| Title | Neoadjuvant docetaxel and capecitabine (TX) versus docetaxel and epirubicin (TE) for locally advanced or early her2-negative breast cancer: an open-label, randomized, multi-center, phase II Trial |
| Authors | Yang, Houpu Xu, Ling Guan, Shan Hao, Xiaopeng Ge, Zhicheng Tong, Fuzhong Cao, Yingming Liu, Peng Zhou, Bo Cheng, Lin Liu, Miao Liu, Hongjun Xie, Fei Wang, Siyuan Peng, Yuan Wang, Chaobin Wang, Shu |
| Affiliation | Peking Univ, Peoples Hosp, Breast Ctr, Beijing, Peoples R China Peking Univ First Hosp, Breast Dis Ctr, Beijing, Peoples R China Capital Med Univ, Beijing Tongren Hosp, Dept Breast Ctr, Beijing, Peoples R China Chinese Peoples Liberat Army Gen Hosp, Med Ctr 1, Dept Gen Surg, Beijing, Peoples R China Capital Med Univ, Beijing Friendship Hosp, Dept Gen Surg, Beijing, Peoples R China |
| Keywords | ANTHRACYCLINE-PRETREATED PATIENTS THYMIDINE PHOSPHORYLASE ADJUVANT CAPECITABINE PLUS DOCETAXEL FOLLOW-UP CHEMOTHERAPY SURVIVAL EFFICACY BENEFIT CYCLOPHOSPHAMIDE |
| Issue Date | 28-Dec-2022 |
| Publisher | BMC CANCER |
| Abstract | Purpose: The combination of taxanes and anthracyclines is still the mainstay of chemotherapy for early breast cancer. Capecitabine is an active drug with a favorable toxicity profile, showing strong anti-tumor activity against metastatic breast cancer. This trial assessed the efficacy and safety of the TX regimen (docetaxel and capecitabine) and compared it with the TE (docetaxel and epirubicin) regimen in locally advanced or high risk early HER2-negative breast cancer. Patients and methods: This randomized clinical trial was conducted at five academic centers in China. Eligible female patients were randomly assigned (1:1) to the TX (docetaxel 75 mg/m(2) d1 plus capecitabine 1000 mg/m(2) twice d1-14, q3w) or TE (docetaxel 75 mg/m(2) d1 plus epirubicin 75 mg/m(2) d1, q3w) groups for four cycles. The primary endpoint was a pathological complete response in the breast (pCR). Secondary endpoints included pCR in the breast and axilla, invasive disease-free survival (iDFS), overall survival (OS), and safety. Results: Between September 1, 2012, and December 31, 2018, 113 HER2-negative patients were randomly assigned to the study groups (TX: n = 54; TE: n = 59). In the primary endpoint analysis, 14 patients in the TX group achieved a pCR, and nine patients in the TE group achieved a pCR (25.9% vs. 15.3%), with a not significant difference of 10.6% (95% CI -6.0-27.3%; P = 0.241). In a subgroup with high Ki-67 score, TX increased the pCR rate by 24.2% (95% CI 2.2-46.1%; P = 0.029). At the end of the 69-month median follow-up period, both groups had equivalent iDFS and OS rates. TX was associated with a higher incidence of hand-foot syndrome and less alopecia, with a manageable toxicity profile. Conclusion: The anthracycline-free TX regimen yielded comparable pCR and long-term survival rates to the TE regimen. Thus, this anthracycline-free regimen could be considered in selected patients. |
| URI | http://hdl.handle.net/20.500.11897/669142 |
| DOI | 10.1186/s12885-022-10439-0 |
| Indexed | SCI(E) |
| Appears in Collections: | 人民医院 第一医院 |
