Table 1.

Patients' demography and characteristics

No. of patientsa
Total number of patients receiving L19-IL2 + dacarbazineb32
 Patients receiving L19-IL2 (10 Mio IU) + dacarbazine (1 g/m2)3
 Patients receiving L19-IL2 (15 Mio IU) + dacarbazine (1 g/m2)3
 Patients receiving L19-IL2 (22.5 Mio IU) + dacarbazine (1 g/m2)26
Gender
 Male23
 Female9
Patients with baseline LDH, IU/I
 <1001
 >100 to <25019
 >25010
 N.A.2
ECOG performance status
 028
 14
10 and 15 Mio IU (n = 6)22.5 Mio IU (n = 26)Total (n = 32)
Stage of metastatic disease at baseline
 Stage IV M1a145
 Stage IV M1b167
 Stage IV M1c41620
Sites of metastatic lesions at baselinec
 Lymph nodes52025
 Lung41822
 Soft tissue61218
 Adrenal gland156
 Spleen156
 Bone145
 Liver-55
 Intestine-33
 Kidney-11
Prior systemic antineoplastic therapies received
 Chemotherapy6612
 Of which dacarbazine426
 Radiotherapy639

Abbreviations: ECOG, Eastern Cooperative Oncology Group; LDH, lactate dehydrogenase; N.A., not applicable.

  • aMedian age, 55 years; range, 30 to 83 years.

  • bMedian number of induction cycles received, 5; range. 1 to 6 cycles.

  • cMedian number of months from diagnosis of metastatic disease to start of treatment, 2.9; range, 0.2 to 61.5 months