Table A3.
DI and RDI in Safety and Per-Protocol Populations
| DI and RDI | Treatment |
|
|---|---|---|
| BEP | T-BEP | |
| Safety population | ||
| No. of patients | 161 | 161 |
| DI | ||
| CDDP, mg/m2/week | ||
| Median | 32.7 | 32.6 |
| Range | 8.1-35.6 | 6.4-35.6 |
| Q1-Q3 | 31.6-32.9 | 31.4-33.0 |
| VP-16, mg/m2/week | ||
| Median | 162.7 | 163.6 |
| Range | 40.7-186.4 | 31.8-187.7 |
| Q1-Q3 | 154.2-164.7 | 157.4-164.7 |
| BLM, mg/wk | ||
| Median | 29.4 | 29.3 |
| Range | 9.5-30.7 | 9.5-30.7 |
| Q1-Q3 | 27.6-29.6 | 27.2-29.6 |
| Taxol, mg/m2/week | ||
| Median | 57.3 | |
| Range | 13.6-61.0 | |
| Q1-Q3 | 55.0-57.7 | |
| RDI | ||
| CDDP | ||
| Median, % | 98.2 | 97.9 |
| Range, % | 24.4-106.8 | 19.3-106.8 |
| Q1-Q3, % | 94.7-98.8 | 94.3-99.0 |
| No. of patients with ≥ 80% RDI | 154 | 153 |
| % | 95.7 | 95.0 |
| No. of patients with ≥ 90% RDI | 143 | 143 |
| % | 88.8 | 88.8 |
| VP-16 | ||
| Median, % | 97.6 | 98.1 |
| Range, % | 24.4-111.8 | 19.1-112.6 |
| Q1-Q3, % | 92.5-98.8 | 94.4-98.8 |
| No. of patients with ≥ 80% RDI | 152 | 150 |
| % | 94.4 | 93.2 |
| No. of patients with ≥ 90% RDI | 134 | 139 |
| % | 83.2 | 86.3 |
| BLM | ||
| Median, % | 97.9 | 97.7 |
| Range, % | 31.8-102.4 | 31.8-102.4 |
| Q1-Q3, % | 92.0-98.8 | 90.6-98.8 |
| No. of patients with ≥ 80% RDI | 144 | 134 |
| % | 89.4 | 83.2 |
| No. of patients with ≥ 90% RDI | 132 | 122 |
| % | 82.0 | 75.8 |
| Taxol | ||
| Median, % | 98.2 | |
| Range, % | 23.4-104.6 | |
| Q1-Q3, % | 94.3-98.9 | |
| No. of patients with ≥ 80% RDI | 141 | |
| % | 87.6 | |
| No. of patients with ≥ 90% RDI | 133 | |
| % | 82.6 | |
| Per-protocol population | ||
| No. of patients | 152 | 148 |
| DI | ||
| CDDP, mg/m2/week | ||
| Median | 32.7 | 32.7 |
| Range | 8.1-35.6 | 6.4-35.6 |
| Q1-Q3 | 31.6-32.9 | 31.5-33.0 |
| VP-16, mg/m2/week | ||
| Median | 162.8 | 163.8 |
| Range | 40.7-186.4 | 31.8-187.7 |
| Q1-Q3 | 154.2-164.7 | 158.4-164.7 |
| BLM, mg/wk | ||
| Median | 29.6 | 29.3 |
| Range | 9.5-30.7 | 9.8-30.7 |
| Q1-Q3 | 27.5-29.6 | 27.2-29.6 |
| Taxol, mg/m2/week | ||
| Median | 0.0 | 57.4 |
| Range | 0.0-8.2 | 13.6-61.0 |
| Q1-Q3 | 0.0-0.0 | 55.2-57.8 |
| RDI | ||
| CDDP | ||
| Median, % | 98.2 | 98.0 |
| Range, % | 24.4-106.8 | 19.3-106.8 |
| Q1-Q3, % | 94.9-98.8 | 94.6-99.1 |
| No. of patients with ≥ 80% RDI | 146 | 142 |
| % | 96.1 | 95.9 |
| No. of patients with ≥ 90% RDI | 135 | 134 |
| % | 88.8 | 90.5 |
| VP-16 | ||
| Median, % | 97.7 | 98.3 |
| Range, % | 24.4-111.8 | 19.1-112.6 |
| Q1-Q3, % | 92.5-98.8 | 95.0-98.8 |
| No. of patients with ≥ 80% RDI | 144 | 139 |
| % | 94.7 | 93.9 |
| No. of patients with ≥ 90% RDI | 126 | 130 |
| % | 82.9 | 87.8 |
| BLM | ||
| Median, % | 98.8 | 97.7 |
| Range, % | 31.8-102.4 | 32.6-102.4 |
| Q1-Q3, % | 91.7-98.8 | 90.6-98.8 |
| No. of patients with ≥ 80% RDI | 136 | 125 |
| % | 89.5 | 84.5 |
| No. of patients with ≥ 90% RDI | 124 | 115 |
| % | 81.6 | 77.7 |
| Taxol | ||
| Median, % | 98.4 | |
| Range, % | 23.4-104.6 | |
| Q1-Q3, % | 94.7-99.0 | |
| No. of patients with ≥ 80% RDI | 130 | |
| % | 87.9 | |
| No. of patients with ≥ 90% RDI | 124 | |
| % | 83.8 | |
Abbreviations: BEP, bleomycin, etoposide, and cisplatin; BLM, bleomycin; CDDP, cisplatin; DI, dose intensity; Q, quartile; RDI, relative dose intensity; T-BEP, paclitaxel–bleomycin, etoposide, and cisplatin.