title: Phase III study (MONET1) of motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous nonsmall-cell lung cancer (NSCLC): Asian subgroup analysis.
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).
  
  
  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%).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  NCT00460317.
authors.affiliation: Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, Tokyo.
authors.forename: K
authors.initials: K
authors.lastname: Kubota
authors.forename: Y
authors.initials: Y
authors.lastname: Ichinose
authors.forename: G
authors.initials: G
authors.lastname: Scagliotti
authors.forename: D
authors.initials: D
authors.lastname: Spigel
authors.forename: J H
authors.initials: JH
authors.lastname: Kim
authors.forename: T
authors.initials: T
authors.lastname: Shinkai
authors.forename: K
authors.initials: K
authors.lastname: Takeda
authors.forename: S-W
authors.initials: SW
authors.lastname: Kim
authors.forename: T-C
authors.initials: TC
authors.lastname: Hsia
authors.forename: R K
authors.initials: RK
authors.lastname: Li
authors.forename: B J
authors.initials: BJ
authors.lastname: Tiangco
authors.forename: S
authors.initials: S
authors.lastname: Yau
authors.forename: W-T
authors.initials: WT
authors.lastname: Lim
authors.forename: B
authors.initials: B
authors.lastname: Yao
authors.forename: Y-J
authors.initials: YJ
authors.lastname: Hei
authors.forename: K
authors.initials: K
authors.lastname: Park
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003967:Diarrhea / Q000139:chemically induced; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007211:Indoles / Q000008:administration & dosage; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000031:analogs & derivatives; D009841:Oligonucleotides; D017239:Paclitaxel / Q000008:administration & dosage; D016016:Proportional Hazards Models; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D007211:Indoles; D009841:Oligonucleotides; D009536:Niacinamide; D016190:Carboplatin; C519562:imetelstat; D017239:Paclitaxel
keywords: Asia; NSCLC; carboplatin; motesanib; paclitaxel