Background: This preplanned subset analysis of the phase III MONET1 study aimed to determine whether motesanib combined with carboplatin/paclitaxel (C/P) would result in improved overall survival (OS) versus chemotherapy alone, in a subset of Asian patients with nonsquamous nonsmall-cell lung cancer (NSCLC). Patients and methods: Patients with nonsquamous NSCLC (stage IIIB/IV or recurrent) and no prior systemic therapy for advanced disease were randomized to IV carboplatin (AUC, 6 mg/ml min) and paclitaxel (200 mg/m2) for up to six 3-week cycles, plus either oral motesanib 125 mg q.d. or placebo. Primary end point was OS; secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. Results: Two hundred twenty-seven Asian patients from MONET1 were included in this descriptive analysis. Median OS was 20.9 months in the motesanib plus C/P arm and 14.5 months in the placebo plus C/P arm (P = 0.0223); median PFS was 7.0 and 5.3 months, respectively, (P = 0.0004); and ORR was 62% and 27%, respectively, (P < 0.0001). Grade ≥3 adverse events were more common in the motesanib plus C/P arm versus placebo plus C/P (79% versus 61%). Conclusion: In this preplanned subset analysis of Asian patients with nonsquamous NSCLC, motesanib plus C/P significantly improved OS, PFS, and ORR versus placebo plus C/P. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.

Phase III study (MONET1) of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous nonsmall-cell lung cancer (NSCLC): Asian subgroup analysis

SCAGLIOTTI, Giorgio Vittorio;
2014-01-01

Abstract

Background: This preplanned subset analysis of the phase III MONET1 study aimed to determine whether motesanib combined with carboplatin/paclitaxel (C/P) would result in improved overall survival (OS) versus chemotherapy alone, in a subset of Asian patients with nonsquamous nonsmall-cell lung cancer (NSCLC). Patients and methods: Patients with nonsquamous NSCLC (stage IIIB/IV or recurrent) and no prior systemic therapy for advanced disease were randomized to IV carboplatin (AUC, 6 mg/ml min) and paclitaxel (200 mg/m2) for up to six 3-week cycles, plus either oral motesanib 125 mg q.d. or placebo. Primary end point was OS; secondary end points included progression-free survival (PFS), objective response rate (ORR), and safety. Results: Two hundred twenty-seven Asian patients from MONET1 were included in this descriptive analysis. Median OS was 20.9 months in the motesanib plus C/P arm and 14.5 months in the placebo plus C/P arm (P = 0.0223); median PFS was 7.0 and 5.3 months, respectively, (P = 0.0004); and ORR was 62% and 27%, respectively, (P < 0.0001). Grade ≥3 adverse events were more common in the motesanib plus C/P arm versus placebo plus C/P (79% versus 61%). Conclusion: In this preplanned subset analysis of Asian patients with nonsquamous NSCLC, motesanib plus C/P significantly improved OS, PFS, and ORR versus placebo plus C/P. © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
2014
25
529
536
K. Kubota;Y. Ichinose;G. Scagliotti;D. Spigel;J. H. Kim;T. Shinkai;K. Takeda;S.- W. Kim;T.- C. Hsia;R. K. Li;B. J. Tiangco;S. Yau;W.- T. Lim;B. Yao;Y.- J. Hei;K. Park
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2318/150328
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