Table 1.
Patient characteristics for immune and viral correlate analysis
Characteristic | Per Protocol (PP) (N=21)a |
Intent To Treat (ITT) (N=5)b |
Total Evaluable (N=26) |
P-valuesc |
---|---|---|---|---|
Median age, years (range) | 48 (34-62) | 51 (26-56) | 49 (26-62) | 0.79 |
Race, N (%) | ||||
White | 14 (67) | 4 (80) | 18 (69) | 1.00 |
African American | 4 (19) | 1 (20) | 5 (19) | |
Asian | 2 (9) | 0 (0) | 2 (8) | |
Other | 1 (5) | 0 (0) | 1 (4) | |
Ethnicity, N (%) | ||||
Non-Hispanic | 14 (67) | 4 (80) | 18 (69) | 1.00 |
Hispanic | 7 (33) | 1 (20) | 8 (31) | |
Histology, N (%) | ||||
Squamous cell carcinoma | 19 (90) | 4 (80) | 23 (88) | 0.49 |
Adenosquamous | 1 (5) | 0 (0) | 1 (4) | |
Adenocarcinoma | 1 (5) | 1 (20) | 2 (8) | |
Lymph node involvement, N (%) | ||||
Pelvic | 15 (71) | 3 (60) | 18 (69) | 0.63 |
Pelvic and Para-aortic | 6 (29) | 2 (40) | 8 (31) | |
FIGOd Stage, N (%) | ||||
1B | 3 (14) | 1 (20) | 4 (15) | 0.69 |
IIA | 1 (5) | 1 (20) | 2 (8) | |
IIB | 11 (52) | 2 (40) | 13 (50) | |
IIIB | 5 (24) | 1 (20) | 6 (23) | |
IVA | 1 (5) | 0 (0) | 1 (4) | |
HLA-A*0201 status, N (%) | ||||
Positive | 8 (38) | 1 (20) | 9 (35) | 0.63 |
Negative | 13 (62) | 4 (80) | 17 (65) | |
Ipilimumab Dose Level, N (%) | ||||
3 mg/kg | 3 (14) | 0 (0) | 3 (12) | 1.00 |
10 mg/kg | 18 (86) | 5 (100) | 23 (88) | |
Ipilimumab Doses, N (%) | ||||
2 | 3 (14) | 0 (0) | 3 (14) | <0.001 |
4 | 18 (86) | 0 (0) | 18 (86) |
PP patients received CRT and ≥ 2 doses ipilimumab
ITT patients received CRT only
Comparing PP patients vs. ITT patients, using the Wilcoxon rank sum test and Fisher’s exact test where appropriate
FIGO, International Federation of Gynecology and Obstetrics