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A randomized phase II study of immunization with dendritic cells modified with poxvectors encoding CEA and MUC1 compared with the same poxvectors plus GM-CSF for resected metastatic colorectal cancer.

Publication ,  Journal Article
Morse, MA; Niedzwiecki, D; Marshall, JL; Garrett, C; Chang, DZ; Aklilu, M; Crocenzi, TS; Cole, DJ; Dessureault, S; Hobeika, AC; Osada, T ...
Published in: Ann Surg
December 2013

OBJECTIVE: To determine whether 1 of 2 vaccines based on dendritic cells (DCs) and poxvectors encoding CEA (carcinoembryonic antigen) and MUC1 (PANVAC) would lengthen survival in patients with resected metastases of colorectal cancer (CRC). BACKGROUND: Recurrences after complete resections of metastatic CRC remain frequent. Immune responses to CRC are associated with fewer recurrences, suggesting a role for cancer vaccines as adjuvant therapy. Both DCs and poxvectors are potent stimulators of immune responses against cancer antigens. METHODS: Patients, disease-free after CRC metastasectomy and perioperative chemotherapy (n = 74), were randomized to injections of autologous DCs modified with PANVAC (DC/PANVAC) or PANVAC with per injection GM-CSF (granulocyte-macrophage colony-stimulating factor). Endpoints were recurrence-free survival overall survival, and rate of CEA-specific immune responses. Clinical outcome was compared with that of an unvaccinated, contemporary group of patients who had undergone CRC metastasectomy, received similar perioperative therapy, and would have otherwise been eligible for the study. RESULTS: Recurrence-free survival at 2 years was similar (47% and 55% for DC/PANVAC and PANVAC/GM-CSF, respectively) (χ P = 0.48). At a median follow-up of 35.7 months, there were 2 of 37 deaths in the DC/PANVAC arm and 5 of 37 deaths in the PANVAC/GM-CSF arm. The rate and magnitude of T-cell responses against CEA was statistically similar between study arms. As a group, vaccinated patients had superior survival compared with the contemporary unvaccinated group. CONCLUSIONS: Both DC and poxvector vaccines have similar activity. Survival was longer for vaccinated patients than for a contemporary unvaccinated group, suggesting that a randomized trial of poxvector vaccinations compared with standard follow-up after metastasectomy is warranted. (NCT00103142).

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Published In

Ann Surg

DOI

EISSN

1528-1140

Publication Date

December 2013

Volume

258

Issue

6

Start / End Page

879 / 886

Location

United States

Related Subject Headings

  • Surgery
  • Poxviridae
  • Neoplasm Recurrence, Local
  • Neoplasm Metastasis
  • Mucin-1
  • Middle Aged
  • Membrane Glycoproteins
  • Male
  • Immunization
  • Humans
 

Citation

APA
Chicago
ICMJE
MLA
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Morse, M. A., Niedzwiecki, D., Marshall, J. L., Garrett, C., Chang, D. Z., Aklilu, M., … Lyerly, H. K. (2013). A randomized phase II study of immunization with dendritic cells modified with poxvectors encoding CEA and MUC1 compared with the same poxvectors plus GM-CSF for resected metastatic colorectal cancer. Ann Surg, 258(6), 879–886. https://doi.org/10.1097/SLA.0b013e318292919e
Morse, Michael A., Donna Niedzwiecki, John L. Marshall, Christopher Garrett, David Z. Chang, Mebea Aklilu, Todd S. Crocenzi, et al. “A randomized phase II study of immunization with dendritic cells modified with poxvectors encoding CEA and MUC1 compared with the same poxvectors plus GM-CSF for resected metastatic colorectal cancer.Ann Surg 258, no. 6 (December 2013): 879–86. https://doi.org/10.1097/SLA.0b013e318292919e.
Morse MA, Niedzwiecki D, Marshall JL, Garrett C, Chang DZ, Aklilu M, Crocenzi TS, Cole DJ, Dessureault S, Hobeika AC, Osada T, Onaitis M, Clary BM, Hsu D, Devi GR, Bulusu A, Annechiarico RP, Chadaram V, Clay TM, Lyerly HK. A randomized phase II study of immunization with dendritic cells modified with poxvectors encoding CEA and MUC1 compared with the same poxvectors plus GM-CSF for resected metastatic colorectal cancer. Ann Surg. 2013 Dec;258(6):879–886.

Published In

Ann Surg

DOI

EISSN

1528-1140

Publication Date

December 2013

Volume

258

Issue

6

Start / End Page

879 / 886

Location

United States

Related Subject Headings

  • Surgery
  • Poxviridae
  • Neoplasm Recurrence, Local
  • Neoplasm Metastasis
  • Mucin-1
  • Middle Aged
  • Membrane Glycoproteins
  • Male
  • Immunization
  • Humans