Pilot phase 2 trial of 4 months of maintenance pegylated liposomal Doxorubicin in patients with advanced ovarian cancer after complete response to platinum and Paclitaxel-based chemotherapy.
OBJECTIVE
Stages III and IV ovarian and peritoneal cancer patients are commonly treated with combination chemotherapy after surgical debulking. This phase II trial investigated the use of pegylated liposomal doxorubicin as consolidation chemotherapy for these patients.


METHODS
Women with stage III or IV ovarian or primary peritoneal carcinoma demonstrating no clinical evidence of disease after primary therapy were eligible for enrollment. Patients received 4 cycles of 40 mg/m(2) IV of pegylated liposomal doxorubicin every 28 days.


RESULTS
Twelve patients were enrolled. There were 6 stage IIIC and 6 stage IV patients. Ten patients received 4 cycles. Two patients had dose limiting skin toxicity manifest as hand-foot syndrome and received only 3 cycles. Forty-six of a planned 48 cycles were administered. Median disease-free survival from registration is 10 months with a mean of 18 months. Median overall survival has not yet been reached. Four patients are disease-free, two have relapsed and six have died from disease progression.


CONCLUSIONS
Pegylated liposomal doxorubicin is a well-tolerated choice for consolidation chemotherapy in patients with ovarian or primary peritoneal carcinoma.
DiSilvestro
Paul A
PA
Long Island Gynecologic Oncologists, Smithtown, NY, USA. pdisilvestro@wihri.org
Fisher
Margaret
M
Pearl
Michael L
ML
Buhl
Ann
A
Chalas
Eva
E
Valea
Fidel A
FA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002945:Cisplatin / Q000008:administration & dosage; D004317:Doxorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017239:Paclitaxel / Q000008:administration & dosage; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000473:pathology; D010865:Pilot Projects; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000627:therapeutic use*; D016019:Survival Analysis; D016896:Treatment Outcome
C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D017239:Paclitaxel; D002945:Cisplatin