Table 4.
Efficacy and safety of various topotecan treatment regimens
| Study | Regimen | Efficacy responses | Grade 3/4 hematologic toxicities, % | |||
|---|---|---|---|---|---|---|
| ORR, % | mOS, weeks | Neutropenia | Thrombocytopenia | Anemia | ||
| von Pawel et al (1999) | 1.5 mg/m2 days 1–5 of 21-day cycle | 24 | 25.0 | 70 | 29 | 41 |
| Treat et al (2004)a | 1.5 mg/m2 days 1–5 of 21-day cycle | 15 | 16.0–36.3b | 90 | 55 | 33 |
| Koschel et al (2000) | 1.25 mg/m2 days 1–5 of 21-day cycle | 15 | 22.4 | 10c | 5c | 1c |
| Perez-Soler et al (1996) | 1.25 mg/m2 days 1–5 of 21-day cycle | 11 | 20.0 | NR | 31c | NR |
| Ogawara et al (2000) | 1.0 mg/m2 days 1–5 of 21-day cycle | 26 | 35.1 | 84 | 42 | 46 |
| Takeda et al (2003) | 1.0 mg/m2 days 1–5 of 21-day cycle | 26 | 37.4 | 92 | 40 | 46 |
| Shipley et al (2006) | 4.0 mg/m2 weekly for 12 weeks | 5 | 19.4 | 21 | 27 | NR |
| Murphy et al (2006) | 4.0 mg/m2 weekly for 12 weeks | 13 | 22.4 (in patients with PR/SD) | 29 | 8 | NR |
| Ardizzoni et al (2003) | Topotecan, 0.75 mg/m2 on days 1–5; cisplatin, 60 mg/m2 on day 1 every 21-days | 27 | S: 27.5, R: 26.2 | S: 76, R: 74 | S: 74, R: 63 | S: 37, R: 40 |
| Christodoulou et al (2006) | Topotecan, 0.9 mg/m2; cisplatin, 20 mg/m2 on days 1–3 every 21-days | 18 | 28.0 | 42 | 15 | 15 |
a
Note: Pooled retrospective analysis of 5 phase II and III trials
b
Survival times were reported based on patient performance status
c
Results reported as percentage of courses.
Abbreviations: ORR, Overall response rate; mOS, Median overall survival; NR, Not reported; S, Chemosensitive; R, Chemorefractory; PR, Partial response; SD, Stable disease.