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Autografting

Phase I/II trial of multicycle high-dose chemotherapy with peripheral blood stem cell support for treatment of advanced ovarian cancer

Bone Marrow Transplantation volume 38, pages 493–499 (2006)Cite this article

Abstract

Ovarian cancer is chemosensitive, but most patients with advanced disease die from tumor progression. As 25% of the patients can be cured by chemotherapy, it is reasonable to evaluate high-dose chemotherapy (HDCT). Forty-eight patients with untreated ovarian cancer were entered in a multicenter phase I/II trial of multicycle HDCT. Median age was 46 (19–59 years); International Federation of Gynecology and Obstetrics-stage was III in 79% and IV in 21%; 31% had residual disease >1 cm after surgery. Two courses of induction/mobilization therapy with cyclophosphamide (250 mg/m2) and paclitaxel (250 mg/m2) were used to collect peripheral blood stem cells. HDCT consisted of two courses of carboplatin (area under curve (AUC) 18–22) and paclitaxel followed by one course of carboplatin and melphalan (140 mg/m2) with or without etoposide (1600 mg/m2). Main toxicity was gastrointestinal. Limiting carboplatin to AUC 20 and eliminating etoposide resulted in manageable toxicity (69% without grade 3/4 toxicity). One patient died from treatment-related pneumonitis. At 8 years median follow-up, median progression-free-survival (PFS) and overall survival (OS) is 13.3 and 37.0 months. Five-years PFS and OS is 18 and 33%. Multicycle HDCT is feasible in a multicenter setting. A European phase III trial based on this regimen is evaluating the efficacy of HDCT.

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Acknowledgements

We gratefully acknowledge the cooperation of the patients, their families and nurses within this trial. All members of the German Study groups AIO and AGO who entered patients into this trial are listed in Appendix A with their current addresses. Funding: Bristol-Myers Squibb and AMGEN supported trial meetings of the study group during conduct of the trial.

Author information

Authors and Affiliations

  1. Department of Hematology/Oncology, Universitätsklinikum Ulm, Ulm, Germany

    N Frickhofen & H Heimpel

  2. Department of Hematology/Oncology, Charité, Universitätsmedizin Berlin, Klinikum Benjamin-Franklin, Berlin, Germany

    W E Berdel

  3. Department of Gynecology, Charité, Universitätsmedizin Berlin, Klinikum Benjamin-Franklin, Berlin, Germany

    F Opri

  4. Department of Hematology/Oncology, Universitätsklinikum Heidelberg, Heidelberg, Germany

    R Haas

  5. Department of Gynecology, Universitätsklinikum Heidelberg, Heidelberg, Germany

    A Schneeweiss

  6. Department of Hematology/Oncology, Technische Universität München, Klinikum rechts der Isar, München, Germany

    M Sandherr

  7. Department of Gynecology, Technische Universität München, Klinikum rechts der Isar, München, Germany

    W Kuhn

  8. Department of Hematology/Oncology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

    D K Hossfeld

  9. Department of Gynecology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany

    C Thomssen

  10. Department of Gynecology, Universitätsklinikum Ulm, Ulm, Germany

    R Kreienberg & V Möbus

  11. Wissenschaftlicher Service Pharma, Langenfeld, Germany

    A Hinke

Authors
  1. N Frickhofen
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  2. W E Berdel
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  3. F Opri
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  4. R Haas
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  5. A Schneeweiss
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  8. D K Hossfeld
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  9. C Thomssen
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  10. H Heimpel
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  11. R Kreienberg
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  12. A Hinke
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  13. V Möbus
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Consortia

on behalf of the German Study Groups Arbeitsgemeinschaft Internistische Onkologie (AIO) und Arbeitsgemeinschaft Gynäkologische Onkologie (AGO)

Corresponding author

Correspondence to N Frickhofen.

Additional information

All institutions are in Germany and all authors are listed with their association at the time of the study.

Appendix A

Appendix A

Members of the German Study groups AIO and AGO, who entered patients into this trial are listed here in alphabetical order with their current addresses: HG Bender, Düsseldorf; WE Berdel, Münster; H Heimpel, Ulm; K Diedrich, Lübeck; H Egger, Neumarkt; H Eimermacher, Hagen; H Elser, Landshut-Achdorf; N Fischer, München; M Freund, Rostock; N Frickhofen, Wiesbaden; R Haas, Düsseldorf; HJ Holländer, Duisburg; DK Hossfeld, Hamburg; C Jackisch, Offenbach; M Königsmann, Magdeburg; R Kreienberg, Ulm; W Kuhn, Bonn; Ch Kurbacher, Köln; KO Metz, Bremerhaven; B Metzner, Oldenburg; J Mezger, Karlsruhe; V Möbus, Frankfurt; D Mühlenstedt, Oldenburg; F Opri, Berlin; K-H Pflüger, Bremen; K Rothe, Halle; M Sandherr, Weilheim; G Schmitz, Herdecke; HJ Schmoll, Halle; A Schneeweiß, Heidelberg; W Schneider, Düsseldorf; R Schwarz, Rostock; C Thomssen, Halle; L Trümper, Göttingen; C Villena-Heinsen, Baden-Baden; T Wagner, Lübeck; H Wandt, Nürnberg; M Westerhausen, Duisburg.

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Frickhofen, N., Berdel, W., Opri, F. et al. Phase I/II trial of multicycle high-dose chemotherapy with peripheral blood stem cell support for treatment of advanced ovarian cancer. Bone Marrow Transplant 38, 493–499 (2006). https://doi.org/10.1038/sj.bmt.1705472

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