Maintenance Therapy Q&A
We have asked Dr. Kenneth Anderson of the Dana-Farber Cancer Institute in Boston, MA, and Dr. Philip Greipp of the Mayo Clinic in Rochester, MN to assist us in answering the following question:
If a patient receives high-dose chemotherapy and stem cell transplant, should he or she receive maintenance therapy afterward?
Dr. Anderson: There is building evidence that the novel agents Revlimid (lenalidomide) and/or Velcade (bortezomib) can improve the extent and duration of response achieved with high-dose chemotherapy and stem cell transplant when used both before the procedure (as induction therapy) and also as a consolidation and maintenance therapy following transplant.
Results of a large, randomized phase III trial conducted in the United States showed that low-dose daily Revlimid maintenance therapy post transplant reduced the risk of disease progression by 58% versus placebo. These results are consistent with interim results of a randomized French trial that showed a 54% reduction in risk with low-dose daily Revlimid maintenance treatment versus placebo post transplant. In both studies, Revlimid doses typically ranged between 10 and 15 mg and benefit was seen regardless of the induction therapy used or whether patients had high-risk or low-risk disease. A large Scandinavian trial similarly showed increased extent and prolongation of responses when Velcade treatment for two cycles post transplant was followed by weekly Velcade maintenance. It is too early—there are not yet sufficient data—to determine whether overall survival is also prolonged with maintenance.
Dr. Greipp: The use of maintenance therapy following high-dose chemotherapy and transplant is something that needs to be decided on a case-by-case basis. For instance, patients who are considered to have standard-risk disease who achieve a complete response or very good partial response following transplant may do very well for years without maintenance therapy. So, close observation or use of maintenance therapy are both viable options for these patients. In contrast, patients with high-risk disease or those with a high tumor burden following transplant generally do not have a long period of response, and thus may need continuing therapy of some kind. However, with maintenance therapy one must also consider the potential side effects that may be associated with using a drug over an extended period of time, as well as the potential risk for developing resistance to the drug. We will have to wait for additional data from ongoing and future studies before we have all the answers we need regarding routine use of maintenance therapy.
Note from the MMRF: Recently updated Multiple Myeloma Practice Guidelines in Oncology developed by the National Comprehensive Cancer Network (NCCN) now include single-agent Revlimid as an option for maintenance therapy. However, it is noted that the results of three randomized trials evaluating Revlimid maintenance have not undergone full peer medical review and the safety and efficacy data are still preliminary. Note that thalidomide, alone and in combination with prednisone, is already included in the guidelines as maintenance therapy. The guidelines state that results regarding use of Velcade as maintenance are too preliminary to make any recommendations.
Last Update: July 19, 2010