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Phase III trial of standard versus dose-intensified doxorubicin, ifosfamide and dacarbazine (MAID) in the first-line treatment of metastatic and locally advanced soft tissue sarcoma

  • PHASE III STUDIES
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Summary

Multidrug chemotherapy increases responses in advanced soft tissues sarcoma. Can a 20% increase of relative dose intensity of the MAID regimen, more improve responses? From 1994 to 1997, 162 patients were randomized in a phase III study to the conventional drug combination (6 cycles of MAID: 60, 7,500, 900 mg/m2 for doxorubicin, ifosfamide and dacarbazine respectively), or at doses 20–33% higher per cycle (5 cycles of intensified MAID for similar cumulative doses) with systematic G-CSF. Primary endpoint was response rate; secondary were toxicity, event-free and overall survival. The objective response rate in assessable patients was 38% with intensified MAID and 35% with MAID (p = 0.72). Event-free and overall survivals were similar in both arms. Only grade 3–4 thrombocytopenia and anemia were significantly higher in intensified arm. Treatment with intensified MAID did not improve response rate neither survival and cannot be recommended for advanced or metastatic soft tissue sarcoma.

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Acknowledgments

V. Picot and F. Bonichon for biostatistics and F. Bertucci and I Ray-Coquard for reading of manuscript.

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Authors and Affiliations

  1. Centre Léon Bérard, Département de Médecine & Inserm U590, Université de Lyon, 28 rue Laennëc, 69008, Lyon, France

    Jérôme Fayette

  2. Centre Oscar Lambret, Lille, France

    Nicolas Penel

  3. Institut Claudius Regaud, Toulouse, France

    Christine Chevreau

  4. Centre Léon Bérard, Département de Médecine & Inserm U590 & Hôpital Edouard Herriot, Université de Lyon, 28 rue Laennëc, 69008, Lyon, France

    Jean-Yves Blay

  5. Centre Val D’Aurelle Montpellier, Montpellier, France

    Didier Cupissol

  6. Centre Antoine Lacassagne, Nice, France

    Antoine Thyss

  7. Centre Henri Becquerel, Rouen, France

    Cécile Guillemet

  8. Centre Alexis Vautrin, Nancy, France

    Maria Rios

  9. Centre René Gauducheau, Nantes, France

    Frédéric Rolland

  10. Centre Georges-François Leclerc, Dijon, France

    Pierre Fargeot

  11. Centre Jean Perrin, Clermont-Ferrand, France

    Jacques Olivier Bay

  12. Institut Bergonié, Bordeaux, France

    Simone Mathoulin-Pelissier, Jean Michel Coindre & Binh Bui-Nguyen

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  1. Jérôme Fayette
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  14. Binh Bui-Nguyen
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Correspondence to Jérôme Fayette.

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Increase doses of chemotherapy in advanced sarcoma.

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Fayette, J., Penel, N., Chevreau, C. et al. Phase III trial of standard versus dose-intensified doxorubicin, ifosfamide and dacarbazine (MAID) in the first-line treatment of metastatic and locally advanced soft tissue sarcoma. Invest New Drugs 27, 482–489 (2009). https://doi.org/10.1007/s10637-008-9217-1

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  • DOI: https://doi.org/10.1007/s10637-008-9217-1

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