Figure 1

Flow chart of patient enrolment and analysis populations. Two patients withdrew their consent and did not start the allocated treatment; a total of 118 patients (60 anastrozole and 58 fulvestrant) were thus assessable for safety. Six patients did not meet the eligibility criteria: four had grade 3 tumours and were younger than 65 years, one had an N2 nodal status, and one had bone metastases. A further four patients were not assessable for the primary end point: one patient refused both evaluation at 6 months and surgery; two patients stopped treatment before the 6 months due to toxicity (one elderly patient had asthenia and vertigo after 4 months of fulvestrant treatment with stable disease and was offered treatment with anastrozole, and one patient had musculoskeletal pain after 2 months of anastrozole); and the fourth patient was lost to follow-up. A total of 108 patients were thus assessable and eligible for the primary efficacy end point.