title: Efficacy and safety of weekly nab-paclitaxel plus carboplatin in patients with advanced non-small cell lung cancer.
abstract: OBJECTIVE
  In a large multicenter international phase III study (CA031) of nab-paclitaxel (nab-P, 130 nm albumin-bound paclitaxel particles) + carboplatin (C) vs solvent-based paclitaxel (sb-P) + C, conducted in 6 countries including Japan, nab-PC produced significantly higher overall response rate (ORR), primary end point compared with sb-PC, and acceptable safety profile. The aim of this analysis was to evaluate the efficacy and tolerability of nab-PC vs sb-PC in Japanese patients with advanced non-small-cell lung cancer (NSCLC) who were enrolled in the CA031 study.
  
  
  METHODS
  In the CA031 study, a total of 1052 patients were randomized to receive either nab-P 100 mg/m(2) weekly or sb-P 200 mg/m(2) every 3 weeks both in combination with C at area under the concentration-time curve (AUC) = 6 on day 1 of each 3-week cycle. This analysis included 149 Japanese patients with previously untreated stage IIIB or IV NSCLC.
  
  
  RESULTS
  The baseline and histologic characteristics of patients were well balanced between the two arms. ORR was higher with nab-PC vs sb-PC (35% vs 27%; response rate ratio = 1.318). Progression-free survival (median 6.9 vs 5.6 months; hazard ratio [HR] = 0.845) and overall survival (median 16.7 vs 15.9 months; HR = 0.930) were better with nab-PC vs sb-PC. Of the grade ≥3 treatment-related adverse events, anemia and thrombocytopenia were more common in nab-PC arm, but sensory neuropathy was less common.
  
  
  CONCLUSIONS
  The nab-PC treatment yielded promising results regarding the efficacy endpoint, and it was generally well tolerated as first-line therapy for Japanese patients with advanced NSCLC.
authors.affiliation: Hyogo Cancer Center, Hyogo, Japan. satouchi@hp.pref.hyogo.jp
authors.forename: Miyako
authors.initials: M
authors.lastname: Satouchi
authors.forename: Isamu
authors.initials: I
authors.lastname: Okamoto
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sakai
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Yamamoto
authors.forename: Yukito
authors.initials: Y
authors.lastname: Ichinose
authors.forename: Hironobu
authors.initials: H
authors.lastname: Ohmatsu
authors.forename: Naoyuki
authors.initials: N
authors.lastname: Nogami
authors.forename: Koji
authors.initials: K
authors.lastname: Takeda
authors.forename: Tetsuya
authors.initials: T
authors.lastname: Mitsudomi
authors.forename: Kazuo
authors.initials: K
authors.lastname: Kasahara
authors.forename: Shunichi
authors.initials: S
authors.lastname: Negoro
mesh_terms: D000368:Aged; D000418:Albumins / Q000008:administration & dosage* / Q000009:adverse effects; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D044466:Asian People; D016190:Carboplatin / Q000008:administration & dosage* / Q000009:adverse effects; 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; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D013921:Thrombocytopenia / Q000139:chemically induced; D016896:Treatment Outcome
chemical_list: C520255:130-nm albumin-bound paclitaxel; D000418:Albumins; D016190:Carboplatin; D017239:Paclitaxel