Journal of Clinical Oncology, Vol 15, 2302-2311, Copyright © 1997 by American Society of Clinical Oncology
Randomized trial of cyclophosphamide, methotrexate, and fluorouracil chemotherapy added to tamoxifen as adjuvant therapy in postmenopausal women with node-positive estrogen and/or progesterone receptor-positive breast cancer: a report of the National Cancer Institute of Canada Clinical Trials Group. Breast Cancer Site Group
KI Pritchard, AH Paterson, S Fine, NA Paul, B Zee, LE Shepherd, H Abu-Zahra, J Ragaz, M Knowling, MN Levine, S Verma, D Perrault, PL Walde, VH Bramwell, M Poljicak, N Boyd, D Warr, BD Norris, D Bowman, GR Armitage, H Weizel and RA Buckman
Toronto-Sunnybrook Regional Cancer Centre, University of Toronto, Ontario, Canada. kathy_pritchard@octrf.on.ca
PURPOSE AND METHODS: By the mid 1980s, tamoxifen alone was considered
standard adjuvant therapy for postmenopausal women with node-positive,
estrogen receptor (ER)- or progesterone receptor (PgR)-positive breast
cancer. From 1984 through 1990, 705 eligible postmenopausal women with
node-positive, ER- or PgR-positive breast cancer were randomized to a
National Cancer Institute of Canada Clinical Trials Group (NCIC CTG) study
that compared tamoxifen 30 mg by mouth daily for 2 years (TAM) versus TAM
plus chemotherapy with all-intravenous cyclophosphamide 600 mg/m2,
methotrexate 40 mg/m2, and fluorouracil 600 mg/m2 given every 21 days for
eight cycles (CMF). RESULTS: There were no significant differences in
overall survival, recurrence-free survival, locoregional recurrence-free
survival, or distant recurrence-free survival between the two treatment
arms. However, there was significantly greater severe toxicity, which
included leukopenia (P < .0001), nausea and vomiting (P < .0001), and
thromboembolic events (P < .0001), as well as significantly more mild or
greater toxicity, which included thrombocytopenia (P = .04), anemia (P =
.02), infection (P = .0004), mucositis (P = .0001), diarrhea (P = .0001),
and neurologic toxicity (P = .006), in women who received TAM plus CMF.
CONCLUSION: The addition of CMF to TAM adds no benefit and considerable
toxicity in this group of women.
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