Everolimus in heavily pretreated metastatic breast cancer: Is real world experience different?
J Bajpai1, A Ramaswamy1, S Gupta1
1Department of Medical Oncology, Tata Memorial Hospital, Mumbai, Maharashtra, India.
Background:
Drugs targeting mammalian target of rapamycin signaling pathway have been recently approved for treatment of hormone receptor (HR) positive metastatic breast cancer (MBC). However, there is lack of real world data from India on the use of this therapeutic strategy.
Materials And Methods:
A retrospective analysis of MBC patients who had recurrence or progression while receiving aromatase inhibitors (AI's) and further treated with everolimus and either tamoxifen/AI/fulvestrant between March 2012 and June 2014, was undertaken.
Results:
There were 41 patients with median age 55 years, 73% with visceral metastasis, and 73% with ≥2 sites of metastases. Thirty (73%) patients had received 3 prior lines of therapy including AI (100%), tamoxifen (94%), fulvestrant (39%), and chemotherapy (100%) while the remaining had received <3 lines of prior therapy. The commonest Grade 3/4 adverse events were stomatitis (19%), hyperglycemia (new/worsening, 17%), fatigue (14.5%), nonneutropenic infections (14%), anemia (12%) and pneumonitis (7%). Everolimus dose reductions were required in 31% patients. There were 30% partial responses, 38% prolonged disease stabilizations and 32% disease progression as best responses to everolimus. The median progression-free survival was 22 weeks (5 months).
Conclusions:
Everolimus based treatment has meaningful activity in heavily pretreated patients with HR-positive MBC but is associated with considerable toxicity and requirement for dose adjustment.
Insights
Everolimus shows activity in heavily pretreated hormone receptor-positive metastatic breast cancer (MBC) patients in India. However, this treatment is linked to significant toxicity and requires dose adjustments.
Area of Science:
- Oncology
- Pharmacology
Background:
- Mammalian target of rapamycin (mTOR) signaling pathway inhibitors are approved for hormone receptor (HR)-positive metastatic breast cancer (MBC).
- Limited real-world data exists in India regarding the efficacy and safety of this therapeutic strategy.
Purpose of the Study:
- To evaluate the real-world effectiveness and toxicity of everolimus in Indian patients with HR-positive MBC.
- To analyze treatment outcomes in heavily pretreated patients.
Main Methods:
- Retrospective analysis of 41 MBC patients treated with everolimus and endocrine therapy (tamoxifen/AI/fulvestrant) after progression on aromatase inhibitors (AIs).
- Data collected between March 2012 and June 2014.
Main Results:
- Median patient age was 55 years; 73% had visceral metastasis and ≥2 metastatic sites.
- Common Grade 3/4 adverse events included stomatitis (19%), hyperglycemia (17%), and fatigue (14.5%).
- 30% partial responses, 38% stable disease, and median progression-free survival of 22 weeks (5 months) were observed.
Conclusions:
- Everolimus-based therapy demonstrates meaningful clinical activity in heavily pretreated HR-positive MBC patients.
- The treatment is associated with significant toxicity, necessitating dose reductions in 31% of patients.
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