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Phase II study of MTX-HSA in combination with Cisplatin as first line treatment in patients with advanced or metastatic transitional cell carcinoma

  • Phase II studies
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Summary

Purpose: To assess the efficacy, tolerability and safety of MTX-HSA (methotrexate (MTX) covalently linked to human serum albumin (HSA)) combined with cisplatin as first line therapy for advanced bladder cancer.

Methods: Patients (pat) were treated with a loading dose of 110 mg/m2 of MTX-HSA followed by a weekly dose of 40 mg/m2 starting on day 8. Cisplatin was given on day 2 of each 28 day cycle at a dose of 75 mg/m2.

Results: Tumor response evaluation was possible in 7 patients. Complete response (CR) and partial response (PR) was observed in 1 patient each (overall response rate: 29%). Key toxicities included CTC Grade (G) 3/4 stomatitis in 6 patients, vomiting G3 in 1 patient, fatigue G3 in 1 patient and thrombocytopenia G3 in 3 patients.

Conclusion: The combination of MTX-HSA with cisplatin is feasible and shows antitumor activity against urothelial carcinomas combined with an acceptable toxicity profile.

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Authors and Affiliations

  1. Medizinische Abteilung, AK St. Georg, Lohmühlenstrasse 5, Hamburg, 20099, Germany

    C. Bolling, T. Graefe, C. Lübbing, W.-H. Meyer-Moldenhauer, M. Weigel & A.-R. Hanauske

  2. Lithuanian Oncology Centre, Vilnius, Lithuania

    F. Jankevicius

  3. City Hospital, Klaipeda, Lithuania

    S. Uktveris & A. Cesas

  4. Fujisawa-Deutschland GmbH, Munich

    H. Starkmann

  5. ClinDescience, Munich, Germany

    K. Burk

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  1. C. Bolling
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Correspondence to C. Bolling.

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None of the authors of this article declares any conflict of interest that could have inappropriately influenced their work.

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Bolling, C., Graefe, T., Lübbing, C. et al. Phase II study of MTX-HSA in combination with Cisplatin as first line treatment in patients with advanced or metastatic transitional cell carcinoma. Invest New Drugs 24, 521–527 (2006). https://doi.org/10.1007/s10637-006-8221-6

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  • DOI: https://doi.org/10.1007/s10637-006-8221-6

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