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

• Published in: International journal of clinical oncology 2015-06, Vol.20 (3), p.480-489
• Main Authors: Gavilá, Joaquín, Guerrero, Ángel, Climent, Miguel Ángel, Fernández, Aranzazu, Gozalbo, Francisco, Carrascosa, María, Camps, Josefina, Guillem, Vicente, Ruiz, Amparo
• Format: Article
• Language: English
• Subjects: Adenocarcinoma - drug therapy; Adenocarcinoma - metabolism; Adult; Aged; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Breast cancer; Breast Neoplasms - drug therapy; Breast Neoplasms - metabolism; Cancer Research; Doxorubicin - administration & dosage; Doxorubicin - analogs & derivatives; Drug therapy; Epidermal growth factor; Female; Humans; Medicine; Medicine & Public Health; Middle Aged; Neoadjuvant Therapy; Oncology; Original Article; Paclitaxel - administration & dosage; Polyethylene Glycols - administration & dosage; Receptor, ErbB-2 - metabolism; Remission Induction; Surgical Oncology; Trastuzumab - administration & dosage; Treatment Outcome; Young Adult
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-014-0727-x

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/m 2 every 3 weeks), paclitaxel (80 mg/m 2 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.