TABLE 1.
Patient characteristics, clinical response, and autoimmune toxicity
| Patient no. | Age (y) | Sex | Disease sites | Prior therapy | Dose (mg/kg) | No. cycles received | Response (mo)a | Autoimmune toxicity (grade III/IV) |
|---|---|---|---|---|---|---|---|---|
| 1 | 45 | M | Adrenal, ALN, kidney, lung hilum, mesenteric, RP, SQ, pleura | S | 1 | 3 | NR | |
| 2 | 61 | M | Brain, SQ | S, I | 1 | 3 | NR | |
| 3 | 42 | M | SQ | S, C, I | 1 | 3 | NR | |
| 4 | 43 | M | Mediastinum | S | 3 | 9 | PR (19+) | |
| 5 | 58 | F | Iliac LN | S, C, I | 3 | 3 | NR | |
| 6 | 54 | M | Lung, SQ, spleen | S, I | 3 | 6 | NR | |
| 7 | 31 | M | Liver, lung, mediastinum, mesentery, SQ | R, S, C, I | 1 | 3 | NR | |
| 8 | 51 | M | ALN, intramuscular | R, S, C | 1 | 6b | PR (7) | Colitis |
| 9 | 33 | M | ALN, intraperitoneal, liver, mediastinum, spleen | S | 1 | 3 | NR | |
| 10 | 49 | F | ALN, liver, SQ | S, I | 2 | 3 | NR | |
| 11 | 60 | F | SQ | S, I | 2 | 3 | NR | Gastritis, enterocolitis, colitis |
| 12 | 60 | M | Lung | S | 2 | 7 | CR (16+) | |
| 13 | 48 | M | Liver, lung | S | 3 | 3 | NR | |
| 14 | 44 | M | Subclavicular LN, submandibular | R, S, C, I | 3 | 9+ | PR (11) | |
| 15 | 47 | M | Abdominal wall, SQ | R, S | 3 | 9 | PR (14+) | |
| 16 | 42 | F | ALN, SQ | S, I | 3 | 3 | NR | |
| 17 | 45 | F | Lung | S, I | 3 | 3 | NR | |
| 18 | 50 | F | Adrenal, brain, lung RP, SQ | S, I | 3 | 3 | NR | |
| 19 | 50 | M | Inguinal LN, lung, mesentery, pulmonary hila, SQ | S, I | 3 | 3 | CR (13+) | Colitis |
| 20 | 67 | F | Inguinal LN, SQ | S, I | 3 | 2 | CR (13+) | |
| 21 | 45 | M | Liver, lung | S, I | 3 | 1 | NR | |
| 22 | 57 | M | Bone, liver, spleen | S, I | 3 | 2 | NR | |
| 23 | 39 | F | Lung | S, I | 3 | 5 | NR | |
| 24 | 28 | F | Iliac LN, liver, lung | S, C, I | 3 | 3 | NR | |
| 25 | 48 | M | Liver, parotid | S | 3 | 6 | NR | |
| 26 | 21 | M | Lung | S, I | 3 | 6 | NR | |
| 27 | 58 | M | ALN submandibular, skin, SQ | R, S, I | 3 | 3 | NR | |
| 28 | 51 | F | Lung, mediastinum, SQ | S | 3 | 9 | PR (11+) | |
| 29 | 40 | M | ALN, lung | S, I | 3 | 3 | NR | Colitis |
| 30 | 48 | F | Lung, SQ | S, I | 3 | 3 | NR | |
| 31 | 25 | M | Abdominopelvic, adrenal, ALN, heart, mediastinum, spleen, SQ | S | 3 | 3 | NR | |
| 32 | 49 | F | Iliac LN, inguinal LN, SQ | R, S, C, I | 3 | 3 | NR | Arthritis, uveitis |
| 33 | 56 | M | ALN, cervical LN, iliac LN, SQ, lung | R, S, C, I | 3 | 2 | NR | |
| 34 | 44 | M | Lung, lung hilum | S, I | 3 | 2 | NR | |
| 35 | 52 | F | Bone, cervical LN, SQ, liver, lung, spleen | S | 3 | 2 | NR | |
| 36 | 58 | F | Adrenal, liver, lung, spleen | S | 3 | 3 | NR |
ALN, axillary lymph node; RP, retroperitoneal; SQ, subcutaneous; S, surgery; NR, no response; I, immunotherapy; C, chemotherapy; PR, partial response; LN, lymph node; R, radiotherapy; CR, complete response.
a
Responses as of December 1, 2004; + indicates ongoing response.
b
Patient 8 had a 7 month PR after six doses at 1 mg/kg. He was later re-treated at 1 mg/kg with subsequent progression of disuse. Patient 14 had an 11-month PR after three doses at 3 mg/kg. He was later re-treated at 3 mg/kg without further response.