Phase 2 trial of pegylated liposomal doxorubicin in advanced endometrial cancer.

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.

• Authors: Pedro F Escobar, Maurie Markman, Kristine Zanotti, Kenneth Webster, Jerome Belinson
• Journal: Journal of cancer research and clinical oncology (J Cancer Res Clin Oncol) Vol. 129 Issue 11 Pg. 651-4 (Nov 2003) ISSN: 0171-5216 [Print] Germany
• PMID: 14505047 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article)

Chemical References

• Antibiotics, Antineoplastic
• CA-125 Antigen
• Liposomes
• Polyethylene Glycols
• Doxorubicin

Topics

• Aged
• Antibiotics, Antineoplastic (therapeutic use)
• CA-125 Antigen (metabolism)
• Doxorubicin (adverse effects, therapeutic use)
• Drug Evaluation
• Endometrial Neoplasms (drug therapy)
• Female
• Humans
• Liposomes
• Middle Aged
• Polyethylene Glycols