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Title: Selective primary systemic treatment for operable breast cancer : a randomised trial
Author: Forouhi, Parto
Awarding Body: University of Edinburgh
Current Institution: University of Edinburgh
Date of Award: 1997
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171 women aged 27-69 with operable (T2-3N0-1M0) breast cancer 31-85 mm in diameter were randomised over 68 months, 86 to conventional treatment (CONV) and 85 to PST. In CONV, surgery was followed by tamoxifen except for node positive premenopausal women who received 6 cycles of cyclophosphamide, methotrexate and 5-fluorouracil. PST was started after tumour oestrogen receptor (ER) measurement. Patients with ER>19 fmol/mg were treated by goserelin if premenopausal or with tamoxifen if postmenopausal. Response was assessed by weekly examination. Sequential mammography and ultrasound, and serum CA 15-3 and HMFG2 measurements were studied as alternative means of monitoring response. Non responding patients and all patients with ER<20 fmol/mg were treated with 6 cycles of cyclophosphamide, doxorubicin and prednisolone (CAP). Surgery followed 12-16 weeks of PST. The first part of the trial included 79 patients with tumours >40 mm, all of whom underwent mastectomy. The second part allowed tumours > 30 mm, and breast conservation was an option. 170 evaluable patients have been followed up for a median of 347 months and have sustained 53 events. No survival difference has emerged. Axillary lymph nodes, ER and tumour response have emerged as independent indicators of prognosis. Systemic therapy produced significant changes in tumour characteristics but post treatment prognostic data was qualitatively similar to conventionally gathered information. Patients experienced increased anxiety during PST, but psychological adjustment was similar after completion of all treatment. Despite longer treatment for PST, quality adjusted survival was identical to that found for CONV. Surgical morbidity was similar for both groups. Ultrasound proved a highly effective method for measuring tumour size and response to primary systemic therapy. Tumour marker levels were generally low and did not reflect response. The present package of primary systemic treatment is a safe and effective method for treating operable breast cancer, does not lead to excess morbidity, and offers the advantages of a response based approach to therapy.
Supervisor: Not available Sponsor: Not available
Qualification Name: Thesis (M.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available