You could be reading the full-text of this article now if you...

If you have access to this article through your institution,
you can view this article in

Efficacy and Safety of Docetaxel Combined With Oxaliplatin as a Neoadjuvant Chemotherapy Regimen for Chinese Triple-Negative Local Advanced Breast Cancer Patients: A Prospective, Open, and Unicentric Phase II Clinical Trial

Fei, Fei MD; Chen, Canming MD, PhD; Xue, Jingyan MD; Di, Gen-Hong MD, PhD; Lu, Jin-Song MD, PhD; Liu, Guang-Yu MD, PhD; Shao, Zhi-Ming MD, PhD; Wu, Jiong MD, PhD

American Journal of Clinical Oncology:
doi: 10.1097/COC.0b013e31825d5317
Original Articles: Breast
Abstract

Background and Aims: To determine the efficacy and toxicity of an oxaliplatin-based regimen as a neoadjuvant chemotherapy setting in triple-negative local advanced breast cancer (TNLABC) patients.

Methods: Patients with stage IIIb or IIIc, chemotherapy-naive TNLABC receive docetaxel 75 mg/m2 day 1 and oxaliplatin 130 mg/m2 day 2, every 21 days for up to 4 cycles. The primary end point is pathologic complete response (CR), and the secondary end points are clinical response (including CR and partial response), disease-free survival, overall survival, and safety.

Results: Twenty-nine TNLABC patients were treated: 17(58.62%) had stage IIIB disease and 12 (41.38%) had stage IIIC disease. After neoadjuvant chemotherapy, there were 10 patients (34.48%) with pathologic CR (95% confidence interval, 21.51%-48.70%). Twenty patients responded (7 CR and 13 partial response) with a 68.97% total clinical response rate (95% confidence interval 57.51%-88.02%). Nearly 27.59% patients (8 patients) had disease progression after at least 2 cycles of chemotherapy, and only 1 patient (3.45%) had the disease stable, respectively. In the 29 treated patients, there were no unusual or unexpected adverse events in a total of 91 cycles for the chemotherapy setting. Common grade 3 or 4 hematologic toxicities were leukocytopenia, which occured in 4 TNLABC patients (13.79%), and thrombocytopenia in 1 patient (3.45%). Grade 3 or 4 transaminase elevation occured in 5 (17.24%) patients and grade 3 vomiting occured in 1(3.45%) patient. One patient experienced grade 3 neurosensory toxicities. There are 5 reports (17.24%) of grade 3 fatigue.

Conclusions: The results of this phase II clinical study suggest that docetaxel combined with oxaliplatin as a neoadjuvant chemotherapy regimen in TNLABC patients is active and well tolerated, and should be further investigated as a favorable treatment alternative for TNLABC patients. A large randomized prospective clinical study is warranted to confirm the results.

Author Information

*Department of Breast Surgery, Fudan University Shanghai Cancer Center

Department of Oncology, Shanghai Medical College, Fudan University, Shanghai, People’s Republic of China

This study was supported by a grant from Sanofi-Aventis Company.

The authors declare no conflicts of interest.

Reprints: Fei Fei, MD, Department of Breast Surgery, Fudan University Shanghai Cancer Center, Dong An Road 270#, Shanghai 200032, People’s Republic of China. E-mail: baketutu520@gmail.com.

© 2013 by Lippincott Williams & Wilkins, Inc