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

Campo, José; Sessa, Cristiana; Krasner, Carolyn; Vermorken, Jan; Colombo, Nicoletta; Kaye, Stan; Gore, Martin; Zintl, Patrik; Gómez, Javier; Parekh, Trilok; Park, Youn; McMeekin, Scott
March 2013
Medical Oncology;Mar2013, Vol. 30 Issue 1, p1
Academic Journal
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.


Related Articles

  • A randomized phase II study evaluating the combination of carboplatin-based chemotherapy with pertuzumab versus carboplatin-based therapy alone in patients with relapsed, platinum-sensitive ovarian cancer. Kaye, S. B.; Poole, C. J.; Dańska-Bidzińska, A.; Gianni, L.; Del Conte, G.; Gorbunova, V.; Novikova, E.; Strauss, A.; Moczko, M.; McNally, V. A.; Ross, G.; Vergote, I. // Annals of Oncology;Jan2013, Vol. 24 Issue 1, p145 

    Background Pertuzumab, a humanized monoclonal antibody targeting human epidermal growth factor receptor (HER)-mediated signalling, has shown activity in ovarian cancer in preclinical models and in the clinic. This randomized phase II study evaluated efficacy and safety of pertuzumab in...

  • Optimal treatment of early-stage ovarian cancer. Collinson, F.; Qian, W.; Fossati, R.; Lissoni, A.; Williams, C.; Parmar, M.; Ledermann, J.; Colombo, N.; Swart, A. // Annals of Oncology;Jun2014, Vol. 25 Issue 6, p1165 

    There is evidence of a long-term benefit of adjuvant post operative chemotherapy for early-stage ovarian cancer. The magnitude of benefit is greatest in patients at a higher risk of recurrence defined as stage 1B/1C grade 2/3, any stage 1 grade 3 or clear cell histology. The use of single agent...

  • Surgical intervention in relapsed ovarian cancer is beneficial: contra. Markman, M. // Annals of Oncology;Dec2013 Supplement 10, Vol. 24, px35 

    Secondary cytoreduction in the management of patients with recurrent ovarian cancer is a commonly employed strategy. Unfortunately, there remain ‘no evidence-based phase III trial data’ to demonstrate the survival benefits of this approach compared with the reintroduction of...

  • Management of Ovarian Cancer and Soft Tissue Sarcoma: Focus on Trabectedin. Dahl, Karen Cowden; Chan, Teresa W.; Balkhi, Bander; Zeineldin, Reema // Clinical Medicine Reviews in Oncology;Aug2011, Issue 3, p93 

    Ovarian cancer (OVCA) and soft tissue sarcoma (STS) are cancers that cause low survival rates when diagnosed at advanced disease stage and patients with these cancers usually suffer from recurrent disease. Trabectedin, an alkaloid of marine origin has recently demonstrated improvement in...

  • Advanced ovarian cancer: what should be the standard of care? Goff, Barbara A. // Journal of Gynecologic Oncology;Mar2013, Vol. 24 Issue 1, p83 

    The standard treatment of advanced ovarian cancer is rapidly changing. As we begin to understand that epithelial ovarian cancer is a heterogeneous disease, our treatment strategies are evolving to include novel biologic drugs that specifically exploit altered pathways. Surgery remains an...

  • Maintenance Therapy in Epithelial Ovarian Cancer: Rationale and Results. Markman, Maurie // Clinical Ovarian Cancer;Jun2008, Vol. 1 Issue 1, p40 

    Although ovarian cancer is highly sensitive to chemotherapy, the majority of patients experience recurrence. As a result, it is rational to consider a maintenance strategy to improve overall survival (even if it does not increase the rate of "cure") and delay the time to symptomatic disease...

  • Clinical features of long-term survivors of recurrent epithelial ovarian cancer. Iwase, Haruko; Takada, Toshio; Iitsuka, Chiaki; Nomura, Hidetaka; Abe, Akiko; Taniguchi, Tomoko; Sakamoto, Kimihiko; Takizawa, Ken; Takeshima, Nobuhiro // International Journal of Clinical Oncology;Feb2015, Vol. 20 Issue 1, p143 

    Background: Although recurrent epithelial ovarian cancer (EOC) is generally regarded as an incurable disease, some patients survive more than 5 years after the first recurrence. The aim of this study was to evaluate the clinical features of patients with recurrent EOC who achieve long-term...

  • ATP-Based Chemotherapy Response Assay in Primary or Recurrent Ovarian and Peritoneal Cancer. Maria Lee; Sang Wun Kim; Eun Ji Nam; Hanbyoul Cho; Jae Hoon Kim; Young Tae Kim; Sunghoon Kim // Yonsei Medical Journal;Nov2014, Vol. 55 Issue 6, p1664 

    Purpose: To investigate chemosensitivity with an adenosine triphosphate-based chemotherapy response assay in patients with epithelial ovarian or peritoneal cancer according to tumor histology, grade, and disease status. Materials and Methods: One hundred specimens were collected during primary...

  • Emerging treatment options for recurrent ovarian cancer: the potential role of olaparib. Shaw, Heather M.; Hall, Marcia // OncoTargets & Therapy;2013, Vol. 6, p1197 

    Olaparib has shown promising anticancer activity as a single agent in the treatment and maintenance of recurrent ovarian cancer in early clinical trials, but it is far from standard therapy. This article outlines the problem of relapsed ovarian cancer and the mechanisms of poly(ADP-ribose)...


Read the Article


Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics