Randomised trial of chemotherapy versus endocrine therapy in patients presenting with locally advanced breast cancer (a pilot study)

Abstract

Summary Sixty patients with locally advanced breast cancer, but with no evidence of distant metastases were randomised to receive primary endocrine therapy or chemotherapy after assessment and 'Trucut' biopsy of the primary tumour. After 12 weeks all patients were assessed. Eight out of 30 (27%) of the patients who received chemotherapy showed complete clinical regression of the primary cancer, eight patients' tumours had regressed by more than 50%, and ten showed a 25-50% reduction in bi-dimensional diameter. Only four (13%) patients' tumours failed to reduce in size. Seven patients were judged to require mastectomy at the end of the 12 week period of treatment with chemotherapy. In contrast, only three out of 30 (10%) patients receiving endocrine therapy showed a greater than 50% reduction in tumour size, and four patients had a 25-50% reduction at 12 weeks. The remaining patients' tumours either stabilised (12 patients) or enlarged (II patients). We conclude that primary chemotherapy in patients with primary breast cancer is more effective in rapidly reducing the size of the primary breast cancer than endocrine therapy (P = 0.001) and alters significantly the future management of these patients. However, at 65 weeks on completion of the follow-up, there is no significant difference in the number of patients' disease-free, locally or distant recurrent, or dead.

A randomized trial exploring the biomarker effects of neoadjuvant sequential treatment with exemestane and anastrozole in post-menopausal women with hormone receptor-positive breast cancer

“…At present, the only interim data comes from the Italian Gruppo Oncologico Nord Ovest (GONO) MIG8 trial which evaluated the efficacy of switching between steroidal and non-steroidal aromatase inhibitors on detection of progressive disease in a cohort of patients with metastatic patients. This trial concluded that switching between steroidal and non-steroidal aromatase inhibitors was efficacious, but noted that this efficacy appeared to be independent of the order in the sequence [6]. As yet, no study has been designed specifically to explore the efficacy of switching between steroidal and non-steroidal aromatase inhibitors in the adjuvant or neoadjuvant setting.…”

Preoperative endocrine therapy for breast cancer.

“…An early study by the Edinburgh group reported a response in 11 of 23 and 12 of 13 patients receiving preoperative endocrine and cytotoxic therapy respectively for primary breast cancer >4 cm (Forrest et al 1986). Stimulated by these phase II studies and by the investigators' own experience of using tamoxifen as primary treatment for elderly patients with primary breast cancer (Gazet et al 1988), the first randomised trial of preoperative endocrine therapy versus chemotherapy was reported by the Royal Marsden Hospital in 1991 (Gazet et al 1991). Thirty patients with locally advanced primary breast cancer were recruited in each arm.…”

Primary chemotherapy in breast invasive carcinoma: predictive value of the immunohistochemical detection of hormonal receptors, p53, c-erbB-2, MiB1, pS2 and GST pi

“…Since 1990 several reports have shown the effectiveness of primary chemotherapy in breast conservative surgery of resectable tumours larger than 3 cm (Bonnadonna et al, 1990;Gazet et al, 1991;Mauriac et al, 1991;Belembaogo et al, 1992;Calais et al, 1994;Smith et al, 1995). This new therapeutic strategy, as well as those used in locally advanced breast disease, requires the validation of clinical and biological factors capable of predicting the tumoral response to cytotoxic therapy, and the subsequent clinical outcome.…”