PMID- 21321086
OWN - NLM
STAT- MEDLINE
DCOM- 20111128
LR  - 20200704
IS  - 1569-8041 (Electronic)
IS  - 0923-7534 (Linking)
VI  - 22
IP  - 9
DP  - 2011 Sep
TI  - 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.
PG  - 2057-2067
LID - S0923-7534(19)38363-2 [pii]
LID - 10.1093/annonc/mdq731 [doi]
AB  - BACKGROUND: This 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 METHODS: Chemotherapy-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). RESULTS: ORRs 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 C(max) and 
      C(min) values were consistent with its pharmacokinetic properties observed in 
      previous studies. CONCLUSIONS: The 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.
FAU - Blumenschein, G R Jr
AU  - Blumenschein GR Jr
AD  - Department of Thoracic/Head and Neck Medical Oncology, The University of Texas 
      M.D. Anderson Cancer Center, Houston. Electronic address: 
      gblumens@mdanderson.org.
FAU - Kabbinavar, F
AU  - Kabbinavar F
AD  - Department of Medicine, University of California Los Angeles Medical Center, Los 
      Angeles; Hematology/Oncology, University of California Los Angeles Medical 
      Center, Los Angeles; Translational Oncology Research International, Los Angeles, 
      USA.
FAU - Menon, H
AU  - Menon H
AD  - Department of Medical Oncology, Tata Memorial Center, Mumbai, India.
FAU - Mok, T S K
AU  - Mok TSK
AD  - Department of Clinical Oncology, The Chinese University of Hong Kong, Hong Kong, 
      China.
FAU - Stephenson, J
AU  - Stephenson J
AD  - Cancer Center of the Carolinas, Greenville.
FAU - Beck, J T
AU  - Beck JT
AD  - Highlands Oncology Group, Fayetteville, USA.
FAU - Lakshmaiah, K
AU  - Lakshmaiah K
AD  - Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bangalore, 
      India.
FAU - Reckamp, K
AU  - Reckamp K
AD  - Department of Medical Oncology and Therapeutics Research, City of Hope 
      Comprehensive Cancer Center, Duarte.
FAU - Hei, Y-J
AU  - Hei YJ
AD  - Department of Oncology.
FAU - Kracht, K
AU  - Kracht K
AD  - Biostatistics and Epidemiology.
FAU - Sun, Y-N
AU  - Sun YN
AD  - Pharmacokinetics and Drug Metabolism, Amgen Inc., Thousand Oaks.
FAU - Sikorski, R
AU  - Sikorski R
AD  - Department of Oncology.
FAU - Schwartzberg, L
AU  - Schwartzberg L
AD  - Department of Hematology and Oncology, The West Clinic, Memphis, USA.
CN  - Motesanib NSCLC Phase II Study Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00369070
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20110214
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antibodies, Monoclonal, Humanized)
RN  - 0 (Indoles)
RN  - 0 (Oligonucleotides)
RN  - 25X51I8RD4 (Niacinamide)
RN  - 2S9ZZM9Q9V (Bevacizumab)
RN  - BG3F62OND5 (Carboplatin)
RN  - F60NE4XB53 (imetelstat)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antibodies, Monoclonal, Humanized/administration & dosage/adverse 
      effects/pharmacokinetics
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse 
      effects/pharmacokinetics/*therapeutic use
MH  - Bevacizumab
MH  - Carboplatin/administration & dosage/adverse effects/pharmacokinetics
MH  - Carcinoma, Non-Small-Cell Lung/blood/*drug therapy
MH  - Disease-Free Survival
MH  - Drug Administration Schedule
MH  - Humans
MH  - Indoles/administration & dosage/adverse effects/pharmacokinetics
MH  - Lung Neoplasms/blood/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Niacinamide/administration & dosage/adverse effects/analogs & 
      derivatives/pharmacokinetics
MH  - Oligonucleotides
MH  - Paclitaxel/administration & dosage/adverse effects/pharmacokinetics
MH  - Survival Rate
EDAT- 2011/02/16 06:00
MHDA- 2011/12/13 00:00
CRDT- 2011/02/16 06:00
PHST- 2011/02/16 06:00 [entrez]
PHST- 2011/02/16 06:00 [pubmed]
PHST- 2011/12/13 00:00 [medline]
AID - S0923-7534(19)38363-2 [pii]
AID - 10.1093/annonc/mdq731 [doi]
PST - ppublish
SO  - Ann Oncol. 2011 Sep;22(9):2057-2067. doi: 10.1093/annonc/mdq731. Epub 2011 Feb 
      14.