title: Phase II study of a novel taxane (Cabazitaxel-XRP 6258) in previously treated advanced non-small cell lung cancer (NSCLC) patients.
abstract: OBJECTIVE
  Given the success of cabazitaxel in patients with prostate cancer who progressed after receiving prior chemotherapy, its preclinical efficacy in various cell lines and possible ability to cross blood-brain barrier, cabazitaxel was hypothesized to increase objective response rate (ORR) in second-line setting in non-small cell lung cancer (NSCLC).
  
  
  METHODS
  This was a phase II 2-stage trial in 28 patients using two different treatment schedules (A: 20 mg/m(2) every 3 weeks intravenously and B: 8.4 mg/m(2) intravenously weekly) to determine the ORR of cabazitaxel with secondary end points including progression-free survival (PFS), safety, and overall survival (OS).
  
  
  RESULTS
  There was one objective response in schedule B. PFS and OS of schedule A was 3 and 6 months, respectively. PFS and OS of schedule B was 3 and 13 months, respectively. The stable disease rate was higher in schedule A (SD = 69.23 %; 95 % CL 38.57, 90.90) as compared to schedule B (SD = 38.46 %; 95 % CL 13.86, 68.42), but this difference was not statistically significant (P value = 0.1156). There were two grade 5 toxicities from sepsis. Hematuria of any grade developed in greater percentage of patients (35%) as compared to previous cabazitaxel phase 3 trial and led to change in our protocol.
  
  
  CONCLUSIONS
  Response to cabazitaxel in NSCLC was not as robust as seen in prostate cancer and not superior to currently used agents such as docetaxel, pemetrexed, and erlotinib. In absence of significant objective responses, the second stage of the study was not undertaken.
authors.affiliation: Division of Hematology/Oncology, Comprehensive Cancer Center, University of Alabama at Birmingham, 1824 Sixth Avenue South, WTI 210B, Birmingham, AL, 934-5077, USA.
authors.forename: Ankit
authors.initials: A
authors.lastname: Madan
authors.affiliation: Division of Hematology/Oncology, Comprehensive Cancer Center, University of Alabama at Birmingham, 1824 Sixth Avenue South, WTI 210B, Birmingham, AL, 934-5077, USA.
authors.forename: Benjamin S
authors.initials: BS
authors.lastname: Jones
authors.affiliation: Georgia Cancer Specialists, Affiliated with Northside Hospital Cancer Institute, Marietta, GA, USA.
authors.forename: Rodolfo
authors.initials: R
authors.lastname: Bordoni
authors.affiliation: Division of Hematology/Oncology, Comprehensive Cancer Center, University of Alabama at Birmingham, 1824 Sixth Avenue South, WTI 210B, Birmingham, AL, 934-5077, USA.
authors.forename: Mansoor N
authors.initials: MN
authors.lastname: Saleh
authors.affiliation: Clinical Studies Unit, Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Mary S
authors.initials: MS
authors.lastname: Jerome
authors.affiliation: Clinical Studies Unit, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Deborah K
authors.initials: DK
authors.lastname: Miley
authors.affiliation: Division of Preventive Medicine, Comprehensive Cancer Center, University of Alabama at Birmingham, Birmingham, AL, USA.
authors.forename: Bradford E
authors.initials: BE
authors.lastname: Jackson
authors.affiliation: Division of Hematology/Oncology, Comprehensive Cancer Center, University of Alabama at Birmingham, 1824 Sixth Avenue South, WTI 210B, Birmingham, AL, 934-5077, USA. pacorobertuab@cs.com.
authors.forename: Francisco
authors.initials: F
authors.lastname: Robert
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; C552428:cabazitaxel
keywords: Cabazitaxel; Chemotherapy; Non-small cell lung cancer; Phase II