Table 2. Trial responses and outcomes.
| ‘First in human’ | ||||
|---|---|---|---|---|
| Overall | Median (range) – n/N (%) | Chemotherapy-based | P-value | |
| Number of Cycles | 2 (1–17) | 2 (1–17) | 4 (1–17) | <0.001 |
| Treatment (weeks) | 7.7 | 6.9 | 10.6 | 0.027 |
| Partial response | 19/202 (9.4) | 5/140 (3.6) | 14/62 (22.6) | 0.001 |
| Stable disease >3 months | 54/202 (26.7) | 31/140 (22.1) | 23/62 (37.1) | <0.01 |
| CBR3 m (PR+SD>3 months) | 73/202 (36.1) | 36/140 (25.7) | 37/62 (59.7) | 0.001 |
| 30 days mortality rate | 4/212 (1.9) | 2/148 (1.3) | 2/64 (3.1) | NS |
| 90 days mortality rate | 39/212 (18.3) | 28/148 (18.9) | 11/64 (17.2) | NS |
| Toxicity-related mortality | 1/212 (0.47) | 1/148 (0.7) | 0/64 (0) | NS |
| Off-trial due to toxicity | 25/212 (11.8) | 19/148 (12.8) | 6/64 (9.4) | NS |
CBR3m=3 months clinical benefit rate; NS=not significant; PR=partial response; SD=stable disease.
P-values calculated by Mann–Withney's U-test, χ2 test and Fisher's F-test.