title: The efficacy and safety of endostar combined with taxane-based regimens for HER-2-negative metastatic breast cancer patients.
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.
authors.affiliation: Department 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.
authors.forename: Weiwei
authors.initials: W
authors.lastname: Huang
authors.affiliation: Department 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.
authors.forename: Jian
authors.initials: J
authors.lastname: Liu
authors.affiliation: Department 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.
authors.forename: Fan
authors.initials: F
authors.lastname: Wu
authors.affiliation: Department 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.
authors.forename: Kan
authors.initials: K
authors.lastname: Chen
authors.affiliation: Department 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.
authors.forename: Nani
authors.initials: N
authors.lastname: Li
authors.affiliation: Department 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.
authors.forename: Yi
authors.initials: Y
authors.lastname: Hong
authors.affiliation: Department 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.
authors.forename: Cheng
authors.initials: C
authors.lastname: Huang
authors.affiliation: Department 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.
authors.forename: Hongyu
authors.initials: H
authors.lastname: Zhen
authors.affiliation: Department 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.
authors.forename: Lin
authors.initials: L
authors.lastname: Lin
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D001952:Bridged-Ring Compounds / Q000008:administration & dosage / Q000009:adverse effects; D018450:Disease Progression; D004334:Drug Administration Schedule; D043169:Endostatins / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009362:Neoplasm Metastasis; D009503:Neutropenia / Q000139:chemically induced; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D011994:Recombinant Proteins; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D001952:Bridged-Ring Compounds; D043169:Endostatins; D018719:Erb-b2 Receptor Tyrosine Kinases; D011994:Recombinant Proteins; D043823:Taxoids; C080625:taxane; C508053:ERBB2 protein, human; C522911:endostar protein
keywords: HER-2 negative; endostar; metastatic breast cancer; taxanes