Clinical Research Papers:

Efficacy and safety of everolimus in Chinese metastatic HR positive, HER2 negative breast cancer patients: a real-world retrospective study

Chengcheng Gong, Yannan Zhao, Biyun Wang _, Xichun Hu, Zhonghua Wang, Jian Zhang and Sheng Zhang

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Oncotarget. 2017; 8:59810-59822. https://doi.org/10.18632/oncotarget.16336

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Chengcheng Gong1,*, Yannan Zhao1,*, Biyun Wang1, Xichun Hu1, Zhonghua Wang1, Jian Zhang1 and Sheng Zhang1

1 Department of Medical Oncology, Fudan University Shanghai Cancer Center, Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, 200032, China

* These authors have contributed equally to this work

Correspondence to:

Biyun Wang, email:

Xichun Hu, email:

Keywords: everolimus, endocrine therapy, metastatic breast cancer, real-world study

Received: November 17, 2016 Accepted: February 15, 2017 Published: March 17, 2017


Background: Everolimus combined with endocrine therapy has been proved to be effective among postmenopausal women with hormone receptor-positive human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (MBC). We aimed to evaluate the efficacy and safety of everolimus plus endocrine therapy in Chinese real-world practice for the first time, and investigate factors associated with efficacy.

Methods: Seventy-five HR+/HER2- MBC patients were included in this retrospective study who received everolimus plus endocrine therapy after progression on prior endocrine therapy in Fudan University Shanghai Cancer Center (FUSCC) between June 2013 and February 2016. Main outcome measures are progression free survival (PFS), overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR) and safety profile.

Results: After a median follow up of 10.3 (range: 2.1-32.2) months, median PFS was 5.9 months (95%CI 4.6-7.2), and median OS was not reached. The CBR was 38.8% (95%CI, 26.8-50.8) and ORR was 9.0% (95%CI, 2.0-16.0). Most common all-grade adverse events were stomatitis (57.1%), fatigue (25.7%), infection (24.3%) and hyperglycemia (21.4%). The most common ≥3 grade adverse events were stomatitis (9.3 %) and thrombocytopenia (5.7%). No treatment-related death was documented during and one month after the drug administration.

Conclusions: The combination of everolimus and endocrine therapy proved to be effective in Chinese population. The safety profiles were similar to previous studies but incidences were lower. In conclusion, everolimus combined with endocrine therapy provides a reasonable option for Chinese HR+/HER2- metastatic breast cancer patients.

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