title: [A randomized clinical trial on the clinical efficacy and toxicities of single-agent paclitaxel liposome versus paclitaxel liposome plus oxaliplatin as first-line chemotherapy for advanced non-small cell lung cancer in elderly patients].
abstract: OBJECTIVE
  The third generation single-agent drug has been recommended as a first-line chemotherapy for elderly patients with advanced non-small cell lung cancer (NSCLC). The aim of the current radomized trial is to compare the clinical efficacy and toxicities of single-agent paclitaxel liposome versus paclitaxel liposome plus oxaliplatin as a first-line chemotherapy for elderly patients.
  
  
  METHODS
  Sixty-nine advanced NSCLC patients from July 2008 to August 2010, confirmed with pathology or cytology and had never received treatment, were randomly divided into two groups. The first group was given 135 mg/m² of single-agent paclitaxel liposome on day 1 of each cycle. The second group was given 135 mg/m² paclitaxel liposome plus 125 mg/m² oxaliplatin on day 1 of each cycle. One cycle is composed of 21 days. Efficacy and toxicities could be evaluated after two or more cycles.
  
  
  RESULTS
  No statistical differences were observed between the two groups in terms of efficacy (22.9% vs 35.3%, P=0.297), disease control rate (60.0% vs 70.6%, P=0.450), and 1-year survival rate (28.6% vs 41.2%, P=0.724). However, the group treated with paclitaxel liposome plus oxaliplatin had longer progression free survival (PFS) (5.0 months vs 3.5 months, P=0.024). In addition, the toxicities that occurred in the two groups were similar including leukocytopenia (P=0.808), thrombocytopenia (P>0.999), anemia (P=0.477), and nausea/vomiting (P=0.777). The number of neurotoxicity that occurred in the two groups were 33 and 3 (97.1% vs 8.6%, P<0.001), respectively. However, all were grade I-II.
  
  
  CONCLUSIONS
  The clinical efficacy of paclitaxel liposome plus oxaliplatin as a first-line chemotherapy for elderly patients with advanced NSCLC is more better than that of the single-agent paclitaxel liposome. It prolongs PFS and is safe for clinical use.
authors.affiliation: Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, China.
authors.forename: Xiaomei
authors.initials: X
authors.lastname: Zeng
authors.forename: Zhixi
authors.initials: Z
authors.lastname: Li
authors.forename: Mei
authors.initials: M
authors.lastname: Hou
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008081:Liposomes / Q000008:administration & dosage*; D008297:Male; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077150:Oxaliplatin; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D008081:Liposomes; D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D017239:Paclitaxel