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A pilot safety trial investigating a vector-based vaccine targeting carcinoembryonic antigen in combination with radiotherapy in patients with gastrointestinal malignancies metastatic to the liver
Open accessAbstract
OBJECTIVE: Previous studies have demonstrated the ability of non-lethal doses of radiation to alter the phenotype of tumor cells to facilitate immune mediated killing. This pilot study evaluated the tolerability of a vector-based vaccine targeting carcinoembryonic antigen (CEA) in combination with radiation therapy in patients with gastrointestinal malignancies metastatic to the liver. METHODS: Patients enrolled had progressive CEA(+) tumors with metastatic liver lesions. Patients had received a median of three previous chemotherapy regimens, with a median of 2 months since their last chemotherapy regimen. Only 58% had metastatic disease limited to the liver. Vaccination commenced day 1 with biweekly boosters and split-course radiation (total 32 Gy) starting on day 21. Blood was collected at baseline and day 91 for immunological analysis. RESULTS/CONCLUSION: A total of 12 patients were enrolled. There were no grade 3 or greater toxicities or grade 2 or greater hepatic toxicities. Median time on-study was 3 months, with the longest time on treatment being 5 months (n = 2). Immunological analysis was limited to two patients; neither showed an increase above baseline in CEA-specific T cells post-therapy. CEA/TRICOM vaccination in combination with low-dose radiation therapy is safe. There was limited evidence of activity in this patient population.
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The CEA/TRICOM vaccine has given some promising results as evidenced in a murine model of colon cancer.
“Interestingly this type of vaccine has given some promising results as evidenced in a murine model of colon cancer [159].”
From Current and Future Trends of Colorectal Cancer Treatment: Exploring Advances in Immunotherapy (2024) · cites this paper as [159]
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“Finally, efforts have been made to combine radiotherapy with vaccination against carcinoembryonic antigen (CEA) combined with GM-CSF in colorectal cancer (163), or against prostate specific antigen (PSA) combined with GM-CSF and IL-2 in patients with prostate cancer (164, 165).”
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Serum CA 19-9 and CEA Levels as a Prognostic Factor in Pancreatic Adenocarcinoma
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Self-citationCarcinoembryonic antigen carrying SLeX as a new biomarker of more aggressive gastric carcinomas
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“Since CEA have been demonstrated as a very promising molecular target in cancer, several clinical trials, mostly using viral vector vaccines, have been developed [60-64].”
BackgroundPoxviral vectors for cancer immunotherapy
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“However, in a small pilot study, where patients with hepatic metastases of GI malignancies were treated with rV/F-CEATRICOM plus radiotherapy to hepatic metastases, no significant clinical benefit was observed [67], primarily because most of the patients were heavily pre-treated with ‡ three prior systemic therapies a…”
BackgroundSelf-citationFloudas, C. S., Brar, G. S., Mabry‐Hrones, D., Duffy, A. G., Wood, B. J., Levy, E. B., Krishnasamy, V. P., Fioravanti, S., Bonilla, C. M., Walker, M., et al. (2019) · Clinical Colorectal Cancer · doi:10.1016/j.clcc.2019.06.004 · Cited by 47
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“Several other studies used CEA vaccination alone or with other epitopes such as MUC-1, with or without radiotherapy and with various platforms, but most patients in those trials did not have PC [23-27].”
BackgroundCurrent and Future Trends of Colorectal Cancer Treatment: Exploring Advances in Immunotherapy
Nikolouzakis, T. K., Chrysos, E., Docea, A. O., Fragkiadaki, P., Souglakos, J., Tsiaoussis, J., & Tsatsakis, A. (2024) · Cancers · doi:10.3390/cancers16111995 · Cited by 37
“POLE-mutated tumors are characterized by certain elements such as infiltration of CD8+ T cells at higher rates, greater expression of cytotoxic markers, and upregulation of immune checkpoints in contrast to POLE wild-type pMMR/MSS tumors.”
ResultAnalyses of Pretherapy Peripheral Immunoscore and Response to Vaccine Therapy
Farsaci, B., Donahue, R. N., Grenga, I., Lepone, L. M., Kim, P. S., Dempsey, B. E., Siebert, J., Ibrahim, N. K., Madan, R. A., Heery, C. R., et al. (2016) · Cancer Immunology Research · doi:10.1158/2326-6066.cir-16-0037 · Cited by 34
Self-citationGarnett‐Benson, C., Hodge, J. W., & Gameiro, S. R. (2014) · Seminars in Radiation Oncology · doi:10.1016/j.semradonc.2014.07.002 · Cited by 32
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Cancer vaccines targeting carcinoembryonic antigen: state-of-the-art and future promise
Gameiro, S. R., Jammeh, M. L., & Hodge, J. W. (2013) · Expert Review of Vaccines · doi:10.1586/erv.13.40 · Cited by 22
Radiation meets immunotherapy – a perfect match in the era of combination therapy?
Soukup, K., & Wang, X. (2015) · International Journal of Radiation Biology · doi:10.3109/09553002.2014.995383 · Cited by 23
“…study was supported by Department of Surgery, Massachusetts General Hospital (X.W.), NIH grant RO3 CA141086 (X.W.), the Austrian Science Funds (FWF) project P23271B11 (K.S.) as well as the PhD program “BioToP – Biomolecular Technology of Proteins” (Austrian Science Funds, FWF project W1224) (K.S.).”
BackgroundBhagat, A., Lyerly, H. K., Morse, M. A., & Hartman, Z. C. (2023) · Human Vaccines & Immunotherapeutics · doi:10.1080/21645515.2023.2291857 · Cited by 12
Malvicini, M., Aquino, J. B., & Mazzolini, G. D. (2015) · Current Gene Therapy · doi:10.2174/1566523214666141224095757 · Cited by 9
“Although the treatment was well tolerated, the low number of patients included precludes reaching a firm conclusion about the efficacy of treatment [120].”
BackgroundColorectal Cancer Immunotherapy: Current State and Prospects (Review)
Kit, O. I., Кириченко, Е. Ю., Novikova, I. A., Maksimov, A. Y., Filippova, S. Y., Grankina, A., & Zlatnik, E. Y. (2017) · Современные технологии в медицине · doi:10.17691/stm2017.9.3.18 · Cited by 5
“It showed high efficiency in mouse colon cancer model and the possibility to be administered safely in patients with metastatic colorectal cancer [56, 57].”
BackgroundAhmadi, R., & Molaei, S. (2015) · Zahedan Journal of Research in Medical Sciences · doi:10.17795/zjrms1281 · Cited by 2
“Enhanced serum CEA levels occur in a large number of epithelial malignancies, including colorectal cancer [4], gastrointestinal malignancies [5], pancreatic and lung adenocarcinoma [6].”
BackgroundBecker, J. T., & McNeel, D. G. (2013) · Journal for ImmunoTherapy of Cancer · doi:10.1186/2051-1426-1-2 · Cited by 2
“While this is the probable case for these patients immunized with PAP-targeted vaccines, immunogenicity and frequency of allelic variation of other vaccine antigens (such as gp100, PSMA, PSA and tyrosinase) may differ greatly from those known presently.”
BackgroundInfluentialPotential Targets and Biomarkers of Radionuclide Therapy in Breast Cancer
Tan, Y., Zeng, C., Wang, J., & Ma, F. (2026) · Cancer Innovation · doi:10.1002/cai2.70043 · Cited by 3
TRICOM Poxviral-Based Vaccines for the Treatment of Cancer
Jochéms, C., Schlom, J., & Gulley, J. L. (2014) · Springer eBooks · doi:10.1007/978-3-7091-1818-4_10 · Cited by 1
Self-citationSadiq, S., Naveed, A. K., Waheed, P., Qaiser, F., & Hashmi, S. N. (2018) · The Professional Medical Journal · doi:10.29309/tpmj/18.4477
Keshavarz‐Fathi, M., & Rezaei, N. (2018) · Elsevier eBooks · doi:10.1016/b978-0-12-814039-0.00013-8
Ahmadi, R., & Molaei, S. (2015) · Zahedan Journal of Research in Medical Sciences · doi:10.5812/zjrms.1281
Metadata
- Authors
- Gulley, J. L., Madan, R. A., Tsang, K.-Y., Arlen, P. M., Camphausen, K., Mohebtash, M., Kamrava, M., Schlom, J., & Citrin, D.
- Affiliations
- National Institutes of Health (US)
- Venue
- Expert Opinion on Biological Therapy
- Publisher
- Informa Healthcare
- Published
- 2011-08-28
- Volume
- 11
- Issue
- 11
- Pages
- 1409-1418
- ISSN
- 1471-2598 (ISSN-L)
- 1744-7682
- PMC
- PMC3513964
- OpenAlex
- W2088478240
- Cited by
- 26
- References
- 52
- Citations by year
- 2026: 1 · 2024: 1 · 2023: 1 · 2021: 1 · 2019: 3 · 2018: 2 · 2017: 1 · 2016: 2 · 2015: 5 · 2014: 2 · 2013: 4 · 2012: 3
- FWCI
- 1.28
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Expert Opinion on Biological Therapy (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health
- National Cancer Institute (Z01BC010945)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Oncology › Cancer Immunotherapy and Biomarkers
- Life Sciences › Biochemistry, Genetics and Molecular Biology › Biotechnology › Bacterial Cancer Therapy
- Keywords
- carcinoembryonic antigen, vector vaccines, low-dose radiotherapy, immunotherapy, gastrointestinal cancer, liver metastasis, vaccine safety, tumor immunology
- MeSH terms
- Adult, Aged, Carcinoembryonic Antigen, Colonic Neoplasms, Fowlpox virus, Genetic Vectors, Humans, Liver Neoplasms, Male, Middle Aged, Pilot Projects, Radiation Dosage, Rectal Neoplasms, Time Factors, United States, Vaccines, Synthetic, Treatment Outcome, Radiotherapy, Adjuvant, Cancer Vaccines, Radiotherapy, Conformal, National Cancer Institute (U.S.)
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