For many years, various melanoma vaccines have been employed. This is a unique melanoma vaccine in that it is a subcellular tumor homogenate and no adjuvants have been added. This vaccine has been given to 129 stage I and 61 stage II melanoma patients. All were followed at least 5 years and had 87.5% and 63.9% 5‐year survival rates, respectively. Sixty‐four stage I males and 65 stage I females had 84% and 90% 5‐year survival rates, respectively. We saw no difference between those with or without lymph node dissection. Thirty‐six stage II males and 25 stage II females had 66.7% and 60% 5‐year survival rates, respectively. Of stage II patients, 23 had only one positive node, 22 had two to four positive nodes, and 9 had five or more positive nodes with 69%, 63%, and 55% 5‐year survival rates, respectively. Large published series were used as historical controls [6,27,28], and significant differences were noted when compared to our stage II patients (P = 0.001)—those with two to four positive nodes (P = 0.03), and those with five or more positive nodes (P = 0.04). We conclude that there is a significant increase in survival for these stage II patients, at high risk of recurrence, receiving a tumor homogenate vaccine. This vaccine warrants further analysis, development, and use in a phase III randomized clinical trial.
- 5‐year survival
- tumor homogenate