Treatment of recurrent platinum-resistant ovarian cancer with pegylated liposomal doxorubicin--an evaluation of the therapeutic index with special emphasis on cardiac toxicity.

Background: To study the efficacy of pegylated liposomal doxorubicin (PLD) at a modified dose of 45 mg/m(2) every 4 weeks in platinum-resistant ovarian cancer and to evaluate toxicities and effects on quality of life (QoL) of this single-agent regimen.
Methods: Treatment response was evaluated by CT scan or CA 125 levels. Toxicity and QoL was recorded according to the common toxicity criteria of the National Cancer Institute and the EORTC QLQ-C30 questionnaire, respectively.
Results: Eighty-five patients entered this nationwide observational study (384 cycles administered) and 4 (4.7%) achieved complete and 22 (25.8%) partial remission, giving an objective response rate of 30.5%. Eight patients experienced therapy-limiting side effects prompting discontinuation of treatment. Palmoplantar erythrodysesthesia (PPE) and/or stomatitis were the main reasons for discontinuation. Grade 3-4 PPE and stomatitis occurred in 4.2 and 2.2% of the 384 cycles, respectively. Grade 3-4 cardiotoxicity was absent and overall QoL was not significantly decreased following PLD treatment.
Conclusion: Single-agent PLD at a dose of 45 mg/m(2) is an efficient treatment in recurrent platinum-resistant ovarian cancer and exhibits an exceptionally favorable therapeutic index.
(Copyright 2009 S. Karger AG, Basel.)