Adjuvant active specific immunotherapy for stage II and III colon cancer with an autologous tumor cell vaccine: Eastern Cooperative Oncology Group study E5283
Abstract
PURPOSE: A randomized phase III clinical trial of adjuvant active specific immunotherapy (ASI) with an autologous tumor cell–bacillus Calmette-Guérin (BCG) vaccine was conducted to determine whether surgical resection plus ASI was more beneficial than resection alone in stage II and III colon cancer patients. PATIENTS AND METHODS: Patients (n = 412) with colon cancer (297 with stage II disease, 115 with stage III disease) were randomly allocated to an observation arm or to a treatment arm in which they received three weekly intradermal vaccine injections of 10 7 irradiated autologous tumor cells beginning approximately 4 weeks after surgery. The first two weekly injections also contained 10 7 BCG organisms. Patients were observed for determination of time to recurrence and disease-free and overall survival. RESULTS: This was a negative study in that after a 7.6-year median follow-up period, there were no statistically significant differences in clinical outcomes between the treatment arms. However, there were disease-free survival (P = .078) and overall survival (P = .12) trends in favor of ASI when treatment compliance was evaluated, ie, patients who received the intended treatment had a delayed cutaneous hypersensitivity (DCH) response to the third vaccination (induration ≥5 mm). Also, the magnitude of the DCH response correlated with improved prognosis. The 5-year survival proportion was 84.6% for those with indurations greater than 10 mm, compared with 45.0% for those with indurations less than 5 mm. CONCLUSIONS: When all randomized patients were evaluated, no significant clinical benefit was seen with ASI in surgically resected colon cancer patients with stage II or III colon cancer. However, there was an indication that treatment compliance with effective immunization results in disease-free and overall survival benefits.
Integrity signals
Registry
Cites
Statistics
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
Current evidence suggests limited efficacy of whole tumor vaccines.
“current evidence suggests limited efficacy”
From Current and Future Trends of Colorectal Cancer Treatment: Exploring Advances in Immunotherapy (2024) · cites this paper as [147]
In a phase III randomized clinical trial in CRC, patients with stage II and III CRC administered autologous whole cancer cells combined with a BCG vaccine did not demonstrate a significant benefit in overall survival or disease-free survival compared with resection.
“in CRC, a phase III randomized clinical trial was conducted, where patients with stage II and III CRC were administered autologous whole cancer cells that were combined with a BCG vaccine. This trial aimed to assess whether surgical resection coupled with vaccination was superior to resection. However, the study failed to demonstrate a significant benefit in terms of OS or disease-free survival (D”
From Current and Future Trends of Colorectal Cancer Treatment: Exploring Advances in Immunotherapy (2024) · cites this paper as [147]
Cites
Nonparametric Estimation from Incomplete Observations
Kaplan, E. L., & Meier, P. (1958) · Journal of the American Statistical Association · doi:10.1080/01621459.1958.10501452 · Cited by 39,158 · see citing works
Asymptotically Efficient Rank Invariant Test Procedures
Peto, R., & Peto, J. (1972) · Journal of the Royal Statistical Society. Series A (General) · doi:10.2307/2344317 · Cited by 3,393 · see citing works
Active specific immunotherapy for stage II and stage III human colon cancer: a randomised trial
Vermorken, J. B., Claessen, A. M. E., van Tinteren, H., Gall, H. E., Ezinga, R., Meijer, S., Scheper, R. J., Meijer, C. J. L. M., Bloemena, E., Ransom, J. H., et al. (1999) · The Lancet · doi:10.1016/s0140-6736(98)07186-4 · Cited by 504 · see citing works
Self-citationHsu, F. J., Caspar, C. B., Czerwinski, D. K., et al. (1997) · Blood · doi:10.1182/blood.v89.9.3129 · Cited by 457 · see citing works
Morton, D. L., Foshag, L. J., Hoon, D. S. �., et al. (1992) · Annals of Surgery · doi:10.1097/00000658-199210000-00010 · Cited by 405 · see citing works
Exact Significance Testing to Establish Treatment Equivalence with Ordered Categorical Data
Mehta, C. R., Patel, N. R., & Tsiatis, A. A. (1984) · Biometrics · doi:10.2307/2530927 · Cited by 333 · see citing works
Postradiation osteogenic sarcoma of bone and soft tissues. A clinicopathologic study of 66 patients
Huvos, A. G., WOODARD, H. Q., Cahan, W. G., Higinbotham, N. L., Stewart, F. W., Butler, A., & Bretsky, S. S. (1985) · Cancer · doi:10.1002/1097-0142(19850315)55:6 · Cited by 325 · see citing works
Berd, D., Maguire, H. C., Jr., McCue, P. A., et al. (1990) · Journal of Clinical Oncology · doi:10.1200/jco.1990.8.11.1858 · Cited by 300 · see citing works
Hoover, H. C., Brandhorst, J. S., Peters, L. C., Surdyke, M. G., Takeshita, Y., Madariaga, J., Muenz, L. R., & Hanna, M. G. (1993) · Journal of Clinical Oncology · doi:10.1200/jco.1993.11.3.390 · Cited by 259 · see citing works
Self-citationMcCune, C. S., O’Donnell, R., Marquis, D. M., et al. (1990) · Cancer Immunology Immunotherapy · doi:10.1007/bf01741726 · Cited by 103 · see citing works
Hoover, H. C., Surdyke, M. G., Dangel, R. B., et al. (1984) · PubMed · Cited by 96 · see citing works
Self-citationPreparation of immunotherapeutic autologous tumor cell vaccines from solid tumors.
Peters, L. C., Brandhorst, J. S., & Hanna, M. G. (1979) · PubMed · Cited by 94 · see citing works
Self-citationPeripheral amino acid levels in patients with cancer
Clarke, E. F., Lewis, A. M., & Waterhouse, C. (1978) · Cancer · doi:10.1002/1097-0142(197812)42:6 · Cited by 85 · see citing works
Immunotherapy of Metastases Enhances Subsequent Chemotherapy
Hanna, M. G., & Key, M. E. (1982) · Science · doi:10.1126/science.6283635 · Cited by 54 · see citing works
Self-citationActive specific immunotherapy of residual micrometastasis
Hanna, M. G., Brandhorst, J. S., & Peters, L. C. (1979) · Cancer Immunology Immunotherapy · doi:10.1007/bf00199194 · Cited by 54 · see citing works
Self-citationAdler, A. G., GILLON, G., Lurie, H., et al. (1987) · PubMed · Cited by 37 · see citing works
Peters, L. C., & Hanna, M. G. (1980) · JNCI Journal of the National Cancer Institute · doi:10.1093/jnci/64.6.1521 · Cited by 31 · see citing works
Self-citationTherapy of spontaneous metastases with an autologous tumor vaccine in a guinea pig model
Hoover, H. C., Peters, L. C., Brandhorst, J. S., et al. (1981) · Journal of Surgical Research · doi:10.1016/0022-4804(81)90180-3 · Cited by 24 · see citing works
Self-citationRESULTS OF THE ECOG TRIAL OF AUTOLOGOUS COLON CARCINOMA VACCINE
Harris, J. E., RYAN, L. M., Adams, G. W., et al. (1993) · Journal of Immunotherapy · doi:10.1097/00002371-199311000-00021 · Cited by 4 · see citing works
Self-citation
Flagged first, then by citations
Cited by
Sorted by citations
Immunotherapy in colorectal cancer: Rationale, challenges and potential
Ganesh, K., Stadler, Z. K., Cercek, A., Mendelsohn, R. B., Shia, J., Segal, N. H., & Diaz, L. A. (2019) · Nature Reviews Gastroenterology & Hepatology · doi:10.1038/s41575-019-0126-x · Cited by 1,954 · see citing works
Colorectal cancer and immunity: What we know and perspectives
Pernot, S. (2014) · World Journal of Gastroenterology · doi:10.3748/wjg.v20.i14.3738 · Cited by 131 · see citing works
Evolution of Cancer Vaccines—Challenges, Achievements, and Future Directions
Tay, B. Q., Wright, Q., Ladwa, R., Perry, C., Leggatt, G., Simpson, F., Wells, J. W., Panizza, B. J., Frazer, I. H., & Cruz, J. L. G. (2021) · Vaccines · doi:10.3390/vaccines9050535 · Cited by 76 · see citing works
Current 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 · see citing works
- Authors
- Harris, J. E., Ryan, L., Hoover, H. C., Stuart, R. K., Oken, M. M., Benson, A. B., Mansour, E., Haller, D. G., Manola, J., & Hanna, M. G.
- Affiliations
- University of Minnesota (US)
- Venue
- Journal of Clinical Oncology
- Published
- 2000-01-01
- Volume
- 18
- Issue
- 1
- Pages
- 148-148
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W1940904684
- Cited by
- 273
- References
- 20
- Citations by year
- 2026: 3 · 2025: 8 · 2024: 7 · 2023: 8 · 2022: 7 · 2021: 11 · 2020: 8 · 2019: 8 · 2018: 10 · 2017: 4 · 2016: 11 · 2015: 11 · 2014: 7 · 2013: 8 · 2012: 7
- FWCI
- 7.54
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Journal of Clinical Oncology (publishedVersion)
- PubMed (publishedVersion)
- Funders
- National Institutes of Health (2u10ca020365-12, 2u10ca025988-16)
- National Cancer Institute (CA-23318, CA 25988, U10CA023318, CA 20365)
- Topics
- Life Sciences › Immunology and Microbiology › Immunology › Immunotherapy and Immune Responses
- Health Sciences › Medicine › Oncology › Colorectal Cancer Treatments and Studies
- Health Sciences › Medicine › Oncology › Colorectal Cancer Surgical Treatments
- Keywords
- colon cancer, adjuvant immunotherapy, active specific immunotherapy, autologous tumor cell vaccine, BCG vaccine, stage II colon cancer, stage III colon cancer, surgical resection, delayed cutaneous hypersensitivity, medication adherence, disease-free survival, overall survival, time to recurrence
- MeSH terms
- Adjuvants, Immunologic, Adult, Aged, Aged, 80 and over, BCG Vaccine, Colonic Neoplasms, Female, Humans, Male, Middle Aged, United States, Survival Rate, Disease-Free Survival, Cancer Vaccines
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
