In a nutshell
This study looked at the effectiveness and safety of high dose steroid treatment with methylprednisolone (Medrol) combined with rituximab (Rituxan) for late stage chronic lymphocytic leukemia (CLL). The authors concluded this combination of treatments is more effective than methylprednisolone treatment alone, but that there are serious safety issues associated with it.
Some background
CLL is a form of leukemia most commonly diagnosed in people over the age of 70. Less severe cases of CLL are often untreated but will be carefully monitored for signs of it progressing. For later stage CLL, chemotherapy with fludarabine (Fludara) and an antibody treatment such as rituximab have been successful at improving the condition and can even lead to remission (no evidence of disease).
Unfortunately some patients will not respond to fludarabine and a different form of treatment is needed. Methylprednisolone is a type of steroid that can kill cancer cells that are known to contribute to CLL. When used with rituximab it can be very successful at treating CLL. This combination may offer an alternative to patients who have not responded to fludarabine.
Methods & findings
14 patients with CLL were included in this study. All patients had previously received between 2 and 5 different therapies. Patients had advanced CLL (B or C on the Binet scale). 13 of the patients had previously received fludarabine. High dose methylprednisolone and rituximab were given in 28 day cycles for up to 6 sessions. Methylprednisolone was delivered through a vein at a dose of 1 gm/m2 evern day for 5 days. Results were compared to a control group from a different study who received only high dose methylprednisolone.
93% of patients responded to the combination of treatments compared to 43% in the control group. Two of 14 patients achieved complete remission. The one patient who did not respond had a genetic mutation (deletion 17p) that makes CLL more difficult to treat. None of the patients in the control group achieved complete remission.
The average time to disease progression was 7 months for the combination treatment group and 8 months for the control group.
Only 59% of patients could complete the treatment due to side effects. Infection was the most common side effect seen. Fungal infections occured in 5 patients. One patient developed secondary diabetes.
The bottom line
The authors concluded that a combination of methylprednisolone and rituximab is effective at treating heavily pretreated patients with advanced CLL but can lead to a high number of serious infections.
The fine print
The data used for the control group came from a different study. This study included a small number of patients. Further studies with larger patient populations need to be carried out.
What’s next?
Consult with your physician to discuss your treatment options if you have not responded to fludarabine or other treatments in the past.
Published By :
Haematologica
Date :
Mar 01, 2008
