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

Abstract

PurposeThe 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.MethodsA 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).ResultspCR 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%.ConclusionThe 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.

Neoadjuvant chemotherapy in combination with surgery in the treatment of local advanced breast cancer

“…Besides, the drug regimen in neo adjuvant chemotherapy is not accurately clinically defined, while anthracyclines, docetaxel and cyclophosphamide are commonly used as neo adjuvant chemotherapy drugs. Jeon et al reported that the application of neo adjuvant chemotherapy in the treatment of LABC could degrade the clinical stages to benefit surgery and clearly understand the sensitivity of breast cancer to chemotherapy drugs 17…”

The impact of metformin use on the outcomes of locally advanced breast cancer patients receiving neoadjuvant chemotherapy: an open-labelled randomized controlled trial

“…Besides, approximately up to 75% of the breast tumors are ER + 39 . In the current trial, a pCR of 10% was set as the baseline value in the control group, based on several studies that showed a pCR of 7.1%, 8.3%, 10.1%, 11%, and 12.4% in locally advanced BC patients 40 – 44 . On the other hand, the setting in this study considered a 25% improvement in the pCR of the metformin group was based on several studies.…”

Evaluation of Post-Neoadjuvant Chemotherapy Pathologic Complete Response and Residual Tumor Size of Breast Cancer: Analysis on Accuracy of MRI and Affecting Factors

“…둘째, 대상 환자군의 신보강화학요법의 종류 및 기간에 다양성이 존재하였고, 이것이 병변의 반응 양상에 영향을 미쳤을 수 있다. 특히 우리 연구에서는 Docetaxel-Gemcitabine 요법으로 치료한 환자군이 상당수 포함되어 있고(35.23%), Docetaxel-Gemcitabine 화학요법은 Anthracycline 및 Taxane을 기반으로 하는 화학요법에 비해 병리적 완전 관해 비율이 다소 떨어질 수 있다( 32 ). 또한 Taxane 화학요법은 잔류 암의 조영증강을 감소시켜 치료에 대한 반응을 과대평가하게 하고 위음성 사례의 원인이 될 수 있다고 알려져 있다( 33 ).…”