2016•Journal of Clinical OncologyRequires access
Real-world experience of exemestane-everolimus (EXE-EVE) in elderly patients with hormone-receptor positive (HR+) metastatic breast cancer (MBC).
Stefania Redana, Elisavet Papadimitraki, David Odhiambo Okonji, Komel Khabra, Eirini Thanopoulou, Jaseela Chiramel, Panagiotis Papanastasopoulos, Andrew M. Wardley, Martin S. Hogg, Sacha Jon Howell, G Zucchini, Laura M. Kenny, Alistair E. Ring, Stephen R.D. Johnston
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Abstract
576 Background: EXE-EVE significantly improved progression free survival (PFS) in patients (pts) with HR+ MBC progressing on a nonsteroidal aromatase inhibitor regardless of age, at the expenses of acceptable toxicities. The majority of elderly MBC pts have HR+ disease and EXE-EVE is a valuable treatment option. Toxicities are likely to be more frequent in non-trial populations, and tolerability in elderly pts is of particular interest. Methods: We retrospectively analysed efficacy and safety of EXE-EVE in 63 elderly ( ≥ 70 years of age) MBC pts treated at 5 UK Institutions between May 2012 and April 2015. Efficacy end points: PFS, response rate (complete CR + partial response PR), clinical benefit rate (CBR = CR + PR + stabilization ≥ 24 weeks), overall survival (OS). Safety end points: dose reductions and interruptions, toxicities. Results: Median age is 74 (range 70-85) years. 24% of pts had ECOG PS 2; 21% had bone only disease. 21% of pts received EXE-EVE as 1st line treatment for MBC, 40% as 3rd line or beyond and 21% had received prior chemotherapy for MBC. At a median follow-up of 11 months (range 1-33), median PFS and OS were 8.3 months (range 5.5-11.1) and 19.6 months (range 13.4-21.1), respectively. RR was 9.5% (95% CI: 4.2-20.0), CBR was 63.5% (95% CI: 50.0-74.6). Median exposure to EXE-EVE was 13.6 weeks (range 0.6-81.4+). Toxicities lead to dose reductions in 27% of pts and interruptions in 51% of pts. 92% of pts discontinued treatment, the main reasons being disease progression (52%) and toxicities (40%). Most frequent any grade toxicities were: stomatitis (59%, 13% grade 3), fatigue (48%), rash (24%) and non infectious pneumonitis (22%, 5% grade 3). No grade 4 toxicities occurred. Conclusions: About 23% of pts in BOLERO-2 were ≥ 70 years. Compared to an exploratory analysis of these pts, our off-study pts were more heavily pre-treated, had worse ECOG PS, and reported higher rate of any grade toxicities. However, we report similar PFS and higher CBR despite shorter exposure to treatment. Our study confirms that EXE-EVE is a valuable treatment option for elderly MBC pts in the real world, nevertheless monitoring toxicities and early dose modifications remain crucial.