Abstract
Approximately 22,700 Canadian women were expected to be diagnosed with breast cancer in 2012. Despite improvements in screening and adjuvant treatment options, a substantial number of postmenopausal women with hormone receptor positive (hr+) breast cancer will continue to develop metastatic disease during or after adjuvant endocrine therapy. Guidance on the selection of endocrine therapy for patients with hr+ disease that is negative for the human epidermal growth factor receptor 2 (her2-) and that has relapsed or progressed on earlier nonsteroidal aromatase inhibitor (nsai) therapy is of increasing clinical importance. Exemestane, fulvestrant, and tamoxifen are approved therapeutic options in this context. Four phase iii trials involving 2876 patients-efect, sofea, confirm, and bolero-2-have assessed the efficacy of various treatment options in this clinical setting. Data from those trials suggest that standard-dose fulvestrant (250 mg monthly) and exemestane are of comparable efficacy, that doubling the dose of fulvestrant from 250 mg to 500 mg monthly results in a 15% reduction in the risk of progression, and that adding everolimus to exemestane (compared with exemestane alone) results in a 57% reduction in the risk of progression, albeit with increased toxicity. Multiple treatment options are now available to women with hr+ her2- advanced breast cancer recurring or progressing on earlier nsai therapy, although current clinical trial data suggest more robust clinical efficacy with everolimus plus exemestane. Consideration should be given to the patient's age, functional status, and comorbidities during selection of an endocrine therapy, and use of a proactive everolimus safety management strategy is encouraged.
Highlights
22,700 Canadian women were expected to be diagnosed with breast cancer in 2012, and 5100 women were expected to die of their disease[1]
Patients receiving a higher dose of fulvestrant (F500 compared with F250) experienced a 20% reduction in the risk of progression and an incremental gain in median pfs of 1.0 month (6.5 months vs. 5.5 months, p = 0.006)
4.3.1 Discussion Endocrine therapy is the preferred option for hr+ abc, even in the presence of visceral disease[6], and chemotherapy is recommended for patients with rapidly progressive or symptomatic visceral disease[5,6]
Summary
22,700 Canadian women were expected to be diagnosed with breast cancer in 2012, and 5100 women were expected to die of their disease[1]. In the advanced breast cancer (abc) setting, sequential endocrine therapy (et) is an optimal treatment strategy for women with reasonably limited and indolent disease; for rapidly progressive or symptomatic disease, chemotherapy is commonly considered optimal[5,6]. Exemestane has demonstrated activity comparable to that of tamoxifen as initial therapy for hr+ metastatic disease in postmenopausal women[9], is not fully cross-resistant with nsais[26], and is commonly recommended as the line of therapy after disease progression on a nsai. Temsirolimus was not found to improve outcomes when combined with letrozole as initial therapy for women with hr+ abc[38,40]; sirolimus and eve have both demonstrated activity when combined with et in hr+ her2– patients recurring or progressing on prior et[10,39]. The present consensus statement weighs available phase iii evidence and clinical issues to formulate evidence-based recommendations for et in this patient population
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