Topotecan versus paclitaxel for the treatment of recurrent epithelial ovarian cancer.
OBJECTIVE
Topotecan and paclitaxel were evaluated in a randomized, multicenter study of patients with advanced epithelial ovarian carcinoma who had progressed during or after one platinum-based regimen.


METHODS
Patients received either topotecan (1.5 mg/m2) as a 30-minute infusion daily for 5 days every 21 days (n = 112) or paclitaxel (175 mg/m2) infused over 3 hours every 21 days (n = 114). Patients had bidimensionally measurable disease and were assessed for efficacy and toxicity.


RESULTS
Response rate was 23 of 112 (20.5%) in topotecan-treated patients and 15 of 114 (13.2%) in paclitaxel-treated patients (P = .138). Disease stabilization for at least 8 weeks was noted in 30% of patients with topotecan and 33% of patients with paclitaxel. Median durations of response to topotecan and paclitaxel were 32 and 20 weeks, respectively (P = .222) and median times to progression were 23 and 14 weeks, respectively (P = .002). Median survival was 61 weeks for topotecan and 43 weeks for paclitaxel (P = .515). Response rates for topotecan and paclitaxel were 13.3% versus 6.7% (P = .303) in resistant patients (not responded to prior platinum-based therapy or progressed within 6 months of an initial response) and 28.8% versus 20.0% (P = .213) in sensitive patients (progressed > 6 months after response). Neutropenia was significantly more frequent on the topotecan arm 79% versus paclitaxel arm 23% (P < .01). It was short-lasting and noncumulative in both arms. Nonhematologic toxicities were generally mild (grades 1 to 2) for both agents.


CONCLUSIONS
Topotecan has efficacy at least equivalent to paclitaxel manifested by the higher response rate and significantly longer time to progression.
ten Bokkel Huinink
W
W
The Netherlands Cancer Institute, Amsterdam. wtbh@nki.nl
Gore
M
M
Carmichael
J
J
Gordon
A
A
Malfetano
J
J
Hudson
I
I
Broom
C
C
Scarabelli
C
C
Davidson
N
N
Spanczynski
M
M
Bolis
G
G
Malmström
H
H
Coleman
R
R
Fields
S C
SC
Heron
J F
JF
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002166:Camptothecin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*; D016019:Survival Analysis; D019772:Topotecan
D000970:Antineoplastic Agents; D019772:Topotecan; D017239:Paclitaxel; D002166:Camptothecin