title: Weekly nab-Paclitaxel in Combination With Carboplatin as First-Line Therapy in Patients With Advanced Non-Small-Cell Lung Cancer: Analysis of Safety and Efficacy in Patients With Diabetes.
abstract: To examine outcomes in a phase 3 trial of nab-paclitaxel plus carboplatin (nab-P/C) versus solvent-based paclitaxel plus carboplatin (sb-P/C) in a subset of patients with advanced non-small-cell lung cancer (NSCLC) and diabetes.
  
  
  
  Patients with stage IIIB/IV NSCLC received nab-P 100 mg/m2on days 1, 8, and 15 or sb-P 200 mg/m2on day 1, both with C at an area under the curve of 6 mg·min/mL on day 1 every 3 weeks. Overall response rate (ORR) and progression-free survival (PFS) were determined by blinded, independent, centralized review. P values were based on chi-square test for ORR and log-rank test for overall survival (OS) and PFS.
  
  
  
  Of the 1052 randomized patients in the phase 3 trial, 61 had diabetes according to prespecified terms (nab-P/C, 31; sb-P/C, 30). ORR for nab-P/C versus sb-P/C in this subset was 52% versus 27% (relative risk ratio, 1.935; P = .046), median PFS was 10.9 versus 4.9 months (hazard ratio, 0.420; P = .016), and median OS was 17.5 versus 11.1 months (hazard ratio, 0.550; P = .057). Treatment differences in PFS remained significant (P ≤ .036) after adjusting for histology, region, stage, race, and age and also remained significant in OS for histology (P = .039). Patients with diabetes experienced lower rates of grade 3 or higher neutropenia and peripheral neuropathy and higher rates of thrombocytopenia and anemia with nab-P/C versus sb-P/C.
  
  
  
  nab-P/C demonstrated improved efficacy and manageable tolerability in patients with advanced NSCLC and diabetes.
authors.affiliation: McGill University, Montreal, Quebec, Canada. Electronic address: vera.hirsh@muhc.mcgill.ca.
authors.forename: Vera
authors.initials: V
authors.lastname: Hirsh
authors.affiliation: Celgene Corporation, Summit, NJ.
authors.forename: Amy
authors.initials: A
authors.lastname: Ko
authors.affiliation: Celgene Corporation, Summit, NJ.
authors.forename: Richard
authors.initials: R
authors.lastname: Pilot
authors.affiliation: Celgene Corporation, Summit, NJ.
authors.forename: Markus F
authors.initials: MF
authors.lastname: Renschler
authors.affiliation: University of Pittsburgh Medical Center, Pittsburgh, PA.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Socinski
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003920:Diabetes Mellitus / Q000503:physiopathology*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D016190:Carboplatin; D017239:Paclitaxel
keywords: Comorbidities; Neuropathy; Taxanes