Research Papers:

This article has an addendum. Addendum in: Oncotarget. 2022; 13:1307-1307.

Impact of BMI on the outcome of metastatic breast cancer patients treated with everolimus: a retrospective exploratory analysis of the BALLET study

Silvia P. Corona _, Fabiola Giudici, Guy Jerusalem, Eva Ciruelos, Carla Strina, Marianna Sirico, Ottavia Bernocchi, Manuela Milani, Martina Dester, Nicoletta Ziglioli, Giuseppina Barbieri, Valeria Cervoni, Filippo Montemurro and Daniele Generali

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Oncotarget. 2020; 11:2172-2181. https://doi.org/10.18632/oncotarget.27612

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Silvia P. Corona1, Fabiola Giudici1,2, Guy Jerusalem3, Eva Ciruelos4, Carla Strina5, Marianna Sirico6, Ottavia Bernocchi1, Manuela Milani5, Martina Dester5, Nicoletta Ziglioli5, Giuseppina Barbieri5, Valeria Cervoni5, Filippo Montemurro7 and Daniele Generali1,5

1 Department of Medicine, Surgery and Health Sciences, University of Trieste, Cattinara Hospital, Trieste, Italy

2 Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padua, Padua, Italy

3 CHU Sart Tilman Liège and Liège University, Liège, Belgium

4 Hospital Universitario 12 de Octubre, Madrid, Spain

5 Multidisciplinary Unit of Breast Pathology and Translational Research, Cremona Hospital, Cremona, Italy

6 Università Cattolica del Sacro Cuore, Roma, Italy

7 Multidisciplinary Outpatient Oncology Clinic, Candiolo Cancer Institute, FPO-IRCCS, Candiolo, Italy

Correspondence to:

Silvia P. Corona,email: [email protected],
[email protected]

Keywords: BMI; weight; everolimus; metastatic breast cancer; outcomes

Received: January 08, 2020     Accepted: May 01, 2020     Published: June 09, 2020


Introduction: Reliable biomarkers of response to mTOR inhibition are yet to be identified. As mTOR is heavily implicated in cell-metabolism, we investigated the relation between BMI variation and outcomes in metastatic breast cancer (mBC) patients treated with everolimus.

Results: we found a linear correlation between everolimus exposure duration and BMI/weight decrease. Patients exhibiting >2 kg weight loss or >3% BMI decrease from baseline at the end of treatment (EOT) had a statistically significant improvement in PFS. Interestingly, a similar BMI/weight decrease within the first 8 weeks of therapy identified patients at higher risk of progression.

Patients and methods: we performed a retrospective analysis of patients enrolled in the BALLET trial who progressed during the study. Primary end-point was progression-free survival (PFS). Secondary end-point was the identification of other predictors of response.

Conclusion: A >3% weight loss at EOT is associated with better outcome in mBC patients treated with everolimus. On the contrary, a significant early weight loss represents a predictor of poor survival and could therefore be used as an early negative prognostic marker. As PI3K-inhibition also converges onto mTOR, these findings might extend to patients treated with selective PI3K inhibitors and warrant further investigation

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