A Phase I trial of high-dose chemotherapy combining topotecan plus cyclophosphamide with hematopoietic stem cell transplantation for ovarian cancer: The ITOV 01bis study

Frédéric Selle, Patricia Pautier, Catherine Lhommé, Patrice Viens, Michel Fabbro, François Lokiec, Joseph Gligorov, Sandrine Richard, Stéphane Provent, Daniele G. Soares, Jean Pierre Lotz

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    Résumé

    Background: Dose-intensive chemotherapy with hematopoietic stem cell transplantation has been evaluated as a salvage treatment for recurrent ovarian cancer, but its benefit has not yet been demonstrated. In a previous phase I trial, we reported the feasibility of administering topotecan as a salvage regimen. Methods: Twenty-one patients were treated with escalating doses of topotecan associated with a fixed dose of cyclophosphamide. Results: The maximum tolerated dose was established at 9.0 mg/m2 on a 5-day regimen, analogously to what was reported for topotecan monotherapy. One toxic death from septic shock and multiorgan failure occurred. Although hematopoietic toxicities were overcome by peripheral blood stem cell transplantation, superior nonhematological toxicities were observed as compared to the initial trial. Conclusion: Response rates were generally short and survival rates were poor. Results of the ITOV 01bis study demonstrate that, in the setting of recurrent ovarian cancer, intensive chemotherapy based on topotecan-cyclophosphamide association is not currently clinically indicated.

    langue originaleAnglais
    Pages (de - à)15-22
    Nombre de pages8
    journalChemotherapy
    Volume61
    Numéro de publication1
    Les DOIs
    étatPublié - 1 nov. 2015

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