Cell division cycle associated gene 1 (CDCA1) and insulin-like growth factor-II mRNA binding protein 3 (IMP-3) are novel cancer-testis antigen overexpressed in non-small-cell lung cancer (NSCLC). The aim of this study was to evaluate the safety, efficacy and immunological response of a novel peptide vaccination therapy, CDCA1 and IMP-3, in patients with previously treated advanced NSCLC.Patients and methods
Human histocompatibility leukocyte (HLA)-A2402-positive advanced NSCLC patients who failed to standard therapy were enrolled if they had a performance status of three or less, were 80 years or younger and had adequate organ function. The cocktail of two peptides was subcutaneously injected with 1 ml of incomplete Freunds adjuvant to axillary or inguinal regions weekly. Immunological response was evaluated with enzyme-linked immunospot assay before and after vaccinations every 4 weeks.Results
From November 2009 through December 2011, 20 patients (13 men and 7 women; median age, 65 years; range, 36–78 years) were enrolled. CDCA1 and IMP-3 specific cytotoxic T lymphocyte responses were observed after vaccinations in 60% and 73% of patients, respectively. The overall response rate was 5% (95% CI, 0.1–24.9%) and stable disease rate was 55% (95% CI, 31.5–76.9%). The median survival time from the start of vaccination therapy was 7 months (range 1–26 months). The median progression-free survival time was 3 months (range 1–15 months). One patient with interstitial lung disease (ILD) had acute exacerbation of ILD during vaccination therapy. The other 19 patients did not have any grade 3 or 4 adverse events.Conclusion
This vaccination therapy was effective and well tolerated in patients with NSCLC who failed to standard therapy, and therefore warrants further clinical studies.