Research Papers:

The efficacy and safety of endostar combined with taxane-based regimens for HER-2-negative metastatic breast cancer patients

Weiwei Huang, Jian Liu _, Fan Wu, Kan Chen, Nani Li, Yi Hong, Cheng Huang, Hongyu Zhen and Lin Lin

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Oncotarget. 2016; 7:31501-31507. https://doi.org/10.18632/oncotarget.8967

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Weiwei Huang1, Jian Liu1, Fan Wu1, Kan Chen1, Nani Li1, Yi Hong1, Cheng Huang1, Hongyu Zhen1, Lin Lin1

1Department of Medical Oncology, Fujian Provincial Cancer Hospital, the Teaching Hospital of Fujian Medical University, the Teaching Hospital of Fujian University of Traditional Chinese Medicine, Fuzhou 350014, China

Correspondence to:

Jian Liu, email: [email protected]

Keywords: endostar, taxanes, HER-2 negative, metastatic breast cancer

Received: February 28, 2016    Accepted: April 04, 2016    Published: April 25, 2016


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.

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