PMID- 22753922
OWN - NLM
STAT- MEDLINE
DCOM- 20121009
LR  - 20181201
IS  - 1527-7755 (Electronic)
IS  - 0732-183X (Linking)
VI  - 30
IP  - 23
DP  - 2012 Aug 10
TI  - International, randomized, placebo-controlled, double-blind phase III study of 
      motesanib plus carboplatin/paclitaxel in patients with advanced nonsquamous 
      non-small-cell lung cancer: MONET1.
PG  - 2829-36
LID - 10.1200/JCO.2011.41.4987 [doi]
AB  - PURPOSE: We evaluated whether motesanib (a selective oral inhibitor of vascular 
      endothelial growth factor receptors 1, 2, and 3; platelet-derived growth factor 
      receptor; and Kit) combined with carboplatin/paclitaxel improved overall survival 
      (OS) versus chemotherapy alone in patients with nonsquamous non-small-cell lung 
      cancer (NSCLC) and in the subset of patients with adenocarcinoma. PATIENTS AND 
      METHODS: Patients with stage IIIB/IV or recurrent nonsquamous NSCLC (no prior 
      systemic therapy for advanced disease) were randomly assigned 1:1 to carboplatin 
      (area under the curve, 6 mg/ml . min) and paclitaxel (200 mg/m(2)) intravenously 
      for up to six 3-week cycles plus either motesanib 125 mg (arm A) or placebo (arm 
      B) once daily orally. OS was the primary end point. Secondary end points included 
      progression-free survival (PFS), objective response rate (ORR), adverse events 
      (AEs), and association between placental growth factor (PLGF) change and OS. 
      RESULTS: A total of 1,090 patients with nonsquamous NSCLC were randomly assigned 
      (arms A/B, n = 541 of 549); of those, 890 had adenocarcinoma (n = 448 of 442). 
      Median OS in arms A and B was 13.0 and 11.0 months, respectively (hazard ratio 
      [HR], 0.90; 95% CI, 0.78 to 1.04; P = .14); median OS for the adenocarcinoma 
      subset was 13.5 and 11.0 months, respectively (HR, 0.88; 95% CI, 0.75 to 1.03; P 
      = .11). In descriptive analyses (arms A v B), median PFS was 5.6 months versus 
      5.4 months (P = < .001); ORR was 40% versus 26% (P < .001). There was no 
      association between PLGF change and OS in arm A. The incidence of grade >/= 3 AEs 
      (arms A and B, 73% and 59%, respectively) and grade 5 AEs (14% and 9%, 
      respectively) was higher with motesanib treatment. CONCLUSION: Motesanib plus 
      carboplatin/paclitaxel did not significantly improve OS over 
      carboplatin/paclitaxel alone in patients with advanced nonsquamous NSCLC or in 
      the adenocarcinoma subset.
FAU - Scagliotti, Giorgio V
AU  - Scagliotti GV
AD  - University of Turin, S. Luigi Hospital, Turin, Italy. scagliotti@ihnet.it
FAU - Vynnychenko, Ihor
AU  - Vynnychenko I
FAU - Park, Keunchil
AU  - Park K
FAU - Ichinose, Yukito
AU  - Ichinose Y
FAU - Kubota, Kaoru
AU  - Kubota K
FAU - Blackhall, Fiona
AU  - Blackhall F
FAU - Pirker, Robert
AU  - Pirker R
FAU - Galiulin, Rinat
AU  - Galiulin R
FAU - Ciuleanu, Tudor-Eliade
AU  - Ciuleanu TE
FAU - Sydorenko, Oleksandr
AU  - Sydorenko O
FAU - Dediu, Mircea
AU  - Dediu M
FAU - Papai-Szekely, Zsolt
AU  - Papai-Szekely Z
FAU - Banaclocha, Natividad Martinez
AU  - Banaclocha NM
FAU - McCoy, Sheryl
AU  - McCoy S
FAU - Yao, Bin
AU  - Yao B
FAU - Hei, Yong-Jiang
AU  - Hei YJ
FAU - Galimi, Francesco
AU  - Galimi F
FAU - Spigel, David R
AU  - Spigel DR
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20120702
PL  - United States
TA  - J Clin Oncol
JT  - Journal of clinical oncology : official journal of the American Society of 
      Clinical Oncology
JID - 8309333
RN  - 0 (Indoles)
RN  - 0 (Oligonucleotides)
RN  - 25X51I8RD4 (Niacinamide)
RN  - BG3F62OND5 (Carboplatin)
RN  - EC 2.7.10.1 (Receptors, Vascular Endothelial Growth Factor)
RN  - F60NE4XB53 (imetelstat)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
CIN - J Clin Oncol. 2012 Aug 10;30(23):2805-8. PMID: 22753916
MH  - Adenocarcinoma/*drug therapy
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Antineoplastic Combined Chemotherapy Protocols/*therapeutic use
MH  - Carboplatin/administration & dosage
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Indoles/*administration & dosage
MH  - Lung Neoplasms/*drug therapy
MH  - Male
MH  - Middle Aged
MH  - Niacinamide/administration & dosage/*analogs & derivatives
MH  - Oligonucleotides
MH  - Paclitaxel/administration & dosage
MH  - Receptors, Vascular Endothelial Growth Factor/*antagonists & inhibitors
MH  - Young Adult
EDAT- 2012/07/04 06:00
MHDA- 2012/10/10 06:00
CRDT- 2012/07/04 06:00
PHST- 2012/07/04 06:00 [entrez]
PHST- 2012/07/04 06:00 [pubmed]
PHST- 2012/10/10 06:00 [medline]
AID - JCO.2011.41.4987 [pii]
AID - 10.1200/JCO.2011.41.4987 [doi]
PST - ppublish
SO  - J Clin Oncol. 2012 Aug 10;30(23):2829-36. doi: 10.1200/JCO.2011.41.4987. Epub 
      2012 Jul 2.