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Granulocyte-macrophage colony-stimulating factor allows safe escalation of dose-intensity of chemotherapy in metastatic adult soft tissue sarcomas : a study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group
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Steward, W. P., Verweij, J., Somers, R., Spooner, D., Kerbrat, P., Clavel, M., Crowther, D., Rouesse, J., Tursz, T., Tueni, E., Van Oosterom, A. T., Warwick, Jane, Greifenberg, B., Thomas, D. and VanGlabbeke, M. (1993) Granulocyte-macrophage colony-stimulating factor allows safe escalation of dose-intensity of chemotherapy in metastatic adult soft tissue sarcomas : a study of the European Organization for Research and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Journal of Clinical Oncology, 11 (1). pp. 15-21. doi:10.1200/JCO.1993.11.1.15
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Official URL: https://doi.org/10.1200/JCO.1993.11.1.15
Abstract
PURPOSE
This study was designed to test the feasibility of administering doxorubicin at an optimal dose-intensity (> 70 mg/m2 per 21 days) in combination with ifosfamide under recombinant human granulocyte-macrophage colony-stimulating factor (rhGM-CSF) cover in patients with metastatic soft tissue sarcomas.
PATIENTS AND METHODS
One hundred four eligible patients (of 111 entered) in 16 centers received doxorubicin 75 mg/m2 plus ifosfamide 5 g/m2 every 3 weeks for up to seven cycles. rhGM-CSF (250 micrograms/m2) was administered once or twice daily by subcutaneous injections for up to 14 days between cycles of chemotherapy.
RESULTS
Full protocol dose-intensity of chemotherapy was administered to the majority of patients with only 15 of 293 cycles being complicated by febrile episodes that required hospitalization. There were two treatment-related deaths: one from septicemia and one from cardiac failure. The main toxicities attributed to rhGM-CSF were pruritus and rash. A 45% response rate (10% complete remission [CR]) was seen, with a median response duration of 9 months and median survival of 15 months.
CONCLUSION
This high-dose regimen of chemotherapy was feasible under rhGM-CSF cover and produced a higher response rate and median survival than previously seen by the European Organization for Research and Treatment of Cancer (EORTC) Soft Tissue Sarcoma Group. A randomized phase III study is now underway comparing this regimen with conventional-dose doxorubicin/ifosfamide to test the dose-response relationship.
| Item Type: | Journal Article | ||||
|---|---|---|---|---|---|
| Subjects: | R Medicine > R Medicine (General) | ||||
| Divisions: | Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit Faculty of Medicine > Warwick Medical School > Health Sciences Faculty of Medicine > Warwick Medical School |
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| Journal or Publication Title: | Journal of Clinical Oncology | ||||
| Publisher: | American Society of Clinical Oncology | ||||
| ISSN: | 0732-183X | ||||
| Official Date: | 1 January 1993 | ||||
| Dates: |
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| Date of first compliant deposit: | 23 July 2018 | ||||
| Volume: | 11 | ||||
| Number: | 1 | ||||
| Page Range: | pp. 15-21 | ||||
| DOI: | 10.1200/JCO.1993.11.1.15 | ||||
| Status: | Peer Reviewed | ||||
| Publication Status: | Published |
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