Docetaxel-carboplatin chemotherapy combined with cetuximab in patients with locally advanced or metastatic non small-cell lung cancer (NSCLC)--results of the nonrandomised phase II study TaxErb

This open label, single arm phase II study was designed to evaluate the efficacy and safety of the addition of cetuximab to first line chemotherapy with carboplatin and weekly docetaxel in patients with advanced non small-cell lung cancer (NSCLC). From February 2007 to December 2008 74 patients with NSCLC (stage IIIB and IV), ECOG PS ≤2 and no prior systemic chemotherapy were enrolled and treated with carboplatin (area under the curve=5 on day 1) and docetaxel (35 mg/m(2) on days 1, 8, and 15). Cycles were repeated every 4 weeks for a minimum of 4 and a maximum of 6 cycles. Cetuximab (400mg/m(2) on day 1 with subsequent doses of 250 mg/m(2) weekly) was administered until progression or intolerable toxicity up to a maximum treatment duration of 12 months. The primary endpoint was the overall response rate (CR+PR) according to RECIST. Secondary endpoints were progression-free survival (PFS), overall survival (OS) and toxicity. Patients received a median of 4 cycles of docetaxel-carboplatin-chemotherapy. The median number of administrations of cetuximab was 14. Sixty-seven patients were evaluable for response. Partial response was seen in 29/67 patients corresponding to an overall response rate (ORR) of 43.3% (95%CI, 28.5-53.7). No patient experienced complete response. The clinical benefit rate (PR+SD) was 79.1%. The 1-year rates for PFS and OS were 11.2% and 64.4%, respectively. Median PFS was 4.8 months (95%CI, 3.70-5.31) and median OS 12.9 months (95%CI 8.26-∞). Adverse events were mainly grades 1-2. Skin toxicity (76% of pts), dyspnea (36.5%) and anemia (31.1%) were most frequent. Results from this phase II study suggest that the addition of cetuximab to first-line doublet carboplatin and weekly docetaxel results in a considerable clinical efficacy with an acceptable toxicity profile for patients with advanced or metastatic NSCLC.