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Low-Dose Thalidomide Appears Safe, Effective For Treatment Of Multiple Myeloma

Low-dose thalidomide (50-100 mg/day) appears safe and effective for treatment of patients with myeloma at various stages of diseases, reports a joint study from Austria and Italy.

Effective treatment of multiple myeloma remains difficult, with conventional chemotherapy regimens associated with median survival rates of less than 3 years and high-dose chemotherapy regimens with autologous stem cell support associated with relapse and disease progression within 3 to 5 years of treatment.

Recent data suggest good response rates for myeloma patients with refractory and relapse disease treated with thalidomide. Based on these good results, Michael Steuer, MD, Abteïlung für Hämatologie & Onkologie, Universitätsklinik für Innere Medizin, Innsbruck, Austria, and colleague initiated a compassionate use program with oral thalidomide to treat 21 patients with myeloma. Two patients were given thalidomide to treat previously untreated indolent myeloma, 3 as maintenance therapy after achieving partial response with previous chemotherapy regimens, 6 to treat relapse and 10 for refractory disease after chemotherapy regimens.

Patients received an initial dose of 50 mg per day, which gradually increased every 2 weeks until reaching a maximum dose without severe side effects. Of the 21 patients, 57.1% received thalidomide monotherapy, 28.6% received combination thalidomide and intermittent dexamethasone, and 14.3% received combination thalidomide and oral cyclophosphamide. At a 12-month median duration of thalidomide treatment, 11 patients were able to stay on long-term treatment on daily doses of 50 mg, 9 on daily doses of 100 mg, and 1 on daily doses of 150 mg.

Overall, 19 patients completed at least 6 weeks of treatment and were used to evaluate overall survival and response. At 16-month follow-up, overall response was 61.9% (50% for patients receiving thalidomide monotherapy and 77.8% for combination therapy). For all patients, regardless of treatment regimen, the median duration of response was 15 months. Overall survival was 61.9%, with relapse in 2 of these patients. Of the 7 patients who died, 6 died of disease progression and 1 of sepsis during combination therapy. For the entire 19 patients, the median progression-free survival time was 20 months.

Although the authors emphasise the need for caution in interpreting these retrospective results, they conclude that these results "encourage further testing of the principle of long-term administration of low-dose thalidomide (50-100 mg/day) within clinical trials."

Onkologie 2004;27:150-154. "Low-dose thalidomide for multiple myeloma: interim analysis of a compassionate use program"

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