Clinical Study

Neurocognitive Function, Psychosocial Outcome, and Health-Related Quality of Life of the First-Generation Metastatic Melanoma Survivors Treated with Ipilimumab

Table 1

Baseline characteristics of the study population.

(100%)

Sex
 Male5 (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
  Work6 (35%)
  Sick leave3 (18%)
  Retired8 (47%)
 Marital status
  Married/cohabitation with partner12 (71%)
  Divorced/separated2 (12%)
  Widowed2 (12%)
  Single/never married1 (6%)
 Children
  Young children (0-21 yrs)5 (29%)
  Adult children (≥21 yrs)10 (59%)
  No children2 (12%)
 Psychiatric history
  Depression1 (6%)
  No psychiatric history15 (88%)
 Psychotropic treatment
  Antidepressant2 (12%)
  Hypnotic benzodiazepine3 (18%)
 ECOG performance status
  07 (41%)
  15 (29%)
  25 (29%)
Treatment
 Previous treatment before ipilimumab
  Chemotherapy9 (53%)
  BRAF/MEK inhibitors1 (6%)
  Study drug (IFN or TriMixDC-MEL)7 (41%)
  Radiotherapy9 (53%) non-CNS, 1 (6%) CNS
  Surgery2 (12%)
 Therapy during ipilimumab treatment
  Radiotherapy2 (12%)
  Surgery2 (12%)
 Retreatment with ipilimumab after interruption3 (18%)
 Dose of ipilumumab per administration
  3 mg/kg8 (47%)
  10 mg/kg9 (53%)
Survival
 Number of patients disease-free and without any cancer treatment at baseline17 (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 assessment15 (88%)
Melanoma
 Median time to diagnosis of stages IIIC-IV in years (range)6.8 (3.4-12.1)
 Location of primary tumor
  Head3 (18%)
  Neck1 (6%)
  Trunk4 (24%)
  Upper extremity2 (12%)
  Lower extremity4 (24%)
  Unknown3 (18%)
 AJCC TNM stage 8th edition
  IIIC2 (12%)
  IV-M1a1 (6%)
  IV-M1b7 (41%)
  IV-M1c6 (35%)
  IV-M1d1 (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.