Biweekly liposomal pegylated doxorubicin in elderly women with advanced breast cancer: A prospective multicenter trial focusing on tolerability and cardiotoxicity.

Abstract

1138 Background: To assess tolerability and activity of liposomal pegylated doxorubicin (PLD) in women older than 70 years with locally advanced or metastatic breast cancer within a multicenter prospective trial. Methods: All pts underwent Multidimensional Geriatric Assessment (MGA) and frail pts (dependence in Activities of Daily Living; three or more severe comorbidities, geriatric syndromes) were excluded. Normal cardiac function was required at baseline. Bi-weekly schedule of 20 mg/m2 was adopted. More than 12 doses were prescribed only to responsive pts. Results: From Feb 2006 to Sep 2009, 28 pts were enrolled, median age 77 yrs (range 70-93), 10.7% had locally advanced disease, 10.7% only bone metastases, 78.6% visceral involvement; 28.6% of pts had been pre-treated with one or more lines of chemotherapy for advanced disease. After MGA, 35.7% were deemed fit and 64.3% vulnerable. A mean of 7.2 doses were delivered (range 1 to 20), with an actual dose intensity of 8.9 mg/m2/week (range 5.2-10). Worst toxicity experienced by pts is outlined in table. No cardiac events were registered. Only 1 pt received both G-CSF and erythropoietin. Causes of treatment interruption were progression 46.4%, refusal/loss at follow-up 21.4%, toxicities 10.7%, other or ongoing 10.7%. RECIST response was obtained in 34.8% of 23 evaluable pts, 30.4% remained stable; with a median TTP of 4.4 mo (11 censored), and a median OS of 15.4 mo. Receiving full dose intensity vs <9 mg/m2/week did not impact on response (p=0.26) and progression (p=0.6), as well as MGA status (vulnerable vs FIT, p=0.65 for response, p=0.9 for progression). Conclusions: Biweekly PLD monochemotherapy is well tolerated in terms of hematological and cardiac safety both by fit and vulnerable pts, with an apparently fairly good response rate. Close follow-up of pts is recommended in order to monitor skin toxicity and avoid early refusal/loss at follow-up. Accrual is still ongoing. Toxicity according to CTCAE v3 Grade 1-2 Grade 3-4 Neutropenia 23% 0 Thrombocytopenia 5% 0 Anemia 18% 9% Palmar-plantar erythrodysesthesia 41% 9% Nausea/vomiting 32% 0 Mucositis 18% 9% Infection 0 5% No significant financial relationships to disclose.