Allogeneic cells vaccine increases disease-free survival in stage III melanoma patients: a non randomized phase II study

RESUMO

The incidence of melanoma is increasing rapidly, and in many cases the primary tumor is excised after metastatic spreading. In 80 percent of the cases, the first metastatic site is in regional lymph nodes (AJCC Stage III). After excision of these nodes, the patient is clinically disease-free, but the chances of recurrency vary between 40-80 percent. Thirty patients with stage III melanoma were treated in a non-randomized Phase II adjuvant trial with a vaccine consisting of a mixture of three allogeneic cell lines IIB-MEL-J, IIB-MEL-LES and IIB-MEL-IAN (5 x 10(6) cells each). The cells were irradiated (5,000cGy) and BCG was used as nonspecific stimulant. Before each vaccination (72 hr) the patients received cyclophosphamide (300 mg/sqm). The untreated control group was composed of 24 Stage III melanoma patients. Vaccination started within 60 days after surgery, and patients received 4 vaccinations, one every 21 days and then 1 every two months during the 1st year; 1 every three months during the 2nd year, and 1 every 6 months during the 3rd, 4th and 5th years. The treated group was composed by 19 men (63.3 percent) and 11 women (36.7 percent); average age 47.6 + 14.1 years (range 16-70 yr). The control group was composed by 18 men (75 percent) and 6 women (25 percent); average age 49.8 + 14.2 yr (range26-73 yr). The median disease free survival (DFS) calculated according to Kaplan-Meier was 7.0 months in the control group vs 20.0 months in the treated group (p < 0.001). The results of this clinical trial suggest that treatment with allogeneic cell vaccines increases DFS in stage III melanoma patients.