Abstract
Purpose
To evaluate the efficacy and toxicity of pegylated liposomal doxorubicin in patients with advanced endometrial cancer.
Methods
Pegylated liposomal doxorubicin was administered at a dose of 40 mg/m2, and repeated on an every 28-day schedule.
Results
A total of 19 patients were enrolled in this phase 2 trial. Fourteen patients had received prior chemotherapy (carboplatin/paclitaxel-9; cisplatin/paclitaxel-3; single agent paclitaxel-2), seven prior radiation therapy, and three prior hormonal therapy. No patients had previously received doxorubicin. Two patients (11%) developed grade 1 hand-foot syndrome following treatment with pegylated liposomal doxorubicin. There were no episodes of cardiac dysfunction (>10% reduction in baseline ejection fraction). Three patients required hospitalization for nausea, vomiting, anemia, and dehydration. Only 2 (11%) patients required dose reduction. Four of 19 patients (21%; 95% CI: 3–39%) evaluable for response exhibited objective and subjective evidence of an antineoplastic effect of therapy (duration of responses: 2 months, 3 months, 4 months, 6+ months).
Conclusion
The pegylated liposomal doxorubicin regimen employed in this trial exhibited an acceptable toxicity profile (cardiac dysfunction, hand-foot syndrome). Definite, although modest, antineoplastic activity in a patient population with recurrent or advanced endometrial cancer was documented.
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Escobar, P.F., Markman, M., Zanotti, K. et al. Phase 2 trial of pegylated liposomal doxorubicin in advanced endometrial cancer. J Cancer Res Clin Oncol 129, 651–654 (2003). https://doi.org/10.1007/s00432-003-0497-8
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DOI: https://doi.org/10.1007/s00432-003-0497-8