Journal of Clinical Oncology, Vol 10, 1712-1722, Copyright © 1992 by American Society of Clinical Oncology
Phase I and II study of high-dose ifosfamide, carboplatin, and etoposide with autologous bone marrow rescue in lymphomas and solid tumors
WH Wilson, V Jain, G Bryant, KH Cowan, C Carter, M Cottler-Fox, B Goldspiel, SM Steinberg, DL Longo and RE Wittes
Medicine Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD 20892.
PURPOSE: High-dose chemotherapy produces durable disease-free remissions in
a minority of patients with resistant lymphomas and solid tumors. In an
attempt to improve on the available regimens, ifosfamide, carboplatin, and
etoposide (ICE) were selected for a new high-dose regimen because of their
favorable spectrum of nonhematopoietic toxicity and evidence of synergy in
in vitro systems. PATIENTS AND METHODS: Forty-one patients with
drug-resistant Hodgkin's and non- Hodgkin's lymphomas, and breast and
testicular cancers were entered onto a phase I and II trial of a single
course of ICE with autologous bone marrow rescue. Before transplantation,
all patients received combination chemotherapy until maximal tumor response
was achieved. RESULTS: Patients received total doses of ifosfamide from 10
to 18 g/m2, carboplatin from 0.9 to 1.98 g/m2, and etoposide from 0.6 to
1.5 g/m2 administered during a 4-day period, with a maximum-tolerated dose
(MTD) of ifosfamide 16 g/m2, carboplatin 1.8 g/m2, and etoposide 1.5 g/m2.
The dose-limiting toxicities included irreversible renal, cardiac, and CNS
dysfunction. There were three toxic deaths (7%), and all occurred above the
MTD. Thirteen patients who were treated at the MTD tolerated the regimen
well; reversible renal dysfunction and grade 2 mucositis commonly were
observed. Of 23 heavily pretreated patients with persistent disease at the
time of transplant, 10 (43%) achieved complete remissions (CRs) and 11
(48%) achieved partial remissions (PRs). Hodgkin's and non-Hodgkin's
lymphoma patients who were treated at or below the MTD had a median
potential follow-up of 11.9 months, and 12-month progression-free survivals
of 62% and 48%, respectively. CONCLUSION: High-dose ICE with bone marrow
rescue was well tolerated with a high response rate, and should be
considered for further testing.
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