E N Parovichnikova1, L A Kuzmina1, L P Mendeleeva1, G A Klyasova1, V V Troitskaya1, A N Sokolov1, Z Kh Akhmerzaeva1, S K Kravchenko1, E O Gribanova1, E E Zvonkov1, S N Bondarenko2, O Yu Baranova3, T V Ryltsova4, L V Gavrilova5, E E Zinina6, A S Pristupa7, T S Kaporskaya8, N V Minaeva9, O S Samoilova10, T S Konstantinova11, V A Lapin12, K D Kaplanov13, I V Kryuchkova14, A S Nizamutdinova15, A V Klimovich16, E A Borisenkova17, V I Moskov18, T V Gaponova1, T V Obukhova1, I V Galtseva1, M A Rusinov1, S M Kulikov1, V G Savchenko1. 1. Hematology Research Center, Ministry of Health of Russia, Moscow, Russia. 2. Research Institute of Pediatric Hematology and Transplantology, I.P. Pavlov Saint Petersburg State Medical University, Ministry of Health of Russia, Saint Petersburg, Russia. 3. N.N. Blokhin Russian Cancer Research Center, Moscow, Russia. 4. Regional Clinical Hospital, Tula, Russia. 5. Regional Clinical Hospital, Saransk, Russia. 6. Regional Clinical Hospital, Surgut, Russia. 7. Regional Clinical Hospital, Ryazan, Russia. 8. Regional Clinical Hospital, Irkutsk, Russia. 9. Kirov Research Institute of Hematology and Blood Transfusion, Federal Biomedical Agency of Russia, Kirov, Russia. 10. Regional Clinical Hospital, Nizhny Novgorod, Russia. 11. Regional Clinical Hospital, Yekaterinburg, Russia. 12. Regional Clinical Hospital, Yaroslavl, Russia. 13. Regional Oncology Dispensary, Volgograd, Russia. 14. Research Institute of Fundamental and Clinical Immunology, Novosibirsk, Russia. 15. City Clinical Hospital Seventeen, Saint Petersburg, Russia. 16. City Clinical Hospital Thirty-One, Saint Petersburg, Russia. 17. Regional Clinical Hospital, Kaluga, Russia. 18. Krasnoyarsk Clinical Hospital, Krasnoyarsk, Russia.
Abstract
AIM: To analyze the efficiency of the ALL-2009 protocol (ClinicalTrials.gov NCT01 193933) in patients with T-cell leukemias, particularly the role of autologous hematopoietic stem cell transplantation (auto-HSCT) after non-myeloablative BEAM conditioning, followed by maintenance therapy. SUBJECTS AND METHODS: Since 2009, the ALL-2009 study has enrolled 90 patients with T-cell acute lymphoblastic leukemia (T-ALL), the treatment results were assessed in 86 patients: 6 and 28 patients underwentallogeneic HSCT and auto-HSCT, respectively. A landmark analysis was used to compare survival rates in patients who had undergone auto-HSCT and in those who had not. For this, the median time from complete remission to the date of auto-HSCT was determined (the median was 6 months). Then to compare with the auto-HSCT group, only 27 patients who had been in complete remission for 6 months or more were included in a chemotherapy group. RESULTS: The achievement of complete remission in patients with thymic T-ALL (100%) was significantly higher than in those with early (85.7%) or mature (70%) variants. The patients with early and mature T-ALL as compared to those with thymic T-ALL showed high death rates in the remission induction (7.4 and 10% versus 0) and the patients with mature T-ALL had a.higher proportion of refractory forms (20% versus 0). The 5-year overall and relapse-free survival rates in all the T-ALL patients were 66 and 76%, respectively. After auto-HSCT, the risk of recurrence was 0% versus 21% after chemotherapy (p=0.03). The relapse-free survival rates significantly differed in the auto-HSCT and non-auto-HSCT groups: 100 and 66%, respectively (p=0.047). CONCLUSION: The long-term survival rates obtained during this multicenter study in the T-ALL patients treated according to the ALL-2009 protocol, the basis for which is the principle of continuity of cytostatic effects, are exclusively optimistic. Late consolidation with auto-HSCT following non-myeloablative BEAM conditioning, followed by maintenance therapy, considerably reduces the risk of recurrence.
RCT Entities:
AIM: To analyze the efficiency of the ALL-2009 protocol (ClinicalTrials.gov NCT01 193933) in patients with T-cell leukemias, particularly the role of autologous hematopoietic stem cell transplantation (auto-HSCT) after non-myeloablative BEAM conditioning, followed by maintenance therapy. SUBJECTS AND METHODS: Since 2009, the ALL-2009 study has enrolled 90 patients with T-cell acute lymphoblastic leukemia (T-ALL), the treatment results were assessed in 86 patients: 6 and 28 patients underwent allogeneic HSCT and auto-HSCT, respectively. A landmark analysis was used to compare survival rates in patients who had undergone auto-HSCT and in those who had not. For this, the median time from complete remission to the date of auto-HSCT was determined (the median was 6 months). Then to compare with the auto-HSCT group, only 27 patients who had been in complete remission for 6 months or more were included in a chemotherapy group. RESULTS: The achievement of complete remission in patients with thymic T-ALL (100%) was significantly higher than in those with early (85.7%) or mature (70%) variants. The patients with early and mature T-ALL as compared to those with thymic T-ALL showed high death rates in the remission induction (7.4 and 10% versus 0) and the patients with mature T-ALL had a.higher proportion of refractory forms (20% versus 0). The 5-year overall and relapse-free survival rates in all the T-ALL patients were 66 and 76%, respectively. After auto-HSCT, the risk of recurrence was 0% versus 21% after chemotherapy (p=0.03). The relapse-free survival rates significantly differed in the auto-HSCT and non-auto-HSCT groups: 100 and 66%, respectively (p=0.047). CONCLUSION: The long-term survival rates obtained during this multicenter study in the T-ALL patients treated according to the ALL-2009 protocol, the basis for which is the principle of continuity of cytostatic effects, are exclusively optimistic. Late consolidation with auto-HSCT following non-myeloablative BEAM conditioning, followed by maintenance therapy, considerably reduces the risk of recurrence.