Journal of Clinical Oncology, Vol 11, 15-21, Copyright © 1993 by American Society of Clinical Oncology
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
WP Steward, J Verweij, R Somers, D Spooner, P Kerbrat, M Clavel, D Crowther, J Rouesse, T Tursz and E Tueni
Beatson Oncology Centre, Western Infirmary, Glasgow, United Kingdom.
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.
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