PMID- 25236982
OWN - NLM
STAT- MEDLINE
DCOM- 20150723
LR  - 20220316
IS  - 1872-8332 (Electronic)
IS  - 0169-5002 (Linking)
VI  - 86
IP  - 2
DP  - 2014 Nov
TI  - Bavituximab plus paclitaxel and carboplatin for the treatment of advanced 
      non-small-cell lung cancer.
PG  - 231-6
LID - S0169-5002(14)00355-9 [pii]
LID - 10.1016/j.lungcan.2014.08.010 [doi]
AB  - OBJECTIVE: Bavituximab is a phosphatidylserine (PS)-targeting monoclonal antibody 
      with immune-modulating and tumor-specific vascular targeting properties. 
      Preclinical studies have shown activity against numerous solid tumors and at 
      least an additive effect in combination with chemotherapy. This study evaluated 
      bavituximab in combination with paclitaxel and carboplatin in patients with 
      previously untreated, locally advanced or metastatic non-small-cell lung cancer 
      (NSCLC). PATIENTS AND METHODS: This phase II, open-label study (NCT00687817) was 
      conducted in 49 patients with stage IIIB/IV NSCLC utilizing a Simon two-stage 
      design. Patients were treated with up to six cycles of carboplatin area under the 
      concentration-time curve (AUC) 5 plus paclitaxel 175 mg/m2 every 21 days with 
      weekly bavituximab 3 mg/kg followed by bavituximab monotherapy until progression 
      or unacceptable toxicity. RESULTS: The primary efficacy endpoint of overall 
      response rate (ORR) was 40.8% (complete response [CR] 2.0%, partial response [PR] 
      was 38.8%). Median progression-free survival (PFS) and overall survival (OS) were 
      6.0 and 12.4 months, respectively. Treatment-related adverse events (AEs) 
      occurred in 40.8% of patients. The most common treatment-related AEs were anemia 
      (10.2%), asthenia, vomiting, paresthesia, anorexia, and fatigue (6.1% each). One 
      patient with a central, cavitating squamous tumor developed fatal hemoptysis and 
      aspiration. CONCLUSION: Bavituximab in combination with paclitaxel-carboplatin as 
      first-line therapy demonstrated a tolerable safety profile and potential efficacy 
      in this single-arm phase II trial in patients with advanced local or metastatic 
      NSCLC. Randomized trials with this regimen are in progress. CLINICALTRIALSGOV 
      IDENTIFIER: NCT00687817.
CI  - Copyright (c) 2014 Elsevier Ireland Ltd. All rights reserved.
FAU - Digumarti, Raghunadharao
AU  - Digumarti R
AD  - Nizam's Institute of Medical Sciences, Hyderabad, India.
FAU - Bapsy, P P
AU  - Bapsy PP
AD  - Apollo Hospitals, Bangalore, India.
FAU - Suresh, Attili V
AU  - Suresh AV
AD  - Yashoda Hospital, Hyderabad, India.
FAU - Bhattacharyya, G S
AU  - Bhattacharyya GS
AD  - Orchid Nursing Home, Kolkata, India.
FAU - Dasappa, Lokanatha
AU  - Dasappa L
AD  - Kidwai Memorial Institute of Oncology, Bangalore, India.
FAU - Shan, Joseph S
AU  - Shan JS
AD  - Peregrine Pharmaceuticals, Inc., Tustin, CA, United States. Electronic address: 
      JShan@peregrineinc.com.
FAU - Gerber, David E
AU  - Gerber DE
AD  - UT Southwestern Medical Center, Dallas, TX, United States.
LA  - eng
SI  - ClinicalTrials.gov/NCT00687817
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20140824
PL  - Ireland
TA  - Lung Cancer
JT  - Lung cancer (Amsterdam, Netherlands)
JID - 8800805
RN  - 0 (Antibodies, Monoclonal)
RN  - BG3F62OND5 (Carboplatin)
RN  - P88XT4IS4D (Paclitaxel)
RN  - Q16CT95N25 (bavituximab)
SB  - IM
MH  - Adult
MH  - Antibodies, Monoclonal/administration & dosage
MH  - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use
MH  - Carboplatin/administration & dosage
MH  - Carcinoma, Non-Small-Cell Lung/*drug therapy/mortality/*pathology
MH  - Female
MH  - Humans
MH  - Lung Neoplasms/*drug therapy/mortality/*pathology
MH  - Male
MH  - Middle Aged
MH  - Neoplasm Staging
MH  - Paclitaxel/administration & dosage
MH  - Risk Factors
MH  - Treatment Outcome
OTO - NOTNLM
OT  - *Bavituximab
OT  - *Carboplatin
OT  - *Immune modulation
OT  - *Monoclonal antibody
OT  - *Non-small-cell lung cancer
OT  - *Paclitaxel
OT  - *Phosphatidylserine
EDAT- 2014/09/23 06:00
MHDA- 2015/07/24 06:00
CRDT- 2014/09/20 06:00
PHST- 2014/03/12 00:00 [received]
PHST- 2014/08/13 00:00 [revised]
PHST- 2014/08/14 00:00 [accepted]
PHST- 2014/09/20 06:00 [entrez]
PHST- 2014/09/23 06:00 [pubmed]
PHST- 2015/07/24 06:00 [medline]
AID - S0169-5002(14)00355-9 [pii]
AID - 10.1016/j.lungcan.2014.08.010 [doi]
PST - ppublish
SO  - Lung Cancer. 2014 Nov;86(2):231-6. doi: 10.1016/j.lungcan.2014.08.010. Epub 2014 
      Aug 24.