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Blood, 1 May 2002, Vol. 99, No. 9, pp. 3163-3168
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Maintenance therapy with alternate-day prednisone improves
survival in multiple myeloma patients
James R. Berenson,
John J. Crowley,
Thomas M. Grogan,
Jeffrey Zangmeister,
Adrienne D. Briggs,
Glenn M. Mills,
Bart Barlogie, and
Sydney E. Salmon
From Cedars Sinai Medical Center and the Jonsson
Comprehensive Cancer Center, University of California-Los Angeles,
School of Medicine; Southwest Oncology Group Statistical Center,
Seattle, WA; University of Arizona Cancer Center, Tucson; Columbus
Community Clinical Oncology Program, OH; Louisiana State University,
Shreveport; and University of Arkansas for Medical Sciences, Little
Rock.
The role of maintenance therapy in multiple myeloma is
controversial. Recent studies have shown an improvement in both
progression-free and overall survival for patients receiving
maintenance treatment with a combination of interferon and
glucocorticoids, compared with interferon alone. The role of
glucocorticoids alone as maintenance therapy has not been
previously addressed. We compared alternate-day, oral prednisone at 2 different dose levels (10 mg versus 50 mg) for remission maintenance
among previously untreated myeloma patients following a response to
induction with standard-dose vincristine, doxorubicin, and
dexamethasone with prednisone (VAD-P) or VAD-P plus quinine (VAD-P/Q).
There were 250 eligible patients registered on Southwest
Oncology Group study 9210 and randomized to receive VAD-P or
VAD-P/Q. There were 125 patients achieving at least a 25% tumor
reduction following induction therapy who were randomized to either
physiologic (10 mg) or pharmacologic (50 mg) doses of alternate-day,
oral prednisone until disease progression. At the time of study entry,
patient characteristics were similar in VAD-P and VAD-P/Q patients and
in the 2 arms randomized to maintenance therapy. After a median
follow-up of 53 months, there was no difference in either
progression-free or overall survival between the 2 induction regimens.
However, from the time of maintenance randomization, both
progression-free (14 versus 5 months; P = .003) and
overall survival (37 versus 26 months; P = .05) were
significantly improved in patients receiving 50 mg as compared with 10 mg alternate-day prednisone. There was no difference in
treatment-related adverse events between the groups. Thus, 50 mg, oral,
alternate-day prednisone is effective maintenance treatment for
multiple myeloma patients who achieve a response to induction chemotherapy.
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