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.

Topics:
dexamethasone, multiple myeloma, thalidomide, autologous stem cell transplant, neoadjuvant therapy, alkylating agents, disease progression, international normalized ratio, low-molecular-weight heparin, maintenance chemotherapy

Disclosures: Drs. Wang, Weber and Giralt have research support from Millenium Pharmaceuticals and from Celgene.; Drs. Alexanian, Wang, Weber and Giralt are on the Speaker’s Bureau of Millenium Pharmaceuticals and Celgene.

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2006, The American Society of Hematology
2006
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