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New Drug Therapies for Waldenstrom's Macroglobulinemia

Waldenstrom's macroglobulinemia (WM) is a rare blood cancer that causes excessively large antibodies to build up in the bloodstream. The disease may strike at any time in life, but is most often diagnosed after age 65.

No cure for WM exists yet. Like many other rare diseases, research into new treatments is limited. Rare diseases simply do not garner the attention of, say, lung cancer. However, a team of researchers at the University of Athens, Greece, has recently performed several studies that suggest that new treatments for Waldenstrom's may become available in the future. Two examples of this team's work are their studies into rituximab and thalidomide.

Rituximab Research
Waldenstrom's tumors carry the cell marker CD-20. Rituximab is a monoclonal antibody designed to bind with CD-20 and "flag" the cells for destruction by the immune system. (Monoclonal antibodies are custom-made antibodies designed to target specific cell structures). The study was a Phase II clinical trial designed to test the effectiveness of the rituximab as a treatment for Waldenstrom's macroglobulinemia, and to see how well WM patients would tolerate the drug.

Twenty-seven participants took part in the trial. All exhibited symptoms of WM, and their average age was 72. Fifteen had not received treatment for the disease. Participants received rituximab intravenously for four weeks. If, after treatment, participants showed no signs of disease progression, they received an additional four weeks of treatment.

The results suggest that rituximab may have a place in Waldenstrom's treatment. Of the 27 participants, twelve showed a positive response to the treatment after three months. Six of these patients were among those who had not received previous treatment. The treatment appeared to have long-term effects: of the twelve participants who responded to the treatment, nine showed no sign of disease progression after fifteen months.

Rituximab treatment was generally well tolerated, although a quarter of the trial groups experienced fevers and chills as side effects. As almost half the participants reacted well to the therapy, researchers hope they can continue their study. They want to see if they disease progression can be halted with continued treatment for an extended period.

Other possible avenues of research include investigating possible combination therapies, using rituximab as a complementary treatment with chemotherapy.

Thalidomide Treatment
In addition to the rituximab clinical trial, the University of Athens research team has investigated the used of thalidomide as a WM treatment. The thalidomide Phase II clinical trial did not yield results as promising as those for the rituximab study, but it does indicate that thalidomide may have a role to play in treating Waldenstrom's macroglobulinemia.

Thalidomide's most common use is to treat erythema nodosum leprosum (ENL), a skin disorder associated with leprosy. The medication has been used to treat a number of different disorders. Since the discovery in the 1960s that thalidomide caused serious birth defects, the medication has not been used extensively.

As the average age of the thalidomide study was 74, the possibility of birth defects was not an issue. Twenty participants volunteered for the study. Of these twenty, ten had never received treatment for Waldenstrom's macroglobulinemia. All participants displayed WM symptoms.

Patients began the test by taking a daily dose of 200 mg of thalidomide. If adverse affects were not reported, this dosage was increased by 200 mg every two weeks until a maximum dose of 600 mg was reached.

Twenty-five percent of the study participants showed some level of response to the thalidomide treatment. Of these five patients, three were from the group who had never been treated for the disease. Only two of the individuals who had previous treatment responded positively to the medication. The response time for the five participants who reacted positively to the medication ranged from 0.8 to 2.8 months.

Thalidomide appeared to be of no benefit to individuals who had experienced a remission of WM followed by relapse. Participants who had been diagnosed with WM for more than two years by the time treatment began were not responsive to thalidomide therapy.

Adverse side effects were common, especially at increased dosages. At high doses, participants suffered from fatigue, mood changes, constipation and somnolence (excessive drowsiness). The study concluded that high dosages of thalidomide were not productive enough to warrant the risk of adverse effects.

Conclusions from the study were mixed. High levels of thalidomide were obviously counter-productive, but lower doses appeared to have positive results with less risk of side effects. The lack of response among participants who had experienced relapses or had lived with the disease for several years suggests that thalidomide may be useful only if WM is caught early.

Researchers believe that thalidomide has a limited place in Waldenstrom's macroglobulemia treatment. While it may not be overly effective as a treatment by itself, the medication may prove to work well with rituximab or chemotherapy. Further testing will explore these possibilities.

Resources

Dimopoulos, M. A., Zervas, C., Zomas, A., Kiamouris, C., Viniou, N. A., Grigoraki, V., Karkantaris, C., et al. (2002). Treatment of Waldenstrom's macroglobulinemia with rituximab. Retrieved May 12, 2003, from www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=
PubMed&list_uids=11981004&dopt=Abstract.

Dimopoulos, M. A., Zomas, A., Viniou, N. A., Grigoraki, V., Galani, E., Matsouka, C., Economou, O., et al. (2001). Treatment of Waldenstrom's macroglobulinemia with thalidomide. Retrieved May 12, 2003, from www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=
PubMed&list_uids=11504741&dopt=Abstract.

Medlineplus.gov. (2002). Thalidomide (systemic). Retrieved May 12, 2003, from
www.nlm.nih.gov/medlineplus/druginfo/uspdi/202692.html#SXX03.
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