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Annals of Oncology 2007 Apr;18(4):716-21. Epub 2007 Feb 13.

Pegylated liposomal doxorubicin HCL (PLD; Caelyx/Doxil®): Experience with long-term maintenance in responding patients with recurrent epithelial ovarian cancer.

Andreopoulou E, Gaiotti D, Kim E, Downey A, Mirchandani D, Hamilton A, Jacobs A, Curtin J, Muggia F.

Division of Medical Oncology, Department of Medicine, New York University School of Medicine, New York, NY 10016.

Significance:

The recent publication "Pegylated liposomal doxorubicin HCL (PLD; Caelyx/Doxil®): Experience with long term maintenance in responding patients with recurrent epithelial ovarian cancer" is being of especial interest to the drug  development sector.

The concept of maintenance after first recurrence is more compelling because subsequent responses tend to be shorter than the first disease-free interval.

Our experience indicates that long term maintenance with (PLD; Caelyx/Doxil®)   in patients with ovarian cancer at risk of relapse is safe and may be important for a continued response.  The issue of maintenance with PLD in the management of relapsed ovarian cancer urgently needs to be addressed in prospective first and second line-trials.  Although a similar strategy is applicable to other drugs used in second line, there are attractive aspects of PLD maintenance: a long dosing interval, near absence of acute or chronic toxicities except for dermatologic, and no need for any accompanying premedication or special venous access requirements.

Abstract:

BACKGROUND: We hypothesized that a response to pegylated liposomal doxorubicin (PLD, Caelyx/Doxil®) followed by maintenance is beneficial and safe in recurrent ovarian cancer.

PATIENTS AND METHODS: Sixteen patients have received PLD for more than 1 year for recurrent ovarian (14) or fallopian tube (2) cancer. All had stable disease or better responses to PLD + carboplatin (5) or topotecan (9) doublets or to PLD alone (2). PLD maintenance therapy 30-40 mg/m(2) was given every 4-8 weeks. This analysis focuses on cardiac status, overall tolerance, and time to recurrence.

RESULTS: Termination of PLD was due to progression in all patients. Noteworthy was the lack of cumulative myelosuppression and, with one exception, clinical cardiac toxicity. This patient was hospitalized with cardiogenic shock and fever complicating grade 4 pancytopenia from topotecan ten months after discontinuation of PLD. Seven patients continue to receive PLD after a median of 1680 mg/m(2) (1180-2460 mg/m(2)). Four of these had documented relapses after 3-6 years on maintenance occurring in the setting of lengthening of the treatment interval. Maintenance PLD was reinstituted after 'reinduction' with a platinum.

CONCLUSIONS: PLD appears to be safe as long-term maintenance in ovarian cancer and may be important for a continued response.

PMID: 17301073