Background and Objectives, The immunomodulatory drug thalidomide can inhibi
t angiogenesis and induce apoptosis in experimental models, It can also ind
uce marked and durable response in advanced myeloma patients, Thalidomide h
as been used at doses ranging from 200 to 800 mg with significant toxicity,
No data are available on the impact of low-dose thalidomide plus dexametha
sone as salvage therapy for relapsed patients.
Design and Methods. To address this issue, myeloma patients were treated wi
th 100 mg/day thalidomide continuously and dexamethasone 40 mg, days 1-4, e
very month, Between June 1999 and August 2000, 77 patients (median age 65 y
ears) who had relapsed or were refractory to chemotherapy were treated with
thalidomide plus dexamethasone.
Results, After a minimum of 3 months of treatment, 14 patients (18%) showed
a myeloma protein reduction of 75%-100%, 18 patients (23%) showed a respon
se of 50-75%, 19 patients (25%) a response of 25-50% and 26 patients (34%)
a response of <25% or disease progression, After a median follow-up of 8 mo
nths, median progression-free survival was 12 months. Thalidomide was well
tolerated. Constipation (12%) and sedation (6%) were mild, Tingling or numb
ness were present in 17% of patients, discontinuation of treatment was requ
ired in 10% of patients.
Interpretation and Conclusions, The association of low-dose thalidomide plu
s dexamethasone is active against advanced myeloma, A significant proportio
n of patients benefit from this treatment as a salvage therapy postponing t
he delivery of chemotherapy. <(c)> 2001, Ferrata Storti Foundation.