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
Sixty-three patients were treated with Doxil 50 mg/m(2) 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.


CONCLUSIONS
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.
University of Southern California/Norris Cancer Center, Los Angeles, California, 90033, USA.
V P
VP
Israel
A A
AA
Garcia
L
L
Roman
L
L
Muderspach
A
A
Burnett
S
S
Jeffers
F M
FM
Muggia
D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D018394:CA-125 Antigen / Q000097:blood; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage* / Q000009:adverse effects; D004337:Drug Carriers; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy; D006801:Humans; D007262:Infusions, Intravenous; D008081:Liposomes; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000532:radiotherapy
D000970:Antineoplastic Agents; D018394:CA-125 Antigen; D004337:Drug Carriers; D008081:Liposomes; D004317:Doxorubicin