Randomized phase II study comparing topotecan/cisplatin administration for 5 days versus 3 days in the treatment of extensive stage small cell lung cancer (SCLC).
BACKGROUND
Topotecan (T) is an active drug in SCLC. A combination of topotecan with cisplatin (DDP) was suggested to be highly synergistic. This phase II trial was initiated to assess the activity of T/DDP in chemotherapy-naive patients suffering from extensive disease small cell lung cancer (SCLC) and to compare the conventional 5-day regime with an experimental 3-day schedule.


METHODS
A total of 86 patients were included. Patients were randomized to receive either T 1.0 mg/m2 d 1-5 and DDP 75 mg/m2 d 5 (arm A) or T 1.5 mg/m2 d 1-3 and DDP 75 mg/m2 d 3 (arm B). Six cycles were given at a 3-week interval.


RESULTS
Data of 84 evaluable patients (67 males and 17 females) were analysed. All patients had metastatic disease. The best response rate was 61.9% in arm A and 59.5% in arm B. Median overall survival was 8.7 months in arm A and 7.6 months in arm B (p=0.6809).


CONCLUSIONS
Combination of T and DDP is active in ED SCLC. Toxicity and median survival were comparable in both arms. Three days treatment seems to be similar to the 5 days regime.
Seifart
U
U
Hamm-Kliniken Brüder Grimm-Str. 2063628 Bad Soden Salmünster Baldingerstrasse, 35043 Marburg, Germany. dr.seifart@hamm-kliniken.de
Jensen
K
K
Ukena
J
J
Mueller
C
C
Schröder
M
M
Fuhr
H G
HG
Keppler
U
U
Neubauer
A
A
Staab
H J
HJ
Wolf
M
M
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D019772:Topotecan / Q000008:administration & dosage
D019772:Topotecan; D002945:Cisplatin