Neoadjuvant docetaxel plus carboplatin vs epirubicin plus cyclophosphamide followed by docetaxel in triple‐negative, early‐stage breast cancer (NeoCART): Results from a multicenter, randomized controlled, open‐label phase II trial

Abstract

Background: Previous studies have shown that the addition of carboplatin to neoadjuvant chemotherapy regimens improved the pathologic complete response (pCR) rate in patients suffering from triple-negative breast cancer (TNBC). However, no studies have assessed the effects of the combination of docetaxel and carboplatin without anthracycline with taxane-and anthracycline-based regimens.Methods: The NeoCART study was designed as a multicenter, randomized controlled, open-label, phase 2 trial to assess the e cacy and safety of docetaxel combined with carboplatin with taxane-and anthracycline-based neoadjuvant chemotherapy in untreated stage II-III TNBC. All eligible patients were randomly assigned, at a 1:1 ratio, to the experimental DCb group (docetaxel plus carboplatin for six cycles) or the EC-D group (epirubicin plus cyclophosphamide followed by docetaxel). In both groups, pCR (ypT0/is ypN0) was evaluated as the primary outcome.Results: Between September 1, 2016, and December 31, 2019, 93 patients from 6 participating centers were randomly assigned, and 88 patients were evaluated for the primary end-point (44 patients in the DCb group and 44 patients in the EC-D group). In the primary end point analysis, 27 patients in the DCb group achieved a pCR (61.4%, 95% CI 47.0-75.8), and 17 patients in the EC-D group achieved a pCR (38•6%, 95% CI 24.3-53.0); with a difference of 22.8% (odds ratio 2.52, 95% CI 2.4-43.1; p non-inferiority=0.004), noninferiority was met, and the DCb regimen was con rmed as superior to the EC-D regimen (p=0.044, superiority margin of 5%). At the end of the 37-month median follow-up period, overall survival and eventfree rates were equivalent in both groups. The grade 3/4 adverse events in the DCb group included anemia (4.5%), thrombocytopenia (2.3%), neutropenia (2.3%) and an increased alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ratio (2.3%).Conclusions: Compared with the taxane-and anthracycline-based regimen, the pCR rate of DCb was higher in TNBC patients.

Efficacy and safety of apatinib combined with dose‐dense paclitaxel and carboplatin in neoadjuvant therapy for locally advanced triple‐negative breast cancer: A prospective cohort study with propensity‐matched analysis

“…A previous study involving two independent prospective cohorts reported a pCR rate of 55% with the treatment of neoadjuvant carboplatin plus docetaxel for TNBC patients, which was comparable with the pCR rates achieved with the treatment of neoadjuvant carboplatin plus anthracycline‐taxane chemotherapy 32 . Recently, the randomized controlled NeoCART study first demonstrated that neoadjuvant docetaxel plus carboplatin achieved a higher pCR rate compared with conventional anthracycline‐taxane followed taxanes regimens for TNBC patients (61.4% vs 38.6%, P = .004), and the survival outcomes were comparable 33 …”

“…32 Recently, the randomized controlled NeoCART study first demonstrated that neoadjuvant docetaxel plus carboplatin achieved a higher pCR rate compared with conventional anthracycline-taxane followed taxanes regimens for TNBC patients (61.4% vs 38.6%, P = .004), and the survival outcomes were comparable. 33 Dose-dense chemotherapy shortens the treatment cycle and increases the dose intensity thus improving anti-tumor efficacy, which has been recommended as a routine postoperative adjuvant chemotherapy option. 34,35 Studies have demonstrated that dose-dense taxanes could significantly improve the pCR rate and long-term survival of patients with early-stage high-risk breast cancer.…”

Neoadjuvant docetaxel plus cisplatin versus docetaxel plus doxorubicin and cyclophosphamide in early-stage triple-negative breast cancer (HELEN-001): results from a multicenter, randomized controlled, open-label phase II trial

“…38.6%, P = 0.044), with a pCR increase of 22.8% 17 . The data of this investigation are consistent with the NeoCART trial, although the absolute increase in pCR in this trial (16.1%) was smaller, likely due to the higher tumor burden of participants, with 63% of patients having node-positive tumors, including those with N3 involvement.…”

Low-dose apatinib combined with neoadjuvant chemotherapy in the treatment of early-stage triple-negative breast cancer (LANCET): a single-center, single-arm, phase II trial

“…The results of our study indicated promising antitumor activity of the combination of apatinib and standard chemotherapy. NeoCART study, 51 a multicenter, randomized controlled, phase II trial conducted by our institution to assess the efficacy and safety of docetaxel plus carboplatin versus EC-D in untreated stage II-III TNBC, showed that the rate of pCR in the EC-D group was 38.6%. Since the rate of pCR (54.8%) achieved in combination of apatinib and standard chemotherapy was dramatically higher than that of chemotherapy alone (38.6%), there may exist promising synergistic effect between apatinib and standard chemotherapy.…”