A. Michelotti et al., ACCELERATED EPIRUBICIN-IFOSFAMIDE-DACARBAZINE REGIMEN IN PATIENTS WITH ADULT SOFT-TISSUE SARCOMAS, American journal of clinical oncology, 19(1), 1996, pp. 78-81
Background. Neutropenia and infections are the dose-limiting toxicitie
s of the EID regimen and can cause dose reduction and/or delay in chem
otherapy administration. The purpose of this study was to verify if EI
D + G-CSF is feasible with an acceptable toxicity in a day hospital se
tting and if G-CSF could allow an increase in the dose intensity of th
e EID regimen by shortening the intervals between the courses. Patient
s and Methods: 20 patients with inoperable primary, metastatic or resi
dual disease after surgery or at high risk of recurrence after complet
e resection, histologically confirmed adult soft tissue sarcoma, enter
ed the study. The dose and schedule of the chemotherapy agents were ep
idoxorubicin 30 mg/m(2) days 1, 2, 3, dacarbazine 300 mg/m(2) days 1,
2, 3, and ifosfamide 2500 mg/m(2) with mesna uroprotection days 1, 2,
3. G-CSF, 300 mu g/day subcutaneously, was administered from day 7 for
a maximum of 14 days and discontinued when WBC was greater than 10 X
10(9)/L. Courses were repeated ''as soon as possible,'' but never earl
ier than 10 days from the previous course and at least 48 hours after
the last G-CSF injection. Results: A total of 66 EID + G-CSF courses w
ere administered. A G3 and G4 (WHO) neutropenia occurred in 66% of eva
luables courses. Nonhematological toxicity was mild. The median number
of G-CSF injections required during any interval between courses was
9 (range: 4-14 injections) and the median interval between courses was
21 days (range: 13-36 days). The median dose intensity at the third c
ourse of chemotherapy was 1.15 (range: 0.71-1.62). Conclusion: This st
udy shows that G-CSF allows a moderate increase in the delivered dose
intensity of chemotherapy with an acceptable toxicity, Further studies
are needed to investigate if this increase in DI may translate into a
n improved response rate.