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RESEARCH PRODUCT

Safety of trastuzumab, alone or in combination, in elderly patients with HER2-positive breast cancer: A 5-year case series.

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e11056 Background: Breast cancer (BC) is frequent in the elderly and is burdened by high recurrence and death rates, due mostly to undertreatment. Trastuzumab (T), in combination with chemotherapy (CT) or hormonotherapy (HT), is a well-established treatment strategy for early and advanced HER2-positive (HER2+) breast cancer, but has been poorly studied in the elderly setting due to its infrequency. The aim of our study is to assess the safety of T in elderly patients with HER2+ BC. Methods: Between 2005 and 2010, consecutive HER2+ breast cancer patients of ≥70 years of age referred to two oncology centers and that received T-based therapy were retrospectively reviewed. All patients were treated according to multidimensional geriatric assessment (MGA) and clinical criteria. Results: Of 59 patients, 51 were evaluable with a mean age of 76 years (range 70-86). Trastuzumab was well tolerated overall. Median left ventricular ejection function (LVEF) at baseline was 61% and at the end of treatment was 55%. The most relevant adverse events consisted of only one case (2%) of symptomatic congestive heart failure, which required treatment withdrawal and six (12%) asymptomatic decreases of LVEF (3 pts >15% and 3 pts >10% versus baseline). Mild to moderate hypersensitivity reactions associated with T-containing infusions occurred in 3 patients (5.8%). Hypertension, obesity and previous anthracycline-based treatment and combination with CTs gave a trend towards a higher incidence of toxic events. Previous radiotherapy, concurrent HT and the different T schedules did not influence toxicity. Conclusions: Our data shows a good trastuzumab safety profile in non-frail women age 70 and older. These favourable findings may be related to the limited number of anthracycline pre-treatments, a substantial patient selection by MGA and close cardiologic monitoring. [Table: see text]