Multitargeted Antifolate LY231514 as First-Line Chemotherapy for Patients With Advanced Non–Small-Cell Lung Cancer: A Phase II Study

• DOI: 10.1200/jco.1999.17.4.1194
• Publication Date: 2017-02-24T06:21:13Z
• Authors: James J. Rusthoven; Elizabeth Eisenhauer; Charles Butts; Richard Gregg; Janet Dancey; Bryn Fisher; Jose Iglesias
• Keywords: Antifolate; Performance status

To evaluate the efficacy and safety of multitargeted antifolate LY231514 (MTA) in patients receiving initial chemotherapy for unresectable, advanced non-small-cell lung cancer (NSCLC).Patients with measurable, NSCLC who had not received previous disease were considered this study. Eligible gave written informed consent initially MTA 600 mg/m(2) intravenously (IV) 10 minutes every 3 weeks. After three treatment at dose, dose was reduced to 500 IV same infusion time frequency because toxicity seen study another Canadian trial colorectal cancer. Patients up four cycles after complete or partial remission six stable documented.Thirty-three accrued onto All assessable toxicity, 30 response. but one patient an Eastern Cooperative Oncology Group performance status score 0 1, 18 (55%) adenocarcinoma, nine (27%) squamous cell carcinoma. Twenty-five (76%) stage disease, remainder IIIB entry. Seven experienced a confirmed response no responses seen; thus, overall rate 23.3% (95% confidence interval, 9.9% 42.3%). The median duration 3.1 months (range, 2. 13.5 months) follow-up period 7.9 months. Four (67%) (12.5%) 24 responded treatment. (13.3%) febrile neutropenia 13 (39%) grade 4 neutropenia, whereas only (3%) developed thrombocytopenia. Nonhematologic generally mild moderate, 39% skin rash. Most other toxicities comprised 1 2 stomatitis, diarrhea, lethargy, anorexia. Ten stopped protocol therapy toxicity.MTA seems have clinically meaningful activity as single agent against NSCLC. Toxicity is tolerable. Further combination cisplatin active drugs warranted disease.