Combination of pegylated liposomal doxorubicin plus gemcitabine in heavily pretreated metastatic breast cancer patients: Long‐term results from a single institution experience
Abstract The combination of Pegylated Liposomal Doxorubicin (PLD) plus Gemcitabine (GEM) has been previously investigated in the treatment of metastatic breast cancer (MBC). PLD is a doxorubicin formulation with prolonged circulation time and better tissue distribution. GEM is a nucleoside analog with nonoverlapping toxicity compared to PLD. The aim of our study was to assess efficacy, toxicity, and long‐term outcome of this combination. Patients with heavily treated MBC were retrospectively analyzed. Chemotherapy consisted of PLD 25 mg/m 2 and GEM 800 mg/m 2 day 1, on a three‐week schedule. Cardiac function was evaluated baseline and during treatment. Radiological response was graded according to RECIST criteria v1.1. Toxicity was scored according to CTCAE v4.0. Progression‐free survival (PFS) and overall survival (OS) were evaluated. From 2001 to 2014, 122 pts were included. Median age was 55 (range: 28‐84). Median previous treatment schedules in the metastatic scenario were 3 (range: 1‐15). Most patients received prior anthracyclines (85%). Median number of metastatic sites was 2 (range: 1‐7). Median number of cycles delivered was 5 (range: 1‐36). Overall response rate was 31% (5% complete responses; 26% partial responses). Stable and progressive diseases were observed in 32% and 26% of patients. Grade ≥3 neutropenia was observed in 29 patients (24%). Grade ≥3 hand‐foot syndrome was detected in 17 patients (14%), mostly since cycle 3 (88%). Median cumulative PLD dose was 125 mg/m 2 . At a median follow‐up of 101 months, median PFS and OS were 7 and 22 months, respectively. PLD‐GEM combination achieves remarkable long‐term outcomes with an acceptable toxicity profile in patients with MBC.
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