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Melanoma brain metastases

TL;DR — Melanoma has one of the highest rates of CNS spread of any solid tumour, and AJCC 8 gave CNS metastasis its own designation, M1d (Gershenwald 2017, PMID 29028110). Combination checkpoint blockade transformed the outlook for asymptomatic brain metastases: CheckMate 204 reported intracranial clinical benefit in 57.4% (95% CI 47.2–67.2) of 101 asymptomatic patients with 36-month intracranial progression-free survival 54.1% and overall survival 71.9%, against 16.7% clinical benefit and 36.6% 36-month OS in 18 symptomatic patients (Tawbi 2021, PMID 34774225). The randomised ABC study now has seven-year follow-up: intracranial response 51% (34–69) in immunotherapy-naive asymptomatic patients randomised to ipilimumab plus nivolumab, 20% (7–41) with nivolumab alone, and 6% (0–30) in the non-randomised cohort with prior brain-directed therapy, neurological symptoms or leptomeningeal disease; 7-year overall survival was 48%, 26% and 13% respectively (Long 2025, PMID 39978375). Adjuvant whole-brain radiotherapy after local treatment did not reduce distant intracranial failure at 12 months (42.0% vs 50.5%; OR 0.71, 0.41–1.23, P = .22) in a 215-patient randomised phase 3 trial (Hong 2019, PMID 31553661). Symptomatic and leptomeningeal disease remain the unsolved problems.

The randomised and prospective evidence

Study Population Result
ABC, 7-year follow-up (Long 2025, PMID 39978375) 79 enrolled (76 analysed) with active, immunotherapy-naive melanoma brain metastases, 4 Australian sites. Asymptomatic, no prior brain-directed therapy randomised 5:4 to cohort A (ipilimumab 3 mg/kg + nivolumab 1 mg/kg ×4 then nivolumab, n = 36) or cohort B (nivolumab alone, n = 27). Cohort C (n = 16, non-randomised): prior brain-directed therapy, neurological symptoms or leptomeningeal disease Median follow-up 7.6 years (IQR 6.9–8.2). Intracranial response 51% (34–69) A, 20% (7–41) B, 6% (0–30) C. 7-year intracranial PFS 42% (29–63), 15% (6–39), 6% (1–42). 7-year OS 48% (34–68), 26% (13–51), 13% (3–46). 50 deaths: 51%, 72%, 88% of each cohort
CheckMate 204 (Tawbi 2021, PMID 34774225; NCT02320058) 119 treated of 165 screened; cohort A asymptomatic (n = 101, ECOG 0–1, no neurological symptoms or steroids), cohort B symptomatic (n = 18, ECOG 0–2, stable symptoms, low-dose dexamethasone allowed); measurable lesions 0.5–3.0 cm Intracranial clinical benefit 57.4% (47.2–67.2) A vs 16.7% (3.6–41.4) B. Objective intracranial response 53.5% vs 16.7%; intracranial complete response 33% vs 17%. 36-month intracranial PFS 54.1% (42.7–64.1) vs 18.9% (4.6–40.5); 36-month OS 71.9% (61.8–79.8) vs 36.6% (14.0–59.8). Commonest grade 3–4 TRAEs: raised ALT and AST (15% each, cohort A)
COMBI-MB (Davies 2017, PMID 28592387) 125 patients with BRAF V600-mutant melanoma brain metastases in four cohorts across 32 institutions in Europe, North America and Australia; dabrafenib 150 mg bd + trametinib 2 mg od Intracranial response 58% (46–69) cohort A (V600E, asymptomatic, no prior local therapy), 56% (30–80) B (V600E, prior local therapy), 44% (20–70) C (V600D/K/R), 59% (33–82) D (symptomatic). Median follow-up 8.5 months. Median duration of response was relatively short
WBRT-Mel (Hong 2019, PMID 31553661) 215 patients randomised at 24 centres 2009–2017 after local treatment of 1–3 melanoma brain metastases: adjuvant whole-brain radiotherapy vs observation Distant intracranial failure within 12 months 42.0% vs 50.5% (OR 0.71, 0.41–1.23, P = .22); over entire follow-up 52.0% vs 57.9% (OR 0.79, 0.45–1.36, P = .39). Local failure lower after WBRT (20.0% vs 33.6%, P = .03). Death at 12 months 41.5% vs 51.4% (P = .28), no difference in neurological death. Median time to performance-status deterioration 3.8 vs 4.4 months. Median follow-up 48.1 months

The asymptomatic/symptomatic divide is the organising fact

Asymptomatic Symptomatic / prior brain therapy / leptomeningeal
CheckMate 204 intracranial clinical benefit 57.4% 16.7%
CheckMate 204 36-month OS 71.9% 36.6%
ABC intracranial response (combination) 51% (cohort A) 6% (cohort C)
ABC 7-year OS 48% (cohort A) 13% (cohort C)

Sources: PMID 34774225; PMID 39978375. The gap is roughly threefold on response and threefold on long-term survival, and it is not explained by tumour burden alone: cohort C in ABC mixes symptomatic disease, prior brain-directed therapy and leptomeningeal disease, all of which independently predict poor outcome. Corticosteroid exposure, required for symptom control, is the most-cited candidate mechanism for reduced immunotherapy efficacy, and both trials restricted or excluded steroid use in their favourable cohorts (PMID 34774225).

COMBI-MB's contrast is instructive in the opposite direction: targeted therapy achieved similar intracranial response rates in symptomatic (59%) and asymptomatic (58%) cohorts (PMID 28592387), so its activity is not steroid-dependent — but its duration of response was short. Targeted therapy buys rapid intracranial control; immunotherapy buys durability, and only in the asymptomatic.

Radiotherapy in the immunotherapy era

The WBRT-Mel randomised trial removed adjuvant whole-brain radiotherapy from routine use after local treatment of 1–3 metastases: no significant reduction in distant intracranial failure, no survival difference, and no difference in neurological death, at the cost of earlier performance-status deterioration — though local failure was significantly reduced (PMID 31553661). Quality-of-life trajectory was analysed as a secondary endpoint of that trial (Bartula 2023, PMID 37441544), and cost analyses of adjuvant whole-brain radiotherapy versus none (PMID 35513735) and of subsequent whole-brain or hippocampal-avoidant radiotherapy versus radiosurgery or surgery alone (PMID 32157631) have been published.

Stereotactic radiosurgery combined with checkpoint inhibition is supported by retrospective data only. Meta-analysis of 16 retrospective studies and 1,356 patients with brain metastases found concurrent radiosurgery plus checkpoint inhibitor associated with longer overall survival than non-concurrent administration (HR 1.43, P = .008) and better 12-month local brain control (HR 1.91, P = .04), with similar 12-month distant brain control (HR 1.12, P = .547) and a numerically higher complication rate (P = .346); concurrent therapy also outperformed checkpoint inhibitor before radiosurgery (HR 2.55, P = .0003) (Badrigilan 2023, PMID 34979828). Multiple single-centre series address patterns of care, timing and dose reduction (PMID 29960685; PMID 33432380; PMID 39465916; PMID 38310157; PMID 35343063; PMID 39594689; PMID 39959719). A systematic review of radiation therapy for melanoma brain metastases frames its survival estimates explicitly as a baseline against which systemic-therapy gains should be measured (Thompson 2022, PMID 35962952).

ABC's authors state that a trial investigating the role of stereotactic surgery in the new immunotherapy paradigm is ongoing (PMID 39978375) — the sequencing question for local therapy is therefore open in exactly the way the systemic sequencing question was before DREAMseq.

Leptomeningeal disease

Leptomeningeal metastasis is the worst-prognosis presentation and is excluded from most trials. A systematic review and network meta-analysis screened 843 records and included seven studies covering 397 patients with melanoma-associated leptomeningeal disease — one observational cohort of 29, one clinical trial of 25, and four retrospective cohorts — quantifying overall survival as log hazard ratios (Teo 2025, PMID 40081385). Survival outcomes based on clinical features in brain and leptomeningeal metastases from cutaneous melanoma have been described (Raizer 2008, PMID 18287337), as have targeted treatment and immunotherapy in this setting (Geukes Foppen 2016, PMID 26961150) and prognostic factors in management (PMID 26778048). Reviews cover current diagnosis and treatment (PMID 37511202; PMID 35790709) and systemic therapy for brain and leptomeningeal metastases together (PMID 38158477).

The entire leptomeningeal evidence base is 397 patients across seven heterogeneous studies with no randomised comparison.

Epidemiology, biology and detection

Melanoma brain metastases are common enough that the European guideline mandates brain MRI as part of staging from stage IIB/C onward, alongside whole-body CT or PET-CT (Garbe 2025, PMID 39700658), and M1d carries the worst survival of the M1 subcategories: in 200 patients on anti-PD-1, both M1c (P = .005) and M1d (P = .001) versus M1a were independent predictors of death alongside pT4b category and elevated baseline S100B and LDH (Janka 2023, PMID 37664072). SEER-derived analyses show scalp and neck primaries carry higher odds of multisite metastasis (adjusted OR 2.23, 1.28–3.88) than other head-and-neck sites (Rashid 2026, PMID 41803580).

Biologically, the intracranial and extracranial compartments are not interchangeable. Clinical features associated with outcome and biomarkers of dabrafenib–trametinib response in BRAF-mutant melanoma brain metastases have been analysed from COMBI-MB material (Wilmott 2023, PMID 36477181), and the resistance programmes catalogued in molecular subtypes and genomics — antigen loss, MHC disruption, PTEN-associated immune exclusion (Lim 2023, PMID 36934113) — apply with the additional constraint of the blood–brain barrier.

Who develops brain metastases, and when

Cohort Finding
779 acral and mucosal melanoma patients, stages I–III, median follow-up 68.0 months (Wang 2022, PMID 36137395) 60 (7.7%) developed brain metastasis and 261 (33.5%) extracranial metastasis. Cumulative incidence accounting for competing risk: 5.1% at 1 year, 10.2% at 2 years, 19.5% at 5 years. Stage III, BRAF mutation and NRAS mutation were associated with higher risk univariably; BRAF and NRAS mutations remained significantly associated with cumulative incidence on multivariable analysis at diagnosis and at 1 and 2 years
315 chemotherapy-naive stage IV patients undergoing brain CT or MRI every 6 weeks (Wang 2014, PMID 24121189) Cumulative incidence of confirmed brain metastases calculated at 12-week intervals with competing-risk regression to identify prognostic factors — one of the few prospective surveillance-schedule datasets in this setting

Radionecrosis is a specific late toxicity of the radiotherapy–immunotherapy combination. Among 135 melanoma brain-metastasis patients treated with radiotherapy plus anti-PD-1 who survived more than a year, 17% developed radionecrosis with a 2-year cumulative incidence of 18%; in an expanded cohort of 148, radionecrosis was associated with elevated lactate dehydrogenase (P = .0496) and prior ipilimumab (P = .0319), was diagnosed on MRI in 100% of cases, symptoms in 69% and pathology in 56%, and was managed with corticosteroids, bevacizumab and neurosurgery (Pires da Silva 2019, PMID 30767428). This is the harm side of the concurrent-radiosurgery-plus-checkpoint strategy whose retrospective survival advantage is described above.

Surgery and response assessment

Surgery. A systematic review screening 2,243 articles published 1995–2015 and reviewing 110 in full (73 included) found level 1 evidence supporting stereotactic radiosurgery alone, whole-brain radiotherapy, and radiosurgery with whole-brain radiotherapy for newly diagnosed melanoma brain metastases (Goyal 2015, PMID 26181286). Craniotomy for melanoma brain metastasis has a long retrospective literature (Wroński 2000, PMID 10883899), including series specifically examining craniotomy after immunotherapy (Hurst 1999, PMID 10404437) and alongside ipilimumab (Jones 2015, PMID 25727227). No randomised trial compares surgery with radiosurgery in melanoma specifically.

Response assessment is a measurement problem, not only a treatment problem. The RANO-BM working group was formed precisely because the brain-metastasis literature is difficult to interpret owing to substantial variation in response and progression criteria across trials, with patients historically excluded from most trials altogether (Lin 2015, PMID 26065612). RANO-BM has since been reappraised for lesions managed by stereotactic radiosurgery, where post-treatment change is hard to distinguish from progression (PMID 37999099), and amino-acid PET-based criteria have been proposed (PMID 40341837), supported by a joint EANM/EANO/RANO/SNMMI practice guideline for PET imaging of brain metastases (PMID 39762634). Intracranial response rates from different eras are therefore not automatically comparable, which is why the ABC and CheckMate 204 figures in the tables above are quoted with their own definitions attached.

What is being tested next

Trial Question Status (verified 2026-09-01)
The ABC authors' stated trial The role of stereotactic surgery in the new paradigm where upfront ipilimumab plus nivolumab is standard Ongoing per PMID 39978375
NCT06500455 Longer-duration versus usual radiation therapy for cancer that has spread to the brain (multi-tumour, not melanoma-specific) Recruiting, n = 269, primary completion 2028-06-30
NCT01223248 Two dosing schedules of hypofractionated image-guided radiation therapy Active, not recruiting, n = 220, primary completion 2026-10

The gap the trial landscape does not address is symptomatic and leptomeningeal disease. ABC and CheckMate 204 both restricted their favourable cohorts to asymptomatic patients without prior brain-directed therapy (PMID 39978375; PMID 34774225), and the entire leptomeningeal evidence base is 397 patients across seven heterogeneous studies with no randomised comparison (PMID 40081385). Full landscape in clinical trials landscape.

Interpretation rules for this page

  • Never quote a brain-metastasis response rate without stating symptomatic status and prior brain-directed therapy — the difference is threefold (PMID 34774225; PMID 39978375).
  • Intracranial and extracranial response are separate endpoints. ABC and CheckMate 204 report intracranial response as primary (PMID 39978375; PMID 34774225).
  • Corticosteroid use is an effect modifier, and the favourable cohorts in both major trials excluded or restricted it (PMID 34774225).
  • COMBI-MB's short response duration is as important as its high response rate (PMID 28592387).
  • Radiosurgery-plus-immunotherapy evidence is entirely retrospective and the timing effect could be confounded by patient selection (PMID 34979828).
  • Leptomeningeal disease is systematically excluded from trials and its evidence base is correspondingly thin (PMID 40081385).

Open questions

  • What is the role of stereotactic radiosurgery when upfront combination immunotherapy is standard? A trial is ongoing (PMID 39978375).
  • Why do symptomatic patients respond so much worse — steroids, blood–brain barrier, tumour burden, or a different immune microenvironment (PMID 34774225)?
  • Can steroid-sparing symptom control improve immunotherapy outcomes in symptomatic brain metastases (PMID 34774225)?
  • Is there any effective therapy for melanoma leptomeningeal disease (PMID 40081385)?
  • Should BRAF-mutant patients with symptomatic brain metastases receive targeted therapy first for speed, then immunotherapy — the opposite of DREAMseq's systemic answer (PMID 28592387; PMID 36166727)?
  • Does the local-failure reduction from whole-brain radiotherapy justify its use in any subgroup, given no survival benefit (PMID 31553661)?

Where this page's numbers should not be transported

  • The ABC and CheckMate 204 figures are from immunotherapy-naive, asymptomatic, steroid-free populations. Neither trial informs practice in a patient who has already progressed on checkpoint blockade.
  • COMBI-MB's response rates apply only to BRAF V600-mutant disease and came with a short median duration of response at a median 8.5 months' follow-up (PMID 28592387).
  • The acral/mucosal cumulative-incidence figures (5.1%/10.2%/19.5% at 1/2/5 years) are from a Chinese cohort of 779 stage I–III patients and should not be applied to cutaneous melanoma, whose brain-metastasis risk profile differs (PMID 36137395).
  • The radiosurgery-plus-checkpoint timing effect is retrospective across 16 studies and 1,356 patients, and concurrent administration may simply select fitter patients (PMID 34979828).
  • Radionecrosis incidence of 17–18% at 2 years was measured in patients who survived more than a year — a survivorship-conditioned denominator (PMID 30767428).

References

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