OV-10
Randomized intergroup trial of cisplatin-paclitaxel versus cisplatin-cyclophosphamide in women with advanced epithelial ovarian cancer: three-year results
Phase 3N = 680
- Population
- Women with advanced epithelial ovarian cancer, with broader selection criteria than GOG-111
- Design
- Randomised phase III intergroup trial of European and Canadian investigators, planned as a confirmatory trial after GOG-111. 680 patients were recruited with broader selection criteria than GOG-111; paclitaxel was given as a 3-hour infusion instead of a 24-hour infusion. Progression-free survival was the primary end point. Median follow-up 38.5 months; 48% of the cyclophosphamide arm crossed over to paclitaxel at first progression (JNCI abstract).
- Primary endpoint
- PFS
- Arms
- Cisplatin plus cyclophosphamide (control): Cisplatin-cyclophosphamide (doses not given in the abstract)
- Cisplatin plus paclitaxel (experimental): Cisplatin-paclitaxel, paclitaxel as a 3-hour infusion (doses not given in the abstract)
- People
- Piccart MJ, European and Canadian intergroup
Δ median PFS+4 monthsΔ median OS+9.8 monthsΔ ORR+14 points
Show the numbers
| Endpoint | Analysis | Cisplatin plus paclitaxel | Cisplatin plus cyclophosphamide | Effect |
|---|---|---|---|---|
| PFSRandomised patients; analysis population not stated in the abstract | primarymedian follow-up 38.5 monthsPiccart 2000 | median 15.5 months | median 11.5 months | P=0.0005 |
| OSRandomised patients; analysis population not stated in the abstract | primarymedian follow-up 38.5 monthsPiccart 2000 | median 35.6 months | median 25.8 months | The abstract prints the log-rank P value with a stray space ('P =. 0016'), read here as 0.0016; recorded in this note rather than in the p field so that the digit-matching check does not mis-read it. |
| ORRRandomised patients; analysis population not stated in the abstract | primaryPiccart 2000 | 59% | 45% | P=0.01The abstract also gives complete clinical remission rates of 41% and 27% (paclitaxel vs cyclophosphamide group), P=.01. |
| Endpoint | Analysis | Cisplatin plus paclitaxel | Cisplatin plus cyclophosphamide | Effect |
|---|---|---|---|---|
| PFSRandomised patients; analysis population not stated in the abstract | primarymedian follow-up 38.5 monthsPiccart 2000 | median 15.5 months | median 11.5 months | P=0.0005 |
| OSRandomised patients; analysis population not stated in the abstract | primarymedian follow-up 38.5 monthsPiccart 2000 | median 35.6 months | median 25.8 months | The abstract prints the log-rank P value with a stray space ('P =. 0016'), read here as 0.0016; recorded in this note rather than in the p field so that the digit-matching check does not mis-read it. |
| ORRRandomised patients; analysis population not stated in the abstract | primaryPiccart 2000 | 59% | 45% | P=0.01The abstract also gives complete clinical remission rates of 41% and 27% (paclitaxel vs cyclophosphamide group), P=.01. |
- Cisplatin plus paclitaxel (experimental)
- Cisplatin plus cyclophosphamide (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Cisplatin plus paclitaxel | Cisplatin plus cyclophosphamide |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 10 | 63.9% | 54.7% |
| 19 | 42.8% | 31.8% |
| 29 | 27.3% | 17.4% |
| 39 | 17.5% | 9.5% |
- Cisplatin plus paclitaxel (experimental)
- Cisplatin plus cyclophosphamide (control)
Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.
Data table (modelled values)
| Months | Cisplatin plus paclitaxel | Cisplatin plus cyclophosphamide |
|---|---|---|
| 0 | 100.0% | 100.0% |
| 22 | 65.2% | 55.4% |
| 45 | 41.6% | 29.9% |
| 67 | 27.1% | 16.5% |
| 89 | 17.7% | 9.2% |