Table 1. Patient characteristics.
IT+PT |
PT | ||||||
---|---|---|---|---|---|---|---|
Cohort | 16 mg | 32 mg | 48 mg | 64 mg | 96 mg | 96 mg | Total |
No. of patients, n | 3 | 3 | 3 | 3 | 5 | 6 | 23 |
Age, years | |||||||
Median | 71 | 67 | 81 | 69 | 73 | 69 | 72 |
Range | 49–71 | 66–76 | 79–85 | 69–80 | 69–77 | 40–85 | 40–85 |
Sex,
n
(%) | |||||||
Male | 2 (67) | 0 (0) | 0 (0) | 1 (33) | 4 (80) | 4 (67) | 11 (48) |
Female | 1 (33) | 3 (100) | 3 (100) | 2 (67) | 1 (20) | 2 (33) | 12 (52) |
ECOG performance status,
n
(%) | |||||||
0 | 2 (67) | 3 (100) | 3 (100) | 4 (80) | 5 (83) | 17 (74) | |
1 | 1 (33) | 3 (100) | 1 (20) | 1 (17) | 6 (26) | ||
Time from diagnosis, years | |||||||
Median | 3.7 | 8.4 | 1.5 | 1.8 | 1.7 | 1.2 | 1.7 |
Range | 0.8–9.8 | 3.0–9.8 | 1.0–3.7 | 0.8–18.4 | 0.7–6.8 | 0.3–2.0 | 0.3–18.4 |
Prior treatment, n (%) | |||||||
Surgery | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 6 (80) | 6 (100) | 23 (100) |
Immunotherapy | 1 (33) | 1 (33) | 1 (33) | 1 (20) | 1 (17) | 5 (22) | |
Radiotherapy | 1 (33) | 1 (33) | 2 (9) | ||||
Chemotherapy | 1 (33) | 1 (33) | 1 (20) | 3 (13) | |||
Melanoma stage at inclusion,
n
(%) | |||||||
III | 2 (67) | 3 (100) | 2 (67) | 2 (67) | 3 (60) | 6 (67) | 16 (70) |
IV | 1 (33) | 1 (33) | 1 (33) | 2 (40) | 2 (33) | 7 (30) | |
Site of metastases,
n
(%) | |||||||
Leg | 3 (100) | 3 (100) | 3 (100) | 3 (100) | 2 (40) | 3 (50) | 17 (74) |
Arm | 1 (27) | 1 (4) | |||||
Chest | 1 (17) | 1 (4) | |||||
Head | 2 (40) | 2 (33) | 4 (17) | ||||
Size of the tumour lesions, mm | |||||||
Injected with DT01 | |||||||
Median | 16 | 8 | 24 | 11 | 10 | 6 | 9 |
Range | 3–36 | 5–25 | 9–33 | 4–17 | 8–25 | 3–30 | 3–36 |
Non-injected with DT01 | |||||||
Median | 2 | 4.5 | 7 | 8 | 7 | 4 | 6 |
Range | 2–15 | 4–6 | 6–20 | 4–20 | 4–17 | 2–10 | 2–20 |
All | |||||||
Median | 5 | 6 | 12 | 9 | 8 | 5 | 7 |
Range | 2–36 | 4–25 | 6–33 | 4–20 | 4–25 | 2–30 | 2–36 |
No. of treated lesions,
n | |||||||
Injected with DT01 | 6 | 5 | 6 | 6 | 10 | 12 | 45 |
Non-injected with DT01 | 5 | 4 | 5 | 7 | 13 | 6 | 40 |
Total | 11 | 9 | 11 | 13 | 23 | 18 | 85 |
Abbreviations: AJCC=American Joint Committee on Cancer; ECOG=Eastern Cooperative Oncology Group; IT=intratumoural; PT=peritumoural.
AJCC classification was used for melanoma staging.