Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel, Carboplatin, and Bevacizumab in First-line Patients with Advanced Nonsquamous Non-small Cell Lung Cancer. Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer [J Thorac Oncol] Journal article | | Title | Phase II Trial of Nanoparticle Albumin-Bound Paclitaxel, Carboplatin, and Bevacizumab in First-line Patients with Advanced Nonsquamous Non-small Cell Lung Cancer. | | Author(s) | Reynolds C, Barrera D, Jotte R, Spira AI, Weissman C, Boehm KA, Pritchard S, Asmar L | | Institution | *US Oncology Research, Inc., The Woodlands, Texas; daggerOcala Oncology, Ocala, Florida; double daggerTexas Cancer Center, Ft. Worth, Texas; section signRocky Mountain Cancer Centers, Denver, Colorado; parallelFairfax Northern Virginia Hematology-Oncology, Fairfax, Virginia; and paragraph signNew York Oncology Hematology, Latham, New York. | | Source | J Thorac Oncol 2009 Oct 31. | | Abstract | INTRODUCTION:: Carboplatin/paclitaxel chemotherapy with bevacizumab is an accepted standard treatment for advanced nonsquamous non-small cell lung cancer (NSCLC). The development of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has circumvented many of the infusion difficulties associated with standard solvent-based paclitaxel (in Cremophor) and offers theoretical advantages in efficacy. This trial evaluated the combination of nab-paclitaxel, carboplatin, and bevacizumab in advanced (stage IIIB/IV) nonsquamous NSCLC.
METHODS:: Fifty patients with stage IIIB/IV NSCLC were enrolled between October 2005 and April 2006; 48 were treated with nab-paclitaxel 300 mg/m, carboplatin area under the curve = 6, and bevacizumab 15 mg/kg every 21 days until progression or intolerable toxicity, up to 4 cycles; an additional 2 cycles could be administered to responding patients and the physician's discretion; maintenance bevacizumab was not administered. Patient demographics included: 56% female, median age 67 years (range, 32-83), performance status 0 (52%) or 1 (48%), adenocarcinoma 86%, and stage IV disease 82%. Responding patients received a minimum of 4 cycles. The primary end point was response rate.
RESULTS:: Response rate was 31% with a stable disease rate of 54%. No complete responses were observed. Median progression-free survival was 9.8 months (range, <1-22.3), and median survival was 16.8 months. Most frequent grades 3 and 4 treatment-related toxicities were neutropenia (54%) and fatigue (17%).
CONCLUSIONS:: The combination of nab-paclitaxel, carboplatin, and bevacizumab was well tolerated with moderate neutropenia. Adverse events were manageable. Survival results are encouraging. These results indicate that this combination has promising activity as first-line therapy in patients with nonsquamous NSCLC. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19887966 |
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