title: Safety and efficacy analysis by histology of weekly nab-paclitaxel in combination with carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer.
abstract: BACKGROUND
  This analysis compared the efficacy and safety outcomes by histology of nab-paclitaxel (nab-P) plus carboplatin (C) versus solvent-based paclitaxel (sb-P) plus C in patients with advanced non-small-cell lung cancer (NSCLC) based on preplanned stratification factors specified in the phase III trial protocol.
  
  
  METHODS
  Patients with untreated stage III/IV NSCLC received 100 mg/m(2) nab-P weekly and C (area under the curve, AUC = 6) every 3 weeks (q3w) or 200 mg/m(2) sb-P plus C (AUC = 6) q3w. Primary end point was objective overall response rate (ORR).
  
  
  RESULTS
  nab-P/C versus sb-P/C produced a significantly higher ORR (41% versus 24%; response rate ratio [RRR] 1.680; P < 0.001) in patients with squamous cell (SCC) NSCLC. For nab-P/C versus sb-P/C, ORRs were 26% versus 27% (RRR 0.966; P = 0.814) in patients with adenocarcinoma, 33% versus 15% (RRR 2.167; P = 0.323) in patients with large cell carcinoma (LC), and 24% versus 15% (RRR 1.593; P = 0.372) in patients with not otherwise specified histology. Median overall survival for nab-P/C versus sb-P/C in patients with SCC was 10.7 versus 9.5 months (HR 0.890; P = 0.310), and 12.4 versus 10.6 months (HR 1.208; P = 0.721) for patients with LC. nab-P/C produced significantly (P < 0.05) less grade 3/4 neuropathy and arthralgia, whereas sb-P/C produced less thrombocytopenia and anemia.
  
  
  CONCLUSIONS
  First-line nab-P/C demonstrated a favorable risk-benefit profile in patients with NSCLC regardless of histology.
authors.affiliation: Division of Hematology/Oncology, University of Pittsburgh Cancer Institute, PA 15232, USA. socinskima@upmc.edu
authors.forename: M A
authors.initials: MA
authors.lastname: Socinski
authors.forename: I
authors.initials: I
authors.lastname: Okamoto
authors.forename: J K
authors.initials: JK
authors.lastname: Hon
authors.forename: V
authors.initials: V
authors.lastname: Hirsh
authors.forename: S R
authors.initials: SR
authors.lastname: Dakhil
authors.forename: R D
authors.initials: RD
authors.lastname: Page
authors.forename: J
authors.initials: J
authors.lastname: Orsini
authors.forename: N
authors.initials: N
authors.lastname: Yamamoto
authors.forename: H
authors.initials: H
authors.lastname: Zhang
authors.forename: M F
authors.initials: MF
authors.lastname: Renschler
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000418:Albumins / Q000009:adverse effects / Q000627:therapeutic use*; D000972:Antineoplastic Agents, Phytogenic / 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*; D018287:Carcinoma, Large Cell / Q000188:drug therapy / Q000401:mortality; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis / Q000188:drug therapy; D018307:Neoplasms, Squamous Cell / Q000188:drug therapy / Q000401:mortality; D009944:Organoplatinum Compounds / Q000009:adverse effects / Q000627:therapeutic use; D017239:Paclitaxel / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D013534:Survival; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D000972:Antineoplastic Agents, Phytogenic; D009944:Organoplatinum Compounds; D016190:Carboplatin; D017239:Paclitaxel
keywords: histology; nab-paclitaxel; non-small-cell lung cancer