Phase II study of oral etoposide and intravenous paclitaxel in extensive-stage small cell lung cancer.
BACKGROUND
This study evaluated the activity and tolerance for the combination of oral etoposide and paclitaxel as first-line therapy for patients with extensive SCLC.


METHODS
A total of 57 patients were enrolled in this study. A cycle of chemotherapy consisted of oral etoposide administered as 50 mg BID on days 1 through 10 and paclitaxel administered as 150 mg/m(2) IV (3 h infusion) along with the first dose of etoposide on day 10. Patients were assessed for response to therapy (regression, stable disease, progression), survival, time to disease progression, and toxicity.


CONCLUSIONS
Fifty-five patients were evaluable for efficacy parameters. Among the 55 patients, there were six with complete regression of disease, 18 with partial regression, 11 with regression, five with stable disease, and 15 with progressive disease, yielding an overall response rate of 63.6% (95% confidence interval, 50.0-76.0%). The 6-month and 1-year progression-free survival rates were 48.2 and 18.9%, respectively. The median time to disease progression was 5.8 months. The overall survival rates were 67.3% at 6 months and 41.8% at 1 year. The combination of oral etoposide and paclitaxel demonstrated significant efficacy as first-line therapy for extensive SCLC, with an overall response rate of 63.6% for 55 evaluable patients. In addition, the treatment was well tolerated with no unexpected toxicities.
Perez
Edith A
EA
Mayo Clinic, Jacksonville, FL 32224, USA. perez.edith@mayo.edu
Geoffroy
Francois J
FJ
Hillman
Shauna
S
Johnson
Elizabeth A
EA
Farr
Gist H
GH
Tazelarr
Henry D
HD
Hatfield
Alan K
AK
Krook
James E
JE
Maillard
James A
JA
Levitt
Ralph
R
Marks
Randolph S
RS
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D018288:Carcinoma, Small Cell / Q000188:drug therapy* / Q000473:pathology; D004357:Drug Synergism; D005047:Etoposide / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage*; D016019:Survival Analysis; D016896:Treatment Outcome
D005047:Etoposide; D017239:Paclitaxel