Phase III study comparing sequential versus alternate administration of cisplatin-etoposide and topotecan as first-line treatment in small cell lung cancer.
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.
Baka
Sophia
S
Hellenic Oncology Research Group (HORG), 55 Lomvardou Str, 11470, Athens, Greece.
Agelaki
Sophia
S
Kotsakis
Athanasios
A
Veslemes
Marinos
M
Papakotoulas
Pavlos
P
Agelidou
Maria
M
Agelidou
Athina
A
Tsaroucha
Emily
E
Pavlakou
Georgia
G
Gerogianni
Aleka
A
Androulakis
Nikolaos
N
Vamvakas
Lambros
L
Kalbakis
Kostas
K
Mavroudis
Dimitris
D
Georgoulias
Vassilis
V
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
D005047:Etoposide; D019772:Topotecan; D002945:Cisplatin