Abstract
The purpose of the present study was to prospectively evaluate the efficacy and safety of endostar, a recombinant product of endostatin, combined with taxane-based regimens for HER-2 negative metastatic breast cancer (MBC) patients. Women with ages between 18–70 years with histologically confirmed MBC documented as HER-2-negative were included. Endostar was administered at 7.5 mg/m2, d1–14, q21d and was continued until progressive disease, unacceptable toxicity, consent withdrawal, or completion of 24 months of endostar, whichever came first. Taxane-based chemotherapy was continued until progressive disease, unacceptable toxicity, consent withdrawal, or up to 8 cycles. The primary endpoint was overall response rate (ORR). Fifty-seven patients were recruited. The ORRs for the whole population, first-, second-, and third-line therapy or beyond were 68.4%, 79.3%, 54.5%, and 16.7%, respectively. The median PFS was 10.8 (8.0–12.1) months, yet the median OS was still not attained. For the patients receiving first-, second-, and third-line therapy or beyond, median PFS was 11.9, 7.5, and 7.4 months, respectively (P=0.048). No significant difference in median PFS between hormonal receptor-positive and -negative patients was observed. The most common drug-related grade 3–4 hematologic toxicities were neutropenia (80.7%) and leukopenia (77.2%). Six (10.5%) patients experienced febrile neutropenia. The most frequent drug-related grade 3–4 non-hematologic toxicities were liver dysfunction (10.5%) and peripheral neurotoxicity (8.8%). No treatment-related deaths were reported. We conclude that Endostar combined with taxane-based regimens may be effective and safe for the treatment of HER-2-negative MBC. However, further investigations on its long-term efficacy and toxicity are warranted.
Highlights
Despite significant improvements in the treatment of early-stage breast cancer, approximately 20%–40% of patients develop relapse and distant recurrence, whereas some present with de novo metastatic disease
Endostar was administered at 7.5 mg/m2, d1–14, q21d and was continued until progressive disease, unacceptable toxicity, consent withdrawal, or completion of 24 months of endostar, whichever came first
Bevacizumab, as a monoclonal antibody directed against circulating vascular endothelial growth factor (VEGF), was removed from metastatic breast cancer (MBC) indication in December 2010 based on the poor results of cost-benefit analysis
Summary
Despite significant improvements in the treatment of early-stage breast cancer, approximately 20%–40% of patients develop relapse and distant recurrence, whereas some present with de novo metastatic disease. The treatment intent in metastatic breast cancer (MBC) patients is primarily noncurative, i.e., palliative, in nature. Treatments that provide more clinical benefit among these patients, especially the human epidermal growth factor receptor 2 (HER-2)-negative subgroup, which lacks anti-HER-2 therapies, will continue to be sought. Antiangiogenesis is a promising antitumor strategy that inhibits tumor vascular formation to suppress tumor growth. Bevacizumab, as a monoclonal antibody directed against circulating vascular endothelial growth factor (VEGF), was removed from MBC indication in December 2010 based on the poor results of cost-benefit analysis. It is imperative to develop another strategy that inhibits angiogenesis in breast cancer
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