Cancers (Feb 2022)
The Association between Patient Characteristics and the Efficacy and Safety of Selinexor in Diffuse Large B-Cell Lymphoma in the SADAL Study
- Josée M. Zijlstra,
- George Follows,
- Rene-Olivier Casasnovas,
- Joost S. P. Vermaat,
- Nagesh Kalakonda,
- Sylvain Choquet,
- Brian Hill,
- Catherine Thieblemont,
- Federica Cavallo,
- Fatima De la Cruz,
- John Kuruvilla,
- Nada Hamad,
- Ulrich Jaeger,
- Paolo Caimi,
- Ronit Gurion,
- Krzysztof Warzocha,
- Sameer Bakhshi,
- Juan-Manuel Sancho,
- Michael Schuster,
- Miklos Egyed,
- Fritz Offner,
- Theodoros P. Vassilakopoulos,
- Priyanka Samal,
- Matthew Ku,
- Jenny Xu,
- Kelly Corona,
- Kamal Chamoun,
- Jatin Shah,
- Miguel Canales,
- Marie Maerevoet
Affiliations
- Josée M. Zijlstra
- Department of Hematology, Amsterdam UMC, Cancer Center, Vrije Universiteit, De Boelelaan 1117, 1081HV Amsterdam, The Netherlands
- George Follows
- Department of Haematology, Cambridge University Hospitals NHS Foundation Trust, Cambridge CB2 0QQ, UK
- Rene-Olivier Casasnovas
- Department of Hematology, University Hospital F. Mitterrand and INSERM 1231, 21000 Dijon, France
- Joost S. P. Vermaat
- Department of Hematology, Leiden University Medical Center, Albinesdreef 2, 2333 ZA Leiden, The Netherlands
- Nagesh Kalakonda
- Department of Molecular and Clinical Cancer Medicine, University of Liverpool, Liverpool L69 3GE, UK
- Sylvain Choquet
- Hematology, Hôpital Pitié Salpêtrière, 47-83 Bd de l'Hôpital, 75013 Paris, France
- Brian Hill
- Department of Hematology and Medical Oncology, Taussig Cancer Institute, Cleveland Clinic, Cleveland, OH 44195, USA
- Catherine Thieblemont
- Hemato-Oncology, APHP, Saint-Louis Hospital & Paris University, 75010 Paris, France
- Federica Cavallo
- Division of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino/AOU, Città della Salute e della Scienza di Torino, 10126 Torino, Italy
- Fatima De la Cruz
- Hospital Universitario Virgen del Rocio, E-41013 Sevilla, Spain
- John Kuruvilla
- Division of Medical Oncology and Hematology, Princess Margaret Cancer Centre, Toronto, ON M5G 2M9, Canada
- Nada Hamad
- Department of Hematology, St. Vincent’s Hospital Sydney, Darlinghurst, NSW 2010, Australia
- Ulrich Jaeger
- Division of Hematology and Hemostaseology, Department of Medicine I, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria
- Paolo Caimi
- Case Comprehensive Cancer Center, School of Medicine, Case Western Reserve University, Cleveland, OH 44106, USA
- Ronit Gurion
- Hematology Institute, Davidoff Center, Rabin Medical Center, Petach Tikva & Tel-Aviv University, Tel-Aviv 49100, Israel
- Krzysztof Warzocha
- Department of Hematology, Instytut Hematologii I Transfuzjologii, Chocimska 5, 00-791 Warsaw, Poland
- Sameer Bakhshi
- Department of Medical Oncology, Dr. B. R. A. Institute Rotary Cancer Hospital, All India Institute of Medical Sciences, New Delhi 110029, India
- Juan-Manuel Sancho
- Clinical Hermatology Department, Hospital Germans Trias i Pujol, Institut Català d'Oncologia, Universitat Autònoma de Barcelona, 08916 Badalona, Spain
- Michael Schuster
- Stony Brook Cancer Center, Stony Brook University Hospital, Stony Brook, NY 11794, USA
- Miklos Egyed
- Department of Hematology, Teaching Hospital Mór Kaposi, Tallian Gy. U 20-32, H-7400 Kaposvár, Hungary
- Fritz Offner
- Department of Hematology, Ghent University Hospital, 9000 Ghent, Belgium
- Theodoros P. Vassilakopoulos
- Department of Hematology, National and Kapodistrian University of Athens, 15772 Athens, Greece
- Priyanka Samal
- Hematology-Hemato-Oncology, Institute of Medical Sciences & SUM Hospital, Bhubaneswar 751003, India
- Matthew Ku
- Department of Haematology, St.Vincent’s Hospital, University of Melbourne, Melbourne, VIC 3065, Australia
- Jenny Xu
- Karyopharm Therapeutics, Newton, MA 02459, USA
- Kelly Corona
- Karyopharm Therapeutics, Newton, MA 02459, USA
- Kamal Chamoun
- Karyopharm Therapeutics, Newton, MA 02459, USA
- Jatin Shah
- Karyopharm Therapeutics, Newton, MA 02459, USA
- Miguel Canales
- Department of Hematology, Autonoma University, La Paz University Hospital, 28046 Madrid, Spain
- Marie Maerevoet
- Department of Hematology, Institut Jules Bordet, 1070 Brussels, Belgium
- DOI
- https://doi.org/10.3390/cancers14030791
- Journal volume & issue
-
Vol. 14,
no. 3
p. 791
Abstract
Selinexor, an oral selective inhibitor of nuclear export, was evaluated in the Phase 2b SADAL study in patients with diffuse large B-cell lymphoma (DLBCL) who previously received two to five prior systemic regimens. In post hoc analyses, we analyzed several categories of patient characteristics (age, renal function, DLBCL subtype, absolute lymphocyte count, transplant status, number of prior lines of therapy, refractory status, Ann Arbor disease stage, and lactate dehydrogenase) at baseline, i.e., during screening procedures, to determine their potential contributions to the efficacy (overall response rate [ORR], duration of response [DOR], overall survival [OS]) and tolerability of selinexor. Across most categories of characteristics, no significant difference was observed in ORR or DOR. OS was significantly longer for patients ULN. The most common adverse events (AEs) across the characteristics were thrombocytopenia and nausea, and similar rates of grade 3 AEs and serious AEs were observed. With its oral administration, novel mechanism of action, and consistency in responses in heavily pretreated patients, selinexor may help to address an important unmet clinical need in the treatment of DLBCL.
Keywords
