J Breast Cancer.  2017 Dec;20(4):340-346. 10.4048/jbc.2017.20.4.340.

A Multicenter Phase II Trial of Neoadjuvant Chemotherapy with Docetaxel and Gemcitabine in Locally Advanced Breast Cancer

• Jeon YW
• Kim TH
• Youn HJ
• Han S
• Jung Y
• Gwak G
• Park YS
• Kim JS
• Suh YJ

• KMID: 2398203
• DOI: http://doi.org/10.4048/jbc.2017.20.4.340

Abstract

PURPOSE
The current multicenter phase II study was conducted to evaluate the efficacy and safety of the combination of docetaxel and gemcitabine as neoadjuvant chemotherapy (NAC) for locally advanced breast cancer.
METHODS
A total of 98 patients with stage II-III breast cancer were enrolled. The primary endpoint was pathological complete response (pCR) rate of invasive cancer after the completion of the fourth cycle of NAC. The secondary endpoints included response rate (RR), rate of breast-conserving surgery, toxicity, and disease-free survival (DFS). This study is registered with ClinicalTrials.gov (NCT01352494).
RESULTS
pCR in the breast and the axillary lymph node was observed in seven of the 98 enrolled patients (7.1%). The overall clinical RR, including partial responses, was 65.3%. Breast-conserving surgery was performed in 75 of the 98 assessable patients (76.5%). Neutropenia was frequent and was observed in 92 of the 98 patients (93.9%), including grade 3 and 4 in 24 patients (24.5%) and 63 patients (64.3%), respectively. Dose reductions were required for 30 of the 92 patients (32.6%). After a median follow-up of 24 months, the overall DFS of the group was 86.7%.
CONCLUSION
The combination of docetaxel and gemcitabine did not improve pCR. However, this regimen has shown potential as a NAC by producing a reasonable rate of breast-conserving surgery and favorable responses in patients with locally advanced breast cancer. The therapeutic efficacy of this regimen will be determined in additional trials to overcome the limitations of the current study.

Keyword

Breast neoplasms; Docetaxel; Gemcitabine; Neoadjuvant therapy

MeSH Terms

Breast Neoplasms*
Breast*
Disease-Free Survival
Drug Therapy*
Follow-Up Studies
Humans
Lymph Nodes
Mastectomy, Segmental
Neoadjuvant Therapy
Neutropenia
Polymerase Chain Reaction

Figure

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  Figure 1 Kaplan-Meier curves showing the disease-free survival of all patients (n=98).

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