Study designs of evaluations included in the review
Multicentre, randomised, parallel-group double-blind for anastrozole and non-blind for megastrol clinical trials.
Specific interventions included in the review
Anastrozole 1 mg once daily compared with anastrozole 10 mg once daily and oral megastrol 40 mg 4 times daily.
Participants included in the review
Women with breast cancer which had progressed during anti-oestrogen therapy for advanced disease, or had relapsed during or after adjuvant tamoxifen therapy for early disease. All women were postmenopausal, had measurable lesions or evaluable but non-measurable lesions, had a WHO performance status score >=2 and had tumours with an oestrogen receptor-positive or unknown-status. Patients exposed to more than one previous course of cytotoxic therapy (except adjuvant chemotherapy) or hormonal therapy for advanced breast cancer were not included.
Outcomes assessed in the review
Primary end points - overall response rate, time to disease progression, objective responses according to the UICC definition (complete and partial response).
Secondary end points - survival (duration of response, time to treatment failure or subjective symptom scores), quality of life (assessed using the Rotterdam Symptom Checklist).
Adverse effects - weight gain, oedema, thromboembolic disorder, gastrointestinal disturbance, hot flushes, vaginal dryness.
How were decisions on the relevance of primary studies made?
Inclusion of studies based mainly on methods section of trials.