Randomised,double-blind trial of carboplatin and paclitaxel with daily oral cediranib or placebo in patients with advanced non-small cell lung cancer: NCIC Clinical Trials Group study BR29 |
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| Institution: | 1. Tufts University Department of Radiation Oncology, Boston, Massachusetts;2. Department of Radiation Oncology, The Warren Alpert School of Medicine of Brown University, Providence, Rhode Island;1. Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo;2. Department of Thoracic Oncology, Saitama Cancer Center, Kita-adachi-gun;3. Division of Integrated Oncology, Institute of Biomedical Research and Innovation, Kobe;4. Department of Thoracic Medical Oncology, Cancer Institute Hospital of JFCR, Tokyo;5. Clinical Research, Innovation and Education Center, Tohoku University Hospital, Sendai;6. Department of Respiratory Medicine and Medical Oncology, Yokohama Municipal Citizen''s HospitalHodogaya-ku;7. Department of Medical Oncology, KKR Sapporo Medical Center, Sapporo;8. Department of Medical Oncology, Japanese Red Cross Medical Center, Tokyo;9. Department of Medical Oncology, Graduate School of Medicine, Chiba University, Chiba;10. Department of Respiratory Medicine, Saitama Medical University International Medical Center, Saitama;11. Second Department of Internal Medicine, Nagasaki University School of Medicine, Nagasaki;12. Division of Thoracic Oncology, National Cancer Center Hospital East, Kashiwa;13. Department of Pulmonary Medicine, Sendai Kousei Hospital, Sendai;14. Department of Respiratory Medicine, Gunma Prefectural Cancer Center, Ota;15. Department of Respiratory Medicine, National Hospital Organization Nagasaki Medical Center, Omura;16. Department of Internal Medicine, Niigata Cancer Center Hospital, Niigata;17. Department of Clinical Medicine (Biostatistics and Pharmaceutical Medicine), Kitasato University School of Pharmacy, Tokyo;18. Double-Barred Cross Hospital Japan Anti-Tuberculosis Association, Tokyo, Japan |
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| Abstract: | IntroductionThis randomised double-blind placebo-controlled study evaluated the addition of cediranib, an inhibitor of vascular endothelial growth factor receptors 1–3, to standard carboplatin/paclitaxel chemotherapy in advanced non-small cell lung cancer.MethodsEligible patients received paclitaxel (200 mg/m2) and carboplatin (area under the concentration time curve 6) intravenously every 3 weeks. Daily oral cediranib/placebo 20 mg was commenced day 1 of cycle 1 and continued as monotherapy after completion of 4–6 cycles of chemotherapy. The primary end-point of the study was overall survival (OS). The trial would continue to full accrual if an interim analysis (IA) for progression-free survival (PFS), performed after 170 events of progression or death in the first 260 randomised patients, revealed a hazard ratio (HR) for PFS of ?0.70.ResultsThe trial was halted for futility at the IA (HR for PFS 0.89, 95% confidence interval CI] 0.66–1.20, p = 0.45). A final analysis was performed on all 306 enrolled patients. The addition of cediranib increased response rate (RR] 52% versus 34%, p = 0.001) but did not significantly improve PFS (HR 0.91, 95% CI 0.71–1.18, p = 0.49) or OS (HR 0.94, 95% CI 0.69–1.30, p = 0.72). Cediranib patients had more grade 3 hypertension, diarrhoea and anorexia.ConclusionsThe addition of cediranib 20 mg daily to carboplatin/paclitaxel chemotherapy increased RR and toxicity, but not survival. |
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| Keywords: | Non-small cell Phase III Angiogenesis inhibitor Systemic therapy |
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