title: A randomized phase II study of carboplatin with weekly or every-3-week nanoparticle albumin-bound paclitaxel (abraxane) in patients with extensive-stage small cell lung cancer.
abstract: BACKGROUND
  Platinum plus etoposide is the standard therapy for extensive-stage small cell lung cancer (ES-SCLC) and is associated with significant myelosuppression. We hypothesized that the combination of carboplatin and nanoparticle albumin-bound paclitaxel (nab-paclitaxel) would be better tolerated. We investigated carboplatin with nab-paclitaxel on every-3-week and weekly schedules.
  
  
  METHODS
  This noncomparative randomized phase II trial used a two-stage design. The primary objective was objective response rate, and secondary objectives were progression-free survival, overall survival, and toxicity. Patients with ES-SCLC and an Eastern Cooperative Oncology Group performance status ≤2 and no prior chemotherapy were randomized in a 1:1 ratio to arm A (carboplatin area under the curve [AUC] of 6 on day 1 and nab-paclitaxel of 300 mg/m(2) on day 1 every 3 weeks) or arm B (carboplatin AUC of 6 on day 1 and nab-paclitaxel 100 mg/m(2) on days 1, 8, and 15 every 21 days). Response was assessed after every two cycles.
  
  
  RESULTS
  Patients required frequent dose reductions, treatment delays, and omission of the weekly therapy. The trial was closed because of slow accrual.
  
  
  CONCLUSIONS
  Carboplatin and nab-paclitaxel demonstrated activity in ES-SCLC but required frequent dose adjustments.
authors.affiliation: Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, USA;
authors.forename: Juneko E
authors.initials: JE
authors.lastname: Grilley-Olson
authors.affiliation: Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, USA;
authors.forename: Vicki L
authors.initials: VL
authors.lastname: Keedy
authors.affiliation: Genentech, South San Francisco, California, USA;
authors.forename: Alan
authors.initials: A
authors.lastname: Sandler
authors.affiliation: Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, USA;
authors.forename: Dominic T
authors.initials: DT
authors.lastname: Moore
authors.affiliation: University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, USA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
authors.affiliation: Lineberger Comprehensive Cancer Center at the University of North Carolina, Chapel Hill, Chapel Hill, North Carolina, USA; thomas_stinchcombe@med.unc.edu.
authors.forename: Thomas E
authors.initials: TE
authors.lastname: Stinchcombe
mesh_terms: D000328:Adult; D000368:Aged; D000068196:Albumin-Bound Paclitaxel / Q000008:administration & dosage*; D000418:Albumins; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D016190:Carboplatin / Q000008:administration & dosage*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D053758:Nanoparticles / Q000008:administration & dosage; D009367:Neoplasm Staging; D017239:Paclitaxel; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000068196:Albumin-Bound Paclitaxel; D000418:Albumins; D016190:Carboplatin; D017239:Paclitaxel