Medical Oncology Branch and Laboratory of Tumor Immunology and Biology, Center for Cancer Research, National Cancer Institute, NIH, Bethesda, Maryland 20892, USA.
Clin Cancer Res. 2011 Nov 15;17(22):7164-73. doi: 10.1158/1078-0432.CCR-11-0649. Epub 2011 Nov 8.
PANVAC is a recombinant poxviral vaccine that contains transgenes for MUC-1, CEA, and 3 T-cell costimulatory molecules. This study was conducted to obtain preliminary evidence of clinical response in metastatic breast and ovarian cancer patients.
Twenty-six patients were enrolled and given monthly vaccinations. Clinical and immune outcomes were evaluated.
These patients were heavily pretreated, with 21 of 26 patients having 3 or more prior chemotherapy regimens. Side effects were largely limited to mild injection-site reactions. For the 12 breast cancer patients enrolled, median time to progression was 2.5 months (1-37+) and median overall survival was 13.7 months. Four patients had stable disease. One patient had a complete response by RECIST and remained on study for 37 months or more, with a significant drop in serum interleukin (IL)-6 and IL-8 by day 71. Another patient with metastatic disease confined to the mediastinum had a 17% reduction in mediastinal mass and was on study for 10 months. Patients with stable or responding disease had fewer prior therapies and lower tumor marker levels than patients with no evidence of response. For the ovarian cancer patients (n = 14), the median time to progression was 2 months (1-6) and median overall survival was 15.0 months. Updated data are presented here for one patient treated with this vaccine in a previous trial, with a time to progression of 38 months.
Some patients who had limited tumor burden with minimal prior chemotherapy seemed to benefit from the vaccine. Further studies to confirm these results are warranted.
PANVAC 是一种重组痘病毒疫苗，包含 MUC-1、CEA 和 3 种 T 细胞共刺激分子的转基因。本研究旨在获得转移性乳腺癌和卵巢癌患者临床应答的初步证据。
招募了 26 名患者并每月进行疫苗接种。评估了临床和免疫结果。
这些患者接受了大量的预处理，26 名患者中有 21 名患者接受了 3 种或更多的化疗方案。副作用主要限于轻度注射部位反应。在招募的 12 名乳腺癌患者中，中位无进展时间为 2.5 个月（1-37+），中位总生存期为 13.7 个月。4 名患者疾病稳定。1 名患者通过 RECIST 达到完全缓解，持续研究 37 个月或更长时间，第 71 天血清白细胞介素（IL）-6 和 IL-8 显著下降。另一名患有纵隔内转移性疾病的患者纵隔肿块减少了 17%，并接受了 10 个月的研究。疾病稳定或有反应的患者与无反应的患者相比，接受的治疗次数更少，肿瘤标志物水平更低。对于 14 名卵巢癌患者，中位无进展时间为 2 个月（1-6），中位总生存期为 15.0 个月。这里介绍了一名在之前试验中接受这种疫苗治疗的患者的更新数据，无进展时间为 38 个月。
一些肿瘤负担有限且接受过最少化疗的患者似乎从疫苗中受益。需要进一步的研究来证实这些结果。
