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Chemotherapy vs. chemoimmunotherapy with methanol extraction residue of bacillus calmette‐guerin (MER) in advanced breast cancer: A randomized trial by the piedmont oncology association
Author(s) -
Muss Hyman B.,
Richards Frederick,
Cooper M. Robert,
White Douglas R.,
Jackson Don V.,
Stuart John J.,
Howard Virginia,
Shore Anita,
Rhyne A. Leonard,
Spurr Charles L.
Publication year - 1981
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(19810501)47:9<2295::aid-cncr2820470932>3.0.co;2-8
Subject(s) - medicine , chemoimmunotherapy , cyclophosphamide , chemotherapy , vincristine , breast cancer , randomized controlled trial , gastroenterology , methotrexate , oncology , doxorubicin , surgery , cancer
Effects of the addition of MER, a nonspecific, nonviable immunostimulant, to two combination chemotherapy programs were explored in patients with metastatic breast cancer. Patients were randomized to either CDVFP [cyclophosphamide (C), doxorubicin (D), vincristine (V), fluorouracil (F) and prednisone (P)] or CD alternating with methotrexate (M) and F (CD/MF). Each group was also randomized to receive MER, 0.4 mg S.C. every four weeks or no immunotherapy. The response rates were CDVFP 56%, CDVFP + MER 54%, CD/MF 43%, and CD/MF + MER 43%. No significant differences were noted in response rate. Median durations of response and survival were similar for each group: CDVFP 16.2 and 25.2 months, respectively; CDVFP + MER 14.0 and 23.3 months, CD/MF 12.1 and 26.1 months, and CD/MF + MER 15.5 and 25.6 months. Patients who achieved CR frequently had soft‐tissue disease (7/17) and patients with disease in 1 or 2 metastatic sites had a significantly higher response rate than those in ≥3 sites. MER did not enhance response rate, duration of response, or survival. Also MER did not diminish myelosuppression.