Table 2.

Treatment group characteristics

ParametersIpilimumab + LPT (n = 45)Ipilimumab (n = 82)P
Age (y, mean)62.1 (25–87)57.3 (22–83)0.10
Sex (n)
 Males25 (55.5%)44 (53.7%)
 Females20 (44.5%)38 (46.3%)0.85
Stage AJCC (n)
 IIIC8 (17.7%)6 (7.3%)
 IV37 (82.2%)76 (92.6%)0.08 (IIIC vs. IV)
 M1a6 (13.3%)3 (3.6%)
 M1b9 (20.0%)14 (17.0%)0.24 (M1a vs. M1b)
 M1c22 (48.8%)59 (71.9%)0.30 (M1b vs. M1c)
BRAF status (n)
 Mutated11 (24.4%)31 (37.8%)
 Wild-type34 (75.6%)51 (62.2%)0.16
LDH level (U/L) (n, patients)
 Normal (≤250 U/L)28 (62.2%)47 (57.3%)
 (mean, SEM)(192.9, 5.57)(186.7, 4.15)
 Elevated (>250 U/L)16 (35.6%)35 (42.7%)0.57 (normal vs. elevated)
 (mean, SEM)(424.0, 68.64)(454.4, 52.13)
 Not available (n, percent)1 (2.2%)
CNS metastases (n, patients)8 (17.8%)41 (50%)<0.001
CNS radiotherapy applieda (n, patients)6 (13.3%)40 (48.8%)<0.001
Ipilimumab cycles (median, range)4 (2–4)4 (1–8)b0.23
IrAE ≥ CTCAE grade 3 (n)8 (17.8%)15 (18.3%)1.0
  • NOTE: All patients were allocated to two groups depending on the application of LPT. LPT included one of the following: local radiotherapy (lymph node, bone, visceral, or skin metastases) or ECT or SIRT. Statistical analyses of contingency tables were performed with the two-sided Fisher exact test. Differences of the mean numbers of ipilimumab cycles in both groups were statistically analyzed with the two-sided Mann–Whitney U test.

  • Abbreviation: LDH, serum lactate dehydrogenase.

  • aOf the total of 49 patients with CNS metastases, 2 patients of the LPT group and one from the non-LPT group did not undergo CNS radiotherapy based on clinical decision or the patient's wish.

  • bOne patient received two treatment cycles of ipilimumab (one cycle = four infusions).