Contributions
Abstract: PB1639
Type: Publication Only
Background
Several clinical and population studies have shown a significant impact of the inclusion of patients with AL in clinical studies on their overall and disease-free survival (DFS). In Russia, such data on the effect of inclusion in clinical trials on the effectiveness of therapy for patients with AL are not available yet.
Aims
Evaluation of OS patients with ALL depending on the inclusion in clinical trials in 5 regions of the Russian Federation according to the AL Register and the clinical study “ALL-2009” (NCT 01193933).
Methods
The AL Registry was conducted since Apr 2009 till Dec 2016. 333 AL cases from Kirov, Ryazan, Kaluga, Tambov regions and Mordovia republic were included into analysis. The Russian multicenter “ALL-2009” trial was conducted since Apr 2009 till Dec 2016 and included 330 Ph-negative ALL patients with a median age 28 y (15-55).
Results
The distribution by AL subtypes was following: AML - 251 (75,3%), ALL - 58 (17,4%), APL - 19(5,7%), other - 5 (1,5%). Median age was for AML – 59y (17-85), ALL - 38y (16-80), APL 51y (21-79) years. Gender female/male proportions 184/149. As the “ALL-2009” study had the inclusion criteria of age <55years, among 42 AL Registry patients under the age of 55 years, 20 were registered in the “ALL-2009” study. 22 patients, not included in the study due to comorbidity, were nontheless treated by the same protocol. 16 older patients received deescalated therapy. The 3-year OS of all ALL patients was 47% (median 27.6 months). The 3-year OS with ALL in the group of patients younger than 55 years was 51% (median 27 months); older than 55 years - 27%; (median 5 months) (p = 0.29). OS in patients from the AL Registry, included in “ALL-2009” study (n = 22), constituted 58%. In patients not included in the “ALL-2009” study, but treated according to this protocol (n = 20), the 3-year OS was slightly lower - 47% than in the patients formally included in the study (p = 0.68). OS of ALL patients, depending on the treatment center, differed significantly. OS in federal institutions and regional centers - 61% versus 46%, respectively (p = 0.003).
Conclusion
OS of ALL patients included and not included in the “ALL-2009” study, but treated according to the protocol, did not significantly differ. This fact demonstrates good reproducibility and effectiveness of treatment protocol. It was shown that the hematological hospital where the treatment was administered became an independent significant prognostic factor for survival of AL patients.
Session topic: 2. Acute lymphoblastic leukemia - Clinical
Keyword(s): acute leukemia, Acute lymphoblastic leukemia, Clinical Trial
Abstract: PB1639
Type: Publication Only
Background
Several clinical and population studies have shown a significant impact of the inclusion of patients with AL in clinical studies on their overall and disease-free survival (DFS). In Russia, such data on the effect of inclusion in clinical trials on the effectiveness of therapy for patients with AL are not available yet.
Aims
Evaluation of OS patients with ALL depending on the inclusion in clinical trials in 5 regions of the Russian Federation according to the AL Register and the clinical study “ALL-2009” (NCT 01193933).
Methods
The AL Registry was conducted since Apr 2009 till Dec 2016. 333 AL cases from Kirov, Ryazan, Kaluga, Tambov regions and Mordovia republic were included into analysis. The Russian multicenter “ALL-2009” trial was conducted since Apr 2009 till Dec 2016 and included 330 Ph-negative ALL patients with a median age 28 y (15-55).
Results
The distribution by AL subtypes was following: AML - 251 (75,3%), ALL - 58 (17,4%), APL - 19(5,7%), other - 5 (1,5%). Median age was for AML – 59y (17-85), ALL - 38y (16-80), APL 51y (21-79) years. Gender female/male proportions 184/149. As the “ALL-2009” study had the inclusion criteria of age <55years, among 42 AL Registry patients under the age of 55 years, 20 were registered in the “ALL-2009” study. 22 patients, not included in the study due to comorbidity, were nontheless treated by the same protocol. 16 older patients received deescalated therapy. The 3-year OS of all ALL patients was 47% (median 27.6 months). The 3-year OS with ALL in the group of patients younger than 55 years was 51% (median 27 months); older than 55 years - 27%; (median 5 months) (p = 0.29). OS in patients from the AL Registry, included in “ALL-2009” study (n = 22), constituted 58%. In patients not included in the “ALL-2009” study, but treated according to this protocol (n = 20), the 3-year OS was slightly lower - 47% than in the patients formally included in the study (p = 0.68). OS of ALL patients, depending on the treatment center, differed significantly. OS in federal institutions and regional centers - 61% versus 46%, respectively (p = 0.003).
Conclusion
OS of ALL patients included and not included in the “ALL-2009” study, but treated according to the protocol, did not significantly differ. This fact demonstrates good reproducibility and effectiveness of treatment protocol. It was shown that the hematological hospital where the treatment was administered became an independent significant prognostic factor for survival of AL patients.
Session topic: 2. Acute lymphoblastic leukemia - Clinical
Keyword(s): acute leukemia, Acute lymphoblastic leukemia, Clinical Trial