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

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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.

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Acknowledgments

The authors would like to acknowledge Antonio Nieto, James Jiao for data analysis and Adnan Tanović for writing assistance for the manuscript. Those studies were supported by funding form PharmaMar, Madrid, Spain, and Janssen Research & Development, L.L.C., Raritan, NJ 08869, USA.

Conflict of interest

Nicoletta Colombo and Stan Kaye were compensated as consultants or advisors. Patrik Zintl and Javier García are employees and stockholders of PharmaMar, S.A (Grupo Zeltia). Trilok Parekh and Youn Choi Park are employees in Janssen Research & Development, L.L.C. and hold stock in Johnson & Johnson Pharmaceutical Research & Development. All remaining authors have declared no conflicts of interest.

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Authors and Affiliations

  1. Gynecological, Head and Neck Cancer Division, Department of Medical Oncology, Vall d’Hebron University Hospital, Passeig Vall d’Hebron 119-129, 08035, Barcelona, Spain

    José María del Campo

  2. Division of Medical Oncology, Istituto Oncologico della Svizzera Italiana, Via Ospedale, 6500, Bellinzona, Switzerland

    Cristiana Sessa

  3. Fondazione IRCCS Istituto Nazionale dei Tumori , Via Venezian, 1, 20133, Milan, Italy

    Cristiana Sessa

  4. Department of Medical Oncology, Massachusetts General Hospital, Boston, MA, 02114, USA

    Carolyn N. Krasner

  5. Department of Medical Oncology, Antwerp University Hospital, Wilrijkstraat 10, 2650, Edegem, Belgium

    Jan B. Vermorken

  6. Department of Medical Oncology, Università Milano-Bicocca, Via Ripamonti, 435, 20141, Milan, Italy

    Nicoletta Colombo

  7. Department of Medical Oncology, Institute of Cancer Research, The Royal Marsden Hospital, Downs Road, Sutton, Surrey, SM2 5PT, UK

    Stan Kaye

  8. Department of Medicine, The Royal Marsden Hospital, Fulham Rd, London, SW3 6JJ, UK

    Martin Gore

  9. PharmaMar, Madrid, Spain

    Patrik Zintl & Javier Gómez

  10. Janssen Research and Development, L.L.C., Raritan, NJ, 08869, USA

    Trilok Parekh & Youn Choi Park

  11. Gynecologic Oncology Section, University of Oklahoma, Oklahoma City, OK, 73190, USA

    Scott McMeekin

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  1. José María del Campo
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Correspondence to José María del Campo.

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del Campo, J.M., Sessa, C., Krasner, C.N. et al. Trabectedin as single agent in relapsed advanced ovarian cancer: results from a retrospective pooled analysis of three phase II trials. Med Oncol 30, 435 (2013). https://doi.org/10.1007/s12032-012-0435-1

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