Thalidomide +/− Corticosteroids for the Treatment of Multiple Myeloma Patients ≥ 70 Years of Age.

Between September 2000 and July 2004, 33 multiple myeloma (MM) patients (pts) ≥ 70 years of age were treated with thalidomide (THAL) alone (4 pts) or THAL plus corticosteroids (CS) (29 pts). Two were treated at diagnosis while 31 received THAL +/− CS after a median of 2 (range 1–5) prior regimens. Prophylactic anticoagulation was not routinely given. In most pts, the THAL dose was slowly increased as tolerated to a maximum of 200 mg/day. Initial CS therapy was pulse dexamethasone (DEX) in 14 and prednisone 50–100 mg every 2 days in 15 pts; in 4, the DEX dose was reduced or changed to prednisone when responses were noted and/or CS toxicity was encountered. Median age was 73 (range 70–88) yrs; median beta2-microglobulin level was 403 (range 153–2120) nmol/L and CRP level 4 (range 1–91) mg/L at referral. MM subtype was IgG kappa:lambda (8:12 pts), IgA kappa:lambda (6:4 pts), light chain kappa:lambda (1:1 pts) and IgD kappa (1pt). Initial stage was IIIA:B in 20:5, IIA:B in 3:1 and IA in 4 pts. Cytogenetic studies were available in 11, of whom 1 had t(4;14), 2 complex changes, 1 monosomy 7 and 1 other abnormalities. Eighteen pts had significant cardiac disease, 3 vascular disease and 4 diabetes at the time therapy was initiated. Four had other hematological malignancies noted before/shortly after THAL +/− CS was started, including MDS in 2, essential thrombocytosis in 1 and AML in 1. The median maximum dose of THAL was 150 (range 50–400) mg and the median duration of therapy was 7 (1.5–19+) mos. To date, 14 (42%) pts have achieved PR and 5 (15%) MR; four (12%) experienced stable disease. The median duration of response was 7 (range 1.5–23+) mos. Fatigue/sleepiness (5), syncope (2), peripheral neuropathy (4) and other reasons (4) necessitated THAL dose reductions in 15 pts; 7 pts stopped THAL due to toxicity. Two TIAs and 1 DVT were observed; 2 of these pts received appropriate medical therapy and continued THAL without further vascular complications. No treatment-related deaths occurred. Eleven of 33 (33%) remain on THAL +/−CS. The actuarial overall survival rate was 80% at 1 year and 55% at 2 yrs after starting THAL +/− CS therapy, while the progression-free survival rate was 42% and 20% at 1 and 2 yrs, respectively. We conclude: 1) THAL +/−CS can be given safely in elderly MM pts, although dose reductions are usually needed; 2) MM response/stabilization was achieved in 69%; 3) THAL +/− CS therapy offers a median benefit of 7 mos in poor prognosis elderly MM pts.