title: Safety and efficacy of weekly nab®-paclitaxel in combination with carboplatin as first-line therapy in elderly patients with advanced non-small-cell lung cancer.
abstract: BACKGROUND
  This analysis evaluates safety and efficacy in elderly (≥ 70 years old) versus younger patients enrolled in a phase III advanced non-small-cell lung cancer (NSCLC) trial.
  
  
  METHODS
  Untreated stage IIIB/IV patients with PS 0/1 were randomly assigned (1:1) to carboplatin AUC6, day 1 every 3 weeks, and either nab-paclitaxel (Abraxane) 100 mg/m(2) weekly (nab-P/C) or solvent-based paclitaxel (Taxol) 200 mg/m(2) day 1 every 3 weeks (sb-P/C). The primary end-point was overall response rate (ORR).
  
  
  RESULTS
  Fifteen percent of 1052 enrolled patients were elderly: nab-P/C, n = 74; sb-P/C, n = 82. In both age cohorts, the ORR was higher with nab-P/C versus sb-P/C (age ≥ 70: 34% versus 24%, P = 0.196; age <70: 32% versus 25%, P = 0.013). In elderly patients, progression-free survival (PFS) trended in favor of nab-P/C (median 8.0 versus 6.8 months, hazard ratio (HR) 0.687, P = 0.134), and overall survival (OS) was significantly improved (median 19.9 versus 10.4 months, HR 0.583, P = 0.009). In younger patients, PFS (median 6.0 versus 5.8 months, HR 0.903, P = 0.256) and OS (median 11.4 versus 11.3 months, HR 0.999, P = 0.988) were similar in both arms. Adverse events were similar in both age groups, with less neutropenia (P = 0.015), neuropathy (P = 0.001), and arthralgia (P = 0.029), and increased anemia (P = 0.007) with nab-P/C versus sb-P/C.
  
  
  CONCLUSIONS
  In elderly NSCLC patients, nab-P/C as first-line therapy was well tolerated and improved the ORR and PFS, with substantially longer OS versus sb-PC.
authors.affiliation: University of Pittsburgh Medical Center, Division of Hematology/Oncology, Pittsburgh. Electronic address: socinskima@upmc.edu.
authors.forename: M A
authors.initials: MA
authors.lastname: Socinski
authors.affiliation: University of Pennsylvania, Fox Chase Cancer Center, Philadelphia, USA.
authors.forename: C J
authors.initials: CJ
authors.lastname: Langer
authors.affiliation: Kinki University Faculty of Medicine, Department of Medical Oncology,Osaka-Sayama, Japan.
authors.forename: I
authors.initials: I
authors.lastname: Okamoto
authors.affiliation: Clearview Cancer Institute, Huntsville, USA.
authors.forename: J K
authors.initials: JK
authors.lastname: Hon
authors.affiliation: McGill University, Department of Oncology, Montreal, Quebec, Canada.
authors.forename: V
authors.initials: V
authors.lastname: Hirsh
authors.affiliation: Cancer Center of Kansas, Wichita.
authors.forename: S R
authors.initials: SR
authors.lastname: Dakhil
authors.affiliation: The Center for Cancer and Blood Disorders, Fort Worth.
authors.forename: R D
authors.initials: RD
authors.lastname: Page
authors.affiliation: Essex Oncology of North Jerse, PA, Belleville.
authors.forename: J
authors.initials: J
authors.lastname: Orsini
authors.affiliation: Celgene, Clinical Research and Development, Summit, USA.
authors.forename: H
authors.initials: H
authors.lastname: Zhang
authors.affiliation: Celgene, Clinical Research and Development, Summit, USA.
authors.forename: M F
authors.initials: MF
authors.lastname: Renschler
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000375:Aging; D000418:Albumins / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000150:complications; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D016190:Carboplatin; D017239:Paclitaxel