title: Phase II trial of nanoparticle albumin-bound paclitaxel, carboplatin, and bevacizumab in first-line patients with advanced nonsquamous non-small cell lung cancer.
abstract: BACKGROUND
  Carboplatin/paclitaxel chemotherapy with bevacizumab is an accepted standard treatment for advanced nonsquamous non-small cell lung cancer (NSCLC). The development of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) has circumvented many of the infusion difficulties associated with standard solvent-based paclitaxel (in Cremophor) and offers theoretical advantages in efficacy. This trial evaluated the combination of nab-paclitaxel, carboplatin, and bevacizumab in advanced (stage IIIB/IV) nonsquamous NSCLC.
  
  
  METHODS
  Fifty patients with stage IIIB/IV NSCLC were enrolled between October 2005 and April 2006; 48 were treated with nab-paclitaxel 300 mg/m2, carboplatin area under the curve = 6, and bevacizumab 15 mg/kg every 21 days until progression or intolerable toxicity, up to 4 cycles; an additional 2 cycles could be administered to responding patients and the physician's discretion; maintenance bevacizumab was not administered. Patient demographics included: 56% female, median age 67 years (range, 32-83), performance status 0 (52%) or 1 (48%), adenocarcinoma 86%, and stage IV disease 82%. Responding patients received a minimum of 4 cycles. The primary end point was response rate.
  
  
  RESULTS
  Response rate was 31% with a stable disease rate of 54%. No complete responses were observed. Median progression-free survival was 9.8 months (range, <1-22.3), and median survival was 16.8 months. Most frequent grades 3 and 4 treatment-related toxicities were neutropenia (54%) and fatigue (17%).
  
  
  CONCLUSIONS
  The combination of nab-paclitaxel, carboplatin, and bevacizumab was well tolerated with moderate neutropenia. Adverse events were manageable. Survival results are encouraging. These results indicate that this combination has promising activity as first-line therapy in patients with nonsquamous NSCLC.
authors.affiliation: US Oncology Research, Inc., The Woodlands, Texas, USA. craig.reynolds@usoncology.com
authors.forename: Craig
authors.initials: C
authors.lastname: Reynolds
authors.forename: David
authors.initials: D
authors.lastname: Barrera
authors.forename: Robert
authors.initials: R
authors.lastname: Jotte
authors.forename: Alexander I
authors.initials: AI
authors.lastname: Spira
authors.forename: Charles
authors.initials: C
authors.lastname: Weissman
authors.forename: Kristi A
authors.initials: KA
authors.lastname: Boehm
authors.forename: Sharon
authors.initials: S
authors.lastname: Pritchard
authors.forename: Lina
authors.initials: L
authors.lastname: Asmar
mesh_terms: D002282:Adenocarcinoma, Bronchiolo-Alveolar / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000068196:Albumin-Bound Paclitaxel; D000418:Albumins / Q000008:administration & dosage; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D000068258:Bevacizumab; D016190:Carboplatin / Q000008:administration & dosage; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000401:mortality / Q000473:pathology; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D053758:Nanoparticles / Q000008:administration & dosage*; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage*; D011379:Prognosis; D011788:Quality of Life; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000068196:Albumin-Bound Paclitaxel; D000418:Albumins; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000068258:Bevacizumab; D016190:Carboplatin; D017239:Paclitaxel