Abstract | OBJECTIVE: PATIENTS AND METHODS: This phase II, open-label study (NCT00687817) was conducted in 49 patients with stage IIIB/IV NSCLC utilizing a Simon two-stage design. Patients were treated with up to six cycles of carboplatin area under the concentration-time curve (AUC) 5 plus paclitaxel 175 mg/m2 every 21 days with weekly bavituximab 3 mg/kg followed by bavituximab monotherapy until progression or unacceptable toxicity. RESULTS: The primary efficacy endpoint of overall response rate (ORR) was 40.8% (complete response [CR] 2.0%, partial response [PR] was 38.8%). Median progression-free survival (PFS) and overall survival (OS) were 6.0 and 12.4 months, respectively. Treatment-related adverse events (AEs) occurred in 40.8% of patients. The most common treatment-related AEs were anemia (10.2%), asthenia, vomiting, paresthesia, anorexia, and fatigue (6.1% each). One patient with a central, cavitating squamous tumor developed fatal hemoptysis and aspiration. CONCLUSION:
Bavituximab in combination with paclitaxel- carboplatin as first-line therapy demonstrated a tolerable safety profile and potential efficacy in this single-arm phase II trial in patients with advanced local or metastatic NSCLC. Randomized trials with this regimen are in progress. CLINICALTRIALSGOV IDENTIFIER: NCT00687817.
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Authors | Raghunadharao Digumarti, P P Bapsy, Attili V Suresh, G S Bhattacharyya, Lokanatha Dasappa, Joseph S Shan, David E Gerber |
Journal | Lung cancer (Amsterdam, Netherlands)
(Lung Cancer)
Vol. 86
Issue 2
Pg. 231-6
(Nov 2014)
ISSN: 1872-8332 [Electronic] Ireland |
PMID | 25236982
(Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
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Copyright | Copyright © 2014 Elsevier Ireland Ltd. All rights reserved. |
Chemical References |
- Antibodies, Monoclonal
- Carboplatin
- Paclitaxel
- bavituximab
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Topics |
- Adult
- Antibodies, Monoclonal
(administration & dosage)
- Antineoplastic Combined Chemotherapy Protocols
(adverse effects, therapeutic use)
- Carboplatin
(administration & dosage)
- Carcinoma, Non-Small-Cell Lung
(drug therapy, mortality, pathology)
- Female
- Humans
- Lung Neoplasms
(drug therapy, mortality, pathology)
- Male
- Middle Aged
- Neoplasm Staging
- Paclitaxel
(administration & dosage)
- Risk Factors
- Treatment Outcome
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