Adjuvant treatment in stage I and II malignant melanoma: a randomized trial between chemoimmunotherapy and immunotherapy.
A randomized trial comparing chemoimmunotherapy (bacillus Calmette-Guérin + chemotherapy) and immunotherapy (bacillus Calmette-Guérin alone) was carried out in high-risk stage I and II malignant melanoma patients. Eight-two evaluable patients were included. The follow-up median duration was 11 years. Recurrent melanoma developed in 28 patients (34%). The overall survival rate was 76% at 5 years and 65% at 10 years. There were no statistical differences in survival probability or disease-free survival (DFS) probability between the two treatment groups. Survival and DFS were also analyzed in relation to various prognostic factors. Statistically significant differences were only seen in a subset of 33 patients with lower limb malignant melanoma, the prognosis being better for the chemoimmunotherapy group in this location. Because of the small number of patients in each group, a week positive effect of either of these two treatments cannot be ruled out. Chemoimmunotherapy only seems to improve the prognosis of stage I or II malignant melanoma of the legs.
Castel
T
T
Cátedra de Dermatología, Hospital Clínic, Barcelona, España.
Estapé
J
J
Viñolas
N
N
Mascaró
J M
JM
Castro
J
J
Vilalta
A
A
Gratacós
R
R
Daniels
M
M
Palou
J
J
Grau
J J
JJ
D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001500:BCG Vaccine / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003606:Dacarbazine / Q000008:administration & dosage; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006918:Hydroxyurea / Q000008:administration & dosage; D008297:Male; D008545:Melanoma / Q000401:mortality / Q000556:secondary / Q000628:therapy*; D008875:Middle Aged; D012878:Skin Neoplasms / Q000401:mortality / Q000628:therapy*; D014750:Vincristine / Q000008:administration & dosage
D001500:BCG Vaccine; D014750:Vincristine; D003606:Dacarbazine; D006918:Hydroxyurea