Abstract:

Objective

To evaluate the efficacy and safety of 500 mg fulvestrant for the treatment of postmenopausal patients with ER-positive metastatic breast cancer.

Methods

We retrospectively analyzed the clinical data of 61 metastatic breast cancer patients treated with 500 mg fulvestrant in Fudan University Shanghai Cancer Center from February 2012 to August 2014. Clinical efficacy,influencing factors and adverse effect were evaluated. Kaplan-Meire analysis, Log-rank test and Cox proportional hazard regression model were used for survival analysis.

Results

After the median follow-up of 17.2 months (2.0 -32.7 months), median progression free survival (PFS) was 6.4 months, clinical benefit rate was 37.7%(23/61), objective response rate was 8.2% (5/61) and median OS was 27.0 months. Log-rank test showed that after the treatment of 500 mg fulvestrant, PFS was significantly correlated with endocrine therapy after metastasis, prior tamoxifen use, bone metastasis alone and visceral metastasis (χ² = 3.963,5.197,5.115,5.479;P = 0.047,0.024,0.023,0.019). COX proportional hazard regression analysis indicated that PFS was correlated with relevant endocrine therapy after metastasis and visceral metastasis respectively (HR = 3.1,95% CI: 1.1 - 8.8,P=0.036;HR=2.3,95%CI:1.2-4.3,P=0.013). The patients receiving endocrine therapy had the risk of disease progression 3.1 times of that in those receiving no hormonal therapy. The patients with visceral metastasis had the risk of disease progression 2.3 times of that in patients without visceral metastasis.

Conclusion

The treatment of 500 mg fulvestrant has a favorable efficacy and safety for postmenopausal patients with ER-positive metastatic breast cancer.

Key words: Menopause, Estrogen receptors, Estrogen receptor modulators, Breast neoplasms, Neoplasm metastasis