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 renal impairment.
abstract: BACKGROUND
  Renal impairment in cancer patients can affect treatment tolerability and outcomes. This analysis evaluated the safety and efficacy of nab-paclitaxel (nab-P) versus solvent-based paclitaxel (sb-P), both in combination with carboplatin (C), in patients with advanced non-small-cell lung cancer (NSCLC) and renal impairment.
  
  
  METHODS
  Untreated patients with stage IIIB/IV disease with NSCLC and a performance status of 0/1 were randomly assigned (1:1) to receive 100 mg/m(2)nab-P weekly plus C (under the curve = 6, every 3 weeks) or 200 mg/m(2) sb-P plus C (under the curve = 6) every 3 weeks. The primary end point was overall response rate.
  
  
  RESULTS
  Of 1038 treated patients in the phase III trial, 38% had mild renal impairment (creatinine clearance > 50 to ≤ 80 mL/min; n = 198 for nab-P/C and n = 206 for sb-P/C) and 5% had moderate renal impairment (creatinine clearance ≤ 50 mL/min: n = 26 for nab-P/C and n = 27 for sb-P/C). For nab-P/C versus sb-P/C, the treatment difference in efficacy in patients with either level of renal impairment was comparable to the overall population but did not reach statistical significance, with an overall response rate of 35% versus 27% (response rate ratio, 1.324; P = .060) in patients with mild renal impairment, and 31% versus 19% (response rate ratio, 1.662; P = .300) in patients with moderate renal impairment. Overall survival and progression-free survival were nonsignificantly longer for nab-P/C versus sb-P/C in these subsets. Patients with renal impairment experienced less grade 3 or higher neutropenia and sensory neuropathy, but more thrombocytopenia and anemia with nab-P/C versus sb-P/C.
  
  
  CONCLUSIONS
  nab-P/C proved beneficial and tolerable in patients with advanced NSCLC and mild and moderate renal impairment.
authors.affiliation: University of Pennsylvania, Perelman Center for Advanced Medicine, Abramson Cancer Center, Philadelphia, PA. Electronic address: corey.langer@uphs.upenn.edu.
authors.forename: Corey J
authors.initials: CJ
authors.lastname: Langer
authors.affiliation: McGill University, Montreal, Quebec, Canada.
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: 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 / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage; D051437:Renal Insufficiency / Q000150:complications / Q000503:physiopathology*; D015996:Survival Rate; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D016190:Carboplatin; D017239:Paclitaxel
keywords: Creatinine clearance; Renal function; Taxanes