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Blood, Vol. 94 No. 10 (November 15), 1999:
pp. 3307-3314
A Phase II Trial of 200% ProMACE-CytaBOM in Patients With Previously
Untreated Aggressive Lymphomas: Analysis of Response, Toxicity, and
Dose Intensity
Leo I. Gordon,
Mary Young,
Edie Weller,
Thomas M. Habermann,
Jane
N. Winter,
John Glick,
Chirantan Ghosh,
Patrick Flynn, and
Peter A. Cassileth
From Northwestern University Medical School, Chicago, IL; Dana Farber
Cancer Institute, Boston, MA; Mayo Clinic, Rochester, MN; University of
Pennsylvania Cancer Center, Philadelphia, PA; Cedar Rapids Oncology
Project, Cedar Rapids, IA; Metro-Minnesota CCOP, St Louis Park, MN; and
University of Miami, Sylvester Cancer Center, Miami, FL.
We showed in a phase I trial that the maximum tolerated dose of the
ProMACE-CytaBOM regimen in patients with aggressive lymphoma was 200%
(Gordon et al, J Clin Oncol 14:1275, 1996). Based on these
observations, we initiated a phase II trial designed to determine
response, toxicity, and dose intensity using this regimen. We analyzed
74 patients with advanced-stage (III or IV) or bulky stage II
aggressive lymphoma. The overall complete response rate was 69% (72%
in evaluable patients). With a median follow-up of 4.5 years, the
median survival has not yet been reached. The 4-year survival rate is
73% (95% confidence interval [CI] 62, 83%) and no difference was
observed among International Prognostic Index (IPI) groups. The 4-year
disease-free survival was 71% (95% CI 58, 84%) with no statistical
difference between patients with IPI 0 to 1 versus 2 to 4. The toxicity
was acceptable, though the grade 4 hematologic toxicity rate for this
regimen was 100%. Grade 4 nonhematologic toxicity was 36%. Three
cases of either myelodysplastic syndrome or acute leukemia occurred at
7 months, 3.4 years, and 4.2 years after registration. Cytogenic
analysis was available in two cases, showing inv(16) without French
American British classification (FAB) M4 EO histology in
one patient and a 5q-syndrome in the other. These data suggest that
200% ProMACE-CytaBOM with either granulocyte-macrophage
colony-stimulating factor (GM-CSF) or G-CSF results in a high complete
remission rate and a disease-free survival comparable to any prior
risk-based analysis in aggressive lymphoma. Before using this regimen
in general practice, phase III clinical trials should be conducted.
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