Abstract | BACKGROUND AND OBJECTIVES: DESIGN AND METHODS: The study was open-label and sequential; GM-CSF administration (5 microg/Kg s.c./d x10) was planned after each chemotherapy cycle and after each HBI session in 18 consecutive patients (group A). Thirty-eight additional patients (group B) were treated by the same therapeutic program, without GM-CSF. In 12 patients (6 in each group) long-term bone marrow cultures (LTBMC) were performed to evaluate the myeloproliferative potential throughout the chemotherapeutic program. RESULTS: Seven of 18 (39%) patients experienced side effects from GM-CSF; 3/7 discontinued GM-CSF due to anaphylactic symptoms. The degree of neutropenia, as well as the frequency of infectious episodes and the need for supportive care were significantly lower in group A than in group B. Iatrogenic thrombocytopenia, and the possibility of performing drug-dose escalation were similar in the two groups. The 5-year event-free survival probabilities for group A and B were similar. LTBMC showed that the chemotherapy-related depletion of myeloid precursors could be more pronounced in patients receiving GM-CSF cyclically. INTERPRETATION AND CONCLUSIONS: In this series, GM-CSF was shown to be effective on iatrogenic neutropenia and related complications, with no impact on thrombopoiesis, drug dose escalation and outcome.
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Authors | R Luksch, M Massimino, G Cefalo, F Lombardi, A Ferrari, M Casanova, L Gandola, M Terenziani, F Spreafico, F Fossati-Bellani |
Journal | Haematologica
(Haematologica)
Vol. 86
Issue 7
Pg. 753-60
(Jul 2001)
ISSN: 0390-6078 [Print] Italy |
PMID | 11454532
(Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
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Chemical References |
- Recombinant Proteins
- Granulocyte-Macrophage Colony-Stimulating Factor
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Topics |
- Adolescent
- Child
- Child, Preschool
- Cohort Studies
- Combined Modality Therapy
- Female
- Granulocyte-Macrophage Colony-Stimulating Factor
(administration & dosage, pharmacology, toxicity)
- Humans
- Infant
- Male
- Neutropenia
(drug therapy, etiology, prevention & control)
- Recombinant Proteins
(administration & dosage, pharmacology)
- Sarcoma, Ewing
(complications, drug therapy, radiotherapy)
- Treatment Outcome
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