A phase II,multicenter, open-label randomized study of motesanib or bevacizumab in combination with paclitaxel and carboplatin for advanced nonsquamous non-small-cell lung cancer |
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| Affiliation: | 1. Department of Thoracic/Head and Neck Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston;2. Department of Medicine, University of California Los Angeles Medical Center, Los Angeles;3. Hematology/Oncology, University of California Los Angeles Medical Center, Los Angeles;4. Translational Oncology Research International, Los Angeles, USA;5. Department of Medical Oncology, Tata Memorial Center, Mumbai, India;6. Department of Clinical Oncology, The Chinese University of Hong Kong, Hong Kong, China;7. Cancer Center of the Carolinas, Greenville;8. Highlands Oncology Group, Fayetteville, USA;9. Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore, India;10. Department of Medical Oncology and Therapeutics Research, City of Hope Comprehensive Cancer Center, Duarte;11. Department of Oncology;12. Biostatistics and Epidemiology;13. Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks;14. Department of Hematology and Oncology, The West Clinic, Memphis, USA |
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| Abstract: | BackgroundThis phase II study estimated the difference in objective response rate (ORR) among patients with advanced nonsquamous non-small-cell lung cancer (NSCLC) receiving paclitaxel–carboplatin (CP) plus motesanib or bevacizumab.Patients and methodsChemotherapy-naive patients (N = 186) were randomized 1:1:1 to receive CP plus motesanib 125 mg once daily (qd) (arm A), motesanib 75 mg twice daily (b.i.d.) 5 days on/2 days off (arm B), or bevacizumab 15 mg/kg every 3 weeks (q3w) (arm C). The primary end point was ORR (per RECIST). Other end points included progression-free survival (PFS), overall survival (OS), motesanib pharmacokinetics, and adverse events (AEs).ResultsORRs in the three arms were as follows: arm A, 30% (95% confidence interval 18% to 43%); arm B, 23% (13% to 36%); and arm C, 37% (25% to 50%). Median PFS in arm A was 7.7 months, arm B 5.8 months, and arm C 8.3 months; median OS for arm A was 14.0 months, arm B 12.8 months, and arm C 14.0 months. Incidence of AEs was greater in arms A and B than in arm C. More grade 5 AEs not attributable to disease progression occurred in arm B (n = 10) than in arms A (n = 4) and C (n = 4). Motesanib plasma Cmax and Cmin values were consistent with its pharmacokinetic properties observed in previous studies.ConclusionsThe efficacy of 125 mg qd motesanib or bevacizumab plus CP was estimated to be comparable. Toxicity was higher but manageable in both motesanib arms. Efficacy and tolerability of motesanib 125 mg qd plus CP in advanced nonsquamous NSCLC are being further investigated in a phase III study. |
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