Objectives: To characterize the incidence of skin toxicity of pegylated liposomal doxorubicin (PLD) administered at a lower dose (40 mg/m(2)) in the treatment of advanced gynecologic malignancies.
Methods: Medical charts of all patients who initiated PLD at a starting dose of 40 mg/m(2) from 1997 to 2003 for the treatment of gynecologic cancers were retrospectively reviewed. PLD was infused over 1-2 h and administered every 4-6 weeks. No patient had previously received doxorubicin. All patients were clinically assessed for adverse reactions including skin toxicity.
Results: Ninety patients (mean age 62 years, range 45-82 years) were included in this analysis. There were 55 ovarian, 16 endometrial, 2 fallopian, and 17 primary peritoneal cancers. The median cumulative dose of PLD was 120 mg/m(2) (range 40-855 mg/m(2)) with a median of 3 cycles (range 1-25). 33/90 (37%) developed a skin reaction during therapy. The overall incidence of grade 1, 2, and 3 skin toxicity was 23 (26%), 9 (10%), and 1 (1%), respectively. Of the 23 cases of grade 1 toxicity, 16 (70%) occurred within 1-3 cycles. All 9 cases of grade 2 toxicity occurred within 1-3 cycles. The only case of grade 3 toxicity occurred after the first cycle. 28/30 (93%) patients who continued treatment did not experience further episodes of skin toxicity with subsequent cycles after a dose reduction (5-20 mg/m(2)). PLD was stopped in only 2/90 (2%) cases due to a skin reaction.
Conclusions: Severe skin toxicity (> or =grade 2) associated with PLD occurs infrequently when initial doses of 40 mg/m(2) are administered. When skin reactions appear, they usually occur early in the course of treatment, respond to dose reduction, and do not appear to limit the duration of treatment.