Table 1.
Characteristics of included phase III trials
| Characteristic | Aggressive histology (N = 38), n (%) | Indolent histology (N = 20), n (%) |
| Sample size | ||
| Median | 382 | 244 |
| Range | 177–1222 | 131–428 |
| Time period of study | ||
| Before 1990 | 16 (42) | 7 (35) |
| 1991–2005 | 22 (58) | 13 (65) |
| Accrual duration (years) | ||
| Median | 4 | 5 |
| Range | 1–10 | 2–9 |
| Follow-up duration (months) | ||
| Median | 55 | 53 |
| Range | 20–108 | 29–144 |
| Design | ||
| Two-arm | 25 (66) | 12 (60) |
| Three-arm | 1 (3) | 2 (10) |
| Four-arm | 1 (3) | 0 |
| Two-arm, Two-stage | 5 (13) | 6 (30) |
| 2 × 2 factorial | 6 (16) | 0 |
| Number of comparisons per trial | ||
| 1 | 33 (87) | 18 (90) |
| 2 | 2 (5) | 2 (10) |
| 3 | 3 (8) | 0 |
| Frequency of reported end pointa | ||
| OS | 36 (94) | 19 (95) |
| EFS | 10 (26) | 6 (30) |
| PFS | 12 (32) | 6 (30) |
| DFS/RFS | 15 (39) | 4 (20) |
| FFS | 8 (21) | 2 (10) |
| TTF | 4 (10) | 10 (50) |
| TTP | 2 (5) | 4 (20) |
| RR | 37 (97) | 15 (75) |
| Outcomes | ||
| Positive | 12 (32) | 11 (55) |
| Negative | 26 (68) | 9 (45) |
a
Includes primary and secondary end points, with percentages presented as a ratio of total number of randomized clinical trials.
OS, overall survival; EFS, event-free survival; PFS, progression-free survival; DFS, disease-free survival; RFS, relapse-free survival; FFS, failure-free survival; TTF, time-to-failure; TTP, time-to-progression; RR, response rate.