Table 4.

(A) Sites of metastases association with response rates
IL-2 alone
IL-2 + vaccine
Total% ResponseP*Total% ResponseP*
Sites of disease
    S.c. and/or cutaneous alone2033≥0.128460.0005
    S.c. and/or cutaneous alone and lymph node1921≥0.12623≥0.1
    Lymph node alone2921≥0.13719≥0.1
    Visceral alone7011≥0.16914≥0.1
    Visceral and cutaneous4513≥0.15511≥0.1
    Visceral and lymph nodes476≥0.16070.05
    Viscera and s.c.3212.5≥0.1579≥0.1
    Bone and any other site(s)2910≥0.12821≥0.1
    Brain and any other site(s)130≥0.12010≥0.1
    Any visceral component19421≥0.1241100.00038
M stage by American Joint Commission on Cancer classification
    M14717≥0.161330.00063
    M222182015
    M32361129812
(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≥0.10.06 ≥0.1
    Nadir≥0.1≥0.1≥0.1≥0.1
    Change≥0.1≥0.1≥0.1≥0.009
Lymphocyte count
    Peak0.006≥0.10.03≥0.1
    Nadir≥0.1≥0.1≥0.1≥0.1
    Change0.050.09≥0.1≥0.1
Eosinophil count
    Peak≥0.1≥0.100.02 0.03
    Nadir0.020.09≥0.1≥0.1
    Change≥0.1≥0.10.040.02
Platelet count
    Peak0.050.02≥0.1≥0.1
    Nadir≥0.1≥0.10.0008≥0.10
    Change≥0.1≥0.1≥0.1≥0.1
Creatinine
    Peak≥0.1≥0.1≥0.100.08
    Nadir≥0.1≥0.10.07≥0.1
    Change≥0.1≥0.1≥0.10.06
Bilirubin
    Peak≥0.1≥0.10.09≥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.