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A randomized Phase III trial of neoadjuvant recombinant human endostatin, docetaxel and epirubicin as first‐line therapy for patients with breast cancer ( CBCRT 01)
Author(s) -
Chen Jianghao,
Yao Qing,
Huang Meiling,
Wang Bo,
Zhang Juliang,
Wang Ting,
Ming Yu,
Zhou Xiaodong,
Jia Qianxin,
Huan Yi,
Wang Jing,
Wang Ling
Publication year - 2017
Publication title -
international journal of cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.475
H-Index - 234
eISSN - 1097-0215
pISSN - 0020-7136
DOI - 10.1002/ijc.31217
Subject(s) - medicine , epirubicin , docetaxel , adverse effect , breast cancer , endostatin , clinical endpoint , oncology , randomized controlled trial , phases of clinical research , regimen , progressive disease , neoadjuvant therapy , chemotherapy , cancer , surgery , angiogenesis
To further assess the efficacy and safety of recombinant human endostatin (rh‐endostatin), a Phase III, multicenter, prospective, randomized, controlled clinical trial was conducted. Patients to be treated with neoadjuvant docetaxel and epirubicin (DE) or DE plus rh‐endostatin (DEE) were eligible for this trial. The primary endpoint was clinical/pathological response. Secondary endpoints included adverse events and quality of life (QOL). Finally, 803 patients were enrolled and randomly assigned to receive DE ( n = 402) or DEE ( n = 401) regimen. After three cycles of neoadjuvant therapy, “complete response” achieved in 14.2% of patients in DEE group versus 6.7% in DE group, “partial response” achieved in 76.8% versus 71.1%, while “stable disease” in 6.0% versus 18.9%, “progressive disease” in 3.0% versus 3.2% of patients. The rate of objective response in DEE and DE group was 91.0% and 77.9%, respectively ( p < 0.001). In spite of a relatively higher pathological complete response achieved following the combination therapy, no significant difference was found between two arms. Adverse events were mostly of Grades 1–2. No significant difference in adverse event and QOL was found between the two arms. In conclusion, the combination of chemotherapy and rh‐endostatin achieved better outcomes than chemotherapy alone, and thus can be considered as a promising therapeutic strategy for breast cancer.