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.


CONCLUSIONS
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.
Steppan
Ilona
I
Department of Obstetrics and Gynecology, Innsbruck Medical University, Innsbruck, Austria.
Reimer
Daniel
D
Sevelda
Ursula
U
Ulmer
Hanno
H
Marth
Christian
C
Zeimet
Alain G
AG
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000903:Antibiotics, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D018394:CA-125 Antigen / Q000097:blood; D004317:Doxorubicin / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D003875:Drug Eruptions / Q000209:etiology; D019008:Drug Resistance, Neoplasm; D005260:Female; D005533:Foot Dermatoses / Q000139:chemically induced; D006229:Hand Dermatoses / Q000139:chemically induced; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009944:Organoplatinum Compounds / Q000494:pharmacology; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000503:physiopathology; D011092:Polyethylene Glycols / Q000009:adverse effects / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D013280:Stomatitis / Q000139:chemically induced; D011795:Surveys and Questionnaires; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D018394:CA-125 Antigen; D009944:Organoplatinum Compounds; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin