Table 2. Patient characteristics at baseline.
| |
Phase II stage |
||
|---|---|---|---|
| Phase I stage (n=28) | Plitidepsin (n=20) | Plitidepsin/DTIC (n=38) | |
|
Gender | |||
| Male | 16 (57%) | 10 (50%) | 21 (55%) |
| Female |
12 (43%) |
10 (50%) |
17 (45%) |
| Median age (years) (range) |
48.0 (20–77) |
51.5 (36–78) |
55.5 (21–76) |
|
ECOG performance status | |||
| 0 | 16 (57%) | 4 (20%) | 21 (55%) |
| 1 | 11 (39%) | 15 (75%) | 16 (42%) |
| 2 |
1 (4%) |
1 (5%) |
1 (3%) |
| Median plasma LDH ( × ULN) (range) |
0.8 (0.4–3.4) |
1.7 (0.5–3.9) |
0.8 (0.4–8.2) |
| ⩽1.1 × ULN | 20 (71%) | 4 (20%) | 23 (61%) |
| >1.1 × ULN |
8 (29%) |
16 (80%) |
15 (39%) |
|
Diseasea | |||
| Metastatic | 26 (96%) | 20 (100%) | 38 (100%) |
| Locally advanced |
1 (4%) |
|
|
|
Sites of diseasea | |||
| Lung | 19 (70%) | 11 (55%) | 25 (68%) |
| Lymph node | 18 (67%) | 17 (85%) | 27 (73%) |
| Soft tissue | 9 (33%) | 5 (25%) | 11 (30%) |
| Liver | 8 (30%) | 11 (55%) | 17 (46%) |
| Bone | 7 (26%) | 7 (35%) | 6 (16%) |
| Peritoneum | 4 (15%) | 4 (20%) | 6 (16%) |
| Pelvis | 3 (11%) | 1 (5%) | 5 (14%) |
| Skin | 2 (7%) | 3 (15%) | 1 (3%) |
| Spleen | 2 (7%) | 4 (20%) | 3 (8%) |
| Kidney | 1 (4%) | 1 (5%) | 5 (14%) |
| Otherb |
5 (19%) |
5 (25%) |
12 (32%) |
|
Number of sites of diseasea,c | |||
| 1–2 Sites | 11 (41%) | 4 (20%) | 13 (35%) |
| ⩾3 Sites |
16 (59%) |
16 (80%) |
24 (65%) |
|
Previous anticancer therapy | |||
| Surgery | 28 (100%) | 20 (100%) | 36 (95%) |
| Radiotherapy | 10 (36%) | 10 (50%) | 7 (18%) |
| Biological therapy | 2 (7%) | 1 (5%) | 2 (5%) |
| Chemotherapyd | 1 (3%) | ||
Abbreviations: DTIC=dacarbazine; ECOG=Eastern Cooperative Oncology Group; LDH=lactate dehydrogenase; ULN=upper limit of normal.
a
One patient in the phase I stage had hepatic haemangioma instead of melanoma (wrong diagnosis), and has been excluded.
b
Adrenal, bladder, breast, central nervous system (CNS), pancreas, parotid gland, pericardial, pleura, stomach and thyroid sites.
c
Missing data for one patient treated with plitidepsin/DTIC in the phase II stage.
d
In the neoadjuvant setting.