Phase II trial of carboplatin and distearoylphosphatidylcholine pegylated liposomal doxorubicin (Lipo-Dox) in recurrent platinum-sensitive ovarian cancer following front-line therapy with paclitaxel and platinum.
OBJECTIVE
To evaluate the effectiveness and toxicity of distearoylphosphatidylcholine pegylated liposomal doxorubicin (DPLD) combined with carboplatin for the treatment of platinum-sensitive, paclitaxel-pretreated, recurrent, epithelial ovarian cancer.


METHODS
A phase II study of carboplatin/DPLD treatment for platinum-sensitive, paclitaxel-pretreated, recurrent, epithelial ovarian cancer was initiated in July 2002. As of March 2008, a total of 32 patients were enrolled.


RESULTS
Of the 32 patients, one achieved a complete response; 19 (59%) achieved a partial response. The overall objective response rate was 62% (95% confidence interval [CI], 45%-80%). The median progression-free survival and overall survival for all 32 patients was 9.1 months (95% CI, 6.4-10.4 months) and 27.9 months (95% CI, 13.9-38.6 months), respectively. Toxicity was tolerable. The most common grade 3 or 4 toxicities were anemia (n=3) and nausea/vomiting (n=3). Grade 3/4 leukopenia (n=2), grade 3/4 thrombocytopenia (n=2) and grade 4 hepatitis (n=1) occurred in five patients.


CONCLUSIONS
Carboplatin/DPLD appears to be an effective regimen with low toxicity for treatment of patients with platinum-sensitive, paclitaxel-pretreated, recurrent, epithelial ovarian cancer.
Hsiao
Sheng-Mou
SM
Department of Obstetrics and Gynecology, Far Eastern Memorial Hospital, Pan-Chiao, Taipei, Taiwan.
Chen
Chi-An
CA
Lin
Ho-Hsiung
HH
Hsieh
Chang-Yao
CY
Wei
Lin-Hung
LH
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D010713:Phosphatidylcholines / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage
D010713:Phosphatidylcholines; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; C010942:1,2-distearoyllecithin; D017239:Paclitaxel