title: Gemcitabine and vinorelbine (GV) versus cisplatin, gemcitabine and vinorelbine (CGV) as first-line treatment in advanced non small cell lung cancer: results of a prospective randomized phase II study.
abstract: The objective of this study was to assess whether adding cisplatin to gemcitabine/vinorelbine combination improves the clinical outcome in patients with non-small-cell lung cancer (NSCLC). Chemotherapy-naïve patients with advanced NSCLC; age < or = 75 years: Karnofsky performance status > or = 60%, and with adequate hematological, renal and hepatic function, were randomized into 2 treatment groups to receive Gemcitabine 1250 mg/m2 + vinorelbine 30 mg/m2 (GV group), or cisplatin 50 mg/m2 + gemcitabine 1000 mg/m2 + vinorelbine 25 mg/m2 (CGV group). All drugs were administered on days 1 and 8 every three weeks: From September 1999 to March 2003, 114 patients were enrolled. No statistically significant difference was observed in GV vs CGV group in objective response (37 versus 47%, respectively; P = 0.5), median time to progression (5 versus 5.8 months; P = 0.6), overall survival (9 versus 10 months; P = 0.9) and 1-year survival (26 versus 28%; P = 0.9). Conversely, toxicities were significantly higher for CGV, including grade 3-4 neutropenia (24 versus 45%); neutropenic fever (4 versus 14%, including one toxic death); grade 3-4 thrombocytopenia (2 versus 14%); and grade 3-4 emesis (2 versus 14%). Our results suggest that the combination of gemcitabine and vinorelbine is less toxic than three-drug combination with cisplatin while showing similar efficacy.
authors.affiliation: Clinical Oncology Services, Hospital Central de Asturias, Oviedo, Asturias, Spain. eestebang@seom.org
authors.forename: Emilio
authors.initials: E
authors.lastname: Esteban
authors.forename: Joaquin
authors.initials: J
authors.lastname: Fra
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Fernández
authors.forename: Norberto
authors.initials: N
authors.lastname: Corral
authors.forename: José M
authors.initials: JM
authors.lastname: Vieitez
authors.forename: Isabel
authors.initials: I
authors.lastname: Palacio
authors.forename: José L
authors.initials: JL
authors.lastname: de Sande
authors.forename: José L
authors.initials: JL
authors.lastname: Fernández
authors.forename: Isabel
authors.initials: I
authors.lastname: Muñiz
authors.forename: Noemi
authors.initials: N
authors.lastname: Villanueva
authors.forename: Enrique
authors.initials: E
authors.lastname: Estrada
authors.forename: Beatriz
authors.initials: B
authors.lastname: Mareque
authors.forename: Esther
authors.initials: E
authors.lastname: Uña
authors.forename: José M
authors.initials: JM
authors.lastname: Buesa
authors.forename: Angel J
authors.initials: AJ
authors.lastname: Lacave
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / 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*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine; D000093542:Gemcitabine