Rossi D et al. - In a trial to determine the activity and safety of a schedule with a low dose of pegylated liposomal doxorubicin (PLD) and weekly paclitaxel in operable and locally advanced breast cancer pts, it was concluded that the combination of biweekly PLD and weekly paclitaxel was active in operable and locally advanced breast cancer with a manageable safety profile Methods
35 pts with histologically confirmed, operable, and locally advanced breast cancer entered the study
The schedule was biweekly PLD at the dose of 15 mg/m2 for 4 administrations and weekly paclitaxel at the dose of 80 mg/m2 for 8 administrations
All pts were evaluable for response and toxicity
Results
26 pts responded: 3 had complete response and 23 had partial response, 7 remained stable, and 1 experienced progression
15 of 27 operable pts underwent conservative surgery; 3 pts had pathological complete response and disappearance of infiltrating disease was documented in 3 pts
The main toxicity was hand-foot syndrome; other nonhematological grade 3 toxicities included stomatitis in 3 pts and liver toxicity in 1 pt
Grade 3-4 neutropenia was documented in another 3 pts and dose reduction was necessary in 2 pts
The fourth administration of PLD was suspended in 4 pts for grade 2-3 hand-foot syndrome
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