Table 1

Patient characteristics

n%
Stage
 IIB314
 III1568
 IV418
Age (yr)
 ≤501150
 >501150
Gender
 Male1254
 Female1046
Sites of metastasis
 None (sentinel node negative, 2; sentinel node not done, 1)314
 Nodes1359
  Nonpalpable lymph node metastases (N1a, 4; N2a, 1)5(23)
  Palpable lymph node metastases8(36)
   N2b2a
   N36b
 Intransit skin29
 Distant418
  Lung1
  Distant skin (2 with unknown primaries)3
Prior IFN-α therapy
 No1477
 Failed on IFN-α314
 Did not tolerate IFN-α15
 Took 1 yr of IFN-α without failure15
No. of patients accrued in groups
 Group 1418
 Group 2523
 Group 3418
 Group 429
 Group 5418
 Group 6314
Adjuvant
 QS-21 (groups 1, 3, and 5)1254
 Montanide ISA-51 (groups 2, 4, and 6)1045
Peptide
 gp100280941
 gp100280 + tetP627
 Chimeric molecule732
  • a Includes 1 patient with recurrent nodal disease.

  • b Includes one patient with clinically evident disease at the time of protocol entry, in the form of multiple satellite metastases after resection of a palpable node.