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A prospective randomized phase II trial of GM-CSF priming to prevent topotecan-induced neutropenia in chemotherapy-naive patients with malignant melanoma or renal cell carcinoma

  1. Author:
    Janik, J. E.
    Miller, L. L.
    Korn, E. L.
    Stevens, D.
    Curti, B. D.
    Smith, J. W.
    Sznol, M.
    Conlon, K. C.
    Sharfman, W.
    Urba, W. J.
    Gause, B. L.
    Longo, D. L.

  2. Author Address

    NCI, Metab Branch, Div Clin Sci, Bldg 10, Rm 4N115, 10 Ctr Dr, Bethesda, MD 20892 USA. NCI, Frederick Canc Res & Dev Ctr, Biol Response Modifiers Program, Frederick, MD 21702 USA. NCI, Clin Serv Program, SAIC Frederick, FCRDC, Frederick, MD 21701 USA. NCI, Biometr Res Branch, Canc Therapy Evaluat Program, Bethesda, MD 20892 USA. NCI, Invest Drug Branch, Canc Therapy Evaluat Program, Bethesda, MD 20892 USA. Providence Portland Med Ctr, Earle A Chiles Res Inst, Portland, OR USA. Janik JE NCI, Metab Branch, Div Clin Sci, Bldg 10, Rm 4N115, 10 Ctr Dr, Bethesda, MD 20892 USA.
    1. Year: 2001
  2. Journal: Blood
    1. 97
    2. 7
    3. Pages: 1942-1946
  4. Type of Article: Article
  1. Abstract:

    We conducted a phase II randomized trial of recombinant granculocyte-macrophage colony-stimulating factor (GM-CSF) administered before topotecan chemotherapy to determine whether it could prevent myelosuppression and to determine the antitumor activity of this topoisomerase I inhibitor in 53 patients with metastatic malignant melanoma and renal cell cancer. All patients received GMCSF after topotecan at a dose of 250 mug/m(2) daily for at least 8 days, Patients randomly assigned to receive GM-CSF priming were treated with GM-CSF at 250 mug/m(2) twice daily for 5 days before treatment. Twenty- five patients were randomly assigned to receive GM-CSF priming and 28 to receive topotecan without priming. The primary analysis was restricted to the protective effects seen during the first cycle of therapy. Grade 4 neutropenia occurred in 8 of 23 patients (35%) and grade 3 neutropenia in 5 of 23 patients (22%) randomized to GM-CSF priming, whereas 18 of 26 (69%) and 5 of 26 (19%) patients experienced grade 4 or 3 neutropenia, respectively, without GM-CSF priming (P =.0074). The mean duration of neutropenia was reduced by GMCSF priming: grade 3 neutropenia from 5.2 +/- 0.7 to 2.8 +/- 0.7 days (P =.0232) and grade 4 neutropenia from 2.7 +/- 0.6 to 1.1 +/- 0.4 days (P = 0.0332). The protective effects of GM-CSF extended to the second cycle of treatment. The incidence of febrile neutropenia was also reduced. Chemotherapy-induced anemia and thrombocytopenia were similar in both groups. One partial response was seen in a patient with melanoma, and one patient with renal cell cancer had complete regression of pulmonary metastases and was rendered disease-free by nephrectomy. (Blood, 2001;97: 1942-1946) (C) 2001 by The American Society of Hematology.

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