Table 2.
Efficacy and safety assessment.
| Chemotherapy + bevacizumab (n = 67) | Chemotherapy alone (n = 62) | p | |
|---|---|---|---|
| Efficacy endpoints | |||
| PFS (months), median (95% CI) | 10.6 (8.5; 15.4) | 5.4 (3.9; 9.1) | 0.011∗ |
| Unadjusted HR (95% CI) | 0.60 (0.41; 0.89) | 1.00 Referent | 0.011∗ |
| Adjusted HR (95% CI)a | 0.60 (0.39; 0.94) | 1.00 Referent | 0.027∗ |
| OS (months), median (95% CI) | 27.0 (18.5; n.c.) | 15.5 (10.7; 30.1) | 0.025∗ |
| Unadjusted HR (95% CI) | 0.56 (0.34; 0.93) | 1.00 Referent | 0.027∗ |
| Adjusted HR (95% CI)a | 0.78 (0.44; 1.38) | 1.00 Referent | 0.389 |
| Objective response, n (%)b | |||
| Complete response (CR) | 12 (18) | 11 (19) | 0.013∗ |
| Partial response (PR) | 26 (39) | 13 (22) | |
| Stable disease (SD) | 14 (21) | 6 (10) | |
| Progressive disease (PD) | 13 (19) | 21 (36) | |
| Could not be determined | 2 (3) | 8 (14) | |
| Objective response rate, n (%)b | 38 (57) | 24 (41) | 0.072 |
| Disease control rate, n (%)c | 52 (78) | 30 (51) | 0.002∗ |
|
| |||
| Safety endpoints | |||
| Treatment discontinuation because of toxicity, n (%)d | 11 (19) | 9 (16) | 0.749 |
| Treatment-related adverse events | |||
| Any grade | 54 (81) | 53 (85) | 0.461 |
| Grades III-IV | 33 (49) | 41 (66) | 0.053 |
| Treatment-related, haematologic adverse events | |||
| Any grade | 44 (66) | 53 (85) | 0.009∗ |
| Grades III-IV | 18 (27) | 31 (50) | 0.007∗ |
| Treatment-related, nonhaematologic adverse events | |||
| Any grade | 51 (76) | 50 (81) | 0.533 |
| Grades III-IV | 22 (33) | 21 (34) | 0.901 |
CI = confidence interval; PFS = progression-free survival; OS = overall survival; HR = hazard ratio; n.c. = not calculable. aAnalysis was adjusted for age at diagnosis, histology, ECOG performance status before the introduction of first-line treatment for metastatic disease, previous treatment with chemotherapy, and previous treatment with radiotherapy. bObjective response rate includes complete and partial response; data were missing for 6/67 (10%) patients treated with TCB and 3/62 (5%) patients treated with chemotherapy alone. cDisease control rate includes complete and partial response and stable disease. dData on treatment discontinuation because of toxicity were missing in 8 (12%) patients treated with TCB and 7 (11%) patients treated with chemotherapy alone. ∗False discovery rate <5%.