GOG-158
Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study
Phase 3N = 792
- Population
- Patients with advanced (optimally resected stage III) ovarian cancer and no residual mass greater than 1.0 cm after surgery
- Design
- Non-inferiority randomised trial. Patients with advanced ovarian cancer and no residual mass greater than 1.0 cm after surgery were randomly assigned to cisplatin 75 mg/m2 plus a 24-hour infusion of paclitaxel 135 mg/m2 (arm I), or carboplatin AUC 7.5 plus paclitaxel 175 mg/m2 over 3 hours (arm II). 792 eligible patients were enrolled.
- Arms
- Cisplatin plus paclitaxel (arm I) (control): Cisplatin 75 mg/m2 plus paclitaxel 135 mg/m2 as a 24-hour infusion
- Carboplatin plus paclitaxel (arm II) (experimental): Carboplatin AUC 7.5 plus paclitaxel 175 mg/m2 over 3 hours
- People
- Ozols RF, Gynecologic Oncology Group
Δ median PFS+1.3 monthsΔ median OS+8.7 months
Show the numbers
| Endpoint | Analysis | Carboplatin plus paclitaxel (arm II) | Cisplatin plus paclitaxel (arm I) | Effect |
|---|---|---|---|---|
| PFSEligible patients (N=792) | primaryOzols 2003 | median 20.7 months | median 19.4 months | The abstract reports a relative risk of progression of 0.88 (95% CI 0.75 to 1.03) for carboplatin plus paclitaxel; it is not labelled a hazard ratio and is given here as published. No p-value is given. |
| OSEligible patients (N=792) | primaryOzols 2003 | median 57.4 months | median 48.7 months | The abstract reports a relative risk of death of 0.84 (95% CI 0.70 to 1.02) for carboplatin plus paclitaxel; it is not labelled a hazard ratio and is given here as published. No p-value is given. |
| Endpoint | Analysis | Carboplatin plus paclitaxel (arm II) | Cisplatin plus paclitaxel (arm I) | Effect |
|---|---|---|---|---|
| PFSEligible patients (N=792) | primaryOzols 2003 | median 20.7 months | median 19.4 months | The abstract reports a relative risk of progression of 0.88 (95% CI 0.75 to 1.03) for carboplatin plus paclitaxel; it is not labelled a hazard ratio and is given here as published. No p-value is given. |
| OSEligible patients (N=792) | primaryOzols 2003 | median 57.4 months | median 48.7 months | The abstract reports a relative risk of death of 0.84 (95% CI 0.70 to 1.02) for carboplatin plus paclitaxel; it is not labelled a hazard ratio and is given here as published. No p-value is given. |
- Carboplatin plus paclitaxel (arm II) (experimental)
- Cisplatin plus paclitaxel (arm I) (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Carboplatin plus paclitaxel (arm II) | Cisplatin plus paclitaxel (arm I) |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 13 | 64.7% | 62.8% |
| 26 | 41.9% | 39.5% |
| 39 | 27.1% | 24.8% |
| 52 | 17.5% | 15.6% |
- Carboplatin plus paclitaxel (arm II) (experimental)
- Cisplatin plus paclitaxel (arm I) (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Carboplatin plus paclitaxel (arm II) | Cisplatin plus paclitaxel (arm I) |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 36 | 64.7% | 59.9% |
| 72 | 41.9% | 35.9% |
| 108 | 27.1% | 21.5% |
| 144 | 17.6% | 12.9% |
Appears in
Sources
Ozols RF, Bundy BN, Greer BE, Fowler JM, Clarke-Pearson D, Burger RA, et al. Phase III trial of carboplatin and paclitaxel compared with cisplatin and paclitaxel in patients with optimally resected stage III ovarian cancer: a Gynecologic Oncology Group study. J Clin Oncol. 2003;21(17):3194-200.