Trabectedin as single agent in relapsed advanced ovarian cancer: Results from a retrospective pooled analysis of three phase II trials

José María Del Campo, Cristiana Sessa, Carolyn N. Krasner, Jan B. Vermorken, Nicoletta Colombo, Stan Kaye, Martin Gore, Patrik Zintl, Javier Gómez, Trilok Parekh, Youn Choi Park, Scott McMeekin

Research output: Contribution to journalArticle

Abstract

Three phase II studies evaluated trabectedin monotherapy as second-/third-line therapy in patients with refractory/recurrent ovarian cancer (ROC). Three different schedules were investigated: 3-h infusion every 3 weeks (3-h-q3w), 24-h infusion q3w (24-h-q3w), and 3-h weekly infusion for 3 weeks of a 4-week cycle. This retrospective pooled analysis evaluated the efficacy and the safety profile of trabectedin according to each administered regimen. Data from 295 patients were used to compare weekly versus q3w schedules, and 3-h versus 24-h infusion given q3w. Both q3w regimens showed higher overall response rate (36 vs. 16 %; p = 0.0001), disease control rate (66 vs. 46 %; p = 0.0007), and longer median progression-free survival (5.6 vs. 2.8 months; p <0.0001) than the weekly schedule. Comparable activity was observed for the 3- and 24-h infusions q3w. Common adverse events were nausea, fatigue, vomiting, transient neutropenia, and transaminase increases. A better safety profile regarding neutropenia, fatigue, and vomiting was seen for the 3-h-q3w regimen as compared to the 24-h-q3w one. Trabectedin given as a single agent q3w as 3-h infusion is the schedule of choice for the treatment of ROC, and its efficacy and safety profile favorably compares with other active salvage treatments.

Original languageEnglish
Article number435
JournalMedical Oncology
Volume30
Issue number1
DOIs
Publication statusPublished - Mar 2013

Keywords

  • Pooled analysis
  • Recurrent ovarian cancer
  • Trabectedin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Hematology
  • Medicine(all)

Fingerprint Dive into the research topics of 'Trabectedin as single agent in relapsed advanced ovarian cancer: Results from a retrospective pooled analysis of three phase II trials'. Together they form a unique fingerprint.

  • Cite this

    Del Campo, J. M., Sessa, C., Krasner, C. N., Vermorken, J. B., Colombo, N., Kaye, S., Gore, M., Zintl, P., Gómez, J., Parekh, T., Park, Y. C., & McMeekin, S. (2013). Trabectedin as single agent in relapsed advanced ovarian cancer: Results from a retrospective pooled analysis of three phase II trials. Medical Oncology, 30(1), [435]. https://doi.org/10.1007/s12032-012-0435-1