SEARCH:   Advanced

This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Rights and Permissions Citing Articles Citing Articles via HighWire Citing Articles via CrossRef Citing Articles via Google Scholar Google Scholar Articles by Janik, J. E. Articles by Longo, D. L. Search for Related Content PubMed PubMed Citation Articles by Janik, J. E. Articles by Longo, D. L. Related Collections Hematopoiesis and Stem Cells Neoplasia Clinical Trials and Observations Social Bookmarking                   What's this?  Previous Article  |  Table of Contents  |  Next Article  Blood, 1 April 2001, Vol. 97, No. 7, pp. 1942-1946 CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS 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 John E. Janik, Langdon L. Miller, Edward L. Korn, Diane Stevens, Brendan D. Curti, John W. Smith II, Mario Sznol, Kevin C. Conlon, William Sharfman, Walter J. Urba, Barry L. Gause, and Dan L. Longo From the Frederick Cancer Research and Development Center, Biological Response Modifiers Program, National Cancer Institute, and Clinical Services Program, SAIC Frederick, NCI-FCRDC, both of Frederick, MD; the Biometric Research Branch and the Investigational Drug Branch, both of the Cancer Therapy Evaluation Program, National Cancer Institute, Bethesda, MD; and the Earle A. Chiles Research Institute, Providence Portland Medical Center, Portland, OR. 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 GM-CSF after topotecan at a dose of 250 µg/m2 daily for at least 8 days. Patients randomly assigned to receive GM-CSF priming were treated with GM-CSF at 250 µg/m2 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 GM-CSF 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. © 2001 by The American Society of Hematology.   CiteULike    Connotea    Del.icio.us    Digg    Reddit    Technorati    What's this? This article has been cited by other articles: A. Daud, N. Valkov, B. Centeno, J. Derderian, P. Sullivan, P. Munster, P. Urbas, R. C. DeConti, E. Berghorn, Z. Liu, et al. Phase II Trial of Karenitecin in Patients with Malignant Melanoma: Clinical and Translational Study Clin. Cancer Res., April 15, 2005; 11(8): 3009 - 3016. [Abstract] [Full Text] [PDF]

	Copyright © 2001 by American Society of Hematology         Online ISSN: 1528-0020