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Neoadjuvant dose-dense gemcitabine plus docetaxel and vinorelbine plus epirubicin for operable breast cancer: improved prognosis in triple-negative tumors.

Medioni J, Huchon C, Le Frere-Belda MA, Hofmann H, Bats AS, Eme D, Andrieu JM, Oudard S, Lecuru F, Levy E - Drugs R D (2011)

Bottom Line: Among those without a pCR, RFS rates for patients with TNBC were significantly lower than for patients without TNBC (p = 0.04).Administering four drugs in a dose-dense alternating sequence gave a high pCR in patients with operable, invasive breast cancer.Patients with TNBC with a pCR had similar OS to patients without TNBC, whereas patients with TNBC without a pCR had poorer survival rate than their non-TNBC counterparts.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Oncology, Georges Pompidou European Hospital, Paris, France. jacques.medioni@egp.aphp.fr

ABSTRACT

Background: Neoadjuvant anti-tumor activity of an alternating taxane- and anthracycline-based dose-dense regimen in patients with operable, non-inflammatory 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/m2 plus docetaxel 75 mg/m2 on days 1 and 15, and vinorelbine 25 mg/m2 plus epirubicin 100 mg/m2 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.

Conclusions: Administering four drugs in a dose-dense alternating sequence gave a high pCR in patients with operable, invasive breast cancer. Patients with TNBC with a pCR had similar OS to patients without TNBC, whereas patients with TNBC without a pCR had poorer survival rate than their non-TNBC counterparts.

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Patient (pt) clinical characteristics
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Tab1: Patient (pt) clinical characteristics

Mentions: Seventy-four patients were enrolled between December 2002 and December 2006, and all were included in the ITT and safety populations. One patient received chemotherapy but refused surgery, thus ] were 73 patients in the per-protocol population. Patient baseline demographic and disease characteristics are given in table I. Most patients had invasive ductal tumors (89%), tumor-node-metastasis (TNM) clinical stage II (81%), and Elston and Ellis histologic grade II (44%) or III disease (23%). Contrary to enrollment criteria, a small proportion of patients with HER2-positive (HER2+) disease were enrolled (two patients expressed ++ HER2). Twenty-two patients had TNBC and 51 had non-TNBC (data missing for one patient). Histologic grade was significantly higher in TNBC than patients without TNBC (p = 0.001).


Neoadjuvant dose-dense gemcitabine plus docetaxel and vinorelbine plus epirubicin for operable breast cancer: improved prognosis in triple-negative tumors.

Medioni J, Huchon C, Le Frere-Belda MA, Hofmann H, Bats AS, Eme D, Andrieu JM, Oudard S, Lecuru F, Levy E - Drugs R D (2011)

Patient (pt) clinical characteristics
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3585987&req=5

Tab1: Patient (pt) clinical characteristics
Mentions: Seventy-four patients were enrolled between December 2002 and December 2006, and all were included in the ITT and safety populations. One patient received chemotherapy but refused surgery, thus ] were 73 patients in the per-protocol population. Patient baseline demographic and disease characteristics are given in table I. Most patients had invasive ductal tumors (89%), tumor-node-metastasis (TNM) clinical stage II (81%), and Elston and Ellis histologic grade II (44%) or III disease (23%). Contrary to enrollment criteria, a small proportion of patients with HER2-positive (HER2+) disease were enrolled (two patients expressed ++ HER2). Twenty-two patients had TNBC and 51 had non-TNBC (data missing for one patient). Histologic grade was significantly higher in TNBC than patients without TNBC (p = 0.001).

Bottom Line: Among those without a pCR, RFS rates for patients with TNBC were significantly lower than for patients without TNBC (p = 0.04).Administering four drugs in a dose-dense alternating sequence gave a high pCR in patients with operable, invasive breast cancer.Patients with TNBC with a pCR had similar OS to patients without TNBC, whereas patients with TNBC without a pCR had poorer survival rate than their non-TNBC counterparts.

View Article: PubMed Central - PubMed

Affiliation: Department of Medical Oncology, Georges Pompidou European Hospital, Paris, France. jacques.medioni@egp.aphp.fr

ABSTRACT

Background: Neoadjuvant anti-tumor activity of an alternating taxane- and anthracycline-based dose-dense regimen in patients with operable, non-inflammatory 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/m2 plus docetaxel 75 mg/m2 on days 1 and 15, and vinorelbine 25 mg/m2 plus epirubicin 100 mg/m2 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.

Conclusions: Administering four drugs in a dose-dense alternating sequence gave a high pCR in patients with operable, invasive breast cancer. Patients with TNBC with a pCR had similar OS to patients without TNBC, whereas patients with TNBC without a pCR had poorer survival rate than their non-TNBC counterparts.

Show MeSH
Related in: MedlinePlus