PMID- 34404623 OWN - NLM STAT- MEDLINE DCOM- 20220407 LR - 20220531 IS - 2152-2669 (Electronic) IS - 2152-2669 (Linking) VI - 21 IP - 12 DP - 2021 Dec TI - Optimal Supportive Care With Selinexor Improves Outcomes in Patients With Relapsed/Refractory Multiple Myeloma. PG - e975-e984 LID - S2152-2650(21)00286-X [pii] LID - 10.1016/j.clml.2021.07.014 [doi] AB - BACKGROUND: Supportive 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 METHODS: The 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. RESULTS: Of 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%). CONCLUSION: These 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). CI - Copyright (c) 2021. Published by Elsevier Inc. FAU - Chari, Ajai AU - Chari A AD - Icahn School of Medicine at Mount Sinai, New York, NY. Electronic address: ajai.chari@mountsinai.org. FAU - Florendo, Erika AU - Florendo E AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Mancia, Ines Stefania AU - Mancia IS AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Cho, Hearn AU - Cho H AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Madduri, Deepu AU - Madduri D AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Parekh, Samir AU - Parekh S AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Richter, Josh AU - Richter J AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Dhadwal, Amishi AU - Dhadwal A AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Thomas, Joanne AU - Thomas J AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Jiang, Grace AU - Jiang G AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Lagana, Alessandro AU - Lagana A AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Bhalla, Sherry AU - Bhalla S AD - Icahn School of Medicine at Mount Sinai, New York, NY. FAU - Jagannath, Sundar AU - Jagannath S AD - Icahn School of Medicine at Mount Sinai, New York, NY. LA - eng SI - ClinicalTrials.gov/NCT02336815 PT - Clinical Study PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20210718 PL - United States TA - Clin Lymphoma Myeloma Leuk JT - Clinical lymphoma, myeloma & leukemia JID - 101525386 RN - 0 (Hydrazines) RN - 0 (Triazoles) RN - 31TZ62FO8F (selinexor) SB - IM MH - Humans MH - *Hydrazines/adverse effects MH - *Multiple Myeloma/drug therapy MH - Treatment Outcome MH - *Triazoles/adverse effects OTO - NOTNLM OT - Adverse effects OT - Anti-emetic OT - Efficacy OT - Palliative care OT - Prophylactic COIS- Disclosure A.C. receives research funding from: Janssen, Celgene, Novartis Pharmaceuticals, Amgen, Pharmacyclics, Seattle Genetics, Millenium/Takeda and has a consulting/advisory role at: Janssen, Celgene, Novartis Pharmaceuticals, Amgen, Bristol Myers Squibb, Karyopharm, Sanofi Genzyme, Seattle Genetics, Oncopeptides, Millenium/Takeda, Antengene, Glaxo Smith Kline Secura Bio; E.F. is part of the speakers bureau for: Karyopharm, Bristol Myers Squibb, Takeda and has an advisory role at: Janssen; S.I.M. none; H.C. received commercial research support from Genentech Roche, Celgene, and Takeda outside the submitted work, and is employed by the Multiple Myeloma Research Foundation in a capacity that does not conflict with the submitted work; D.M. has a consulting/advisory role at: Janssen, Celgene, Takeda, Legend, GSK, Foundation Medicine, Abbvie; S.P. has a consulting role at Foundation Medicine and receives research funding from: Celgene, Karyopharm; J.R. is part of the speakers bureau for: Celgene, Janssen and has a consulting/advisory role at: Celgene, Janssen, Karyopharm, Antengene, Oncopeptides, X4 pharmaceuticals, Adaptive biotechnologies, SecuraBio, Sanofi; A.D. None; J.T. None; G.J. None; A.L. None; S.B. None; S.J. has a consulting role at: AbbVie, Bristol Myers Squinn, Janssen, Karyopharm, Merk & Xo. EDAT- 2021/08/19 06:00 MHDA- 2022/04/08 06:00 CRDT- 2021/08/18 05:46 PHST- 2021/05/28 00:00 [received] PHST- 2021/07/06 00:00 [revised] PHST- 2021/07/12 00:00 [accepted] PHST- 2021/08/19 06:00 [pubmed] PHST- 2022/04/08 06:00 [medline] PHST- 2021/08/18 05:46 [entrez] AID - S2152-2650(21)00286-X [pii] AID - 10.1016/j.clml.2021.07.014 [doi] PST - ppublish SO - Clin Lymphoma Myeloma Leuk. 2021 Dec;21(12):e975-e984. doi: 10.1016/j.clml.2021.07.014. Epub 2021 Jul 18.