Table 3.
Patient characteristics and clinical outcome in 2 different trials
| Study I14 | Study II | p values | ||
|---|---|---|---|---|
| Number of patients | 46 | 28 | ||
| Age (mean) | 61 | 58.1 | 0.3 | |
| Sex (male), no. of patients (%) | 27 (59 %) | 21 (75 %) | 0.2 | |
| No. of metastatic sites (mean) | 2.9 | 3.5 | 0.11 | |
| AJCC Stage, no. of patients (%) | M1a | 10 (22 %) | 2 (7 %) | 0.12 |
| M1b | 6 (13 %) | 5 (18 %) | 0.5 | |
| M1c | 30 (65 %) | 21 (75 %) | 0.4 | |
| Treatment naïve, no of patients (%) | 17 (37 %) | 2 (7 %) | 0.005 | |
| Lactate dehydrogenase (U/L) | 303 | 261 | 0.2 | |
| C-reactive protein (mg/L) | 42 | 26 | 0.2 | |
| Hemoglobin (mmol/L) | 8.1 | 8.2 | 0.7 | |
| Stable disease, no. of patients (%) | 11 (24 %) | 16 (57 %) | 0.006 | |
| Progression-free survival (months) | 1.9 | 4.5 | 0.06 | |
| Overall survival (months) | 5.1 | 9.4 | 0.5 | |
| Measurable immune responses# | 6/10 (60 %) | 9/15 (60 %) | 1.0 | |
More patients included in study II had previously received antineoplastic systemic treatment when compared to patients in study I. Otherwise, the patients were comparable
#HLA-multimer staining was used for evaluating vaccine-specific immune responders in study I, whereas an IFN-γ ELISPOT assay was performed for study II. The table shows number of patients having an induction in vaccine-specific immune responses out of the tested patients (%). >50 spots/well and a more than twofold increase compared to baseline level define an induced immune response in the IFN-γ ELISPOT assay
Levels of lactate dehydrogenase (Units (U)/L), C-Reactive Protein (mg/L), and Hemoglobin (mmol/L) are shown as mean values at baseline. (no number)