Incidence, management, and resolution of stomatitis and noninfectious pneumonitis in BOLERO-2.

Abstract:

159 Background: Although the mTOR inhibitor everolimus (EVE) was generally well tolerated in combination with exemestane (EXE) in patients (pts) with HR+/HER2– advanced breast cancer, stomatitis and noninfectious pneumonitis (NIP) are the most clinically relevant and potentially dose-limiting toxicities. The incidence, grade, and clinical course of stomatitis and NIP among pts participating in the BOLERO-2 study are described. Methods: Pts were randomized 2:1 to receive EVE + EXE or placebo (PBO) + EXE. Incidence and severity of stomatitis and NIP, consequent dose interruptions/adjustments, study drug discontinuations, and time to resolution were recorded. Results: Stomatitis (any grade) occurred more frequently with EVE + EXE than with PBO + EXE (59% vs 12%, respectively). Grade 3 stomatitis occurred in 8% vs 1% of EVE + EXE vs PBO + EXE pts, respectively; no grade 4 events were reported …

Año de publicación:

2013

Keywords:

Fuente:

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