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. 2016 May 3;114(11):1199–1205. doi: 10.1038/bjc.2016.120

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.