title: Phase 2 trial of pegylated liposomal doxorubicin in advanced endometrial cancer.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  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.
mesh_terms: D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000627:therapeutic use*; D018394:CA-125 Antigen / Q000378:metabolism; D004317:Doxorubicin / Q000009:adverse effects / Q000627:therapeutic use*; D004341:Drug Evaluation; D016889:Endometrial Neoplasms / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008081:Liposomes; D008875:Middle Aged; D011092:Polyethylene Glycols
chemical_list: D000903:Antibiotics, Antineoplastic; D018394:CA-125 Antigen; D008081:Liposomes; D011092:Polyethylene Glycols; D004317:Doxorubicin