Primary endpoint | ACC n=45 | Non-ACC n=50 |
NPR6m | 33.3% (one-sided 95% CI 21.8 to NE) | 14.0% (one-sided 95% CI 6.8 to NE) |
Pts alive without progression at 6 months | n=15/45 (1 NE) | n=7/50 (2 NE) |
Secondary endpoints | ACC n=46 | Non-ACC n=52 |
Median PFS (in months) | 43 PFS events 5.3 (95% CI 3.2 to 5.6) | 51 PFS events 1.8 (95% CI 1.7 to 3.5) |
Median OS (in months) | 26 OS events 17.2 (95% CI 12.5 to NE) | 32 OS events 11.5 (95% CI 7.5 to 14.8) |
Overall response rate (at best overall response) | 8.7% (95% CI 2.4 to 20.8) | 3.8% (95% CI 0.5 to 13.2) |
CR | 0 (0%) | 0 (0%) |
PR | 4 (8.7%)* | 2 (3.8%)† |
SD | 26 (56.5%) | 22 (42.3%) |
PD | 16 (34.8%) | 28 (53.8%) |
*The histological types of the four ACC responders were soft pelate, larynx, paranasal sinuses and submandibular. Duration of best overall response was 3.2, 20.7, 9.7 and 5.9 months.
†The histological types of the two non-ACC responders were epidermoid and adenocarcinoma.
ACC, adenoid cystic carcinoma; CR, complete response; NPR6m, non-progression rate at 6 months; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease.