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Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone
David H Johnson1, Louis Fehrenbacher1, William F Novotny1
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, Philadelphia, PA.
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.
