Περίληψη:
Patients with RR DLBCL who have received >= 2 lines of therapy have
limited treatment options and an expected overall survival (OS) of < 6
months. The SADAL study evaluated single-agent oral selinexor in
patients with RR DLBCL and demonstrated an overall response rate (ORR)
of 29.1% with median duration of response (DOR) of 9.3 months. The
analyses described here evaluated a number of subpopulations in order to
understand how response correlates with survival outcomes in order to
identify patients who could most optimally benefit from selinexor
treatment. Median age was 67 years; 44.8% of patients were >= 70 years
of age. The median OS was 9.0 months (95% CI 6.2, 13.7) at a median
follow-up of 14.8 months. The median OS was not reached in patients with
a CR or PR, while patients who did not respond have a median OS of 4.9
months (p < 0.0001). Patients < 70 years had an OS of 11.1 months
compared with 7.8 months in patients >= 70 years. Among patients with or
without prior ASCT, the median OS was 10.9 and 7.8 months, respectively.
Among patients with disease refractory to the most recent DLBCL
treatment regimen, the median OS was 7.0 months compared with 11.1
months for disease not refractory to the most recent treatment. In a
patient population in which survival is expected to be < 6 months,
treatment with single-agent oral selinexor was associated with a median
survival of 9 months. Increased median OS observed in patients
responding to selinexor was consistent across subgroups regardless of
age, prior ASCT therapy, or refractory status. Randomized studies of
selinexor in combination with a variety of other anti-DLBCL agents are
planned.
Συγγραφείς:
Maerevoet, Marie
Zijlstra, Josee M.
Follows, George and
Casasnovas, Rene-Olivier
Vermaat, J. S. P.
Kalakonda, Nagesh and
Goy, Andre
Choquet, Sylvain
Van den Neste, Eric
Hill, Brian
and Thieblemont, Catherine
Cavallo, Federica
De la Cruz, Fatima
and Kuruvilla, John
Hamad, Nada
Jaeger, Ulrich
Caimi, Paolo
and Gurion, Ronit
Warzocha, Krzysztof
Bakhshi, Sameer and
Sancho, Juan-Manuel
Schuster, Michael
Egyed, Miklos
Offner,
Fritz
Vassilakopoulos, Theodoros P.
Samal, Priyanka
Ku,
Matthew
Ma, Xiwen
Corona, Kelly
Chamoun, Kamal
Shah,
Jatin
Shacham, Sharon
Kauffman, Michael G.
Canales, Miguel
