Everolimus plus Exemestane Effective in Asian Women

Patient ethnicity may play a role in the safety profile and efficacy of targeted agents.11 In Asian patients with lung cancer, increased efficacy of targeted agents has been demonstrated; however, specific AEs may be increased with an epidermal growth factor inhibitor.12

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In an exploratory analysis of Asian women treated in the BOLERO-2 trial, the addition of everolimus to exemestane was found to prolong PFS with manageable AEs, Shinzaburo Noguchi, MD, PhD, of Osaka University, Osaka, Japan, and colleagues reported at ASCO 2012.4

Of 143 patients of Asian origin enrolled in this study, 98 (72% Japanese) received everolimus plus exemestane and 45 (78% Japanese) received placebo plus exemestane. Everolimus plus exemestane significantly reduced risk of a PFS event by 44% vs placebo plus exemestane in the intent-to-treat population (HR 0.56 [95% CI 0.37‑0.87]; P<0.05).

Overall, PFS in both treatment arms was found to be better in Asian than in non-Asian patients: in the everolimus plus exemestane arm, median PFS was 8.48 months in Asian patients and 7.33 months in non-Asian patients vs 4.14 months in Asian patients and 2.83 months in non-Asian patients in the placebo plus exemestane arm. The ORR was 19% in Asian patients and 11% in non-Asian patients among those treated with everolimus plus exemestane.

Among Asian patients who received everolimus plus exemestane, the most common AEs (vs non-Asian patients) were stomatitis (80% vs 54%), rash (50% vs 36%), dysgeusia (31% vs 20%), fatigue (24% vs 40%), and headache (24% vs 22%). AE incidences were similar between Asian and non-Asian patients; stomatitis and interstitial lung disease were higher in Asian patients and incidence of anemia was lower in Asian patients. Among patients who received everolimus plus exemestane, incidence of grade 3/4 AEs were 46% in Asian patients vs 55% in non-Asian patients.

Dr. Noguchi concluded that the safety profile of everolimus plus exemestane was generally similar between Asian and non-Asian patients and, with a few manageable exceptions, no notable safety concerns arose among Asian patients treated with everolimus in BOLERO-2.