Neoadjuvant Dose-Dense Gemcitabine plus Docetaxel and Vinorelbine plus Epirubicin for Operable Breast Cancer

Abstract

Background: Neoadjuvant anti-tumor activity of an alternating taxane-and anthracycline-based dose-dense regimen in patients with operable, noninflammatory large breast cancer was investigated. Objective: The objective is to study the rate of pathological complete response in patients with breast cancer receiving dose-dense chemotherapy sequentially with gemcitabine plus docetaxel and vinorelbine plus epirubicin. Methods: Women (n = 74) with clinical stage II or III breast cancer were enrolled in this open-label, multicenter study to receive six 2-weekly courses of gemcitabine 1000 mg/m 2 plus docetaxel 75 mg/m 2 on days 1 and 15, and vinorelbine 25 mg/m 2 plus epirubicin 100 mg/m 2 on days 29 and 43. Patients with an objective response on day 56 then received another cycle of gemcitabine/docetaxel on day 57 and of vinorelbine/epirubicin on day 71. Conservative surgery was scheduled for all patients. Results: Of the patients enrolled, 30% had triple-negative breast cancer (TNBC). The pathologic complete response (pCR) rate was 22% overall, but was higher in TNBC than patients without TNBC (40.9% vs 14.0%; p = 0.028). Among patients with a pCR, patients with TNBC had similar recurrence-free survival (RFS) and overall survival (OS) to patients without TNBC. Among those without a pCR, RFS rates for patients with TNBC were significantly lower than for patients without TNBC (p = 0.04). The most common severe hematologic toxicity was neutropenia.

A randomized controlled phase II trial of a novel composition of paclitaxel embedded into neutral and cationic lipids targeting tumor endothelial cells in advanced triple-negative breast cancer (TNBC)

“…Both in advanced BC [10] and in operable TNBC [11], dose-dense weekly or biweekly taxanes achieved greater efficacy than larger doses given less often. EndoTAG™-1 is a cationic liposome formulation of lipid-embedded paclitaxel, targeting paclitaxel to negatively charged, activated tumor endothelial cells [12].…”

Effect of neoadjuvant chemotherapy in patients with triple-negative breast cancer: A meta-analysis

“…A total of 480 studies were first identified for evaluation. Based on the criteria described in the methods, 19 publications were eligible for inclusion in the present meta-analysis (10,12,(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28)(29)(30)(31). The bibliographies of these 19 publications were also searched, but this did not provide further studies for inclusion.…”

“…A total of 13 stu dies (10,(15)(16)(17)(18)(19)(20)24,25,(27)(28)(29)(30) reported the pCR rates in patients with TNBC and non-TNBC who received NAC. There was no heterogeneity between the results of different studies (I 2 =23%, P=0.21), so the fixed-effects model was applied for data analysis.…”

Evaluation of Efficacy and Toxicity of Neoadjuvant Alternating Chemotherapy in Patients With Locally Advanced Triple Negative Breast Cancer

“…Medioni J. с соавт. сообщают о 40,9 % пПР при использовании альтерниру-ющего режима, включающего комбинации «гемцитабин + доцетаксел» и «эпирубицин + винорелбин» [22].…”