HR+/HER2- Advanced Breast Cancer Pretreated With Non-Steroid AIs
HR+/HER2- Advanced Breast Cancer Pretreated With Non-Steroid AIs
Indirect evidence from head-to-head, Phase III clinical trials conducted in a homogeneous population of patients suggest that only the combination of everolimus and exmestane is associated with a prolonged PFS and a more evident clinical benefit than its comparator in the treatment of postmenopausal mBC patients who progressed or relapsed after endocrine therapy with a NSAI (a population often encountered in clinical practice). This advantage appears consistent regardless of a number of clinical variables; however, the cost of this new association therapy should be taken into account.
It is our opinion that the condition of prior NSAI therapy is 'per se' able to individuate the patients candidate to everolimus treatment (at least in the population examined in the present analysis, i.e., patients who progressed on a prior NSAI used for the treatment of metastatic disease or who progressed within 1 year on a prior NSAI in the adjuvant setting). However, more robust data from head-to-head trials will provide more grounded evidence on this issue. For instance, the ongoing BOLERO-6 trial compares everolimus and capecitabine monotherapies with the everolimus/exemestane combination in mBC woman with prior NSAI failure, will likely give new insights on the choice between chemotherapy and a combination of hormone and targeted therapy; other trials, such as an evaluation of an intense regimen of fulvestrant in patients with previous failure on NSAI, may also be planned.
Conclusion
Indirect evidence from head-to-head, Phase III clinical trials conducted in a homogeneous population of patients suggest that only the combination of everolimus and exmestane is associated with a prolonged PFS and a more evident clinical benefit than its comparator in the treatment of postmenopausal mBC patients who progressed or relapsed after endocrine therapy with a NSAI (a population often encountered in clinical practice). This advantage appears consistent regardless of a number of clinical variables; however, the cost of this new association therapy should be taken into account.
It is our opinion that the condition of prior NSAI therapy is 'per se' able to individuate the patients candidate to everolimus treatment (at least in the population examined in the present analysis, i.e., patients who progressed on a prior NSAI used for the treatment of metastatic disease or who progressed within 1 year on a prior NSAI in the adjuvant setting). However, more robust data from head-to-head trials will provide more grounded evidence on this issue. For instance, the ongoing BOLERO-6 trial compares everolimus and capecitabine monotherapies with the everolimus/exemestane combination in mBC woman with prior NSAI failure, will likely give new insights on the choice between chemotherapy and a combination of hormone and targeted therapy; other trials, such as an evaluation of an intense regimen of fulvestrant in patients with previous failure on NSAI, may also be planned.
