Ten studies were identified (n=1,457 participants, range 27 to 693): one double-blind randomised controlled trial (RCT) (n=693), three non-randomised comparative studies (n=410, range 30 to 299) and six single-arm observational studies (n=354, range 27 to 108).
Efficacy of SAI after NSAI (nine studies): The clinical benefit of exemestane after NSAI ranged from 12% to 55% (nine studies). Complete response to exemestane after NSAI ranged from zero to 6% (six studies). Partial response ranged from 2% to 23% (six studies). Overall response rate ranged from 2% to 26% (six studies). Stable disease after at least 24 weeks ranged from 10% to 47% with exemestane (seven studies). Time to progression with exemestane ranged from 3.7 months to 5.2 months (three studies). One study reported median survival time as 15.2 months.
Efficacy of NSAI after SAI (one study): The clinical benefit of NSAI after SAI was 55%.
Efficacy of NSAI after NSAI (one study): The overall response rate for anastrozole after aminoglutethimide was 18% with a stable disease rate of 41% after at least eight weeks.
Safety of SAI after NSAI (nine studies): The authors reported no drug-related deaths for three studies, but Table 4 reported 10% mortality for one study. Discontinuation of treatment due to toxicity ranged from zero to 3% (five studies). Adverse events ranged from 24% to 77% (five studies). The most common adverse events were nausea, fatigue, hot flushes, dizziness, weakness, sweating, androgenic symptoms and peripheral oedema. Serious drug-related adverse events were reported in 1% of patients in one study.
Safety of NSAI after SAI (one study): Adverse events were reported in 28% patients.
Safety of NSAI after NSAI (one study): Results for the patients in this study were unclear.
The one RCT compared treatment with exemestane with fulvestrant and found no significant differences.