Trastuzumab and Vinorelbine as Highly Effective and Safe Therapy for HER-2-Overexpressing Metastatic Breast Cancer. A Single Institution Experience

Abstract

Aims and Background Trastuzumab-based therapy has improved survival of women with human epidermal growth factor receptor 2 (HER2)-overexpressing metastatic breast cancer. Study Design From September 2002 to July 2006, 45 women with metastatic breast cancer HER2 3+, or 2+ and positive for HER2 gene amplification, were enrolled in the study and received a combination therapy with vinorelbine, 25 mg/m2 weeks 1 and 2, plus trastuzumab, 4 mg/kg loading dose and then 2 mg/kg weekly, in a three weeks cycle. Eligibility criteria included measurable disease and a baseline ejection fraction ≥50%. Forty-two percent of the patients were not pretreated, whereas 58% had received a previous chemotherapy regimen for metastatic disease, including anthracy-clines and/or taxanes (47%), and trastuzumab plus taxol (11%). Results We observed 14 (31%) complete responses and 21 (47%) partial responses, with an overall response rate of 78%. Stable disease >6 months was assessed for 5 (11%) patients with a clinical benefit of 89%. Five (11%) patients progressed. With a median follow-up of 11 months, median time to progression was 9 months and median duration of response was 7.6 months for complete remissions and 4 months for partial remissions. Median survival was 29 months. Conclusions In spite of a smaller dose intensity of vinorelbine than previously reported, the regimen evaluated was notably effective in terms of response rate, time to progression and survival, with very mild toxicity.

Trastuzumab and Gemcitabine in Pretreated HER2 Overexpressing Metastatic Breast Cancer Patients: Retrospective Analysis of Our Series

“…Although the combination of taxane with trastuzumab is considered the reference therapy for HER2 overexpressing MBC, the recent published data of Traviota and Hernata study support the use of trastuzumab plus weekly VNR, as appropriate first-line regimen, as well as second-line regimen [ 9 – 21 ].…”

“…In a previous study, we tested efficacy and tolerability of trastuzumab plus vinorelbine (VNR) regimen in first- and second-line setting for HER2 overexpressing MBC, with value for response rate (RR) of 78%, median time to progression (TTP) of 9 months, and median overall survival (OS) of 28 mounths. Very mild toxicity was observed [ 9 ].…”