Trabectedin with pegylated liposomal doxorubicin (PLD) may provide long-term benefits for pre-treated patients with platinum-sensitive recurrent ovarian cancer (ROC), according to a study published in the Journal of Cancer Research and Clinical Oncology.
Ingo B. Runnebaum, MD, MBA, of the Department of Gynecology and Reproductive Medicine and ESGO Training Center for Gynecologic Oncology at Jena University Hospital in Germany, and associates conducted a noninterventional, prospective real-life analysis to determine the effects of trabectedin plus PLD in platinum-sensitive ROC patients.
Eligible participants were older than age 18 years (median age, 66 years) with advanced ovarian cancer and recurrence after a platinum-free interval of 6 or more months. Seventy-seven patients were pretreated with ≥ 1 platinum-containing treatment/ s. The main outcome studied was the safety and tolerability of the trabectedin (1.1 mg/m2) plus PLD (30 mg/m2) combination therapy.
Patients were administered a median of 6 cycles of treatment (range 1-21) with median durations for 4.2 months (range 0.7-18.8); 50.6% of patients (n=39) received more than 6 cycles. Treatments were mostly administered on an outpatient basis (83.3% of participants).
The most frequent trabectedin-related adversities were leukopenia (18.2%), neutropenia (15.6%), thrombocytopenia (9.1%), alanine (7.8%) and aspartate (6.5%) aminotransferase elevations, and nausea/vomiting (5.2%). No unexpected adversities or deaths resulting from drug-related adverse events occurred during the study; 6.5% and 24.7% of participants had complete and partial response, respectively (median response duration, 6.25 months). Disease control was 51.9%, and median progression-free and overall survival rates were 6.3 months and 16.4 months, respectively.
“Trabectedin plus PLD confer clinically meaningful benefit to pre-treated patients with platinum-sensitive ROC, being comparable to those previously observed in selected populations from clinical trials and with a manageable safety profile,” the authors concluded.
Runnebaum IB, Reichert D, Ringsdorf U, et al. Trabectedin plus pegylated liposomal doxorubicin (PLD) for patients with platinum-sensitive recurrent ovarian cancer: a prospective, observational, multicenter study. J Cancer Res Clin Oncol. 2018;144:1185