Table 1. Characteristics, summary of treatment and immune responses, and survival for the individual patients.
Characteristics (baseline)
|
Treatment weeks 1–12
|
Follow-up and survival
|
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Dose group | Patient No. | Age (sex) | KPS (%) | Tumour site/metastasisa (+/−) | No. of Injections/ Completed study | Immune-responses DTH/T cells | No. of booster injections | DTH | Survival days from start of treatment |
Low | 1 | 69 (M) | 85 | cap/+ | 6/no | −/− | — | — | 28 |
2 | 69 (M) | 100 | cap/− | 8/yes | +/− | — | — | 144 | |
3 | 64 (M) | 80 | cap, cor/− | 7/no | −/− | — | — | 40 | |
4 | 61 (F) | 70 | cap/+ | 8/yes | −/− | — | — | 190 | |
5 | 61 (M) | 100 | cau, cor/+ | 6/no | −/− | — | — | 31 | |
7b | 60 (F) | 85 | cau, cor/+ | 5/no | −/− | — | — | 20 | |
8 | 59 (F) | 85 | cap/+ | 8/yes | +/− | — | — | 146 | |
9c | 37 (M) | 85 | cor/+ | 6/no | −/− | — | — | 94 | |
10b,d | 59 (F) | 100 | cap/− | 4/no | −/− | — | — | 290 | |
11b | 47 (M) | 70 | ?/+ | 1/no | −/− | — | — | 3 | |
12 | 59 (M) | 100 | cap/− | 8/yes | +/− | 3 | − | 243 | |
Intermediate | 101 | 73 (F) | 95 | cap/+ | 8/yes | +/−e | 6 | + | 325 |
102 | 55 (F) | 95 | cor, cau/− | 8/yes | +/+ | 7 | + | 362 | |
103 | 58 (F) | 95 | cap/+ | 8/yes | +/− | 2 | − | 133 | |
104 | 64 (F) | 95 | cap/− | 8/no | −/+ | — | — | 68 | |
105 | 58 (M) | 95 | cap/+ | 8/yes | +/+ | 3 | + | 189 | |
106 | 49 (M) | 85 | cor/+ | 7/no | −/− | — | — | 80 | |
107 | 73 (M) | 85 | cau/+ | 8/no | −/− | — | — | 132 | |
108 | 56 (M) | 95 | cap/+ | 8/yes | +/+ | 10 | + | 381 | |
109c | 68 (M) | 95 | ?/? | 6/no | −/nt | — | — | 228 | |
110 | 59 (M) | 90 | cor, cau/− | 8/yes | −/− | 4 | − | 292 | |
111 | 68 (M) | 100 | cap/− | 8/yes | −/+ | 2 | − | 337 | |
112 | 67 (F) | 95 | cap/− | 8/yes | +/+ | 1 | − | 199 | |
113 | 58 (M) | 95 | cap/− | 8/yes | −/+ | 2 | + | 432 | |
114b | 71 (F) | 95 | cau/+ | 5/no | −/nt | 23 | |||
115 | 60 (F) | 90 | cap/− | 8/yes | +/+ | 13 | + | 575 | |
116 | 66 (F) | 95 | cau/− | 8/yes | +/+ | 6 | − | 323 | |
117 | 69 (M) | 90 | cap/− | 8/yes | +/− | — | — | 91 | |
High | 201 | 45 (F) | 80 | cap/− | 10/yes | +/+ | — | — | 320 |
202 | 58 (M) | 85 | cor, cau/− | 8/yes | +/+ | — | — | 165 | |
203b | 54 (F) | 85 | cap/+ | 2/no | −/nt | — | — | 27 | |
204 | 70 (F) | 90 | cap/+ | 7/no | −/nt | — | — | 53 | |
205b | 42 (F) | 70 | cap/+ | 4/no | −/nt | — | — | 10 | |
206b | 49 (M) | 75 | cor, cau/+ | 4/no | −/nt | — | — | 12 | |
207 | 58 (F) | 95 | cap/− | 8/no | −/− | — | — | 82 | |
208 | 75 (M) | 95 | cap/− | 8/yes | −/+ | 6 | − | 307 | |
209 | 54 (M) | 80 | ?/? | 8/yes | −/+ | 121 | |||
210 | 53 (F) | 85 | cor/+ | 7/no | −/− | 75 | |||
211 | 73 (M) | 95 | cor/− | 8/yes | −/− | 4 | − | 249 | |
212b,f | 40 (F) | 90 | cor/− | 8/yes | −/+ | 1 | − | 120 | |
213b,f | 68 (F) | 95 | cap/− | 8/yes | +/+ | 3 | − | 176 | |
214 | 56 (M) | 85 | cor/− | 8/yes | −/− | 2 | + | 154 | |
215 | 64 (M) | 90 | cap/− | 8/yes | −/+ | — | — | 119 | |
216 | 58 (M) | 90 | cap/− | 8/yes | −/+ | 1 | − | 153 | |
217b | 63 (M) | 75 | cap/+ | 4/no | −/− | — | — | 12 | |
218 | 46 (M) | 90 | cap/− | 8/yes | −/+ | — | — | 106 | |
219 | 72 (F) | 95 | cor/+ | 8/yes | −/+ | 8 | − | 365 | |
221 | 70 (F) | 95 | cap, cor/− | 8/yes | +/+e | 5 | + | 233 | |
DTH=delayed-type hypersensitivity; KPS=Karnofsky performance status; nt=not tested; na=not applicable; cap=caput; cau=cauda; cor=corpus; ?=unknown.
81% of patients with metastasis had liver metastasis.
Not evaluable.
Withdrawn to other treatment after week 4.
Withdrawn to surgery.
Positive at base line.
Earlier resected patient.