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International Journal of Clinical Oncology
Published in: International Journal of Clinical Oncology 3/2015

01-06-2015 | Original Article

Efficacy and safety of neoadjuvant chemotherapy with concurrent liposomal-encapsulated doxorubicin, paclitaxel and trastuzumab for human epidermal growth factor receptor 2-positive breast cancer in clinical practice

Authors: Joaquín Gavilá, Ángel Guerrero, Miguel Ángel Climent, Aranzazu Fernández, Francisco Gozalbo, María Carrascosa, Josefina Camps, Vicente Guillem, Amparo Ruiz

Published in: International Journal of Clinical Oncology | Issue 3/2015

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Abstract

Background

Based on previous results obtained with non-pegylated liposomal-encapsulated doxorubicin (TLC-D99) together with paclitaxel and trastuzumab in patients with human epidermal growth factor receptor 2 (HER2)-positive locally advanced or metastatic breast cancer (BC), a similar regimen was evaluated in the neoadjuvant setting in a prospectively selected series of consecutive patients with clinical stage II–III BC. Primary and secondary objectives included the rate of pathologic complete response (pCR), safety, and predictive factors of pCR.

Methods

Patients received six cycles of TLC-D99 (50 mg/m2 every 3 weeks), paclitaxel (80 mg/m2 weekly) and trastuzumab (4 mg/kg initial dose and 2 mg/kg weekly). All patients underwent surgery after treatment. pCR was defined as the absence of invasive cancer cells in the breast and the axilla.

Results

Sixty-two patients with a median age of 46.6 years were analyzed. Stage IIIA was diagnosed in 43.5 % of patients and 14.5 % had inflammatory BC. Conservative surgery was performed in 46.8 % of the patients and pCR was achieved in 63 % (95 % CI 50.5–75.5). Patients with estrogen receptor (ER)-negative tumors presented a significantly higher pCR rate than patients with ER-positive tumors (74.4 vs 43.5 %; P = 0.028). Forty-five patients (72.6 %) completed study treatment and 80.6 % received at least five treatment cycles. No patients developed congestive heart failure and 14.5 % of patients showed a ≥10 % decrease in the left ventricular ejection fraction.

Conclusion

The triple combination therapy assessed is effective and safe, offering a high pCR rate in patients with HER2-positive BC.
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Metadata
Title
Efficacy and safety of neoadjuvant chemotherapy with concurrent liposomal-encapsulated doxorubicin, paclitaxel and trastuzumab for human epidermal growth factor receptor 2-positive breast cancer in clinical practice
Authors
Joaquín Gavilá
Ángel Guerrero
Miguel Ángel Climent
Aranzazu Fernández
Francisco Gozalbo
María Carrascosa
Josefina Camps
Vicente Guillem
Amparo Ruiz
Publication date
01-06-2015
Publisher
Springer Japan
Published in
International Journal of Clinical Oncology / Issue 3/2015
Print ISSN: 1341-9625
Electronic ISSN: 1437-7772
DOI
https://doi.org/10.1007/s10147-014-0727-x

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