{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T20:04:31Z","timestamp":1791057871698,"version":"4.1.0"},"reference-count":21,"publisher":"American Society of Clinical Oncology (ASCO)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JCO"],"published-print":{"date-parts":[[2000,1,1]]},"abstract":"<jats:p>PURPOSE: A randomized phase III clinical trial of adjuvant active specific immunotherapy (ASI) with an autologous tumor cell\u2013bacillus Calmette-Gu\u00e9rin (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.<\/jats:p>\n                  <jats:p>\n                    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\n                    <jats:sup>7<\/jats:sup>\n                    irradiated autologous tumor cells beginning approximately 4 weeks after surgery. The first two weekly injections also contained 10\n                    <jats:sup>7<\/jats:sup>\n                    BCG organisms. Patients were observed for determination of time to recurrence and disease-free and overall survival.\n                  <\/jats:p>\n                  <jats:p>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 \u22655 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.<\/jats:p>\n                  <jats:p>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.<\/jats:p>","DOI":"10.1200\/jco.2000.18.1.148","type":"journal-article","created":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T04:21:04Z","timestamp":1487910064000},"page":"148-148","source":"Crossref","is-referenced-by-count":226,"title":["Adjuvant Active  Specific Immunotherapy for Stage II  and III Colon Cancer With an Autologous Tumor Cell Vaccine: Eastern  Cooperative Oncology Group Study  E5283"],"prefix":"10.1200","volume":"18","author":[{"given":"Jules E.","family":"Harris","sequence":"first","affiliation":[{"name":"From  the Rush-Presbyterian-St. Luke\u2019s Medical Center; Northwestern University  School of MedicineChicago, IL; Dana-Farber Cancer Institute, Boston, MA;  Lehigh Valley Hospital, Allentown, PA; Medical University of South Carolina,  Charleston, SC; University of Minnesota, Minneapolis, MN; Case Western Reserve  University MetroHealth Medical Center, Cleveland, OH; University of  Pennsylvania, Philadelphia, PA; and Intracel Corporation, Rockville,  MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Louise","family":"Ryan","sequence":"additional","affiliation":[{"name":"From  the Rush-Presbyterian-St. Luke\u2019s Medical Center; Northwestern University  School of MedicineChicago, IL; Dana-Farber Cancer Institute, Boston, MA;  Lehigh Valley Hospital, Allentown, PA; Medical University of South Carolina,  Charleston, SC; University of Minnesota, Minneapolis, MN; Case Western Reserve  University MetroHealth Medical Center, Cleveland, OH; University of  Pennsylvania, Philadelphia, PA; and Intracel Corporation, Rockville,  MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Herbert C.","family":"Hoover","sequence":"additional","affiliation":[{"name":"From  the Rush-Presbyterian-St. Luke\u2019s Medical Center; Northwestern University  School of MedicineChicago, IL; Dana-Farber Cancer Institute, Boston, MA;  Lehigh Valley Hospital, Allentown, PA; Medical University of South Carolina,  Charleston, SC; University of Minnesota, Minneapolis, MN; Case Western Reserve  University MetroHealth Medical Center, Cleveland, OH; University of  Pennsylvania, Philadelphia, PA; and Intracel Corporation, Rockville,  MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert K.","family":"Stuart","sequence":"additional","affiliation":[{"name":"From  the Rush-Presbyterian-St. Luke\u2019s Medical Center; Northwestern University  School of MedicineChicago, IL; Dana-Farber Cancer Institute, Boston, MA;  Lehigh Valley Hospital, Allentown, PA; Medical University of South Carolina,  Charleston, SC; University of Minnesota, Minneapolis, MN; Case Western Reserve  University MetroHealth Medical Center, Cleveland, OH; University of  Pennsylvania, Philadelphia, PA; and Intracel Corporation, Rockville,  MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin M.","family":"Oken","sequence":"additional","affiliation":[{"name":"From  the Rush-Presbyterian-St. Luke\u2019s Medical Center; Northwestern University  School of MedicineChicago, IL; Dana-Farber Cancer Institute, Boston, MA;  Lehigh Valley Hospital, Allentown, PA; Medical University of South Carolina,  Charleston, SC; University of Minnesota, Minneapolis, MN; Case Western Reserve  University MetroHealth Medical Center, Cleveland, OH; University of  Pennsylvania, Philadelphia, PA; and Intracel Corporation, Rockville,  MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"III","given":"Al B.","family":"Benson","sequence":"additional","affiliation":[{"name":"From  the Rush-Presbyterian-St. Luke\u2019s Medical Center; Northwestern University  School of MedicineChicago, IL; Dana-Farber Cancer Institute, Boston, MA;  Lehigh Valley Hospital, Allentown, PA; Medical University of South Carolina,  Charleston, SC; University of Minnesota, Minneapolis, MN; Case Western Reserve  University MetroHealth Medical Center, Cleveland, OH; University of  Pennsylvania, Philadelphia, PA; and Intracel Corporation, Rockville,  MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward","family":"Mansour","sequence":"additional","affiliation":[{"name":"From  the Rush-Presbyterian-St. Luke\u2019s Medical Center; Northwestern University  School of MedicineChicago, IL; Dana-Farber Cancer Institute, Boston, MA;  Lehigh Valley Hospital, Allentown, PA; Medical University of South Carolina,  Charleston, SC; University of Minnesota, Minneapolis, MN; Case Western Reserve  University MetroHealth Medical Center, Cleveland, OH; University of  Pennsylvania, Philadelphia, PA; and Intracel Corporation, Rockville,  MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel G.","family":"Haller","sequence":"additional","affiliation":[{"name":"From  the Rush-Presbyterian-St. Luke\u2019s Medical Center; Northwestern University  School of MedicineChicago, IL; Dana-Farber Cancer Institute, Boston, MA;  Lehigh Valley Hospital, Allentown, PA; Medical University of South Carolina,  Charleston, SC; University of Minnesota, Minneapolis, MN; Case Western Reserve  University MetroHealth Medical Center, Cleveland, OH; University of  Pennsylvania, Philadelphia, PA; and Intracel Corporation, Rockville,  MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Judith","family":"Manola","sequence":"additional","affiliation":[{"name":"From  the Rush-Presbyterian-St. Luke\u2019s Medical Center; Northwestern University  School of MedicineChicago, IL; Dana-Farber Cancer Institute, Boston, MA;  Lehigh Valley Hospital, Allentown, PA; Medical University of South Carolina,  Charleston, SC; University of Minnesota, Minneapolis, MN; Case Western Reserve  University MetroHealth Medical Center, Cleveland, OH; University of  Pennsylvania, Philadelphia, PA; and Intracel Corporation, Rockville,  MD."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"Jr","given":"Michael G.","family":"Hanna","sequence":"additional","affiliation":[{"name":"From  the Rush-Presbyterian-St. Luke\u2019s Medical Center; Northwestern University  School of MedicineChicago, IL; Dana-Farber Cancer Institute, Boston, MA;  Lehigh Valley Hospital, Allentown, PA; Medical University of South Carolina,  Charleston, SC; University of Minnesota, Minneapolis, MN; Case Western Reserve  University MetroHealth Medical Center, Cleveland, OH; University of  Pennsylvania, Philadelphia, PA; and Intracel Corporation, Rockville,  MD."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"233","reference":[{"key":"R1-0005","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(197812)42:6<2613::AID-CNCR2820420617>3.0.CO;2-K"},{"key":"R2-0005","doi-asserted-by":"crossref","unstructured":"Hanna   MG Jr,   Brandhorst   JS,   Peters   LC:   Active-specific  immunotherapy of residual micrometastases:  An  evaluation of sources, doses and ratios of BCG with tumor cells.  Cancer Immunol Immunother 7:160,1979-173,","DOI":"10.1007\/BF00199194"},{"key":"R3-0005","doi-asserted-by":"crossref","unstructured":"Peters   LC,   Hanna   MG Jr:   Active-specific immunotherapy  of established metastases:  Effect of  cryopreservation procedures on tumor cell immunogenicity in guinea pigs.  J Natl Cancer Inst 64:521,1980-1525,","DOI":"10.1093\/jnci\/64.6.1521"},{"key":"R4-0005","unstructured":"Peters   LC,   Brandhorst   JS,   Hanna   MG Jr:   Preparation of  immunotherapeutic autologous tumor cell vaccines from solid tumors.   Cancer Res 39:1353,1979-1360,"},{"key":"R5-0005","doi-asserted-by":"publisher","DOI":"10.1016\/0022-4804(81)90180-3"},{"key":"R6-0005","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19850315)55:6<1236::AID-CNCR2820550616>3.0.CO;2-#"},{"key":"R7-0005","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1993.11.3.390"},{"key":"R8-0005","doi-asserted-by":"crossref","unstructured":"Harris   JE,   Ryan   L,   Benson   A, et al:   Results of the ECOG trial of autologous  colon carcinoma vaccine.  J Immunother 14:358,1993","DOI":"10.1097\/00002371-199311000-00021"},{"key":"R9-0005","unstructured":"Harris   JE,   Ryan   L,   Adams   G, et al:   Survival and relapse in adjuvant  autologous tumor vaccine therapy for Dukes B and C colon cancer:   EST 5283. Proc  Am Soc Clin Oncol 13:295a,1994  (abstr)"},{"key":"R10-0005","doi-asserted-by":"publisher","DOI":"10.1126\/science.6283635"},{"key":"R11-0005","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1958.10501452"},{"key":"R12-0005","doi-asserted-by":"publisher","DOI":"10.2307\/2344317"},{"key":"R13-0005","doi-asserted-by":"publisher","DOI":"10.2307\/2530927"},{"key":"R14-0005","unstructured":"Hoover   HC Jr,   Surdyke   M,   Dangel   RB, et al:   Delayed cutaneous hypersensitivity to  autologous tumor cells in colorectal cancer patients immunized with an  autologous tumor cell:  Bacillus  Calmette-Gu\u00e9rin vaccine. Cancer Res 44:1671,1984-1676,"},{"key":"R15-0005","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19880315)61:6<1065::AID-CNCR2820610602>3.0.CO;2-L"},{"key":"R16-0005","doi-asserted-by":"publisher","DOI":"10.1007\/BF01741726"},{"key":"R17-0005","unstructured":"Adler   A,   Gillon   G,   Hedwig   L, et al:   Active specific immunotherapy of renal  cell carcinoma patients:  A prospective randomized  study of hormono-immuno-versus hormonotherapy\u2014Preliminary report of  immunological and clinical aspects. Biol  Res Mod 6:610,1987-624,"},{"key":"R18-0005","doi-asserted-by":"publisher","DOI":"10.1200\/JCO.1990.8.11.1858"},{"key":"R20-0005","doi-asserted-by":"publisher","DOI":"10.1182\/blood.V89.9.3129"},{"key":"R21-0005","doi-asserted-by":"publisher","DOI":"10.1097\/00000658-199210000-00010"},{"key":"R22-0005","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(98)07186-4"}],"container-title":["Journal of Clinical Oncology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/ascopubs.org\/doi\/pdfdirect\/10.1200\/JCO.2000.18.1.148","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,5,25]],"date-time":"2022-05-25T17:59:57Z","timestamp":1653501597000},"score":1,"resource":{"primary":{"URL":"https:\/\/ascopubs.org\/doi\/10.1200\/JCO.2000.18.1.148"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2000,1,1]]},"references-count":21,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2000,1,1]]}},"alternative-id":["10.1200\/JCO.2000.18.1.148"],"URL":"https:\/\/doi.org\/10.1200\/jco.2000.18.1.148","relation":{},"ISSN":["0732-183X","1527-7755"],"issn-type":[{"value":"0732-183X","type":"print"},{"value":"1527-7755","type":"electronic"}],"subject":[],"published":{"date-parts":[[2000,1,1]]}}}