Updated efficacy of adjuvant epirubicin plus cyclophosphamide followed by taxanes versus carboplatin plus taxanes in early triple-negative breast cancer in phase 2 trial: 8.1-year median follow-up.

Abstract

BACKGROUND:

Paclitaxel/docetaxel after doxorubicin plus cyclophosphamide (ECT) is considered as an adjuvant chemotherapy and improves the survival of early triple-negative breast cancer (TNBC) patients. We aim to assess whether carboplatin plus taxanes (TP) is non-inferior to ECT in prolonging the survival time.

METHODS:

TNBC patients were randomized (1:1) to receive ECT (90 mg/m2 epirubicin + 600 mg/m2 cyclophosphamide followed by 75 mg/m2 docetaxel or 175 mg/m2 paclitaxel every 3 weeks, n = 154) or TP (75 mg/m2 docetaxel or 175 mg/m2 paclitaxel + carboplatin AUC 5 every 3 weeks, n = 154). These expression of SPARC, PD-L1, and BRCA were studied. Patients were followed up for disease-free survival (DFS), overall survival (OS), and safety.

RESULTS:

We recruited 308 TNBC patients (median follow-up of 97.6 months). The median DFS and OS were not reached; the 8-year DFS rate of ECT and TP arms was 78.4% and 81.7%, respectively, while the 8-year OS rate were 87.2% and 89.1%, respectively. In the SPARC (> 50%) subgroup analysis, the TP arm had longer DFS (P = 0.049) and a tendency with better OS (P = 0.06) than ECT arm. No significant differences were observed in the DFS and OS between the ECT arm and TP arm in TNBC with SPARC (≤ 50%), PD-L1 (-) PD-L1 (+), and BRCA mutation or BRCA wild (all P values > 0.05).

CONCLUSION:

TP showed non-inferiority for DFS and OS compared with ECT in early TNBC. TP may be an effective alternative chemotherapy for TNBC patients whom the standard ECT regimen is not being used.

TRAIL REGISTRATION:

ClinicalTrials.gov identifier NCT01150513.

• Authors: Fangchao Zheng, Feng Du, Wenmiao Wang, Yongsheng Wang, Ming Li, Jiuda Zhao, Xue Wang, Jian Yue, Jiayu Wang, Zixuan Yang, Ruigang Cai, Fei Ma, Ying Fan, Qing Li, Pin Zhang, Binghe Xu, Peng Yuan
• Journal: Breast cancer research and treatment (Breast Cancer Res Treat) Vol. 191 Issue 1 Pg. 97-105 (Jan 2022) ISSN: 1573-7217 [Electronic] Netherlands
• PMID: 34648118 (Publication Type: Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)
• Copyright: © 2021. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

Chemical References

• Taxoids
• Epirubicin
• Cyclophosphamide
• Carboplatin
• Paclitaxel

Topics

• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Carboplatin (adverse effects)
• Chemotherapy, Adjuvant
• Cyclophosphamide (adverse effects)
• Epirubicin (adverse effects)
• Female
• Follow-Up Studies
• Humans
• Paclitaxel (adverse effects)
• Taxoids (adverse effects)
• Treatment Outcome
• Triple Negative Breast Neoplasms (drug therapy)