Last week I became involved in a heated “off line” discussion with several activist patients about the pros and cons of using novel therapy agents before the myeloma progressed into active, full-blown multiple myeloma. The underlying issue here is whether a patient should delay treatment as long as possible and/or use as few drugs as possible. Here is a summary of the clinical study I found on CancerConsultants.com, which seemed to ignite the debate:
Early Treatment of Smoldering Multiple Myeloma May Be of Benefit
Researchers from Spain and Portugal have reported that compared with delayed therapy, early treatment of smoldering (asymptomatic) multiple myeloma (MM) may benefit patients at risk of progression to symptomatic MM. The details of this study were presented at the 2009 meeting of the American Society of Hematology in New Orleans in early December.
The major decisions concerning treatment of early-stage MM are if and when treatment should be initiated. It may be useful to think of monoclonal gammopathy of undetermined significance (MGUS), smoldering multiple myeloma, and Stage I multiple myeloma as a continuation or gradual progression of multiple myeloma. Patients with these diagnoses do not require immediate treatment, as these conditions may persist and be stable for several years. Currently, patients with smoldering MM are advised to delay therapy until there are clinical signs or symptoms that indicate MM progression. However, though early treatment may be of benefit compared with delaying therapy, there are few, if any, clinical trials addressing this issue. A recent article in the Journal of Clinical Oncology defined the diagnostic criteria and risk factors for progression in patients with smoldering MM.
The current study addressed the issue of early treatment of smoldering MM in patients at high risk of progression. Patients with smoldering MM who were at high risk for progression were defined as those with the presence of 10% or more of plasma cells and/or a serum M-component of 3 g/dl or more without end-organ damage. One of these factors was sufficient for study entry if a patient also had more than 95% aberrant plasma cells (PCs) by immunophenotyping or abnormal free light chains (FLCs). This study will ultimately include 120 patients who will be randomly allocated to be treated with Revlimid® (lenalidomide) and dexamethasone or therapy at the time of disease progression. Eighty patients have been randomized, and 40 patients were evaluable. Only 16 patients had received all nine cycles of therapy at the time of this report. The overall response rate for these 16 patients was 100%, with 48% having at least a very good partial remission. In the control arm, eight patients progressed to active MM with a median time to progression of 17.5 months. Six of these eight patients developed bone lesions. There were no progressions in patients treated with chemotherapy. These authors suggest that this study may ultimately show benefit from early treatment of smoldering MM.
This is, in fact, a controversial conclusion on so many levels. First, as my before mentioned patient friends out there in cyberspace were quick to point out, studies like this may encourage patients to begin expensive and potentially damaging treatments before they need to. Second, is there a hidden drug company agenda here? If myeloma docs were to start prescribing the use of novel therapy drugs sooner, that would inevitably lead to a lot more sales of these very expensive drugs. Third, what about the use of alternative supplements, such as curcumin, to help slow myeloma’s early progression? These are all valid questions and concerns. My only point–the comments which ignited this exchange in the first place–was it looks like future trends point toward the use of novel therapy agents earlier and more aggressively. This trend is likely because there are more effective and safer myeloma drugs being developed all of the time. Hey! I’m just the messenger here! I don’t necessarily support this idea. I’m just the reporter, OK?
Feel good and keep smiling! Pat