Immunotherapy, using peptide-based cancer vaccines is being studied to assess its potential in breast cancer. Trials of HLA-restricted peptide vaccines have been difficult to enroll given HLA subtype restrictions. It is necessary to determine the prognostic significance of HLA-status in breast cancer if patients who are ineligible to receive a vaccine due to their HLA-status are used as controls. The impact of targeted tumor associated antigen expression, when it effects eligibility is also important. We examined control patients from two randomized phase II trials that tested HER2-peptide vaccines to determine the effect of HLA-A2 status and HER2 expression on disease-free survival. The analysis showed that HLA-A2-status does not affect disease-free survival, regardless of HER2 expression suggesting that HLA-A2 negative patients can be used as control patients. Additionally, HER2 over-expression was associated with a better disease-free survival in this population, underscoring the need for additional therapies in HER2 low-expressing breast cancer.

ClinicalTrials.gov Identifier: NCT00524277

正在研究使用基于肽的癌症疫苗的免疫疗法，以评估其在乳腺癌中的潜力。考虑到HLA亚型的限制，很难进行HLA限制性肽疫苗的试验。如果将因HLA状态而不能接受疫苗的患者用作对照，则有必要确定HLA状态在乳腺癌中的预后意义。当靶向肿瘤相关抗原表达影响合格性时，其影响也很重要。我们检查了来自两项随机II期试验的对照患者，这些试验对HER2肽疫苗进行了测试，以确定HLA-A2状态和HER2表达对无病生存的影响。分析表明，HLA-A2-状态不会影响无病生存期，不论HER2表达如何，均提示HLA-A2阴性患者可以用作对照患者。此外，HER2过表达与该人群中更好的无病生存率相关，这突显了在HER2低表达乳腺癌中需要其他疗法的需要。

ClinicalTrials.gov标识符：NCT00524277