PMID- 36426808
OWN - NLM
STAT- MEDLINE
DCOM- 20230123
LR  - 20230424
IS  - 1549-490X (Electronic)
IS  - 1083-7159 (Print)
IS  - 1083-7159 (Linking)
VI  - 28
IP  - 1
DP  - 2023 Jan 18
TI  - Nab-paclitaxel Followed by Dose-dense Epirubicin/Cyclophosphamide in Neoadjuvant 
      Chemotherapy for Triple-negative Breast Cancer: A Phase II Study.
PG  - 86-e76
LID - 10.1093/oncolo/oyac223 [doi]
AB  - BACKGROUND: The anti-tumor activity of nab-paclitaxel followed by 
      epirubicin/cyclophosphamide (EC) as neoadjuvant chemotherapy (NAC) in Asian 
      patients remain unclear, particularly in the aggressive subtype triple-negative 
      breast cancer (TNBC). This study aimed to evaluate the efficacy and safety of 
      this NAC regimen in TNBC. METHODS: In this Simon's two-stage, phase II study, 
      treatment-naive patients with unilateral primary invasive TNBC were enrolled. 
      Eligible patients received nab-paclitaxel 125 mg/m2 weekly on day 1 for 12 weeks, 
      followed by dose-dense EC (epirubicin 90 mg/m2; cyclophosphamide 600 mg/m2) on 
      day 1 for four 2-week cycles. The primary endpoint was the total pathological 
      complete response (tpCR, ypT0/is ypN0) rate. RESULTS: A total of 55 eligible 
      patients were enrolled and treated. After NAC, tpCR and breast pathological 
      complete response were respectively observed in 43.1% (95% CI, 29.3-57.8) and 
      49.0% (95% CI, 34.8-63.4) of 51 evaluable patients for pathological response 
      evaluation. 44 had an objective response as their best response (80.0%; 95% CI, 
      67.0-89.6). No correlations between clinicopathological variables and 
      pathological/clinical response were observed. Grade 3 or more adverse events 
      (AEs) occurred in 63.6% of 55 patients. The most frequent AEs were alopecia. No 
      treatment-related surgical delay or death occurred. CONCLUSION: Nab-paclitaxel 
      followed by dose-dense EC as NAC demonstrates promising anti-tumor activity and 
      acceptable tolerability for patients with TNBC. (ClinicalTrials.gov Identifier: 
      NCT03799679).
CI  - (c) The Author(s) 2022. Published by Oxford University Press.
FAU - Liu, Yin
AU  - Liu Y
AD  - Department of Breast Surgery, Fudan University Shanghai Cancer Center and Key 
      Laboratory of Breast Cancer in Shanghai, Department of Oncology, Shanghai Medical 
      College, Fudan University, Shanghai, People's Republic of China.
FAU - Fan, Lei
AU  - Fan L
AD  - Department of Breast Surgery, Fudan University Shanghai Cancer Center and Key 
      Laboratory of Breast Cancer in Shanghai, Department of Oncology, Shanghai Medical 
      College, Fudan University, Shanghai, People's Republic of China.
FAU - Wang, Zhong-Hua
AU  - Wang ZH
AD  - Department of Breast Surgery, Fudan University Shanghai Cancer Center and Key 
      Laboratory of Breast Cancer in Shanghai, Department of Oncology, Shanghai Medical 
      College, Fudan University, Shanghai, People's Republic of China.
FAU - Shao, Zhi-Ming
AU  - Shao ZM
AUID- ORCID: 0000-0002-4503-148X
AD  - Department of Breast Surgery, Fudan University Shanghai Cancer Center and Key 
      Laboratory of Breast Cancer in Shanghai, Department of Oncology, Shanghai Medical 
      College, Fudan University, Shanghai, People's Republic of China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03799679
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Oncologist
JT  - The oncologist
JID - 9607837
RN  - 0 (130-nm albumin-bound paclitaxel)
RN  - 8N3DW7272P (Cyclophosphamide)
RN  - 3Z8479ZZ5X (Epirubicin)
RN  - P88XT4IS4D (Paclitaxel)
SB  - IM
MH  - Female
MH  - Humans
MH  - *Antineoplastic Combined Chemotherapy Protocols/adverse effects
MH  - Cyclophosphamide/therapeutic use
MH  - Epirubicin/therapeutic use
MH  - *Neoadjuvant Therapy/adverse effects
MH  - Paclitaxel/therapeutic use
MH  - Treatment Outcome
MH  - *Triple Negative Breast Neoplasms/drug therapy/pathology
PMC - PMC9847528
OTO - NOTNLM
OT  - nab-paclitaxel
OT  - breast cancer
OT  - neoadjuvant chemotherapy
OT  - triple-negative breast cancer
COIS- The authors indicated no financial relationships.
EDAT- 2022/11/26 06:00
MHDA- 2023/01/21 06:00
PMCR- 2022/11/25
CRDT- 2022/11/25 07:12
PHST- 2022/06/28 00:00 [received]
PHST- 2022/09/26 00:00 [accepted]
PHST- 2022/11/26 06:00 [pubmed]
PHST- 2023/01/21 06:00 [medline]
PHST- 2022/11/25 07:12 [entrez]
PHST- 2022/11/25 00:00 [pmc-release]
AID - 6847064 [pii]
AID - oyac223 [pii]
AID - 10.1093/oncolo/oyac223 [doi]
PST - ppublish
SO  - Oncologist. 2023 Jan 18;28(1):86-e76. doi: 10.1093/oncolo/oyac223.