[Thalidomide in the treatment of refractory multiple myeloma: a Dutch study of 72 patients: an antitumor effect in 45%].

OBJECTIVE

To determine the efficacy and side effects of thalidomide in the treatment of refractory multiple myeloma.

DESIGN

Retrospective, descriptive.

METHOD

Data were obtained by means of case research on patients with refractory multiple myeloma who were treated with thalidomide at four regional hematological centres in the period from 1 May 1999 to 31 May 2001. The patients had previously been treated with one, two or three schedules of chemotherapy. The starting dose of thalidomide was 200 mg per day and the dose was increased gradually to a maximum of 800 mg per day depending on the tolerance.

RESULTS

The 72 patients included 43 men and 29 women with an average age of 62 years (range: 38-82 years). The median follow-up was 13 months (range: 2-25). Thalidomide as a single agent was prescribed for 64 patients, of whom 29 (45%) responded; a complete response was achieved in 3 patients, a partial response in 18, and a minor response in 8. In 4 of 11 patients with an extramedullary plasmacytoma a decrease in size was observed. The median duration of the response was 9 months (range: from 2 till > 24). The median overall survival from the start of thalidomide treatment was 9 months. Thalidomide plus dexamethasone was given to 9 patients who did not respond to thalidomide alone, and in 6 of them a reduction of M-protein was then observed. The most frequent adverse effects were constipation, drowsiness, somnolence, dizziness, venous thrombosis and polyneuropathy. Doses of up to 400 mg per day were generally well tolerated.

CONCLUSION

Thalidomide has antitumour activity in refractory multiple myeloma.