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Effect of the methanol extraction residue of Bacillus Calmette‐Guerin in advanced Hodgkin's disease
Author(s) -
Cooper M. Robert,
Pajak Thomas F.,
Nissen Nis I.,
Brunner Kurt,
Stutzman Leon,
Bank Arthur,
Falkson Geoffrey,
Barker Barbara E.,
Haurani Farid I.,
Richards Frederick,
Gottlieb Arlan,
Holland James F.
Publication year - 1982
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/1097-0142(19820601)49:11<2226::aid-cncr2820491104>3.0.co;2-r
Subject(s) - medicine , randomization , surgery , chemotherapy , radiation therapy , immunotherapy , stage (stratigraphy) , toxicity , gastroenterology , bcg vaccine , disease , randomized controlled trial , immunology , cancer , vaccination , paleontology , biology
One‐hundred‐ninety‐six patients with Stage III and IV Hodgkin's disease were prospectively randomized to receive either treatment with the methanol extraction residue of Bacillus Calmette‐Guerin (MER/BCG) or no immunotherapy. Prior to the MER/BCG randomization, patients received six courses of induction and two years of maintenance chemotherapy so that a group with a presumptively low tumor burden could be established. Only patients achieving a complete remission were evaluated. During the first two years of immunotherapy, the MER/BCG group had a relapse frequency twice that of controls. The overall crude relapse frequency and disease‐free survival were similar between the two treatment groups. The MER/BCG dose schedule used in this study was associated with a high frequency of unacceptable toxicity. Ulcerations of greater than 1 cm occurred in one‐third of the patients with associated pain, fever, and occasional lymphadenopathy. A high degree of patient noncompliance (36%) was observed. Age ( P = 0.002), prior radiotherapy ( P = 0.032), and chemotherapy ( P = 0.044) were prognostic factors found to significantly influence remission duration. These factors were balanced between patients treated with immunotherapy and those who were not. MER/BCG therapy did not significantly delay or prevent relapse.