Table 1.
Actual‐Over‐Expected Ratio for Trials Using OS as a Primary Endpoint
| Trial No. | Reference | Setting | Control Arm | Experimental Arm | Expected OS for Control Arm | Actual OS | Sample Size of Control Arm | Size Effect Studied | A/E Ratio |
|---|---|---|---|---|---|---|---|---|---|
| 1 | du Bois 200625 | First‐line | Paclitaxel and carboplatin | Paclitaxel, carboplatin, and epirubicin | 36 mo (median) | 41 mo | 635 | 1.2 | 1.1 |
| 2 | Spriggs 200726 | First‐line | Cisplatin and paclitaxel (24 h) | Cisplatin and paclitaxel (96 h) | 27 mo (median) | 29.9 mo | 140 | 1.3 | 1.1 |
| 3 | ICON Group 200220 | First‐line | Carboplatin or cyclophosphamide, doxorubicin, and cisplatin | Paclitaxel and carboplatin | 50% (2‐y OS) | 63% (2‐y OS) | 1364 | 1.1 | 1.5 |
| 4 | Bolis 201019 | First‐line | Paclitaxel and carboplatin | Paclitaxel, carboplatin, and topotecan | 20% (3‐y OS) | 53% (3‐y OS) | 172 | 1.8 | 2.5 |
| 5 | Bolis 200418 | First‐line | Cisplatin and paclitaxel (175 mg/m2) | Cisplatin and paclitaxel (225 mg/m2) | 30% (4‐y OS) | 46% (4‐y OS) | 207 | 1.3 | 1.6 |
| 6 | Ray‐Coquard 200723 | First‐line | Cyclophosphamide (500 mg/m2), epirubicin, and cisplatin | Cyclophosphamide (1800 mg/m2), epirubicin, cisplatin, and G‐CSF | 50% (2‐y OS) | 66% (2‐y OS) | 85 | 1.3 | 1.7 |
| 7 | Pfisterer 200622 | First‐line maintenance | Observation | Topotecan maintenance | 50% (3‐y OS) | 58% (3‐y OS) | 650 | 1.2 | 1.3 |
| 8 | Rustin 201024 | Recurrence | Delayed treatmenta | Early treatmenta | 5% (2‐y OS) | 53% (2‐y OS) | 264 | 3.0 | 4.7 |
| 9 | Colombo 201013 | Recurrence | Pegylated liposomal doxorubicin | Patupilone | 8.9 mo (median) | 12.7 mo | 416 | 1.3 | 1.4 |
| 10 | Vergote 200927 | Recurrence | Pegylated liposomal doxorubicin or topotecan | Canfosfamide | 6 mo (median) | 13.5 mo | 229 | 1.4 | 2.3 |
| 11 | Hall 200428 | Recurrence | Observation | Interferon | 15 mo (median) | 33 mo | 151 | 1.5 | 2.2 |
| 12 | Meier 200916 | Recurrence | Treosulfan | Topotecan | 55% at 6 mo (median, 6.7 mo) | 9.5 mo | 119 | 1.3 | 1.4 |
| 13 | Parmar 200321 | Recurrence | Any platinum‐based therapy | Paclitaxel and carboplatin | 5% (2‐y OS) | 50% (2‐y OS) | 392 | 1.2 | 4.3 |
| 14 | du Bois 200215 | Recurrence | Leuprolide | Treosulfan | 40% (6‐mo OS) (median, 4.8 mo) | 6.9 mo | 39 | 1.5 | 1.5 |
| 15 | Alberts 200829 | Recurrence | Carboplatin | Carboplatin and pegylated liposomal doxorubicin | 18 mo (median) | 18 mo | 30 | 1.3 | 1.0 |
Abbreviations: A/E, actual‐over‐expected ratio; G‐CSF, granulocyte‐colony‐stimulating factor; ICON, International Collaborative Ovarian Neoplasm Group; OS, overall survival.
Detailed is expected survival of the control arm used for statistical calculations and actual survival achieved by this arm as well as size effect expected from the experimental treatment. Finally, the actual‐over‐expected ratio for survival of the control arm is given. A/E ratios were rounded to one decimal place.
a
This trial was designed to determine if there was a survival benefit with early treatment of relapse based on an elevated CA125 concentration alone.