WASHINGTON, March 19, 2021 / PRNewswire / – The combination of lenalidomide therapy in combination with the steroid dexamethasone (also known as Rd) is considered a standard treatment for elderly patients with multiple myeloma. However, prolonged steroid use can be harmful for some older adults.
New study published in Blood found that switching elderly patients selected to a lower dose of lenalidomide and discontinuing dexamethasone after nine months was not only safe, but also yielded similar results compared with patients who received persistent Rd.
Multiple myeloma, a cancer that affects the blood plasma cells (a type of white blood cell in the bone marrow), usually occurs in people older than 60. Due to older age, they are usually more prone to adverse events due to a higher rate of health conditions or other functional problems, and some medications have a different effect on the body as we age.
In this phase III clinical trial there were 33 medical centers Italy and is the first to evaluate a modified Rd treatment schedule that suppresses steroid use in elderly patients. Participants included people with multiple neonatal myeloma (middle age 76) who were perceived as intermediate fitness for treatment, either due to their age or deficits in their ability to function of daily life, such as a bath or clothes.
“Patients with myeloma are a very diverse population, including appropriate patients who may receive full-dose treatments, and intermediate and debilitated patients who are more prone to potentially serious adverse events. adverse effects on the whole and the outcome of treatment due to the presence of comorbidities and functional disorders, thus requiring modified treatment, ”said the lead author. Alessandra Larocca, MD, PhD University Turin into Italy. “Our study shows that, for the first time, dose reduction or treatment intensity is a viable option and yields results similar to conventional dose treatment for moderately appropriate patients.”
Today, a number of patients with myeloma typically receive ongoing treatment including steroids, which are usually prescribed until a patient’s disease progresses or they are unable to recover. suffer treatment, according to Dr. Larocca. But as she explained, “Long-term steroid use is rarely acceptable, even in younger patients, and patients may need frequent dose reductions or interruptions.”
Indeed, long-term use of dexamethasone-based regimens has been linked to insomnia, anxiety, restlessness, weight gain, and inflammation (edema) in the legs.
Finding ways to change treatments for elderly patients and those with functional deficits is crucial to allow them to stay on treatment longer and control diseases. Therefore, researchers wanted to evaluate whether early discontinuation of dexamethasone, after initial treatment, and tapering the dose of lenalidomide (up to 10 mg / day) would still be of benefit to eligible patients. moderately with multiple neonatal myeloma that did not merit recurrence.
A total of 199 patients were enrolled and randomized to one of two study groups between October 2014 and October 2017. Only individuals deemed moderately eligible were eligible for study; patients were excluded if they were deemed appropriate or weak based on the sensitivity scale of the International Myeloma Working Group. Of these participants, 98 were randomized to receive continuous Rd and 101 received the modified dose and schedule after nine Rd induction rounds (known as induction therapy).
After a median follow-up of 37 months, those who did not take dexamethasone experienced a significantly longer duration of life without a side effect or relapse compared with those who continued the standard Rd treatment (survival without an event of 10.4 months vs 6.9 months, respectively). The specific approach was also better adopted, resulting in fewer adverse effects. Of the adverse events observed on the procedure performed specifically, the majority were minor, including low white blood cell count, infections and skin disorders. The groups showed similar response levels, as well as similar opportunities to live free from disease progression.
Decisions on use can have a significant impact. Dr. Larocca estimates that about a third of patients with myeloma do not qualify for gas cell transplantation, a dangerous but common and effective method of treatment, according to the criteria used in the this study.
“We expect the results of this study to help develop and optimize the treatment of elderly patients who may be at increased risk of treatment toxicity and poor survival as a result of the study. age or their comorbidities, “she said, adding that ongoing trials are now evaluating steroid sparing in conjunction with monoclonal antibody or the role of sensitivity – guided treatment.
Blood (www.bloodjournal.org), the most peer-reviewed publication in the field of hematology, available weekly in print and online. Blood is a journal of the American Society of Hematology (ASH) (www.hematology.org).
SOURCE of blood