| (A) Sites of metastases association with response rates | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| IL-2 alone | IL-2 + vaccine | |||||||||||
| Total | % Response | P* | Total | % Response | P* | |||||||
| Sites of disease | ||||||||||||
| S.c. and/or cutaneous alone | 20 | 33 | ≥0.1 | 28 | 46 | 0.0005† | ||||||
| S.c. and/or cutaneous alone and lymph node | 19 | 21 | ≥0.1 | 26 | 23 | ≥0.1 | ||||||
| Lymph node alone | 29 | 21 | ≥0.1 | 37 | 19 | ≥0.1 | ||||||
| Visceral alone | 70 | 11 | ≥0.1 | 69 | 14 | ≥0.1 | ||||||
| Visceral and cutaneous | 45 | 13 | ≥0.1 | 55 | 11 | ≥0.1 | ||||||
| Visceral and lymph nodes | 47 | 6 | ≥0.1 | 60 | 7 | 0.05 | ||||||
| Viscera and s.c. | 32 | 12.5 | ≥0.1 | 57 | 9 | ≥0.1 | ||||||
| Bone and any other site(s) | 29 | 10 | ≥0.1 | 28 | 21 | ≥0.1 | ||||||
| Brain and any other site(s) | 13 | 0 | ≥0.1 | 20 | 10 | ≥0.1 | ||||||
| Any visceral component | 194 | 21 | ≥0.1 | 241 | 10 | 0.00038‡ | ||||||
| M stage by American Joint Commission on Cancer classification | ||||||||||||
| M1 | 47 | 17 | ≥0.1 | 61 | 33 | 0.00063† | ||||||
| M2 | 22 | 18 | 20 | 15 | ||||||||
| M3 | 236 | 11 | 298 | 12 | ||||||||
| (B) Laboratory values after starting IL-2: association with prognosis (two-tailed P values) | ||||||||||||
| IL-2 alone | IL-2 + vaccine | |||||||||||
| Response | Survival§ | Response | Survival§ | |||||||||
| WBC count | ||||||||||||
| Peak | ≥0.1 | ≥0.1 | 0.06 ∥ | ≥0.1 | ||||||||
| Nadir | ≥0.1 | ≥0.1 | ≥0.1 | ≥0.1 | ||||||||
| Change | ≥0.1 | ≥0.1 | ≥0.1 | ≥0.009 | ||||||||
| Lymphocyte count | ||||||||||||
| Peak | 0.006¶ | ≥0.1 | 0.03¶ | ≥0.1 | ||||||||
| Nadir | ≥0.1 | ≥0.1 | ≥0.1 | ≥0.1 | ||||||||
| Change | 0.05¶ | 0.09∥ | ≥0.1 | ≥0.1 | ||||||||
| Eosinophil count | ||||||||||||
| Peak | ≥0.1 | ≥0.10 | 0.02 ¶ | 0.03 | ||||||||
| Nadir | 0.02∥ | 0.09 | ≥0.1 | ≥0.1 | ||||||||
| Change | ≥0.1 | ≥0.1 | 0.04¶ | 0.02 | ||||||||
| Platelet count | ||||||||||||
| Peak | 0.05¶ | 0.02¶ | ≥0.1 | ≥0.1 | ||||||||
| Nadir | ≥0.1 | ≥0.1 | 0.0008∥ | ≥0.10 | ||||||||
| Change | ≥0.1 | ≥0.1 | ≥0.1 | ≥0.1 | ||||||||
| Creatinine | ||||||||||||
| Peak | ≥0.1 | ≥0.1 | ≥0.10 | 0.08∥ | ||||||||
| Nadir | ≥0.1 | ≥0.1 | 0.07¶ | ≥0.1 | ||||||||
| Change | ≥0.1 | ≥0.1 | ≥0.1 | 0.06∥ | ||||||||
| Bilirubin | ||||||||||||
| Peak | ≥0.1 | ≥0.1 | 0.09¶ | ≥0.1 | ||||||||
| Nadir | ≥0.1 | ≥0.1 | ≥0.1 | ≥0.1 | ||||||||
| Change | ≥0.1 | ≥0.1 | ≥0.1 | ≥0.1 | ||||||||
↵* P values are for comparison between the fraction with the site of disease stated versus all patients who have disease in any other sites. The association between the three M stage classification groups and response was determined by a generalized version of Fisher’s exact test.
↵† Higher response rate.
↵‡ Lower response rate.
↵§ Survival at 4 y.
↵∥ Lower in responders or survivors.
↵¶ Higher in responders or survivors.