Table 2 Overview of available pCSI LMD data in adult patients

Yang et al. [7]

Prospective phase I

24 (21 eligible for analysis)

Median: 52 years

Range: 30–67 years

NSCLC (n = 11), breast carcinoma (n = 7), esophageal adenocarcinoma (n = 1), rectal adenocarcinoma (n = 1), adenoid cystic carcinoma of parotid (n = 1)

Yes

pCSI

30 Gy in 10 fractions (RBE)

Median CNS PFS: 7 months, 95% CI: 5–13

Median: 8 months, 95% CI: 6 - not reached

20 patients eligible for analysis:

Fatigue [19 patients (95%)]: grade 1 (n = 10, 50%), grade 2 (n = 8, 40%), grade 3 (n = 1, 5%)

Lymphopenia [18 patients (90%)]: grade 2 (n = 1, 5%), grade 3 (n = 15, 75%), grade 4 (n = 2, 10%)

Thrombocytopenia [10 patients (50%)]: grade 1 (n = 7, 35%), grade 2 (n = 2, 10%), grade 4 (n = 1, 5%)

Yang et al. [8]

Prospective randomized phase II

98 (42 pCSI, 21 IFRT, 35 exploratory pCSI)

Median: 57 years (pCSI), 61 years (IFRT), 61 years (exploratory pCSI)

Range: 27–79 years

NSCLC (n = 36) and breast (n = 27), (other entities in the exploratory pCSI group: ovarian (n = 7), esophageal (n = 6), melanoma (n = 6), colorectal (n = 5), head and neck (n = 3), pancreatic (n = 2), SCLC (n = 1), anal (n = 1), biliary (n = 1), prostate (n = 1), unknown primary (n = 1))

Yes

pCSI vs. photon IFRT

3 Gy in 10 fractions (RBE)

Median CNS PFS: 7.5 months (pCSI), 2.3 months (IFRT)

Median: 9.9 months (pCSI), 6.0 months (IFRT)

pCSI grade 4: lymphopenia (10%)

pCSI grade 3: fatigue (2%), pain (2%), vomiting (2%)

No difference between pCSI and IFRT

Lam et al. [9]

Retrospective

45

Median: 54 years

Range:

23–79 years

Breast cancer (n = 24), NSCLC (n = 8), melanoma (n = 4), gastrointestinal cancer (n = 2), atypical neuroendocrine lung cancer (n = 1), other (n = 6)

Yes

pCSI

3 Gy in 10 fractions (RBE) (n = 39)

Median PFS: 6.5

months

Median:

13.7 months

Non-hematologic events during or right after pCSI: 76% of patients had nausea, 51% headache, 31% fatigue, 4% dizziness

Hematologic events:

overall numerical decrease in white blood count, hemoglobin level, and platelet count 4 weeks after

radiation, recovered by 8 weeks after pCSI, no

hematologic values were critically low

Webb et al. [10]

Retrospective

1

60 years

Large cell neuroendocrine carcinoma (n = 1)

Yes

pCSI, bevacizumab, and pembrolizumab

30 Gy in 10 fractions (RBE not specified)

4.6 months

6 months

ICI-induced hypophysitis, lymphopenia, thrombocytopenia, and fatigue

Sener et al. [11]

Retrospective

2

Not specified (one patient “in his 30s”, one patient “in his 70s”)

Melanoma (n = 2)

Yes

pCSI and various ICI

30 Gy in 10 fractions (RBE not specified)

Patient 1: 3 months; Patient 2: 5 months

Patient 1: 7 months (still alive); Patient 2: 5 months (still alive)

Acute: grade 1 fatigue, grade 1 headache; Late: ICI-induced hepatitis