Chemotherapy vs. chemoimmunotherapy with methanol extraction residue of bacillus calmette-guerin (MER) in advanced breast cancer: A randomized trial by the piedmont oncology association

✍ Scribed by Hyman B. Muss; Frederick Richards II; M. Robert Cooper; Douglas R. White; Don V. Jackson; John J. Stuart; Virginia Howard; Anita Shore; A. Leonard Rhyne; Charles L. Spurr

• Publisher: John Wiley and Sons
• Year: 1981
• Tongue: English
• Weight: 597 KB
• Volume: 47
• Category: Article
• ISSN: 0008-543X
• DOI: 10.1002/1097-0142(19810501)47:9<2295::aid-cncr2820470932>3.0.co;2-8

✦ Synopsis

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 (CDIMF). 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 CDlMF + 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 CDIMF + 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 2 3 sites. MER did not enhance response rate, duration of response, or survival. Also MER did not diminish myelosuppression.