Table 2.
Randomized phase II–III trials with bevacizumab in metastatic colorectal cancer in elderly patients.
| Author (Reference) | No. Pts | Treatments | HR PFS/OS < 0.8 | Adequate Control Arm | Any Change in Primary Endpoint or Sample Size | Achieved Pre-Specified Objective | Quality Design | ESMO/MCBS (PFS) |
|---|---|---|---|---|---|---|---|---|
| Cunningham D [58] | 280 | Cape Cape–Bvz |
0.53/0.79 | Yes | No | Yes | 3 | 3 |
| Kabbinavar FF [59] | 209 | 5-FU–LV 5-FU–LV–Bvz |
0.50/0.79 | Yes | No | Yes | 3 | 3 |
| Aparicio T [60] | 102 | Any QT Any QT–Bvz |
0.79/0.73 | Yes | No | Yes | 3 | * |
Abbreviations: Pts, patients; HR, Hazard rate; PFS, progression-free survival; OS, overall survival; ESMO, (European Society for Medical Oncology); MCBS, (Magnitude of Clinical Benefit Scale); Cape, capecitabine; Bvz, bevaciumab; 5-FU, 5-fluorouracil; LV, leucovorin; FOLFIRI, 5-fluorouracil–leucovorin–irinotecan. * ESMO/MCBS for OS not evaluable because the primary objective in both trials was PFS.