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Annals of Oncology 2007 18(Supplement 6):vi11-vi15; doi:10.1093/annonc/mdm217
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© 2007 European Society for Medical Oncology

monoclonal antibodies anti-EGFR and anti-VEGF

Safety and activity of trastuzumab-containing therapies for the treatment of metastatic breast cancer: our long-term clinical experience (GOIM study)

V Adamo1,*, T Franchina1, B Adamo1, G Ferraro1, R Rossello1, M Maugeri Saccà1, C Scibilia2, MR Valerio2 and A Russo2

1 Department of Human Pathology, Medical Oncology and Integrated Therapies Unit, Universitary Policlinic "G.Martino" of Messina, Messina
2 Department of Surgery and Oncology, Section of Medical Oncology, Università di Palermo, Palermo, Italy

* Correspondence to: Dr V. Adamo, U.O. Oncologia medica e Terapie Integrate, A.O. Universitaria Policlinico G. Martino, via Consolare Valeria, 98124 Messina, Italy. Tel: +0902213238; Fax: +0902213669; E-mail: adamovi{at}libero.it

Background: Trastuzumab is widely used as the treatment of choice for HER2-positive metastatic breast cancer (MBC).

Patients and methods: Seventy patients, median age 57 years and range 31–81 years, were included in our retrospective analysis with the aim to evaluate safety and activity of trastuzumab-containing therapies.

Results: We observed for first-line treatment response rate (RR) 41%, stable disease (SD) 47% and time to progression (TTP) 8 months (range 1–44). Corresponding numbers for second line were RR 23%, SD 62% and (TTP) 9 months (range 3–23) and beyond second line RR 22%, SD 78% and (TTP) 9 months (range 4–19). Overall survival was 19.2 months (3–62 months). The median cumulative dose of trastuzumab administrated was 5286 mg (464–17 940 mg). Trastuzumab was well tolerated. Median left ventricular ejection function (LVEF) at baseline was 62% and at the end of treatment was 59%. The more relevant adverse events consisted of an asymptomatic decrease in LVEF to 40% (baseline 60%) and a grade 3 symptomatic increase in bilirubin.

Conclusion: Trastuzumab-containing therapies in MBC show a good safety and toxicity profile and a remarkable activity even in heavily pretreated women. Patients should benefit from continued trastuzumab therapy, as shown by the maintenance of (TTP) even beyond second-line treatment.

Key words: cardiac safety, clinical experience, heavily pretreated women, metastatic breast cancer, retrospective analysis, trastuzumab


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