Efficacy of pegylated liposomal doxorubicin (PLD) plus carboplatin in ovarian cancer patients who recur within six to twelve months: a phase II study.

Abstract:

OBJECTIVES: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. METHODS: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. RESULTS: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. CONCLUSIONS: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.

journal_name

Gynecol Oncol

journal_title

Gynecologic oncology

authors

Power P,Stuart G,Oza A,Provencher D,Bentley JR,Miller WH Jr,Pouliot JF

doi

10.1016/j.ygyno.2009.04.037

subject

Has Abstract

pub_date

2009-09-01 00:00:00

pages

410-4

issue

3

eissn

0090-8258

issn

1095-6859

pii

S0090-8258(09)00285-6

journal_volume

114

pub_type

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