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. 2018 May 24;8:161. doi: 10.3389/fonc.2018.00161

Table 5.

Immunotherapy (IT) in BMs.

Main studies on IT (checkpoint inhibitors) in BMs
 Results
Reference Agent tested Primary tumor Number of pts Clinical trial characteristics
Margolin et al. (244) Ipilimumab Melanoma BM 72 Single-agent, open-label phase II study

  • Cohort A: 51 asymptomatic Pts with active BM who were not on corticosteroids; cohort B: 21 Pts with symptomatic melanoma-derived BM taking a corticosteroid

  • Immune-related response criteria: the RR of 25% (13 Pts) and 10% (2 Pts) in cohorts A and B, respectively

  • mOS: 7.0 months in cohort A and 3.7 months in cohort B
Di Giacomo et al. (252) Ipilimumab and fotemustine Melanoma BM 20/83 with asymptomatic BM Open-label, single-arm, phase II trial

  • The mPFS in Pts with BM was 3.0 months

  • 3-year follow-up of group with BM: mOS of 12.7 months
Patel et al. (297) SRS vs SRS + ipilimumab Melanoma BM

  • SRS: 34

  • SRS + ipilimumab: 20

 Restrospective comparative analysis

  • SRS: 1 year LC 91%; 12 months OS: 38%

  • SRS + ipilimumab: 1 year LC 71%; 12 months OS 37%
Weber et al. (298) Ipilimumab/budesonide (asymptomatic BM) Melanoma BM 12 Retrospective analysis of phase II trial

  • Intracranial RR: 41.6%

  • mOS: 14
Knisely et al. (261) SRS vs SRS + ipilimumab Melanoma BM

  • SRS: 17

  • SRS + ipilimumab: 11

 Retrospective comparative analysis

  • SRS: OS 4 months

  • SRS + ipilimumab: OS 21.3 months
Silk et al. (299) SRS vs SRS + ipilimumab Melanoma BM

  • SRS: 37

  • SRS + ipilimumab: 33

 Retrospective comparative analysis

  • SRS: PFS 3.3 months; OS 5.3 months

  • SRS + ipilimumab: PFS 2.7 months; OS 8.3 months
Mathew et al. (300) SRS vs SRS + ipilimumab Melanoma BM

  • SRS: 33

  • SRS + ipilimumab: 25

 Retrospective comparative analysis

  • SRS: 6-month OS 56%

  • SRS + ipilimumab: 6-month OS 45%
Ahmed et al. (265) SRS/nivolumab Melanoma BM 26 Retrospective analysis

  • OS 11.8 months
Goldberg et al. (221) Pembrolizumab NSCLC, melanoma BM 36 (18 NSCLC, 18 melanoma) Phase II trial

  • Brain metastasis response was achieved in 4 (22%) of 18 Pts with melanoma and 6 (33%) of 34 Pts with NSCLC. Responses were durable
Schachter et al. (301) Pembrolizumab Melanoma BM 834

  • Median follow-up was 22.9 months

  • Median overall survival was not reached in either pembrolizumab group and was 16 months with ipilimumab

  • Pembrolizumab continued to provide superior overall survival vs ipilimumab
Parakh et al. (302) Nivolumab and pembrolizumab Melanoma BM 66 Retrospective analysis

  • The IC overall RR was 21% and disease control rate 56%. Responses occurred in 21% of Pts with symptomatic BM. The median OS was 9.9 months (95% CI 6.93–17.74). Pts with symptomatic BM had shorter PFS than those without symptoms (2.7 vs 7.4 months, p = 0.035) and numerically shorter OS (5.7 vs 13.0 months, p = 0.068). Pts requiring corticosteroids also had a numerically shorter PFS (3.2 vs 7.4 months, p = 0.081) and OS (4.8 vs 13.1 months, p = 0.039)

Pts, patients; BMs, brain metastases; NSCLC, non-small-cell lung cancer; RR, response rate; mOS, median overall survival; mPFS, median progression-free survival; 1 year LC, local control; IC RR, intracranial response rate.