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

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.

• Authors: 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
• Journal: Medical oncology (Northwood, London, England) (Med Oncol) Vol. 30 Issue 1 Pg. 435 (Mar 2013) ISSN: 1559-131X [Electronic] United States
• PMID: 23397080 (Publication Type: Journal Article, Meta-Analysis, Research Support, Non-U.S. Gov't)

Chemical References

• Antineoplastic Agents, Alkylating
• Dioxoles
• Tetrahydroisoquinolines
• Trabectedin

Topics

• Adult
• Aged
• Aged, 80 and over
• Antineoplastic Agents, Alkylating (administration & dosage, adverse effects, therapeutic use)
• Clinical Trials, Phase II as Topic
• Dioxoles (administration & dosage, adverse effects, therapeutic use)
• Disease-Free Survival
• Drug Administration Schedule
• Fatigue (chemically induced)
• Female
• Humans
• Middle Aged
• Neoplasm Recurrence, Local (therapy)
• Neutropenia (chemically induced)
• Ovarian Neoplasms (drug therapy, mortality)
• Tetrahydroisoquinolines (administration & dosage, adverse effects, therapeutic use)
• Trabectedin
• Treatment Outcome
• Vomiting (chemically induced)