GOG-172
Intraperitoneal cisplatin and paclitaxel in ovarian cancer
Phase 3N = 429
- Population
- Women with stage III ovarian or primary peritoneal carcinoma and no residual mass greater than 1.0 cm after surgery
- Design
- Randomised phase 3 trial. Patients with stage III ovarian or primary peritoneal carcinoma and no residual mass greater than 1.0 cm were randomly assigned to intravenous paclitaxel 135 mg/m2 over 24 hours followed by either intravenous cisplatin 75 mg/m2 on day 2 or intraperitoneal cisplatin 100 mg/m2 on day 2 and intraperitoneal paclitaxel 60 mg/m2 on day 8. Treatment every three weeks for six cycles; quality of life was assessed. 429 patients were randomised and 415 were eligible.
- Arms
- Intravenous paclitaxel plus intravenous cisplatin (control): Paclitaxel 135 mg/m2 intravenously over 24 hours, then cisplatin 75 mg/m2 intravenously on day 2
- Intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel (experimental): Paclitaxel 135 mg/m2 intravenously over 24 hours, cisplatin 100 mg/m2 intraperitoneally on day 2, paclitaxel 60 mg/m2 intraperitoneally on day 8
- People
- Armstrong DK, Gynecologic Oncology Group
Δ median PFS+5.5 monthsΔ median OS+15.9 months
Show the numbers
| Endpoint | Analysis | Intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel | Intravenous paclitaxel plus intravenous cisplatin | Effect |
|---|---|---|---|---|
| PFSRandomised patients (429), of whom 415 were eligible; the abstract does not say which set the survival analyses used | primaryArmstrong 2006 | median 23.8 months | median 18.3 months | P=0.05P value by the log-rank test, as printed in the abstract. |
| OSRandomised patients (429), of whom 415 were eligible; the abstract does not say which set the survival analyses used | primaryArmstrong 2006 | median 65.6 months | median 49.7 months | P=0.03P value by the log-rank test, as printed in the abstract. |
| Endpoint | Analysis | Intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel | Intravenous paclitaxel plus intravenous cisplatin | Effect |
|---|---|---|---|---|
| PFSRandomised patients (429), of whom 415 were eligible; the abstract does not say which set the survival analyses used | primaryArmstrong 2006 | median 23.8 months | median 18.3 months | P=0.05P value by the log-rank test, as printed in the abstract. |
| OSRandomised patients (429), of whom 415 were eligible; the abstract does not say which set the survival analyses used | primaryArmstrong 2006 | median 65.6 months | median 49.7 months | P=0.03P value by the log-rank test, as printed in the abstract. |
- Intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel (experimental)
- Intravenous paclitaxel plus intravenous cisplatin (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel | Intravenous paclitaxel plus intravenous cisplatin |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 15 | 64.6% | 56.7% |
| 30 | 41.7% | 32.1% |
| 45 | 27.0% | 18.2% |
| 60 | 17.4% | 10.3% |
- Intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel (experimental)
- Intravenous paclitaxel plus intravenous cisplatin (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Intravenous paclitaxel plus intraperitoneal cisplatin and paclitaxel | Intravenous paclitaxel plus intravenous cisplatin |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 41 | 64.8% | 56.5% |
| 82 | 42.0% | 31.9% |
| 123 | 27.3% | 18.0% |
| 164 | 17.7% | 10.2% |