title: Phase III study comparing sequential versus alternate administration of cisplatin-etoposide and topotecan as first-line treatment in small cell lung cancer.
abstract: OBJECTIVE
  To compare the efficacy and tolerance of sequential versus alternate front-line administration of cisplatin-etoposide (PE) and topotecan (T) in patients with extensive stage small cell lung cancer (SCLC).
  
  
  METHODS
  Patients were randomized to receive either 4 cycles PE (cisplatin 80 mg/m(2) i.v. day 1 and etoposide100 mg/m(2)/d i.v. days 1-3 every 21 days) followed by 4 cycles T (1.5 mg/m(2)/d i.v. days 1-5 every 21 days) (arm A, 183 patients) or the same regimens using an alternate sequence (arm B, 181 patients).
  
  
  RESULTS
  There was no significant difference in terms of compliance with treatment, overall response rates (51.4% vs. 55.2%; p=0.458), median response duration (4.3 vs. 5.2 months; p=0.780), median time to tumour progression (5.7 vs. 6.4 months; p=0.494), median overall survival (10.9 vs. 9.8 months; p=0.186) and 1-year survival (43.8% vs. 36.5%) between the two arms. The incidence of severe grade 3-4 haematological and grade 2-4 non-haematological (asthenia, mucositis, diarrhoea and neurotoxicity) toxicity was comparable between the two arms.
  
  
  CONCLUSIONS
  The comparison of sequential versus alternate administration of cisplatin-etoposide and topotecan as front-line treatment of patients with extensive stage SCLC revealed no clinically meaningful differences in terms of efficacy and tolerance.
authors.affiliation: Hellenic Oncology Research Group (HORG), 55 Lomvardou Str, 11470, Athens, Greece.
authors.forename: Sophia
authors.initials: S
authors.lastname: Baka
authors.forename: Sophia
authors.initials: S
authors.lastname: Agelaki
authors.forename: Athanasios
authors.initials: A
authors.lastname: Kotsakis
authors.forename: Marinos
authors.initials: M
authors.lastname: Veslemes
authors.forename: Pavlos
authors.initials: P
authors.lastname: Papakotoulas
authors.forename: Maria
authors.initials: M
authors.lastname: Agelidou
authors.forename: Athina
authors.initials: A
authors.lastname: Agelidou
authors.forename: Emily
authors.initials: E
authors.lastname: Tsaroucha
authors.forename: Georgia
authors.initials: G
authors.lastname: Pavlakou
authors.forename: Aleka
authors.initials: A
authors.lastname: Gerogianni
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Androulakis
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Kostas
authors.initials: K
authors.lastname: Kalbakis
authors.forename: Dimitris
authors.initials: D
authors.lastname: Mavroudis
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D018450:Disease Progression; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D055752:Small Cell Lung Carcinoma / Q000188:drug therapy*; D015996:Survival Rate; D019772:Topotecan / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D005047:Etoposide; D019772:Topotecan; D002945:Cisplatin