• Oncology Clinical Trials
• Breast Cancer

• Oncology Clinical Trials
• Breast Cancer
• Oncology

Administration of everolimus (EVE) combined with exemestane (EXE) in real-world conditions extends progression-free survival (PFS) in postmenopausal women with hormone receptor (HR)-positive advanced breast cancer. Data from the German Breast Cancer Treatment With Afinitor (Everolimus) and Exemestane for ER+ Women trial [BRAWO] were presented by Peter Fasching, MD, PhD, Universitätsklinikum Erlangen Frauenklinik, Erlangen, Germany.

The data confirm findings from the pivotal phase 3 Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole trial [BOLERO-2; NCT00863655], in which the combination of EVE and EXE more than doubled median PFS vs placebo in postmenopausal women with HR-positive advanced breast cancer whose disease is progressing after treatment with a nonsteroidal aromatase inhibitor.

BRAWO is a noninterventional study of 3000 patients with advanced or metastatic HR-positive and HER2-negative breast cancer treated with EVE and EXE. As part of the study, data on routine clinical treatment with EVE 10 mg/d and EXE 25 mg/d were collected at about 400 sites throughout Germany. The results of the second preplanned interim analysis, 12 months after the inclusion of the 500th patient, were presented. The population of patients in BRAWO was broader than that for BOLERO-2, in that BRAWO could include patients treated previously with EXE and >1 previous line of chemotherapy in the palliative setting (Table 1).

The median time from primary diagnosis was 7.2 years and the median time from first diagnosis to recurrence or metastasis was 2.7 years. Compared with BOLERO-2, patients in BRAWO were older (66 vs 62 years) and fewer had ECOG performance status 0 (43.6% vs 60%). The percentage of patients with visceral metastasis at baseline was comparable between the 2 studies (53.7% in BRAWO and 58.0% in BOLERO-2).

In BRAWO, 86.7% of patients received 10 mg of EVE at the start of therapy. Most patients received EVE and EXE as first- (26.2%) or second-line treatment (28.8%) for advanced disease; 18.8% received it as third-line treatment and 26.2% as fourth- or later-line treatment. There were 445 patients (89.0%) who switched to EVE plus EXE because of disease progression on a prior therapy. Among the patients who received EVE plus EXE as first- or second-line therapy in the advanced setting, the most common last prior antineoplastic therapies were letrozole and anastrozole.

The median PFS was 8.0 months. For the 131 patients who received EVE plus EXE as first-line treatment in the advanced setting, the median PFS was 10.1 months. These values were consistent with the median PFS values achieved in BOLERO-2 (7.8 months in the overall study population and 11.5 months in those who received the combination as first- or second-line treatment), said Prof Fasching.

Adverse events in BRAWO were consistent with those previously reported with EVE and EXE in advanced breast cancer. The percentage of patients with stomatitis was lower in BRAWO (39.8%) compared with BOLERO-2 (59%), which was probably related to the almost 87% of patients in BRAWO who received prophylactic treatment for stomatitis, noted Prof Fasching. Other common adverse events of any grade in BRAWO were fatigue (15.6%), diarrhea (13.2%), dyspnea (13.0%), nausea (12.0%), and decreased appetite (10.4%). Nearly one-half of patients (48.1%) required EVE dose reduction.

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