Clinical Study

The Florida Melanoma Trial I: A Prospective Multicenter Phase I/II Trial of Postoperative Hypofractionated Adjuvant Radiotherapy with Concurrent Interferon-Alfa-2b in the Treatment of Advanced Stage III Melanoma with Long-Term Toxicity Follow-Up

Table 1

Baseline characteristics ( 𝑛 = 2 3 ).

𝑛 ( % )

Sex
 M13 (56.5)
 F10 (43.5)
Race
 White22 (95.7)
 Hispanic1 (4.3)
Staging
 Missing4 (17.4)
 11 (4.3)
 25 (21.7)
 37 (30.4)
 56 (26.1)
Initial ECOG performance status (PS)
 Missing2 (8.7)
 014 (60.9)
 17 (30.4)
End of treatment ECOG PS
 Missing3 (13.0)
 03 (13.0)
 116 (69.6)
 21 (4.3)
ECOG PS change (end versus baseline)
 Missing5 (21.7)
 Better1 (4.3)
 Same6 (26.1)
 Worse11 (47.8)
Number of eligibility items qualified*
 112 (52.2)
 29 (39.1)
 32 (8.7)
Qualified for criterion (1)
 Yes10 (43.5)
 No13 (56.5)
Qualified for criterion (2)
 Yes10 (43.5)
 No13 (56.5)
Qualified for criterion (3)
 Yes15 (65.2)
 No8 (34.8)
Qualified for criterion (4)
 Yes1 (4.3)
 No22 (95.7)
Ulceration of primary
 Yes8 (34.8)
 No12 (52.2)
 Unknown3 (13.0)
Primary site
 Ant trunk6 (26.1)
 H/N3 (13.0)
 Pos trunk4 (17.4)
 Upper ext4 (17.4)
 Unknown6 (26.1)
Primary tumor thickness
 Unknown2 (8.7)
 Breslow ≤.75 Clark II8 (34.8)
 Breslow  .76–1.5 Clark III5 (21.7)
 Breslow 1.51–4.0 Clark IV7 (30.4)
 Breslow >4.0 Clark V or satellite1 (4.3)
Nodal site
 Axilla16 (69.6)
 Groin4 (17.4)
 Neck3 (13.0)
Number of positive nodes
 Missing1 (4.3)
 0–313 (56.5)
 4–104 (17.4)
 >105 (21.7)
Nodal involvement
 Missing1 (4.3)
 No regional LN1 (4.3)
 1 regional station, node(s) mobile and  diameter 3 cm7 (30.4)
 1 lymph node station, diameter >3 cm or fixed14 (60.9)

*See Section 2.1.