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- Title
Chemotherapy vs. chemoimmunotherapy with methanol extraction residue of Bacillus Calmette-Guerin (MER) in advanced breast cancer: a randomized trial by the Piedmont Oncology Association.
- Authors
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.; Muss, H B; Richards, F 2nd; Cooper, M R; White, D R; Jackson, D V; Stuart, J J; Howard, V; Shore, A; Rhyne, A L; Spurr, C L
- Abstract
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 greater than or equal to 3 sites. MER did not enhance response rate, duration of response, or survival. Also MER did not diminish myelosuppression.
- Publication
Cancer (0008543X), 1981, Vol 47, Issue 9, p2295
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/1097-0142(19810501)47:9<2295::AID-CNCR2820470932>3.0.CO;2-8