The reduction of unnecessary excisions when using digital dermoscopy compared with dermoscopy alone in our study suggests that access to digital dermoscopy offers a better management of pigmented lesions in daily practice. The high number of early lesions diagnosed by this technique confirms that its use is safe.
3022 Background: Therapeutic vaccination of metastatic melanoma patients with detectable disease is followed by tumor regression in ±10% of the patients, mostly with locoregional disease. Considering the absence of an effective treatment to prevent relapses of cutaneous melanoma, we have applied a multipeptide vaccine in the adjuvant setting. Methods and Results: We treated 45 HLA-A2-positive melanoma patients with no evidence of disease but at high risk of relapse. They received 5 vaccines every 3 weeks, then one every 3 months over 2 years. A first group (n=14) received 4 antigenic peptides derived from MAGE-A3, NA17, gp100 and Tyrosinase, emulsified independently in 4x1ml of Montanide ISA51. A second group (n=16) received the 4 peptides emulsified together in 1x1ml of Montanide. A third group (n= 15) received the 4 peptides alone. Forty-one patients were eligible for immune response analysis after 5 injections. A T-cell response to at least one peptide was detected in 21/27 patients vaccinated with Montanide, but in none of 14 vaccinated with peptides alone. Median follow-up time was 24 months ±10 months (SD). Relapse free survival (RFS) at 18 months was 37% for all the patients and no significant difference was observed between patients vaccinated with or without Montanide: 41% and 27%, respectively. Median distant metastasis-free survival time (DMFS) was doubled for patients vaccinated with vs without Montanide (p=0.132). Multivariate analysis for various prognostic factors including sex, age, PS, vaccine type, or immune response suggested that the ulceration of the primary tumor was associated with a better clinical course following vaccination (HR=0.295 with IC95%: 0.09–0.97). Conclusions: Vaccination with mutiple peptides in Montanide is well tolerated and elicits specific immune responses. Patients vaccinated with peptides in Montanide have a prolonged RFS and DMFS compared to whose vaccinated with peptides alone. Patients who had an ulcerated primary tumor seem to benefit more from this adjuvant vaccine. These results warrant further evaluation of such vaccines in a randomized trial with the ulceration of the primary tumor as a stratification factor. No significant financial relationships to disclose.
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