Randomized phase II study of weekly docetaxel plus trastuzumab versus weekly paclitaxel plus trastuzumab in patients with previously untreated advanced nonsmall cell lung carcinoma

摘要: BACKGROUND Trastuzumab is a monoclonal antibody directed against the human epidermal growth factor receptor-2 (HER-2). Nonsmall cell lung carcinoma (NSCLC) overexpresses HER-2 protein in approximately 20% of cases. In current study, authors combined trastuzumab with weekly taxanes an attempt to improve outcomes over standard chemotherapy patients advanced NSCLC. METHODS The primary objective was determine whether docetaxel plus or paclitaxel superior regimen based on response and toxicity, either appropriate for further testing randomized Phase III trial. After stratification results immunohistochemistry, chemotherapy-naive were receive paclitaxel. The study designed so without overexpression would be distributed equally between arms. RESULTS Immunohistochemistry expression attempted 182 pathologic samples from 169 patients. Twenty-eight 179 evaluable (16%) revealed 2+ 3+ staining. rate 23% (7 30 patients) treated 32% (11 34 (P=0.76, Wilcoxon test). No difference noted median survival (16 mos vs. 14 mos) 1-year (57% 55%) (P=0.998). Toxicities mild both treatment arms. regard rates HER-2–positive (2+ 3+) HER-2–negative (0–1+) patients. CONCLUSIONS The NSCLC this found similar that reported previous series. toxicities trasuzumab not significantly different, though arms better than expected. status did appear affect uniform group who comparable fashion. Because infrequency overexpression, absence improved other studies, neither tested will Cancer 2005. © 2005 American Society.