Chemotherapy versus tamoxifen versus chemotherapy plus tamoxifen in node-positive, estrogen receptor-positive breast cancer patients: results of a multicentric Italian study. Breast Cancer Adjuvant Chemo-Hormone Therapy Cooperative Group.

Abstract

Between November 1, 1983 and June 30, 1987, 510 node-positive, estrogen receptor (ER)-positive breast cancer patients have been randomly allocated to receive either chemotherapy (six intravenous [IV] cyclophosphamide, methotrexate, and fluorouracil [CMF] courses followed by four IV epirubicin courses) or 5 years of tamoxifen treatment or a combination of both therapies. After a median follow-up of 40 months, patients receiving the combined treatment achieved the best results, and those treated with chemotherapy alone achieved the worst, the difference being particularly evident in postmenopausal women. However, while the concurrent use of chemotherapy and tamoxifen did improve the results achieved by chemotherapy alone, particularly in postmenopausal women and in those with four or more involved nodes, it did not significantly improve the results achieved by tamoxifen alone, particularly in patients with higher ER tumor concentrations. Side effects were more numerous and more severe in patients receiving chemotherapy (with or without tamoxifen). Our findings, although still preliminary, confirm that tamoxifen should be the treatment of choice for postmenopausal breast cancer patients with node-positive, ER-positive tumors. In addition, the findings suggest that tamoxifen may represent a safe alternative to chemotherapy (at least to the cytotoxic regimen we used) for younger women, provided they have ER-positive tumors. In patients with ER-positive tumors, the addition of chemotherapy to tamoxifen does not seem to improve significantly the effectiveness of tamoxifen alone.

Chemotherapy versus tamoxifen versus chemotherapy plus tamoxifen in node-positive, oestrogen receptor-positive breast cancer patients. Very late results of the ‘gruppo di ricerca per la chemio-ormonoterapia adiuvante (GROCTA)’ 01-Trial in early breast cancer

“…Details about study design, assigned treatments and main results have been previously published [6,13]. Five hundred and four, 35-65 year old patients with node-positive, ER-positive tumors and no evidence of distant metastases were recruited.…”

“…Several individual trials and large meta-analysis have contributed to the building-up of the present state of art [5][6][7][8][9][10][11][12].…”

The prognosis of breast cancer patients in relation to the oestrogen receptor status of both primary disease and involved nodes

“…Such macro-homogeneity is potentially valuable for selecting therapy for patients with 'poor prognosis' disease, such as those presenting with histologically-involved nodes. In some centres, all such patients would be treated with first-line chemotherapy, yet patients with hormone-sensitive disease might benefit more from endocrine therapy or combined endocrine/chemotherapy (see GROCTA study -Boccardo et al, 1990).…”

“…1987, 23, 31) that, in almost all cases, involved nodes are only oestrogen receptor positive (ER+) Collaborative Group, 1988) and, in many countries, nodeinvolved, premenopausal patients are all treated with firstline chemotherapy. Information which argues against such blanket treatment, comes from the multi-centre (GROCTA) study (Boccardo et al, 1990) in Italy. This showed that node positive, oestrogen receptor positive breast cancer patients have both improved disease-free and total survival when treated with hormone-plus-chemotherapy or hormone therapy alone, when compared with chemotherapy alone.…”

“…Indeed, it was found (Castagnetta et al, 1987) Collaborative Group, 1988) and, in many countries, nodeinvolved, premenopausal patients are all treated with firstline chemotherapy. Information which argues against such blanket treatment, comes from the multi-centre (GROCTA) study (Boccardo et al, 1990) Both N-l (n = 66) and N-2 (n = 8) patients were included. All patients underwent Pateymodified radical mastectomy.…”