Trastuzumab in combination with cisplatin and gemcitabine in patients with Her2-overexpressing, untreated, advanced non-small cell lung cancer: report of a phase II trial and findings regarding optimal identification of patients with Her2-overexpressing disease

摘要: The purpose of this study was to evaluate the feasibility, efficacy, safety, and pharmacokinetics trastuzumab plus cisplatin gemcitabine in patients with Her2-overexpressing stages IIIB or IV non-small cell lung cancer (NSCLC) relationship between results from two methods for determining levels Her2 overexpression. Chemonaive were eligible if they had NSCLC either a score at least 1+ by immunohistochemical (IHC) analysis serum shed antigen level 15 ng/ml enzyme-linked immunosorbent assay (ELISA). Treatment consisted 75 mg/m(2) day one 1250 days eight 4 mg/kg 2 weekly thereafter on 21-day cycle six cycles followed maintenance therapy. Of 21 enrolled, 8 (38%) partial response. 1-year survival rate 62% (13/21). Median time progression 36 weeks. Pharmacokinetic studies revealed no interaction cisplatin. In screened study, expression zero 283/360 (79%); 32/360 (9%); 2+ 27/360 (8%); 3+ 18/360 (5%). Serum >15 27/ 288 (9%) patients. who both assays, 24% (4/17) ELISA scores IHC 3+, compared only 2% (3/145) would greatly increase efficiency screening though cost excluding nearly half analysis. Thus, sequential consisting is implemented, it may make trial feasible but should ultimately be supplanted another system shown beneficial some 3+.