Table 1.
Baseline characteristics of the study population.
| N = 17 (100%) | |
|---|---|
| Sex | |
| Male | 5 (29%) |
| Median age in years (range) | 63.4 (42-85) |
| Demographics | |
| Education | |
| Low (junior high school) | 5 (29%) |
| Intermediate (senior high school) | 7 (41%) |
| High (graduate bachelor or master) | 5 (29%) |
| Work situation | |
| Work | 6 (35%) |
| Sick leave | 3 (18%) |
| Retired | 8 (47%) |
| Marital status | |
| Married/cohabitation with partner | 12 (71%) |
| Divorced/separated | 2 (12%) |
| Widowed | 2 (12%) |
| Single/never married | 1 (6%) |
| Children | |
| Young children (0-21 yrs) | 5 (29%) |
| Adult children (≥21 yrs) | 10 (59%) |
| No children | 2 (12%) |
| Psychiatric history | |
| Depression | 1 (6%) |
| No psychiatric history | 15 (88%) |
| Psychotropic treatment | |
| Antidepressant | 2 (12%) |
| Hypnotic benzodiazepine | 3 (18%) |
| ECOG performance status | |
| 0 | 7 (41%) |
| 1 | 5 (29%) |
| 2 | 5 (29%) |
| Treatment | |
| Previous treatment before ipilimumab | |
| Chemotherapy | 9 (53%) |
| BRAF/MEK inhibitors | 1 (6%) |
| Study drug (IFN or TriMixDC-MEL) | 7 (41%) |
| Radiotherapy | 9 (53%) non-CNS, 1 (6%) CNS |
| Surgery | 2 (12%) |
| Therapy during ipilimumab treatment | |
| Radiotherapy | 2 (12%) |
| Surgery | 2 (12%) |
| Retreatment with ipilimumab after interruption | 3 (18%) |
| Dose of ipilumumab per administration | |
| 3 mg/kg | 8 (47%) |
| 10 mg/kg | 9 (53%) |
| Survival | |
| Number of patients disease-free and without any cancer treatment at baseline∗ | 17 (100%) |
| Median time since starting ipilimumab at baseline in years (range) | 5.6 (2.1-9.3) |
| Median time since stopping ipilimumab at baseline in years (range) | 4.0 (1.9–8.6) |
| Median time since complete remission or best overall response at baseline in years (range) | 4.0 (1.6–8.6) |
| Number of patients who completed the 1-year follow-up assessment | 15 (88%) |
| Melanoma | |
| Median time to diagnosis of stages IIIC-IV in years (range) | 6.8 (3.4-12.1) |
| Location of primary tumor | |
| Head | 3 (18%) |
| Neck | 1 (6%) |
| Trunk | 4 (24%) |
| Upper extremity | 2 (12%) |
| Lower extremity | 4 (24%) |
| Unknown | 3 (18%) |
| AJCC TNM stage 8th edition | |
| IIIC | 2 (12%) |
| IV-M1a | 1 (6%) |
| IV-M1b | 7 (41%) |
| IV-M1c | 6 (35%) |
| IV-M1d | 1 (6%) |
∗One survivor obtained a complete metabolic response on 18F-FDG/PET and a partial response on CT scan; 1 survivor obtained a stable disease both on 18F-FDG/PET and CT scan; 15 survivors obtained a complete response, defined as the absence of any abnormality on whole-body 18F-FDG PET/CT.