Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer

American Society of Clinical Oncology (ASCO) - Tập 22 Số 11 - Trang 2184-2191 - 2004
Clifton D. Fuller1, Louis Fehrenbacher1, William Novotny1, Roy S. Herbst1, John Nemunaitis1, David M. Jablons1, Corey J. Langer1, Ronald DeVore1, Jacques Gaudreault1, Lisa A. Damico1, Eric Holmgren1, Fairooz F. Kabbinavar1
1From the Division of Hematology & Oncology, Vanderbilt University Medical School, Nashville, TN; Department of Thoracic/Head & Neck Medical Oncology, M.D. Anderson Cancer Center, Houston; US Oncology, Sammons Cancer Center, Baylor University Medical Center, Mary Crowley Medical Research Center, Dallas, TX; Kaiser Permanente, Vallejo; Thoracic Oncology Program, University of California San Francisco/Mount Zion Medical Center; Genentech Inc, South San Francisco, CA; and Fox Chase Cancer Center,...

Tóm tắt

Purpose To investigate the efficacy and safety of bevacizumab plus carboplatin and paclitaxel in patients with advanced or recurrent non-small-cell lung cancer. Patients and Methods In a phase II trial, 99 patients were randomly assigned to bevacizumab 7.5 (n = 32) or 15 mg/kg (n = 35) plus carboplatin (area under the curve = 6) and paclitaxel (200 mg/m2) every 3 weeks or carboplatin and paclitaxel alone (n = 32). Primary efficacy end points were time to disease progression and best confirmed response rate. On disease progression, patients in the control arm had the option to receive single-agent bevacizumab 15 mg/kg every 3 weeks. Results Compared with the control arm, treatment with carboplatin and paclitaxel plus bevacizumab (15 mg/kg) resulted in a higher response rate (31.5% v 18.8%), longer median time to progression (7.4 v 4.2 months) and a modest increase in survival (17.7 v 14.9 months). Of the 19 control patients that crossed over to single-agent bevacizumab, five experienced stable disease, and 1-year survival was 47%. Bleeding was the most prominent adverse event and was manifested in two distinct clinical patterns; minor mucocutaneous hemorrhage and major hemoptysis. Major hemoptysis was associated with squamous cell histology, tumor necrosis and cavitation, and disease location close to major blood vessels. Conclusion Bevacizumab in combination with carboplatin and paclitaxel improved overall response and time to progression in patients with advanced or recurrent non-small-cell lung cancer. Patients with nonsquamous cell histology appear to be a subpopulation with improved outcome and acceptable safety risks.

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American Society of Clinical Oncology (ASCO)

Tập 22 Số 11

2184-2191

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