The goal of treatment of relapsed/refractory multiple myeloma (RRMM) is to control the disease, prolong survival, reduce disease-related symptoms, and improve quality of life (QoL). Comprehensive evaluation of new treatment regimens in RRMM pts is worthwhile. We aimed to evaluate QoL, treatment satisfaction, response to treatment and safety during Ixazomib-Lenalidomide-Dexamethasone (IRd) treatment as ≥ 2nd line in RRMM pts in a real world setting. Adult pts with RRMM who have been assigned IRd as ≥2nd line treatment were enrolled in multicenter observational prospective study. Treatment response was evaluated by IMWG 2011, adverse events (AEs) - by CTCAE v.4.0. Pts filled out RAND SF-36 and ESAS-R at baseline and at 1 and 3 mos, and thereafter every 3 mos till 18 mos after IRd treatment start; Patient Treatment Satisfaction Cheklist (PTSC) - at each time-point after IRd treatment start. For analysis of meaningful QoL changes during IRd treatment the proportion of pts with baseline significant QoL impairment who experienced meaningful QoL improvement during IRd treatment was evaluated as well as the number of pts without baseline QoL impairment who maintained it during IRd treatment. For statistical analysis GLM paired test and GEE were employed with adjustment to age, gender and baseline QoL. In total, 40 pts with RRMM were enrolled into the pilot study: median age - 64 years (range, 33-80), 29% males, Durie-Salmon stage at study entry: I/II/III - 3/41/56%, ECOG status 0/1 - 68.7%, 2/3 - 31.6%. Median time since initial MM diagnosis - 51.4 mos (range, 2.9-100.7), disease status at study entry: relapsed - 26%, refractory - 21%, relapsed and refractory - 53%. Median number of lines of prior therapy is 3 (range, 1-3). At the time of analysis the median number of IRd cycles administered is 5, median follow-up - 4.6 (0.4-13.7) mos. Treatment response was not evaluated in 11 pts: 1 - death (at 3 months), 1- refusal, 9 - too early for evaluation. Out from 29 pts one patient achieved complete response (CR), seven pts achieved partial response (PR) and one patient - very good partial response (VGPR), 12 - minor response (MR). Thus, a clinical benefit rate was 70%. Also, seven pts achieved stable disease (23%), one patient was primary refractory to IRd (3.5%), one patient died (3.5%). At the time of analysis all the pts with CR/PR/VGPR (30%) maintained their response to treatment, 4 pts (13%) maintained stable disease and 9 pts (30%) maintained minor response; 7 pts (23%) experienced disease progression. AEs were revealed in 47% pts: grades 1-2 AEs - 12 pts; grades 3-4 AEs - 4 pts; SAEs - 3 pts (neurological toxicity, gastric bleeding, hypotension), all pts with SAEs discontinued IRd treatment. Baseline QoL was dramatically impaired by the majority of SF-36 scales with significant QoL impairment in 42% pts. The most worsening was revealed for physical functioning, role functioning, general health and vitality (Mean scores varied from 24.6 to 47.0 out from 100 scores). At baseline 88% pts had moderate-to severe symptoms (≥4 scores on the scale from 0 to 10); moderate-to severe worse wellbeing, tiredness, pain and shortness of breath had 72,5%, 67,5%, 61,5% and 45% pts, respectively. At 1 month of IRd treatment QoL meaningfully improved or was stable without significant impairment in 61% pts, at 3 months - in 50% pts. In 1 mos of IRd treatment significant improvement was revealed for physical functioning (GLM, 44.9 vs 54.7, p=.01) and general health (GLM, 47.8 vs 56.3, p<.001). Further during IRd treatment no significant QoL worsening was identified (GEE, p>.05). At 1 month of treatment, meaningful decrease of shortness of breath (in 42% pts), tiredness (36%), and pain (28%) was revealed; at 3 months of IRd treatment this proportion was 33%, 27%, and 13%, accordingly. Regarding treatment satisfaction pts reported the following: at 1 month after treatment start 94% of pts were satisfied with symptoms decrease due to IRd, 89% pts confirmed that IRd was convenient and 97% pts reported global satisfaction with IRd; at 3 months of treatment all the pts confirmed the convenience of IRd regimen, 84% pts were satisfied with IRd treatment. The results obtained in a real-world setting demonstrate clinical benefits of IRd regimen in RRMM pts, which were achieved without negatively affecting QoL and with satisfactory symptom control in these heavily pretreated patients. IISR funded by Takeda Disclosures Ionova: BMS: Research Funding; Takeda: Research Funding. Vinogradova:Novartis: Honoraria, Research Funding.
Background: The greatest progress in treatment of lymphoproliferative malignancy multiple myeloma (MM) was achieved in the past decade. According to population studies, in the last decade 5-year overall survival (OS) rate in patients (pts) with MM in the Germany was 39%, in the USA - 47%. Aims: To evaluate 5-year OS and progression-free survival (PFS) rates, to reveal the main independent predictor of mortality in pts with MM in Russia. Patients and Methods: Five medical centers participated in prospective study in Russian Federation. During the period from January 1st, 2009 to January 1st, 2012 170 pts with newly diagnosed MM were included (68 male, 102 female) in the study. The median age was 61 years (range 42 - 86). The primary endpoint was January 1st, 2015. 111 of pts (65%) were younger 65 years. At the moment of diagnosis most pts (25%) were in age between 55 and 60 years. The largest incidence rate for both sexes was in age between 60 and 65 years (Figure 1). Distribution of disease stages according to the Durie Salmon system was the following: III stage - 50%, II stage - 45%, I stage - only 5%. The most pts (55%) were with myeloma G. 83% of pts received bortezomib-based first line treatment, 16% of pts received only chemotherapeutic drugs; refusal of treatment was registered in 1% of cases. Autologous transplantation was performed in 14 (13%) patients in the age under 65 years. Overall response was achieved in 68% of pts, complete remission - in 26%. OS and PFS were evaluated using Kaplan-Meier analysis. Time to OS and PFS (events: progression or death) were measured from the initiation of treatment. Multivariate Cox proportional hazards regression analysis (after univariate analysis) was used to identify the main independent predictor of death. Statistical analysis was performed with SAS v.9.1. Results: 5-year OS rate was 37%, 5-year PFS - 16%, the median follow-up was 38 months (Figure 2 and 3). According to multivariate analysis the main factor associated with mortality was the stage of disease. For the I stage 5-year OS was 100%, for the II stage - 36%, for the III stage - 25% (the pairwise differences between OS was statistically significant, ð<0.05). Conclusion: Our study revealed that the median age in a study pts with MM is ten years less than in Europe and USA. Main independent predictor of OS rate is the stage of disease. Figure 1. Multiple myeloma crude incidence rates (x 100,000) by age class and gender based on five regions of Russia. Figure 1. Multiple myeloma crude incidence rates (x 100,000) by age class and gender based on five regions of Russia. Figure 2. OS and PFS (without resistant cases) in pts with multiple myeloma. Figure 2. OS and PFS (without resistant cases) in pts with multiple myeloma. Figure 3. OS and PFS (without resistant cases) in pts with multiple myeloma. Figure 3. OS and PFS (without resistant cases) in pts with multiple myeloma. Disclosures Volodicheva: CELLTRION, Inc.: Research Funding.
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