1. SAFETY AND EFFICACY OF EVEROLIMUS PLUS EXEMESTANE IN METASTATIC BREAST CANCER BEYOND THE SECOND LINE TREATMENT: A SINGLE INSTITUTION EXPERIENCE
M. Giampaglia, E. Basso, R. Romano, A. Dinota, D. Ferrara, G. Rosati, D. Bilancia
A49
Background
Patients and Methods
Results
Conclusion
Breast cancer (BC) is the most common form of malignancy occurring in women. Treatment for metastatic BC (MBC) include endocrine therapy as the preferred option for hormone receptor positive disease with asyntomatic visceral disease.
Additionally, hyperactivation of the mTOR pathway has been observed in patients progressing on endocrine therapy. The BOLERO-2 trial reported improved progression-free survival in ER+ HER2-postmenopausal pretreated women in the advanced breast cancer setting by combining everolimus (an oral mTOR inhibitor) with exemestane. This combination was approved by FDA in July 2013 to treat patients with metastatic breast cancer (MBC) after progression with aromatase inhibitors.
We have evaluated the safety and efficacy of this combination beyond the second line of treatment by using assessment of adverse events and laboratory data (hematology/chemistry).
From August 2013 to April pts with MBC were treated in our Institution.
Mean Everolimus + exemestane treatment duration was 4 months (range 1-8).
26% of pts (4pts) reported >1 adverse event G1-G2 among asthenia, diarrhea, hyperglycemia, mucositis, anemia and thrombocytopenia.
Grade ≥3 adverse events occurred in 30% of pts (5 pts): 6% (1 pt) mucositis, 12% (2pts) thrombocytopenia, 6% (1 pt) hyperglycemia, 6% (1 pt) diarrhea with subsequent dose reduction.
Disease control rate was 50% (20% PR, 30% SD).
Our experience, although with a small number of pts, demonstrates that combination treatment with everolimus and exemestane in ER+ HER2-postmenopausal MBC beyond the second line has a similar safety profile and efficacy than that of the BOLERO-2 study but with greater hematologic toxicity
Characteristic patients
No. patients
Number patients 15
Age (years)
58 (48-70)
ECOG 1 6 9
Metastatic site (%) Bone
Liver
Lung
Brain
No. of metastatic sites 2
>2
Reference
Stomatitis
Thrombocytopenia
Anemia
Hyperglycemia
Diarrhea
1. Baselga J, Campone M et al: “Everolimus in Postmenopausal Hormone- Receptor–Positive Advanced Breast Cancer” N Engl J Med Feb 9;366(6):520-9.
Tab. 1 – Patient and Tumor Characteristics at baseline
Fig. 2: Adverse events compared to Bolero-2 trial
Fig. 1 – Lines of chemotherapy treatment performed in MBC