“Real-world” data on the efficacy and safety of lenalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma who were treated according to the standard clinical practice: a study of the Greek Myeloma Study Group

Abstract

Lenalidomide and dexamethasone (RD) is a standard of care for relapsed/refractory multiple myeloma (RRMM), but there is limited published data on its efficacy and safety in the "real world" (RW), according to the International Society of Pharmacoeconomics and Outcomes Research definition. We studied 212 RRMM patients who received RD in RW. Objective response (≥PR (partial response)) rate was 77.4 % (complete response (CR), 20.2 %). Median time to first and best response was 2 and 5 months, respectively. Median time to CR when RD was given as 2nd or >2(nd)-line treatment at 4 and 11 months, respectively. Quality of response was independent of previous lines of therapies or previous exposure to thalidomide or bortezomib. Median duration of response was 34.4 months, and it was higher in patients who received RD until progression (not reached versus 19 months, p < 0.001). Improvement of humoral immunity occurred in 60 % of responders (p < 0.001) and in the majority of patients who achieved stable disease. Adverse events were reported in 68.9 % of patients (myelosuppression in 49.4 %) and 12.7 % of patients needed hospitalization. Peripheral neuropathy was observed only in 2.5 % of patients and deep vein thrombosis in 5.7 %. Dose reductions were needed in 31 % of patients and permanent discontinuation in 38.9 %. Median time to treatment discontinuation was 16.8 months. Performance status (PS) and initial lenalidomide dose predicted for treatment discontinuation. Extra-medullary relapses occurred in 3.8 % of patients. Our study confirms that RD is effective and safe in RRMM in the RW; it produces durable responses especially in patients who continue on treatment till progression and improves humoral immunity even in patients with stable disease.

Efficacy and safety of lenalidomide treatment in multiple myeloma (MM) patients—Report of the Polish Myeloma Group

“…In the Polish group, AEs occurred in 73.2% of patients, and their incidence was comparable to previous reports [10]. The main AE, similarly to reports from the Greek and Spanish groups, was myelosupression, which occurred in 51.6% of patients, including grade 3 and 4 events observed in 16.7% of subjects [6,10].…”

“…Our studies demonstrated that LEN is an effective and safe drug in the above mentioned patients. In the entire observation period, the overall response rate (ORR) was 75.5%, and was consistent with findings obtained by Greek and German groups: 73% and 77.4%, respectively [5,10]. It should be noted, however, that in the German group's study LEN + DEX and doxorubicin was used.…”

“…The main AE, similarly to reports from the Greek and Spanish groups, was myelosupression, which occurred in 51.6% of patients, including grade 3 and 4 events observed in 16.7% of subjects [6,10]. In studies by Kneppers, grade 3 and 4 myelosupression occurred in 37% of patient [20].…”

“…In his studies, Stadmauer revealed that in group of MM patients with first relapse overall response and very good partial response rate was 39.8%, and was significantly higher compared to patients treated LEN + DEX during subsequent relapses (27.7%) [12]. According to Katodritou and Mele, the number of previous lines of treatment had no important impact on response quality [7,10]. In our group, nearly 70% of patients received previously at least 3 lines of treatment.…”

“…It was revealed that the association between the number of previous lines of treatment and treatment response achievement was on the borderline of statistical significance. Similarly to previous reports, it was revealed that previous ASCT, thalidomide or bortezomib treatment had no impact neither on therapeutic response achievement nor on the depth of such a response [3,10,13]. In 2008, Wang demonstrated that thalidomide use before LEN treatment had no impact on ORR, TTP and PFS [14].…”