Prolonged oral versus high-dose intravenous etoposide in combination with carboplatin for stage IV non-small-cell lung cancer (NSCLC): a randomized trial.
In order to investigate whether dose-intensive intravenous (i.v.) etoposide offers an advantage over prolonged oral administration of etoposide when combined with carboplatin (CBDCA), between January, 1991 and December, 1994, 171 patients with metastatic (stage IV) non-small cell lung cancer were randomized to receive CBDCA, 400 mg/m2, day 1 with either oral etoposide, 50 mg/m2, days 1-21 (group I) or i.v. etoposide, 200 mg/m2, days 1-3 (group II), every 4 weeks for up to six cycles or until tumour progression. Of the patients 168 were fully assessable for response, survival and toxicity. There were three (4%) CR and 16 (19%) PR in group 1, and the overall response rate was 23%. There were four (5%) CR and 12 (14%) PR in group II, and the overall response rate was 19% (P = 0.82). The median survival time (MST) in group I was 8 months, and 1- and 2-year survival rates were 35 and 9.5%, respectively, while the corresponding figures for group II were 7 months, and 31 and 7.1%, respectively (P = 0.40). Both haematological and non-haematological toxicity was significantly more frequent in group II with six (7%) patients in that group dying of treatment-related infection. Intensive i.v. etoposide combined with CBDCA was similar in efficacy to but more toxic than prolonged oral etoposide plus carboplatin and we do not recommend it for further investigation.
Jeremic
B
B
Department of Oncology, University Hospital, Kragujevac, Yugoslavia. bjeremic@med.uni-tuebingen.de
Shibamoto
Y
Y
Milicic
B
B
Milisavljevic
S
S
Nikolic
N
N
Dagovic
A
A
Aleksandrovic
J
J
Radosavljevic-Asic
G
G
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D012189:Retrospective Studies; D015996:Survival Rate; D016896:Treatment Outcome
D005047:Etoposide; D016190:Carboplatin