Phase II Study of Liposomal Doxorubicin in Advanced Gynecologic Cancers

Objective. Pegylated liposomal doxorubicin (Doxil) may have enhanced therapeutic efficacy and reduced toxicity compared with the parent compound. This phase II study further evaluates the activity of Doxil in patients with ovarian cancer and explores activity in other gynecologic cancers. Methods. S...

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Bibliographic Details
Published in:Gynecologic oncology 2000-08, Vol.78 (2), p.143-147
Main Authors: Israel, Valerie P., Garcia, Augustin A., Roman, Linda, Muderspach, Laila, Burnett, Alexander, Jeffers, Susan, Muggia, Franco M.
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic agents
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Biological and medical sciences
CA-125 Antigen - blood
Chemotherapy
Combined Modality Therapy
Disease-Free Survival
Doxorubicin - administration & dosage
Doxorubicin - adverse effects
Drug Carriers
Female
Genital Neoplasms, Female - drug therapy
Genital Neoplasms, Female - pathology
Genital Neoplasms, Female - radiotherapy
Humans
Infusions, Intravenous
Liposomes
Medical sciences
Middle Aged
Ovarian Neoplasms - drug therapy
Ovarian Neoplasms - pathology
Ovarian Neoplasms - radiotherapy
Pharmacology. Drug treatments
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Summary:Objective. Pegylated liposomal doxorubicin (Doxil) may have enhanced therapeutic efficacy and reduced toxicity compared with the parent compound. This phase II study further evaluates the activity of Doxil in patients with ovarian cancer and explores activity in other gynecologic cancers. Methods. Sixty-three patients were treated with Doxil 50 mg/m2 infused over 1 h; 44 were evaluable. Forty-eight had epithelial ovarian cancer and all received prior treatment with cisplatin and paclitaxel: 27 received two to six prior regimens, 44 were platinum resistant, 21 patients had measurable disease, and 27 had evaluable disease only. Results. The overall survival of these patients was 10 months (range, 0.25–33); progression-free survival was 3 months (range, 0.25–18). The response rate among those with measurable disease was 19%, with a median duration of 4.5 months (range, 3–12). The response rate of 22 patients with elevated CA-125 was 59%; median duration was 3.5 months (range, 1–12). Also, 27% achieved prolonged stabilization of disease for a median of 7 months (range, 5–18). Overall, treatment was well tolerated in this heavily pretreated population. Grade 3 and 4 toxic effects were: 5 grade 3 stomatitis, 3 grade 3 skin, 1 each grade 4 neutropenia and thrombocytopenia, 5 admits for infection, and no neutropenic fever; nausea and vomiting were uncommon in 204 cycles to ovarian cancer patients. Conclusion. This study demonstrates the activity of Doxil in heavily pretreated patients with ovarian cancer and poor prognostic features and confirms the prolonged responses and favorable toxicity profile. Encouraging findings were also observed in the patients with nonovarian gynecologic cancers.
ISSN:0090-8258
1095-6859
DOI:10.1006/gyno.2000.5819