Efficacy of prednisone in refractory multiple myeloma and measurement of glucocorticoid receptors. A Southwest Oncology Group study.
BACKGROUND
Prednisone is an active drug in the treatment of multiple myeloma. The optimal dose, frequency, and role of glucocorticoid receptors (GR) in response to prednisone is unknown.


OBJECTIVE
The purposes of this study were (1) to estimate the response rate of alternate-day high dose prednisone in patients with relapsing and refractory multiple myeloma; (2) to measure the rate of GR levels; and (3) to correlate the response of prednisone with GR status.


METHODS
Between 8/86 and 1/90, 127 patients were entered onto the study with 121 evaluable for response. The number of GR sites/cell was determined on mononuclear cells isolated from pretreatment bone marrow aspirates using a one point GR binding assay. Patients received prednisone 100 mg po qod x 2 weeks, followed by 50 mg po qod x 10 weeks.


RESULTS
The overall response rate was 10% (95% CI: 5-15%) with a median survival of 11.8 months. The GR sites/cell ranged from 0-53,212 with a mean of 8,371 sites/cells. Stratification of GR sites into 0-2,500, 2,501-6,000 and > 6,000 sites/cells was associated with a response rate of 6%, 27% and 4% respectively (p = 0.009). The median survival of patients in these categories was 8.1, 14.9 and 10.6 months respectively. This was not significant by the logrank test (p = 0.11). Although myeloma patients with intermediate levels of GR sites/cell initially responded more favorably to prednisone, their long-term survival was not significantly improved.


CONCLUSIONS
Alternate-day high-dose prednisone was well tolerated and may provide palliative benefit for a subset of patients with relapsing and refractory multiple myeloma. The survival of patients on this study was comparable to that reported with other but more toxic doses of glucocorticoids.
University of Texas Medical Branch, Galveston.
V
V
Gupta
E B
EB
Thompson
D
D
Stock-Novack
S E
SE
Salmon
H I
HI
Pierce
J D
JD
Bonnet
D
D
Chilton
J
J
Beckford
D000368:Aged; D000369:Aged, 80 and over; D004334:Drug Administration Schedule; D006801:Humans; D008875:Middle Aged; D009101:Multiple Myeloma / Q000188:drug therapy* / Q000378:metabolism; D011241:Prednisone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011965:Receptors, Glucocorticoid / Q000032:analysis*; D016896:Treatment Outcome
D011965:Receptors, Glucocorticoid; D011241:Prednisone