Table 1.
Demographic and clinical characteristics of the study population.
| Characteristics | All patients, N = 258 (100%) |
|---|---|
| Mean age, years (SD) | 64.6 (10.6) |
| Sex | |
| Female | 150 (58.1%) |
| Male | 108 (41.9%) |
| ECOG PS | |
| 0 | 129 (50%) |
| 1 | 115 (44.6%) |
| 2 | 14 (5.4%) |
| Tumor type | |
| Breast | 83 (32.1%) |
| Lung | 50 (19.4%) |
| Kidney | 9 (3.5%) |
| Prostate | 5 (1.9%) |
| Colorectal | 51 (19.8%) |
| Urothelial | 11 (4.3%) |
| Pancreatic | 6 (2.3%) |
| Gastric | 11 (4.3%) |
| Skin (Melanoma, Merkel-cell) | 5 (1.9%) |
| Gynaecological | 8 (3.1%) |
| Head and Neck | 3 (1.2%) |
| Brain | 6 (2.3%) |
| Othera | 10 (3.9) |
| Extent of disease | |
| Local | 72 (27.9%) |
| Metastatic | 186 (72.1%) |
| Type of last active treatment | |
| Cytotoxic chemotherapy | 96 (37.2%) |
| Targeted therapy | 92 (35.6%) |
| Immune checkpoint inhibitors | 30 (11.6%) |
| Hormonal therapy | 13 (5%) |
| Cytotoxic chemotherapy + biological therapy | 18 (6.9%) |
| Treatment setting | |
| Adjuvant or neoadjuvant | 80 (31%) |
| Metastatic, first line | 126 (48.9%) |
| Metastatic, second or later line | 52 (20.1%) |
| Time from last active treatment | |
| > 28 days | 60 (23.3%) |
| ≤ 28 days | 198 (76.7%) |
| Reasons for discontinuation of active treatment | |
| Treatment completion | 52 (20.1%) |
| Disease progression | 6 (2.3) |
| Refusal to continue | 1 (0.4%) |
| Other reasons | 1 (0.4%) |
| Time (days) from the first dose of vaccine, median (IQR) | 185 (167–197) |
| Time (days) from the second dose of vaccine, median (IQR) | 164 (149–177) |
| Corticosteroid therapyb | 43 (17%) |
| G-CSF therapyc | 8 (3%) |
SD standard deviation, ECOG PS Eastern Cooperative Oncology Group Performance Status, IQR interquartile range, G-CSF granulocyte-colony stimulating factor, NA not applicable. aOther cancer types included soft-tissue sarcoma, thymoma, testicular cancer, hepatobiliary cancer, esophageal cancer, and GIST; bcorticosteroid therapy indicates ≥ 10 mg per day of prednisone or equivalent for at least 7 days in the 28 days preceding third vaccine dose; cG-CSF therapy indicates administration of granulocyte colony-stimulating factor in the 28 days preceding third vaccine dose.