PurposeThis retrospective analysis evaluated treatment with trabectedin plus
pegylated liposomal doxorubicin (PLD) in 34 heavily pretreated patients
(median number of previous lines, 3; range, 2-10) with platinum-sensitive
relapsed ovarian cancer (ROC) at a single center in Italy.MethodsTrabectedin/PLD treatment consisted of trabectedin administered every 3 weeks
as a 3-hour intravenous (i.v.) infusion at a dose of 1.1 mg/m2,
immediately after PLD 30 mg/m2 i.v. infusion. Study objectives
were the evaluation of the objective response rate (ORR), progression-free
survival (PFS) and overall survival (OS).ResultsThree complete responses and 8 partial responses were observed, with an ORR
of 32.4% (95% CI, 17.450.5%). Median PFS was 6.1 months (95% CI, 4.4-8.9
months). Median OS was 16.3 months (95% CI, 6.8-23.5). Most responses (9 of
11) were found in patients with partially platinum-sensitive disease (ORR
40.9% in this subset; median PFS 6.8 months and median OS 20.8 months).
Grade 3 treatment-related adverse events consisted of nausea/vomiting (n =
5; 14.7%), mucositis (n = 2; 5.9%), alanine aminotransferase increase,
anemia and neutropenia (n = 1 each; 2.9%).ConclusionsThe overall findings appear consistent with those previously observed in a
randomized controlled clinical trial, and support the use of trabectedin/PLD
in heavily pretreated patients with platinum-sensitive ROC, especially those
with partially platinum-sensitive disease.