Table 1.
Patient demographics, baseline characteristics, and exposure to study treatment for patients treated with melphalan/Hepatic Delivery System (treated population)
| Characteristic | Melphalan/HDS (n = 91) n (%) |
|---|---|
| Demographics and baseline characteristics | |
| Median age: years (range) | 61.0 (20–78) |
| Male sex | 44 (48.4) |
| Ethnicity | |
| Hispanic or Latino | 2 (2.2) |
| Non-Hispanic or Latino | 86 (94.5) |
| No response | 3 (3.3) |
| Race | |
| White | 86 (94.5) |
| Other | 2 (2.2) |
| No response | 3 (3.3) |
| Median time since primary diagnosis: months (range)a | 39.3 (0.7–198.9) |
| Median time since diagnosis of liver metastases: months (range)a | 5.5 (0.2–67.5) |
| Median time from primary diagnosis to metastasis to liver: months (range) | 33.0 (0.0–159.1) |
| ECOG performance status score | |
| 0 | 80 (87.9) |
| 1 | 9 (9.9) |
| Not recorded | 2 (2.2) |
| Elevated LDH | 32/86 (37.2) |
| Extent of liver involvement (%)b | |
| ≤25 | 72 (79.1) |
| 26−50 | 19 (20.9) |
| Largest hepatic lesionc,d | |
| ≤ 3 cm (stage M1a) | 35 (38.5) |
| 3.1 to 8 cm (stage M1b) | 51 (56.0) |
| ≥ 8.1 cm (stage M1c) | 5 (5.5) |
| Extrahepatic lesionsd | |
| Lung | 11/27 (40.7) |
| Lymph node | 5/27 (18.5) |
| Bonee | 4/27 (14.8) |
| Soft tissuef | 10/27 (37.0) |
| Brain | 0/27 (0.0) |
| Other visceralg | 6/27 (22.2) |
| Prior therapiesh | 40 (44.0) |
| Radiation | 10 (11.0) |
| Surgeryi | 13 (14.3) |
| Systemic | 23 (25.3) |
| Immune checkpoint inhibitor | 21 (23.1) |
| Chemotherapy | 3 (3.3) |
| SIRT | 1 (1.1) |
| TACE | 1 (1.1) |
| Targeted small molecule | 1 (1.1) |
| Exposure to study treatment | |
| No. of treatment cycles completed | |
| 1 | 7 (7.7) |
| 2 | 18 (19.8) |
| 3 | 11 (12.1) |
| 4 | 15 (16.5) |
| 5 | 6 (6.6) |
| 6 | 34 (37.4) |
HDS, hepatic delivery system; ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; SIRT, Selective internal radiation therapy; TACE, transarterial chemoembolization
aMonths from diagnosis of either primary tumor or liver metastases to either randomization (double-arm phase) or eligibility (single-arm phase)
bAssessed by the investigator
cTumor staging per AJCC Cancer Staging Manual,7th edition
dBased on Independent Review Committee assessment
eIncludes spine, lumbar spine, pelvis, ribs, sacrum, and skull
fIncludes subcutaneous trunk and chest wall
gIncludes spleen and adrenal gland
hPatients with multiple therapies of a given type are counted once for that type
iIncludes only therapeutic surgeries/procedures and excludes non-therapeutic prior surgeries/procedures (e.g., biopsy). Each surgery/procedure was retrospectively classified as therapeutic or non-therapeutic