Efficacy of pegylated liposomal doxorubicin (PLD) plus carboplatin in ovarian cancer patients who recur within six to twelve months: a phase II study.
Pegylated liposomal doxorubicin is one of the preferred alternatives for ovarian cancer patients with early relapse (<6 months) and taxane/carboplatin for late relapse (>12 months), but the optimal therapy for the partially platinum-sensitive (6-12 months) population has not been defined. This single-arm phase II trial was designed to assess the efficacy of pegylated liposomal doxorubicin (PLD)/carboplatin in ovarian cancer patients who relapse between 6 and 12 months after initial treatment with platinum-based chemotherapy.



Ovarian cancer patients who previously completed a course of therapy with paclitaxel/carboplatin were administered PLD 30 mg/m(2) followed by carboplatin AUC 5 mg/mL/minute every 4 weeks.



Fifty-eight patients were enrolled in the study and 54 were eligible for the efficacy analysis, of whom most (75%) received at least 6 cycles of PLD/carboplatin. The objective response rate was 46% (4% CR and 42% PR), with an additional 33% experiencing disease stabilization >6 months. For those patients with measurable CA-125, the response rate was 66% (28% CR and 38% PR), with an additional 18% experiencing disease stabilization >6 months. Median time-to-progression was 10 months (1.5-25). Median overall survival was 19.1 months (2.2-38.9). The most frequent adverse effects were neutropenia, thrombocytopenia, and constipation.



The combination of PLD/carboplatin is efficacious and well tolerated in women with partially platinum-sensitive ovarian cancer and represents a valuable alternative for patients who relapse within 6-12 months of completing paclitaxel/carboplatin chemotherapy.
Power
Patti
P
Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland, Canada A1B 3V6. patti.power@easternhealth.ca
Stuart
Gavin
G
Oza
Amit
A
Provencher
D
D
Bentley
James R
JR
Miller
Wilson H
WH
Pouliot
Jean-François
JF
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D018394:CA-125 Antigen / Q000097:blood; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000097:blood / Q000188:drug therapy*; D017239:Paclitaxel / Q000008:administration & dosage; D011092:Polyethylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
D018394:CA-125 Antigen; C506643:liposomal doxorubicin; D011092:Polyethylene Glycols; D004317:Doxorubicin; D016190:Carboplatin; D017239:Paclitaxel