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Randomized Controlled Trial
. 2015 Sep;262(3):456-64; discussion 462-4.
doi: 10.1097/SLA.0000000000001419.

Long-term outcomes of helper peptide vaccination for metastatic melanoma

Yinin Hu  1 , Helen Kim, Christopher M Blackwell, Craig L Slingluff Jr
Affiliations
Randomized Controlled Trial

Long-term outcomes of helper peptide vaccination for metastatic melanoma

Yinin Hu et al. Ann Surg. 2015 Sep.

Abstract

Objective: The objective of this study was to compare the long-term outcome of patients with metastatic melanoma vaccinated with 6MHP to that of a group of unvaccinated historical controls.

Background: A multipeptide vaccine (6MHP), designed to induce helper T cells against melanocytic and cancer-testis antigens, has been shown to induce specific Th1-dominant CD4+ T cell responses.

Methods: The 6MHP vaccine was administered to patients with metastatic melanoma. Circulating CD4+ T cell responses were measured by proliferation or direct IFN-gamma ELIspot assay. Overall survival of vaccinated patients was compared to a group of clinically comparable historical controls using multivariable Cox regression analysis and Kaplan-Meier survival analysis, taking into account age, metastatic site, and resection status.

Results: Across 40 vaccinated patients and 87 controls, resection status (HR 0.54, P = 0.004) and vaccination (HR 0.24, P < 0.001) were associated with improved overall survival. Forty pairs of vaccinated patients and controls were matched by metastatic site, resection status, and age within 10 years. Median survival was significantly longer for vaccinated patients (5.4 vs 1.3 years, P < 0.001). Among the vaccinated patients, the development of a specific immune response after vaccination was associated with improved survival (HR 0.35, P = 0.040).

Conclusions: Helper peptide vaccination is associated with improved overall survival among patients with metastatic melanoma. These data support a randomized prospective trial of the 6MHP vaccine.

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Figures

Figure 1
Figure 1
Inclusion criteria and matching protocol for study patients. 6MHP: 6 melanoma helper peptide vaccine; HbA1c: hemoglobin A1c level; NYHA: New York Heart Association; PS: Eastern Cooperative Oncology Group performance status;
Figure 2
Figure 2
Calculation of the area under the curve (AUC) measure of immune response. Data from patient VMM504, participant within MEL 41. Stimulation index (R) is the ratio of the number of T-cells responding to vaccine peptides versus negative control.
Figure 3
Figure 3
Kaplan-Meier survival analyses. Comparison of matched vaccinated and control patients (A). Stratification of vaccinated patients by immune response (B) and resection status (C, D). AUC: area under the immune response curve; NED: no evidence of disease at time of first vaccination.
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