Alternating cyclical hormonal-cytotoxic combination chemotherapy in postmenopausal patients with breast cancer. An EORTC trial.
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Biomedical subjects
Publications and source records attributed to E Engelsman.
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A pilot study of adjuvant chemotherapy and hormonal therapy for inoperable breast cancer was performed. The patients were known to have a bad prognosis because of occult generalized disease. At the time of first treatment, the patients selected showed no signs of systemic disease. Local control of the breast and regional lymph nodes was achieved by radiotherapy. Adjuvant therapy consisted of alternating chemotherapy and tomoxifen. Adriamycin was dropped from the treatment schedule after 1 year because of enchanced radiation side-effects. Meanwhile the radiotherapy schedule was changed. A questionable control group was formed by patients radiated in the same period who failed to meet the entry criteria for various reasons. At presents, patients in the treated group show a better relapse-free survival than patients in the control group. The differences is statistically significant for premenopausal women. There is no significant difference in the overall survival between the treated group and the control group after an average follow-up of 2 years. After 2 years, the pilot study was closed. A randomized controlled clinical trial was started. In one group of this trial intensive chemotherapy is the first treatment employed.
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A randomized clinical trial of nafoxidine, a non-steroidal oestrogen antagonist, and ethinyloestradiol in postmenopausal patients with advanced breast cancer produced objective remissions in 31% of 49 women receiving nafoxidine and in 14% of 49 receiving ethinyloestradiol. The differences in remission rates was almost significant (0.05 less than P less than 0.10). Life-threatening complications were more frequent with ethinyloestradiol than with nafoxidine but the latter produced specific toxic reactions on skin and hair that may limit its practical usefulness. Synthetic oestrogen antagonists may occupy a privileged place in the treatment of breast cancer, and other representatives of this new class of compounds should be accurately assessed in randomized clinical trials.
L-Dopa lowers plasma prolactin levels, and there have been reports that patients with advanced breast cancer have been successfully treated with L-dopa. To test the potential value of L-dopa in this disease a randomized clinical trial of L-dopa and nafoxidine (as the reference compound) was conducted in postmenopausal women with advanced breast cancer. Objective remissions were obtained in sever out of 36 patients (19%) treated with nafoxidine but in none out of 40 patients treated with L-dopa. L-Dopa in the dose schedule used seems to be ineffective in advanced breast cancer.
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Oestrogen receptor determinations were done in metastatic breast cancer tissue of patients with advanced breast cancer. In 37 patients with progressive disease evaluation of the response to endocrine treatment was possible, following the criteria of the E.O.R.T.C. Co-operative Breast Cancer Group. In 20 patients with receptor-negative tumours two objective remissions were noted; in 17 patients with receptor-positive tumours 14 objective remissions were seen. There seems to be a striking correlation between the presence or absence of oestrogen receptor in tumour tissue and the clinical response to hormonal therapy.
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