320PD - Significantly superior outcome after neoadjuvant chemotherapy with docetaxel, anthracycline and cyclophosphomide versus docetaxel plus cyclophosphom...

Date 29 September 2012
Event ESMO Congress 2012
Session Breast cancer, early stage
Topics Anti-Cancer Agents & Biologic Therapy
Breast Cancer, Locally Advanced
Presenter Xiaosong Chen
Authors X. Chen1, G. Ye2, C. Zhang3, X. Li4, K. Shen1
  • 1Comprehensive Breast Health Center, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, 200023 - Shanghai/CN
  • 2Department Of Breast Surgery, 2. The First People's Hospital of Foshan, Foshan/CN
  • 3Department Of Breast Surgery, 3. Guangzhou General Hospital of Guangzhou Military Area, Guangzhou/CN
  • 4Department Of Breast Surgery, 4. Shanxi Provincical Cancer Hospital, Taiyuan/CN

 

Abstract

Objective

To evaluate the activity and safety of docetaxel plus cyclophosphomide (TC) compared with docetaxel, anthracycline and cyclophosphomide (TAC) in neoadjuvant treatment of triple negative or HER2 positive breast cancer, which may help us to determine the role of anthracycline in breast cancer treatment.

Methods

Clinical stage IIB or III breast cancer patients were treated with six cycles of TC (docetaxle 75 mg/m2 and cyclophosphomide 600 mg/m2) or TAC (docetaxle 75 mg/m2, anthracycline, and cyclophosphomide 500 mg/m2). Either epirubicin 60mg/m2 or adimycin 50mg/m2 was allowed as an anthracycline regimen. The primary end point was pathological complete remission (pCR), defined as no residual invasive cancer in breast and axillary lymph node. Seconday end points included safety, clinical response rate, event free survival (EFS), disease free survival (DFS), and overall survival (OS).

Results

102 patients were randomized and 96 patients were available for analysis (TC: n = 45; TAC: n = 51). After surgery, pCR rate was 6.8% (3/45) and 17.6% (9/51) in TC and TAC group, respectively, P = 0.113. There was also no difference in clinical response rate. However, with mean follow up of 20 (3-36) months, TAC treatment, compared with TC, resulted in a significantly superior EFS (80.4% vs 60.0%, respectively; adjusted HR = 2.42 (95% CI: 1.11 to 5.30); P = 0.027), better DFS (84.3% vs 64.4%, respectively; adjusted HR = 2.85 (95% CI: 1.21 to 6.74); P = 0.017) and a trend towards less death (96.1% vs 86.7%, respectively; adjusted HR = 2.52 (95% CI: 0.41-15.38); P = 0.315). Patients treated with TAC had relative high rates of grade 3-4 neutropenia and leukopenia, and rates of other severe adverse events were similar and no patients died on treatment.

Conclusions

pCR rate was not significantly different between TAC and TC in neodajuvant treatment of triple negative or HER2 positive breast cancer. Adding anthracycline to TC can significantly improve patients' outcome, which deserves further investigation. (Sponsored by Sanofi; ClinicalTrials.gov number, NCT00912444.)

Disclosure

All authors have declared no conflicts of interest.