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Clinical Trial
. 2016 Sep 13;7(37):60647-60656.
doi: 10.18632/oncotarget.10607.

Better pathologic complete response and relapse-free survival after carboplatin plus paclitaxel compared with epirubicin plus paclitaxel as neoadjuvant chemotherapy for locally advanced triple-negative breast cancer: a randomized phase 2 trial

Pin Zhang  1 , Yi Yin  2 , Hongnan Mo  1 , Bailin Zhang  3 , Xiang Wang  3 , Qing Li  1 , Peng Yuan  1 , Jiayu Wang  1 , Shan Zheng  4 , Ruigang Cai  1 , Fei Ma  1 , Yin Fan  1 , Binghe Xu  1
Affiliations
Clinical Trial

Better pathologic complete response and relapse-free survival after carboplatin plus paclitaxel compared with epirubicin plus paclitaxel as neoadjuvant chemotherapy for locally advanced triple-negative breast cancer: a randomized phase 2 trial

Pin Zhang et al. Oncotarget. .

Abstract

Background: No standard chemotherapy is used as neoadjuvant therapy in triple negative breast cancer (TNBC). This study has compared carboplatin plus paclitaxel with commonly used epirubicin plus paclitaxel as neoadjuvant chemotherapy (NAC) in TNBC.

Results: 91 patients with a median age of 47 years (PC 47 patients, EP 44 patients) were enrolled. 65% of the patients were premenopausal. While the objective response rate was similar in the PC and EP arm (89.4% vs. 79.5%, P = 0.195), the pCR rate in the PC arm was significantly higher (38.6% vs. 14.0%, P = 0.014). The median follow-up time was 55.0 months. 5-year RFS were 77.6% and 56.2%, significantly higher in the PC arm, P = 0.043. No significant difference in OS was observed between the two arms (P = 0.350). Adverse events were similar, except for more thrombocytopenia in the PC arm (P = 0.001).

Methods: Patients with stage II/III TNBC were randomized to receive either paclitaxel (175 mg/m2, day1) plus carboplatin (Area Under the Curve = 5, day2) (PC) or epirubicin (75mg/m2, day1) plus paclitaxel (175 mg/m2, day2) (EP) as NAC every three weeks for 4-6 cycles. The primary endpoint was rate of pathologic complete response (pCR).The secondary endpoints included relapse-free survival (RFS), overall survival (OS) and safety.

Conclusions: This study suggested that the addition of carboplatin to paclitaxel was superior to the regimen of epirubicin plus paclitaxel as NAC for TNBC in terms of improving pCR rate and RFS. Further phase 3 study has already started.

Keywords: breast cancer; carboplatin; neoadjuvant chemotherapy; paclitaxel; triple negative.

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Conflict of interest statement

CONFLICTS OF INTEREST

The authors have declared no conflicts of interest.

Figures

Figure 1
Figure 1. Trial profile
Figure 2
Figure 2. The pathologic complete response (pCR) rate of patients in different arms
When compared with those in the EP arm, patients in the PC arm had significantly higher pCR (ypT0/isN0) rate (38.6% vs. 14.0%; P = 0.014), both in breast (ypT0/is; 43.2% vs. 18.60%; P = 0.024) and in axilla (ypN0; 62.5% vs. 29.4%; P = 0.008).
Figure 3
Figure 3. Subgroup analysis in patients achieving pCR after two different treatments
PC, paclitaxel plus carboplatin regimen; EP, epirubicin plus paclitaxel regimen; pCR, pathologic complete response.
Figure 4
Figure 4. Kaplan-Meier plot of Relapse-free survival (RFS) and overall survival (OS) (a) by different neoadjuvant regimens, and (b) in patients who achieved pathologic complete response (pCR) or not (non-pCR)
a. Patients in the paclitaxel plus carboplatin (PTX+CBP) arm had significant better RFS when compared to the epirubicin plus paclitaxel (PTX+EPI) arm (P = 0.043). The long-term OS of patients in the PTX+CBP arm were almost the same as that of patients in the PTX+EPI arm (P = 0.350). b. The pCR patients had significantly better RFS (P = 0.001) and OS (P = 0.004) than the non-pCR patients.
See this image and copyright information in PMC

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