Table 1:
Baseline patient characteristics for all n=61 eligible treated patients
| BV-Ipi (n=21) | BV-Nivo (n=18) | BV-Nivo-Ipi (n=22) | All (N=61) | |
|---|---|---|---|---|
| Age | 33 (20–49) | 40 (21–70) | 35 (19–60) | 34 (19–70) |
| Median (range) | ||||
| Time Since Initial Diagnosis: n (%) | ||||
| <6 mo | 2 (10%) | 2 (11%) | 1 (4%) | 5 (8%) |
| 6–12 mo | 3 (14%) | 3 (17%) | 5 (23%) | 11 (18%) |
| 1–2 yr | 6 (29%) | 3(17%) | 11 (50%) | 20 (33%) |
| >=2 yrs | 10 (48%) | 10 (55%) | 5 (28%) | 25 (41%) |
| Time since most recent treatment: n (%) | ||||
| <6 mo | 7 (33%) | 7 (39%) | 10 (45%) | 24 (39%) |
| 6–12 mo | 4(19%) | 4 (22%) | 6 (27%) | 14 (23%) |
| 1–2 yr | 7 (33%) | 3 (17%) | 2 (9%) | 12 (20%) |
| >=2 yrs | 3 (14%) | 4 (22%) | 4 (18%) | 11 (18%) |
| Female Gender: n (%) | 10 (48%) | 9 (50%) | 11 (50%) | 30 (49%) |
| Stage: n (%) | ||||
| I | 0 | 1 (6%) | 2 (9%) | 3 (5%) |
| II | 10 (48%) | 7(39%) | 12(55% | 29 (48%) |
| III | 6 (29%) | 4(22%) | 3(14%) | 13 (21%) |
| IV | 5 (24%) | 6(33%) | 5 (23%) | 16 (26%) |
| B Symptoms: n (%) | 3 (14%) | 5 (28%) | 5 (23%) | 13 (21%) |
| ECOG PS: n (%) | ||||
| 0 | 16 (76%) | 10 (56%) | 12 (55%) | 38 (62%) |
| 1–2 | 5 (24%) | 8 (44%) | 10 (45%) | 23 (38%) |
| # extra nodal sites: n (%) | ||||
| 0–1 | 18 (86%) | 16(89%) | 20 (91%) | 54 (88%) |
| >=2 | 3 (14%) | 1 (11%) | 2 (9%) | 7 (12%) |
| Bulky Disease (≥7cm) : n (%) | 0 | 2 (11%) | 2 (9%) | 4 (7%) |
| # Prior Chemotherapies: n (%) | ||||
| 1 | 9 (43%) | 9 (50%) | 8 (36%) | 26(43%) |
| 2 | 5 (24%) | 3 (17%) | 9 (41%) | 17 (28%) |
| 3 | 2 (10%) | 4 (22%) | 4 (18%) | 10 (16%) |
| >=4 | 5 (23%) | 2 (11%) | 1 (5%) | 8 (13%) |
| Prior BV: n (%) | 3 (14%) | 4 (22%) | 1 (5%) | 8 (13%) |
| Time since last BV (yr) | 1.20 (1.14–2.94) | 1.27 (0.66–2.05) | 1.34 | 1.27 (0.66–2.94) |
| Median (range) | ||||
| Prior Transplant: n (%) | ||||
| Allogeneic | 1 (5%) | 2 (11%) | 1 (5%) | 4 (7%) |
| Autologous | 7 (33%) | 6 (33%) | 8 (36%) | 21 (34%) |
| Response to last therapy | ||||
| Refractory | 10 (48%) | 9 (50%) | 16 (73%) | 35 (57%) |
| ≥ 6 mos ≤ 1 year | 4 (19%) | 4 (22%) | 2 (9%) | 10 (17%) |
| Response ≥ 1 year | 5 (24%) | 5 (28%) | 3 (14%) | 13 (21%) |
| Unevalauble | 2 (9%) | 0 | 1 (4%) | 3 (5%) |
3 patients ineligible: 1) Received prior immunotherapy; 2) Labs out of window; 3) Baseline ANC < 1500