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June 1, 1997Journal 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.

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Authors

KPKathleen I. PritchardAPAlexander PatersonSFShai Fine

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Overview

Randomized trial reveals no survival benefit and increased toxicity from adding CMF chemotherapy to tamoxifen in breast cancer, suggesting hormone therapy alone remains optimal.

Key Points

  • To evaluate whether adding adjuvant cyclophosphamide, methotrexate, and fluorouracil (CMF) chemotherapy to tamoxifen improves clinical outcomes compared with tamoxifen alone in postmenopausal women with node-positive, hormone receptor-positive breast cancer.
  • Randomized trial conducted by the NCIC Clinical Trials Group from 1984 to 1990 enrolling 705 postmenopausal women with node-positive, ER-positive or PgR-positive breast cancer.
  • Participants were assigned to oral tamoxifen (30 mg daily for 2 years) alone or tamoxifen plus eight 21-day cycles of intravenous CMF chemotherapy (cyclophosphamide 600 mg/m², methotrexate 40 mg/m², and fluorouracil 600 mg/m²).
  • No significant differences were observed between treatment arms for overall survival, recurrence-free survival, locoregional recurrence-free survival, or distant recurrence-free survival.
  • Severe toxicity was significantly higher in the TAM plus CMF arm, including leukopenia (P < .0001), nausea and vomiting (P < .0001), and thromboembolic events (P < .0001).
  • Mild or greater adverse events were also significantly more frequent with TAM plus CMF, including mucositis (P = .0001), diarrhea (P = .0001), infection (P = .0004), neurologic toxicity (P = .006), anemia (P = .02), and thrombocytopenia (P = .04).

Cite This Study

Pritchard et al. (1997) studied this question.

synapsesocial.com/papers/6a1c6be0107ed6dc7cc3cb5chttps://doi.org/10.1200/jco.1997.15.6.2302
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Adjuvant randomized trials of doxorubicin/cyclophosphamide versus doxorubicin/cyclophosphamide/tamoxifen and CMF chemotherapy versus tamoxifen in women with node-positive breast cancer.1993 · 54 citations
  2. 2CMF (Cyclophosphamide, Methotrexate, 5-Fluorouracil) Versus CNF (Cyclophosphamide, Mitoxantrone, 5-Fluorouracil) as Adjuvant Chemotherapy for Stage II Lymph-Node Positive Breast Cancer2001 · 8 citations
  3. 3Adjuvant chemotherapy with doxorubicin plus cyclophosphamide, methotrexate, and fluorouracil in the treatment of resectable breast cancer with more than three positive axillary nodes.1991 · 163 citations
  4. 4Combination Chemotherapy with Cyclophosphamide, Fluorouracil, and Either Epirubicin or Mitoxantrone: a Comparative Randomized Multicenter Study in Metastatic Breast Carcinoma1991 · 17 citations
  5. 5A randomized multicenter trial comparing mitoxantrone, cyclophosphamide, and fluorouracil with doxorubicin, cyclophosphamide, and fluorouracil in the therapy of metastatic breast carcinoma.1988 · 110 citations