Table 3. Best tumour response and time-related efficacy end points in evaluable patients during the phase II stage.
|
Plitidepsin (n=16) |
Plitidepsin/DTIC (n=28) |
|||
|---|---|---|---|---|
| n | % | n | % | |
| Complete response |
|
|
1 |
3.6 |
| Partial response |
|
|
5a |
17.9 |
| Stable disease |
2 |
12.5 |
9b |
32.1 |
| Progressive disease |
14 |
87.5 |
13 |
46.4 |
| |
Median (months) |
Range |
Median (months) |
Range |
| Duration of response |
|
|
4.5 |
1.4–16.5 |
| Duration of stable disease |
2.9 |
2.8–3.0 |
3.9 |
3.1–13.2 |
| |
Median (months) |
95% CI |
Median (months) |
95% CI |
|
All evaluable patients | ||||
| n | 16 | 28 | ||
| PFS |
1.5 |
0.9–1.9 |
3.3 |
1.6–4.6 |
|
Patients with baseline LDH ⩽1.1 × ULN | ||||
| n | 3 | 20 | ||
| PFS |
1.6 |
1.6–2.8 |
4.3 |
2.0–7.9 |
|
Patients with baseline LDH >1.1 × ULN | ||||
| n | 13 | 8 | ||
| PFS | 1.1 | 0.9–1.9 | 1.4 | 1.1–1.6 |
Abbreviations: CI=confidence interval; DTIC=dacarbazine; LDH=lactate dehydrogenase; n=number of patients evaluable for efficacy; PFS=progression-free survival; ULN=upper limit of normal.
a
Two of these responses occurred among the first 17 patients evaluable for efficacy in this arm.
b
Includes one patient treated with plitidepsin/DTIC who had unconfirmed partial response.