title: Gemcitabine plus vinorelbine versus vinorelbine alone in elderly patients with advanced non-small-cell lung cancer.
abstract: OBJECTIVE
  To evaluate whether the addition of gemcitabine (G) to vinorelbine (V) improves survival and quality of life (QoL) among elderly patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with NSCLC aged >/= 70 years with advanced disease were randomly allocated to receive V 30 mg/m(2) on days 1 and 8 every 3 weeks or G 1,200 mg/m(2) + V 30 mg/m(2) on days 1 and 8 every 3 weeks. The estimated sample size was 120 patients per arm, but an interim analysis of survival was planned based on the first 60 patients per arm.
  
  
  RESULTS
  In May 1999, the survival data were analyzed of 120 eligible patients (V group = 60; G + V group = 60) who had been randomized from June 1997 to February 1999. Forty-nine patients had stage IIIB disease, and 71 had stage IV. At a median potential follow-up of 14 months (range, 3 to 22 months), 93 patients had died (G + V group = 41; V group = 52). In the G + V group, median survival time was 29 weeks and projected 1-year survival was 30%; these values were 18 weeks and 13% in the V group. According to multivariate Cox analysis, the risk of death in the G + V arm compared with the V arm was 0.48 (95% confidence interval, 0. 29 to 0.79; P <.01). Combination therapy was also associated with a clear delay in symptom and QoL deterioration. The overall response rates were 22% and 15% in the G + V and V groups, respectively.
  
  
  CONCLUSIONS
  In elderly patients with NSCLC, G + V treatment is associated with significantly better survival than is V alone.
authors.affiliation: Division of Medical Oncology, City Hospital, Avellino, Italy. GIFRASCI@SIRIO-ONCOLOGY.IT
authors.forename: G
authors.initials: G
authors.lastname: Frasci
authors.forename: V
authors.initials: V
authors.lastname: Lorusso
authors.forename: N
authors.initials: N
authors.lastname: Panza
authors.forename: P
authors.initials: P
authors.lastname: Comella
authors.forename: G
authors.initials: G
authors.lastname: Nicolella
authors.forename: A
authors.initials: A
authors.lastname: Bianco
authors.forename: G
authors.initials: G
authors.lastname: De Cataldis
authors.forename: A
authors.initials: A
authors.lastname: Iannelli
authors.forename: D
authors.initials: D
authors.lastname: Bilancia
authors.forename: M
authors.initials: M
authors.lastname: Belli
authors.forename: B
authors.initials: B
authors.lastname: Massidda
authors.forename: F
authors.initials: F
authors.lastname: Piantedosi
authors.forename: G
authors.initials: G
authors.lastname: Comella
authors.forename: M
authors.initials: M
authors.lastname: De Lena
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000009:adverse effects; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D011788:Quality of Life; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000972:Antineoplastic Agents, Phytogenic; D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine