title: Single-agent gemcitabine versus cisplatin-etoposide: early results of a randomised phase II study in locally advanced or metastatic non-small-cell lung cancer.
abstract: BACKGROUND
  This randomised study was designed to determine the response rate survival and toxicity of single-agent gemcitabine and cisplatin-etoposide in chemo-naïve patients with locally advanced or metastatic non-small-cell lung cancer.
  
  
  METHODS
  Gemcitabine 1,000 mg/m2 was given as a 30 min intravenous infusion on days 1, 8, 15 of a 28-day cycle, cisplatin 100 mg/m2 on day 1, and etoposide 100 mg/m2 on days 1 (following cisplatin), 2 and 3. Major eligibility criteria included histologically confirmed non-small-cell lung cancer, measurable disease, Zubrod PS 0-2; no prior chemotherapy, no prior radiation of the measured lesion, and no CNS metastases.
  
  
  RESULTS
  146 patients were enrolled, 71 patients on gemcitabine and 75 patients on cisplatin-etoposide. Patient characteristics were well matched across both arms. Sixty-six gemcitabine patients and 72 cisplatin-etoposide patients were evaluable. Partial responses were seen in 12 gemcitabine patients (18.2%; 95% CI: 9.8-30) and 11 cisplatin-etoposide patients (15.3%; 95% CI: 7.9-25.7). Early indications show no statistical differences between the two treatments with respect to time to disease progression or survival. Haematological and laboratory toxicity were moderate and manageable. However, hospitalisation because of neutropenic fever was required for 6 (8%) cisplatin-etoposide patients but not for any gemcitabine patients. Non-haematological toxicity was more pronounced with significant differences in nausea and vomiting (grade 3 and 4: 11% gemcitabine vs. 29% cisplatin-etoposide; despite the allowance for 5-HT3 antiemetics during the first cycle of cisplatin-etoposide), and alopecia (grade 3 and 4:3% gemcitabine vs. 62% cisplatin-etoposide).
  
  
  CONCLUSIONS
  In this randomised study, single-agent gemcitabine was at least as active but better tolerated than the combination cisplatin-etoposide.
authors.affiliation: Thoraxklinik Heidelberg, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Manegold
authors.forename: B
authors.initials: B
authors.lastname: Bergman
authors.forename: A
authors.initials: A
authors.lastname: Chemaissani
authors.forename: W
authors.initials: W
authors.lastname: Dornoff
authors.forename: P
authors.initials: P
authors.lastname: Drings
authors.forename: P
authors.initials: P
authors.lastname: Kellokumpu-Lehtinen
authors.forename: K
authors.initials: K
authors.lastname: Liippo
authors.forename: K
authors.initials: K
authors.lastname: Mattson
authors.forename: J
authors.initials: J
authors.lastname: van Pawel
authors.forename: S
authors.initials: S
authors.lastname: Ricci
authors.forename: C
authors.initials: C
authors.lastname: Sederholm
authors.forename: R A
authors.initials: RA
authors.lastname: Stahel
authors.forename: G
authors.initials: G
authors.lastname: Wagenius
authors.forename: N
authors.initials: N
authors.lastname: van Walree
authors.forename: W
authors.initials: W
authors.lastname: ten Bokkel-Huinink
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D005047:Etoposide; D002945:Cisplatin; D000093542:Gemcitabine