Table 1. Characteristics of RCTs.
| RCTs, overall | Treatment in experimental arm | ||||||
|---|---|---|---|---|---|---|---|
| Combination chemotherapy with DOX | Other regimens without DOX | ||||||
| No. of studies (%) | No. of patients (%) | Median no. of patients | No. of studies (%) | No. of patients (%) | No. of studies (%) | No. of patients (%) | |
| 27 (100) | 6156 (100) | 133 | 14 (100) | 3954 (100) | 13 (100) | 2202 (100) | |
| Trial phase | |||||||
| II | 10 (37.0) | 1137 (18.5) | 122 | 4 (28.6) | 508 (12.8) | 6 (46.2) | 629 (28.6) |
| III | 11 (40.7) | 3534 (57.4) | 279 | 5 (35.8) | 2169 (54.9) | 6 (46.2) | 1365 (62.0) |
| Not specified | 6 (22.2) | 1485 (24.1) | 268 | 5 (35.8) | 1277 (32.3) | 1 (7.6) | 208 (9.4) |
| Primary endpoint | |||||||
| OS | 2 (7.4) | 1095 (17.8) | NA | 2 (14.3) | 1095(27.7 | 0 | 0 |
| Other time-to-event (PFS, 3m-PFS, etc) | 10 (37.0) | 1589 (25.8) | 130 | 4 (28.6) | 508 (12.8) | 6 (46.2) | 1081 (49.1) |
| RR | 1 (3.7) | 95 (1.5) | N | 0 | 0 | 1 (7.6) | 95 (4.3) |
| Not specified | 14 (51.9) | 3377 (54.9) | 215.5 | 8 (57.1) | 2351 (59.5) | 6 (46.2) | 1026 (46.6) |
| ITT analysis included | |||||||
| Yes | 9 (33.3) | 2075 (33.7) | 133 | 4 (28.6) | 1343 (34.0) | 5 (38.5) | 732 (33.2) |
| No | 18 (66.7) | 4081 (66.3) | 209 | 10 (71.4) | 2611 (66.0) | 8 (61.5) | 1470 (66.8) |
| Post-protocol treatment described | |||||||
| Yes | 14 (51.9) | 2897 (47.1) | 132.5 | 7 (50.0) | 1824 (46.1) | 8 (61.5) | 1188 (54.0) |
| No | 13 (48.1) | 3259 (52.9) | 279 | 7 (50.0) | 2130 (53.9) | 5 (38.5) | 1014 (46.0) |
A phase II/III study was counted as phase III study. Abbreviations: RCT, randomized controlled trial; DOX, doxorubicin; OS, overall survival; PFS, progression-free survival; 3m-PFS, 3 month-PFS; RR, response rate; ITT, intention-to-treat.