Thalidomide alone was effective in patients with newly diagnosed myeloma. The combination with dexamethasone induced a high frequency of response, rapid onset of remission, and low incidence of serious irreversible toxicity. These observations support further studies of this promising combination for patients with newly diagnosed multiple myeloma.
Summary. Between November 1998 and April 2000, the combination of thalidomide and dexamethasone was evaluated in 47 consecutive patients with multiple myeloma that was resistant to prior high‐dose dexamethasone‐based therapies. Remission was observed in 22 patients (47%), including six patients with complete remission. Side‐effects were frequent, mild and usually reversible, but deep vein thrombosis occurred in 8% of patients. Survival and remission times were longer among patients treated for previous resistant disease rather than for resistant relapse. This experience supports the use of thalidomide–dexamethasone in myeloma patients with resistant disease and justifies further trials in newly diagnosed patients.
Background: In three recent Phase 2 and 3 studies, the combination of thalidomide-dexamethasone (TD) induced responses in 64–72% of patients, including complete responses in 4–16% of patients. However, long term outcomes of patients receiving induction therapy with TD have not been well described.
Patients and Methods: In a retrospective fashion, we updated our experience (median f/u of 50 mos.) of 58 patients treated between 7/2000 and 5/2002, with thalidomide at 100mg nightly, increasing by 100mg every 7 days as tolerated to a maximum dose of 400mg (median 200mg), and dexamethasone (20mg/m2) on days 1–4, 9–12, and 17–20 (decreased to days 1–4 only, beginning with cycle 3). Cycles were repeated on day 28 and patients were treated on protocol for a maximum of 4 courses. To prevent thrombosis, 34 patients received therapeutic doses of either warfarin (INR 2–3) or low molecular weight heparin.
Results: Of 58 patients, 31 proceeded to myeloablative therapy followed by autologous stem cell support. Another 16 patients received maintenance chemotherapy until disease progression. The median age at enrollment was 60.5 (37–78), and 60% were male. By International Staging System criteria, 41% of patients were stage 1, 33% stage 2 and 26% stage 3. The overall response rate was 72%, including 12% with CR. Median overall survival (OS) of those who received autologous stem cell transplant (ASCT) exceeds 59.6 months. Median OS of those who did not receive ASCT was 31.8 months. The observed difference in OS may be partially explained by differences in performance status between the 2 groups.
Conclusion: Our survival data with TD induction does not differ significantly from either historical data with alkylating agent based therapy, or from previously noted prolongation of OS after intensive therapy with stem cell support (IFM-90). Further study of the impact of thalidomide and other novel agents as induction therapy in both the ASCT and non-ASCT settings is warranted.
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