Table 1 Patient demographics and key clinical features

From: Concurrent intrathecal and intravenous nivolumab in leptomeningeal disease: phase 1 trial interim results

 

n (%)

Median age at LMD diagnosis (range)

43 (30–73) years

Male

14 (56)

Site of primary melanoma

 

Cutaneous

10 (40)

Primary CNS

3 (12)

Uveal

2 (8)

Acral lentiginous

1 (4)

Mucosal

1 (4)

Unknown

8 (32)

Melanoma mutation

 

BRAF V600E

15 (60)

BRAF V600K

1 (4)

GNA11/GNAQ

4 (16)

NRAS

2 (8)

Other

2 (8)

Unknown (not sufficient tissue for sequencing)

1 (4)

ECOG performance status

 

0

11 (44)

1

11 (44)

2

3 (12)

LDH elevated above institutional limit

8 (32)

CSF positive for malignant cells at baseline

14 (56)

MRI brain findings consistent with LMD at baseline (MRI spine with no evidence of LMD)

12 (48)

MRI spine findings consistent with LMD at baseline (MRI brain with no evidence of LMD)

3 (12)

Both MRI brain and spine consistent with LMD at baseline

10 (40)

Parenchymal brain metastases before LMD diagnosis

19 (76)

Extracranial disease present at time of LMD diagnosis

12 (48)

Prior therapies to LMD diagnosis

 

Systemic therapy

23 (92)

Checkpoint inhibitors

21 (84)

BRAF, MEK or BRAF/MEK inhibitors

16 (64)

(Bio)Chemotherapy

3 (12)

Othera

5 (20)

Median number of previous metastatic melanoma directed therapies (range)

2 (range 0–6)

Radiation to brain or spine

21 (84)

Whole-brain radiotherapy

9 (36)

Stereotactic radiation

14 (56)

LMD directed systemic therapies before IT/IV nivolumab

8 (32)

Checkpoint inhibitors

3 (12)

BRAF, MEK or BRAF/MEK inhibitors

6 (24)

Chemotherapy

1 (4)

Intrathecal therapy with IL-2

5 (20)

On dexamethasone/corticosteroids at enrollment

10 (40)

Dexamethasone (or equivalent) dose, median (mg d−1)b

2.0 (range 1–4)

On concurrent BRAF/MEK therapy

11 (44)

  1. LDH, lactate dehydrogenase.
  2. aIMCgp100, olaparib, axitinib, relatlimab, azacitadine, TLR9 agonist, CD40 antibody.
  3. bPatients requiring corticosteroids.