Abstract
BackgroundSupportive care improves outcomes in many cancers. In the pivotal STORM study selinexor, a first-in-class, oral, selective exportin 1 inhibitor, and low-dose dexamethasone proved to be an effective treatment for patients with triple-class refractory myeloma. We conducted a post-hoc analysis to test the hypothesis that increased utilization of supportive care measures in a sub-cohort of the STORM study prolonged treatment duration with- and improved efficacy of- selinexor. Materials and MethodsThe STORM protocol included specific recommendations for dose modifications and supportive care to mitigate selinexor most common adverse events (AEs) including nausea, fatigue, and thrombocytopenia. The Tisch Cancer Center at Mount Sinai School of Medicine (MSSM) incorporated additional supportive care strategies within the framework of the STORM protocol. ResultsOf 123 patients enrolled in STORM, 28 were enrolled at MSSM. The overall response rate was 26.2% in the overall STORM population and 53.6% in the MSSM cohort. Moreover, duration of response, progression free survival, and overall survival were longer in the MSSM cohort. AEs and dose modification events were similar in the 2 groups. The MSSM cohort had more dose reductions (67.9% vs. 50.5%), and higher use of multiple antiemetic agents (71.4% vs. 50.1%) and romiplostim (32.1% vs. 6.3%), but less discontinuations due to treatment-related AEs (3.6% vs. 25.3%). ConclusionThese results suggests that in addition to more frequent dose reductions, prompter and more aggressive supportive care may have contributed to the low discontinuation rate, longer duration therapy, and greater efficacy rates observed in the MSSM cohort. (ClinicalTrials.gov NCT02336815).
Highlights
Multiple myeloma treatments, including selinexor, exacerbate symptoms of the disease and induce additional adverse effects
There were more women (60.7% vs. 36.2%) in the Mount Sinai School of Medicine (MSSM) cohort, disease characteristics, including time since diagnosis, median number of prior regimens, and exposure/refractoriness to prior therapies were similar between the groups, as were the number of patients with neutropenia or thrombocytopenia at baseline (Table 1)
Weekly selinexor dosing at 60 to 100 mg along with dexamethasone and daratumumab, IMIDs, and proteasome inhibitors (PI) have been reported with encouraging efficacy and safety profile.[23,24,29,30]
Summary
Multiple myeloma treatments, including selinexor, exacerbate symptoms of the disease and induce additional adverse effects. Supportive care has been shown to improve outcomes in other cancers.[13,14,15] Part 2 of the STORM study enrolled heavily pretreated (median number of prior treatment regimens: 7) patients with a median age of 65 years, multiple comorbidities (median: 10) and polypharmacy (median nononcologic prescriptions: 10).[5] The protocol included specific recommendations for dose modifications and supportive care to mitigate the most common AEs associated with selinexor, which include fatigue, gastrointestinal and hematological events. Patients were informed that the study drug dose would be reduced or interrupted based on tolerability and myeloma control in order to optimize the risk-benefit profile for each patient This post-hoc analysis of STORM part 2 was conducted to assess the effect of specific supportive care strategies at the MSSM site on patient outcomes
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