Yondelis Ovarian Cancer . Multicenter Retrospective study to Evaluate the Impact of Trabectedin plus Pegylated Liposomal Doxorubicin on the subsequent Treatment in Women with Recurrent, Platinum-Sensitive Ovarian Cancer .

Copyright © 2019 Wolters Kluwer Health, Inc.

Ignacio Romero; Pedro Mallol; Ana Santaballa; José Del Campo; Marta Mori; Santiago González-Santiago; Antonio Casado; David Vicente; Eugenia Ortega; Ana Herrero; Eva Guerra; Pilar Barretina-Ginesta, María Rubio; Alejandro Martínez; Isabel Bover; Laura Vidal; Ángels Arcusa; Lola Martín; Yolanda García; Antonio González-Martín .

Abstract

Debulking surgery, followed by taxane/platinum-based chemotherapy has traditionally been the First-line treatment for advanced ovarian cancer.

However, most patients will experience recurrence afterwards, and receive subsequent lines of therapy.

It has been proposed that extending the treatment-free interval of platinum can improve the response to a subsequent platinum-based chemotherapy, and reduce associated toxicities in women with recurrent, platinum-sensitive ovarian cancer.

The aim was to determine the impact, in clinical practice, of trabectedin with pegylated liposomal doxorubicin (trabectedin/PLD) on the subsequent platinum-based therapy in these patients, and to explore the prognosis for breast cancer gene status and the expression of diverse genes.

This was a multicenter, retrospective, postauthorization study that involved 79 patients. Germline or somatic mutations of breast cancer gene 1/2 were present in 21.5%.

The median time between trabectedin/PLD and the onset of the subsequent treatment was 6.7 months. The overall response rate during the trabectedin/PLD period was 36.7%.

In the subsequent first-line platinum-based therapy, the overall response rate was 51.4%. Progression-free survival and overall survival were 11.8 and 25.4 months, respectively, from the onset of trabectedin/PLD treatment.

Partially platinum-sensitive (between 6 and 12 months) and platinum-sensitive patients (treatment-free interval of platinum≥12 months) showed no differences in progression-free survival and overall survival.

Grade 3 neutropenia and asthenia were reported in 15.2 and 10.1% of patients, respectively. Most frequent adverse events in more than 10% of patients were neutropenia (45.6%), asthenia (43.0%), nausea (25.3%), and anemia (13.9%).

The intercalation with a nonplatinum regimen may improve the response to a subsequent platinum-based therapy in women with recurrent, platinum-sensitive ovarian cancer.