Phase 2 Trial of Linifanib (ABT-869) in Patients with Advanced Non-small Cell Lung Cancer
| Autor: | Thomas A. Hensing, Raymond Thertulien, Ravi Salgia, Frank A. Scappaticci, David R. Gandara, Rajendra S. Pradhan, Dawn M. Carlson, Nasser H. Hanna, Jiang Qian, Glenwood D. Goss, James Chih-Hsin Yang, Benjamin Besse, Ross A. Soo, Christa Lee, J. L. Ricker, Michael S. Wertheim, Eng Huat Tan, Neeraj Gupta, Julien Mazieres, Qin Qin |
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| Rok vydání: | 2011 |
| Předmět: |
Male
Pulmonary and Respiratory Medicine medicine.medical_specialty Indazoles Lung Neoplasms PDGFR Nausea Administration Oral Salvage therapy Adenocarcinoma NSCLC Gastroenterology VEGFR chemistry.chemical_compound Carcinoma Non-Small-Cell Lung Internal medicine medicine Carcinoma Clinical endpoint Humans Adverse effect Lung cancer Survival rate Neoplasm Staging Salvage Therapy Linifanib (ABT-869) business.industry Phenylurea Compounds International Agencies Receptor Protein-Tyrosine Kinases Middle Aged medicine.disease Surgery Survival Rate Linifanib Treatment Outcome chemistry Oncology Carcinoma Squamous Cell Female Angiogenesis medicine.symptom business Follow-Up Studies |
| Zdroj: | Journal of Thoracic Oncology. 6(8):1418-1425 |
| ISSN: | 1556-0864 |
| DOI: | 10.1097/jto.0b013e318220c93e |
| Popis: | Introduction This study assessed activity and safety of linifanib (ABT-869), a selective inhibitor of vascular endothelial growth factor and platelet-derived growth factor receptors, in patients with locally advanced or metastatic non-small cell lung cancer. Methods In this open-label trial (NCT00517790), patients who received one to two prior lines of systemic therapy were randomized to oral linifanib 0.10 mg/kg (low dose) or 0.25 mg/kg (high dose) once daily. Tumor responses were assessed by independent central imaging review every 8 weeks. The primary end point was progression-free rate at 16 weeks. Secondary end points included objective response rate, time to progression, progression-free survival, and overall survival. Safety was also assessed. Results Between August 2007 and October 2008, 139 patients were enrolled; 60% had two or more prior regimens, and 88% had nonsquamous cell carcinoma. The objective response rate (low dose and high dose) was 5.0% (3.1 and 6.8%), progression-free rate at 16 weeks was 33.1% (32.3 and 33.8%), median time to progression was 3.6 months (3.6 and 3.7 months), median progression-free survival was 3.6 months (3.5 and 3.6 months), and median overall survival was 9.0 months (10.0 and 8.3 months). The most common linifanib-related adverse events were fatigue (42%), decreased appetite (38%), hypertension (37%), diarrhea (32%), nausea (27%), palmar-plantar erythrodysesthesia (24%), and proteinuria (22%). These events were more common in the high-dose group. The most common linifanib-related grade 3 or 4 adverse event was hypertension (14%). Conclusions Linifanib is active in advanced non-small cell lung cancer as second- or third-line therapy. Increased adverse event rates were observed at the high dose of linifanib. |
| Databáze: | OpenAIRE |
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