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Selinexor, bortezomib, and dexamethasone versus bortezomib and dexamethasone in previously treated multiple myeloma: Outcomes by cytogenetic risk

S. Richard, A. Chari, S. Delimpasi, M. Simonova, I. Spicka, L. Pour, I. Kriachok, MA. Dimopoulos, H. Pylypenko, HW. Auner, X. Leleu, G. Usenko, R. Hajek, R. Benjamin, TK. Dolai, DK. Sinha, CP. Venner, M. Garg, DA. Stevens, H. Quach, S. Jagannath,...

. 2021 ; 96 (9) : 1120-1130. [pub] 20210705

Jazyk angličtina Země Spojené státy americké

Typ dokumentu klinické zkoušky, fáze III, časopisecké články, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc21024976

In the phase 3 BOSTON study, patients with multiple myeloma (MM) after 1-3 prior regimens were randomized to once-weekly selinexor (an oral inhibitor of exportin 1 [XPO1]) plus bortezomib-dexamethasone (XVd) or twice-weekly bortezomib-dexamethasone (Vd). Compared with Vd, XVd was associated with significant improvements in median progression-free survival (PFS), overall response rate (ORR), and lower rates of peripheral neuropathy, with trends in overall survival (OS) favoring XVd. In BOSTON, 141 (35.1%) patients had MM with high-risk (presence of del[17p], t[4;14], t[14;16], or ≥4 copies of amp1q21) cytogenetics (XVd, n = 70; Vd, n = 71), and 261 (64.9%) exhibited standard-risk cytogenetics (XVd, n = 125; Vd, n = 136). Among patients with high-risk MM, median PFS was 12.91 months for XVd and 8.61 months for Vd (HR, 0.73 [95% CI, (0.4673, 1.1406)], p = 0.082), and ORRs were 78.6% and 57.7%, respectively (OR 2.68; p = 0.004). In the standard-risk subgroup, median PFS was 16.62 months for XVd and 9.46 months for Vd (HR 0.61; p = 0.004), and ORRs were 75.2% and 64.7%, respectively (OR 1.65; p = 0.033). The safety profiles of XVd and Vd in both subgroups were consistent with the overall population. These data suggest that selinexor can confer benefits to patients with MM regardless of cytogenetic risk. ClinicalTrials.gov identifier: NCT03110562.

Baylor University Medical Center Dallas Texas USA

Charles University and General Hospital Prague Czech Republic

CHU Lille Service des Maladies du Sang F 59000 Lille France

City Clinical Hospital No 4 of Dnipro City Council Dnipro Ukraine

Clinic of Internal Medicine Hematology and Oncology University Hospital Brno Brno Czech Republic

Cross Cancer Institute University of Alberta Edmonton Alberta Canada

Dana Farber Cancer Institute Boston Massachusetts USA

Department of Hemato oncology University Hospital Ostrava University of Ostrava Ostrava Czech Republic

Department of Hematology Cherkassy Regional Oncological Center Cherkassy Ukraine

Department of Hematology CHU la Miletrie and Inserm CIC 1402 Poitiers France

General Hospital Evangelismos Athens Greece

Hospital Universitario de Salamanca Salamanca Spain

Icahn School of Medicine at Mount Sinai Tisch Cancer Institute New York New York USA

Imperial College London London UK

Institute of Blood Pathology and Transfusion Medicine of National Academy of Medical Sciences of Ukraine Lviv Ukraine

Karyopharm Therapeutics Inc Newton Massachusetts USA

Kings College Hospital NHS Foundation Trust London UK

Medical University of Silesia Katowice Poland

National Cancer Institute Ukraine Kiev Ukraine

Nil Ratan Sircar Medical College and Hospital Kolkata India

Norton Cancer Institute St Matthews Campus Louisville Kentucky USA

School of Medicine National and Kapodistrian University of Athens School of Medicine Athens Greece

Seràgnoli Institute of Hematology Bologna University School of Medicine Bologna Italy

Simmons Comprehensive Cancer Center UT Southwestern Medical Center Dallas Texas USA

State Cancer Institute Indira Gandhi Institute of Medical Sciences Patna India

University Hospital Hotel Dieu Nantes France

University Hospitals of Leicester NHS Trust Leicester UK

University of Calgary Charbonneau Cancer Research Institute Calgary Alberta Canada

University of Maryland Greenebaum Comprehensive Cancer Center Baltimore Maryland USA

University of Melbourne St Vincent's Hospital Melbourne Victoria Australia

Citace poskytuje Crossref.org

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$a In the phase 3 BOSTON study, patients with multiple myeloma (MM) after 1-3 prior regimens were randomized to once-weekly selinexor (an oral inhibitor of exportin 1 [XPO1]) plus bortezomib-dexamethasone (XVd) or twice-weekly bortezomib-dexamethasone (Vd). Compared with Vd, XVd was associated with significant improvements in median progression-free survival (PFS), overall response rate (ORR), and lower rates of peripheral neuropathy, with trends in overall survival (OS) favoring XVd. In BOSTON, 141 (35.1%) patients had MM with high-risk (presence of del[17p], t[4;14], t[14;16], or ≥4 copies of amp1q21) cytogenetics (XVd, n = 70; Vd, n = 71), and 261 (64.9%) exhibited standard-risk cytogenetics (XVd, n = 125; Vd, n = 136). Among patients with high-risk MM, median PFS was 12.91 months for XVd and 8.61 months for Vd (HR, 0.73 [95% CI, (0.4673, 1.1406)], p = 0.082), and ORRs were 78.6% and 57.7%, respectively (OR 2.68; p = 0.004). In the standard-risk subgroup, median PFS was 16.62 months for XVd and 9.46 months for Vd (HR 0.61; p = 0.004), and ORRs were 75.2% and 64.7%, respectively (OR 1.65; p = 0.033). The safety profiles of XVd and Vd in both subgroups were consistent with the overall population. These data suggest that selinexor can confer benefits to patients with MM regardless of cytogenetic risk. ClinicalTrials.gov identifier: NCT03110562.
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