Table 3 Clinical Outcomes for All Eligible and Treated Patients
Arm A (n = 19) | Arm B (n = 17) | Total (n = 36) | |
|---|---|---|---|
Survival status | |||
Dead - Disease-related | 4 (21.1%) | 2 (11.8%) | 6 (16.7%) |
Alive - Without Recurrence | 15 (78.9%) | 10 (58.8%) | 25 (69.4%) |
Alive - With Recurrence | 0 (0.0%) | 5 (29.4%) | 5 (13.9%) |
Number of doses of Atezolizumab | |||
1 | 1 (5.3%) | 3 (17.6%) | 4 (11.1%) |
2 | 1 (5.3%) | 1 (5.9%) | 2 (5.6%) |
3 | 17 (89.5%) | 13 (76.5%) | 30 (83.3%) |
Number of doses of cisplatin | |||
0 | 1 (5.3%) | 0 (0.0%) | 1 (2.8%) |
2 | 1 (5.3%) | 1 (5.9%) | 2 (5.6%) |
3 | 1 (5.3%) | 1 (5.9%) | 2 (5.6%) |
4 | 2 (10.5%) | 2 (11.8%) | 4 (11.1%) |
5 | 3 (15.8%) | 6 (35.3%) | 9 (25.0%) |
6 | 11 (57.9%) | 7 (41.2%) | 18 (50.0%) |
Dose modification | |||
No | 13 (68.4%) | 8 (47.1%) | 21 (58.3%) |
Yes with at least 1 dose modification | 6 (31.6%) | 9 (52.9%) | 15 (41.7%) |
RT Completion | |||
External Beam Dose per Protocol | 17 (89%) | 17 (100%) | 34 (94%) |
Brachytherapy Treatment | 17 (89%) | 17 (100%) | 34 (94%) |
Pathologic treatment effect on day 28 biopsy | |||
no tumor cells present, pathologic complete response | 5 (26.3%) | 5 (29.4%) | 10 (27.8%) |
tumor cells present with treatment effect | 6 (31.6%) | 1 (5.9%) | 7 (19.4%) |
tumor cells present | 5 (26.3%) | 9 (52.9%) | 14 (38.9%) |
biopsy not done | 3 (15.8%) | 2 (11.8%) | 5 (13.9%) |
Metabolic response at 3 months post-treatment based on PET/CT SUV max for cervix | |||
complete metabolic response | 5 (26.3%) | 6 (35.3%) | 11 (30.6%) |
partial metabolic response | 0 (0.0%) | 6 (35.3%) | 6 (16.7%) |
stable metabolic response | 2 (10.5%) | 0 (0.0%) | 2 (5.6%) |
missing | 12 (63.2%) | 5 (29.4%) | 17 (47.2%) |
Disease-free at 12 months | |||
No | 4 (21.1%) | 4 (23.5%) | 8 (22.2%) |
Not evaluable | 1 (5.3%) | 1 (5.9%) | 2 (5.6%) |
Yes | 14 (73.7%) | 12 (70.6%) | 26 (72.2%) |
Disease-free at 24 months (2-year DFS) | |||
No | 4 (21.1%) | 7 (41.2%) | 11 (30.6%) |
Not evaluable | 2 (10.5%) | 1 (5.9%) | 3 (8.3%) |
Yes | 13 (68.4%) | 9 (52.9%) | 22 (61.1%) |
