results: Forty-eight patients were enrolled in this multicenter phase II trial. Most patients were male (62.5%) and white (77.1%) with stage IV disease (93.8%) and adenocarcinoma histologic type (66.7%). The overall response rate in module A was 10.4%, in module B it was 15.1%, and in module C it was 5.5%. The study achieved its primary endpoint, with a nonprogression rate of 45.8% in module A. The median overall survival (OS) was 12.6 months. Conclusion: The novel systemic therapy regimen is feasible in patients with advanced NSCLC. However there is no further role for developing this regimen in unselected patients with NSCLC. Clinical Lung Cancer, Vol. 13, No. 2, 123-8 (C) 2012 Elsevier Inc. All rights reserved.