Table 2.
Efficacy evaluation of sintilimab during the whole triala
| Efficacy outcomes | Primary endpoint | Cycle 3 | Cycle 6 | Cycle 9 | Cycle 13 | Cycle 17 |
|---|---|---|---|---|---|---|
| Last follow-up | 6 weeks | 15 weeks | 24 weeks | 36 weeks | 48 weeks | |
| n = 28 | n = 26 | n = 25 | n = 20 | n = 20 | n = 20 | |
| CR | 6 (21.4%) | 1 (3.8%) | 1 (4.0%) | 2 (10.0%) | 3 (15.0%) | 3 (15.0%) |
| PR | 15 (53.6%) | 13 (50.0%) | 7 (28.0%) | 4 (20.0%) | 0 (0.0%) | 0 (0.0%) |
| SD | 3 (10.7%) | 4 (15.4%) | 8 (32.0%) | 6 (30.0%) | 17 (85.0%) | 17 (85.0%) |
| PD | 3 (10.7%) | 8 (30.8%) | 9 (36.0%) | 7 (35.0%) | 0 (0.0%) | 0 (0.0%) |
| Unevaluable | 1 (3.6%) | 0 (0.0%) | 0 (0.0%) | 1 (5.0%) | 0 (0.0%) | 0 (0.0%) |
| Objective response (CR + PR) | 21 (75%) | 53.8% | 32.0% | 30.0% | 15.0% | 15.0% |
| Objective response rate (95% CI) | 55.1–89.3% | 33.4–73.4% | 14.9–53.5% | 11.9–54.3% | 3.2–37.9% | 3.2–37.9% |
| Disease control (CR + PR + SD) | 24 (85.7%) | 69.2% | 64.0% | 60.0% | 100.0% | 100.0% |
| Disease control rate (95% CI) | 67.3–96% | 48.2–85.7% | 42.5–82.0% | 36.1–80.9% | 83.2–100.0% | 83.2–100.0% |
CR complete response, DCR disease control rate, ORR objective response rate, PD progressive disease, PR partial response, SD stable disease
aBinomial distribution was adopted for ORR and disease control rate to calculate the confidence intervals (CIs)