title: Randomized phase III study of gemcitabine-cisplatin versus etoposide-cisplatin in the treatment of locally advanced or metastatic non-small-cell lung cancer.
abstract: OBJECTIVE
  We conducted a randomized trial to compare gemcitabine-cisplatin with etoposide-cisplatin in the treatment of patients with advanced non-small-cell lung cancer (NSCLC). The primary end point of the comparison was response rate.
  
  
  METHODS
  A total of 135 chemotherapy-naive patients with advanced NSCLC were randomized to receive either gemcitabine 1,250 mg/m2 intravenously (IV) days 1 and 8 or etoposide 100 mg/m2 IV days 1 to 3 along with cisplatin 100 mg/m2 IV day 1. Both treatments were administered in 21-day cycles. One hundred thirty-three patients were included in the intent-to-treat analysis of response.
  
  
  RESULTS
  The response rate (externally validated) for patients given gemcitabine-cisplatin was superior to that for patients given etoposide-cisplatin (40.6% v 21.9%; P = .02). This superior response rate was associated with a significant delay in time to disease progression (6.9 months v 4.3 months; P = .01) without an impairment in quality of life (QOL). There was no statistically significant difference in survival time between both arms (8.7 months for gemcitabine-cisplatin v 7.2 months for etoposide-cisplatin; P = .18). The overall toxicity profile for both combinations of drugs was similar. Nausea and vomiting were reported more frequently in the gemcitabine arm than in the etoposide arm. However, the difference was not significant. Gemcitabine-cisplatin produced less grade 3 alopecia (13% v 51%) and less grade 4 neutropenia (28% v 56% ) but more grade 3 and 4 thrombocytopenia (56% v 13%) than did etoposide-cisplatin. However, there were no thrombocytopenia-related complications in the gemcitabine arm.
  
  
  CONCLUSIONS
  Compared with etoposide-cisplatin, gemcitabine-cisplatin provides a significantly higher response rate and a delay in disease progression without impairing QOL in patients with advanced NSCLC.
authors.affiliation: Hospital Duran i Reynals, Barcelona, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Cardenal
authors.forename: M P
authors.initials: MP
authors.lastname: López-Cabrerizo
authors.forename: A
authors.initials: A
authors.lastname: Antón
authors.forename: V
authors.initials: V
authors.lastname: Alberola
authors.forename: B
authors.initials: B
authors.lastname: Massuti
authors.forename: A
authors.initials: A
authors.lastname: Carrato
authors.forename: I
authors.initials: I
authors.lastname: Barneto
authors.forename: M
authors.initials: M
authors.lastname: Lomas
authors.forename: M
authors.initials: M
authors.lastname: García
authors.forename: P
authors.initials: P
authors.lastname: Lianes
authors.forename: J
authors.initials: J
authors.lastname: Montalar
authors.forename: C
authors.initials: C
authors.lastname: Vadell
authors.forename: J L
authors.initials: JL
authors.lastname: González-Larriba
authors.forename: B
authors.initials: B
authors.lastname: Nguyen
authors.forename: A
authors.initials: A
authors.lastname: Artal
authors.forename: R
authors.initials: R
authors.lastname: Rosell
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / 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; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018450:Disease Progression; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D008875:Middle Aged; D011788:Quality of Life; D015996:Survival Rate; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D005047:Etoposide; D002945:Cisplatin; D000093542:Gemcitabine