{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,18]],"date-time":"2026-10-18T00:15:18Z","timestamp":1792282518384,"version":"4.4.0"},"reference-count":16,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2004,3,18]],"date-time":"2004-03-18T00:00:00Z","timestamp":1079568000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancer"],"published-print":{"date-parts":[[2004,4,15]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>BACKGROUND<\/jats:title><jats:p>The local and systemic effects of bacillus Calmette\u2013Guerin (BCG) have been known for decades. To investigate the adjuvant effect of BCG on resected American Joint Committee on Cancer (AJCC) Stage I\u2013III melanoma, the Eastern Cooperative Oncology Group conducted a large trial to study the use of BCG alone or a combination of BCG and dacarbazine between 1974 and 1978.<\/jats:p><\/jats:sec><jats:sec><jats:title>METHODS<\/jats:title><jats:p>A total of 734 patients were randomized to 4 clinical groups consolidated into 2 cohorts. Cohort I compared BCG with observation and Cohort II compared BCG with a combination of BCG and dacarbazine. The primary end points were survival time and time to disease progression.<\/jats:p><\/jats:sec><jats:sec><jats:title>RESULTS<\/jats:title><jats:p>Within Cohort I, no statistically significant difference in disease\u2010free survival (DFS) (<jats:italic>P<\/jats:italic> = 0.84) or overall survival (OS) (5\u2010year survival 67% vs. 62%; <jats:italic>P<\/jats:italic> = 0.40) was observed between BCG treatment and observation. Within Cohort II, the addition of dacarbazine to BCG did not improve DFS (<jats:italic>P<\/jats:italic> = 0.74) or OS (<jats:italic>P<\/jats:italic> = 0.81) compared with BCG alone. Toxicity was mild to moderate in both cohorts. Although toxicity with this agent is mild, the use of BCG is associated with the development of punctate abscesses in greater than two\u2010thirds of patients treated.<\/jats:p><\/jats:sec><jats:sec><jats:title>CONCLUSIONS<\/jats:title><jats:p>In what to our knowledge is the largest ever trial to test the role of BCG as adjuvant therapy for melanoma, no benefit for BCG was observed for patients with AJCC Stage I\u2013III disease. The mature results of the current trial projected to 30 years confirmed the negative results of previous smaller studies utilizing this agent. Cancer 2004. \u00a9 2004 American Cancer Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/cncr.20166","type":"journal-article","created":{"date-parts":[[2004,3,30]],"date-time":"2004-03-30T19:02:13Z","timestamp":1080673333000},"page":"1692-1698","source":"Crossref","is-referenced-by-count":89,"title":["Mature results of a phase III randomized trial of bacillus Calmette\u2013Guerin (BCG) versus observation and BCG plus dacarbazine versus BCG in the adjuvant therapy of American Joint Committee on Cancer Stage I\u2013III melanoma (E1673)"],"prefix":"10.1002","volume":"100","author":[{"given":"Sanjiv S.","family":"Agarwala","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Donna","family":"Neuberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuhyun","family":"Park","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John M.","family":"Kirkwood","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2004,3,18]]},"reference":[{"key":"e_1_2_5_2_2","first-page":"233","article-title":"Demonstration of antibodies against human malignant melanoma by immunofluorescence","volume":"64","author":"Morton DL","year":"1968","journal-title":"Surgery"},{"key":"e_1_2_5_3_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(73)90526-6"},{"key":"e_1_2_5_4_2","doi-asserted-by":"publisher","DOI":"10.1097\/00000658-197410000-00029"},{"key":"e_1_2_5_5_2","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19850215)55:4<707::AID-CNCR2820550406>3.0.CO;2-5"},{"key":"e_1_2_5_6_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0039-6109(16)42582-X"},{"key":"e_1_2_5_7_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM198210073071503"},{"key":"e_1_2_5_8_2","first-page":"677","article-title":"Randomized trial of adjuvant therapy for \u201chigh\u2010risk\u201d primary malignant melanoma","volume":"83","author":"Wood WC","year":"1978","journal-title":"Surgery"},{"key":"e_1_2_5_9_2","first-page":"459","article-title":"Intralymphatic and regional surgical adjuvant immunotherapy in high\u2010risk melanoma of the extremities","volume":"92","author":"Ariyan S","year":"1982","journal-title":"Surgery"},{"key":"e_1_2_5_10_2","doi-asserted-by":"publisher","DOI":"10.1080\/01621459.1958.10501452"},{"key":"e_1_2_5_11_2","doi-asserted-by":"crossref","first-page":"187","DOI":"10.1111\/j.2517-6161.1972.tb00899.x","article-title":"Regression models and life tables","volume":"74","author":"Cox DR","year":"1972","journal-title":"J R Stat Soc B"},{"key":"e_1_2_5_12_2","first-page":"1","article-title":"Scientific basis for adjuvant and primary (neoadjuvant) chemotherapy","volume":"14","author":"Goldie JH","year":"1987","journal-title":"Semin Oncol"},{"key":"e_1_2_5_13_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0025-7125(16)31893-4"},{"key":"e_1_2_5_14_2","doi-asserted-by":"publisher","DOI":"10.1002\/1097-0142(19950115)75:2 <726::AID-CNCR2820751417>3.0.CO;2-R"},{"key":"e_1_2_5_15_2","doi-asserted-by":"publisher","DOI":"10.1007\/BF00205238"},{"key":"e_1_2_5_16_2","first-page":"605","volume-title":"Cutaneous melanoma","author":"Agarwala S","year":"2003"},{"key":"e_1_2_5_17_2","first-page":"S81","article-title":"An assessment of DTIC versus levamisole or placebo in the treatment of high risk stage I patients after surgical removal of a primary melanoma of the skin. A phase II adjuvant study (EORTC protocol 18761)","volume":"24","author":"Lejeune FJ","year":"1988","journal-title":"Eur J Cancer"}],"container-title":["Cancer"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fcncr.20166","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cncr.20166","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,12]],"date-time":"2025-10-12T10:59:52Z","timestamp":1760266792000},"score":1,"resource":{"primary":{"URL":"https:\/\/acsjournals.onlinelibrary.wiley.com\/doi\/10.1002\/cncr.20166"}},"subtitle":["A trial of the Eastern Cooperative Oncology Group"],"short-title":[],"issued":{"date-parts":[[2004,3,18]]},"references-count":16,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2004,4,15]]}},"alternative-id":["10.1002\/cncr.20166"],"URL":"https:\/\/doi.org\/10.1002\/cncr.20166","archive":["Portico"],"relation":{},"ISSN":["0008-543X","1097-0142"],"issn-type":[{"value":"0008-543X","type":"print"},{"value":"1097-0142","type":"electronic"}],"subject":[],"published":{"date-parts":[[2004,3,18]]}}}