BACKGROUND AND OBJECTIVES: The optimal post-remission therapy for adults with high-risk acute lymphoblastic leukemia (ALL) is not well established. This multicenter randomized trial by the Spanish PETHEMA Group was addressed to compare three options of post-remission therapy in adults with high-risk ALL: chemotherapy, allogeneic stem cell transplantation (SCT) and autologous SCT. DESIGN AND METHODS: A total of 222 valid high-risk ALL patients entered the trial. All received a standard five-drug/five-week induction course. Patients in complete remission with an HLA-identical family donor were assigned toallogeneic SCT (n=84) and the remaining were randomized to autologous SCT (n=50) or to delayed intensification followed by maintenance chemotherapy up to 2 years in complete remission (n=48). RESULTS: Overall, 183 patients achieved complete remission (82%). With a median follow-up of 70 months, the median disease-free survival and overall survival were 17 and 23 months, respectively. The 5-year disease-free survival and overall survival were 35% (95% CI, 30%-41%) and 34% (95% CI, 28%-39%), respectively. Patients allocated to the chemotherapy, allogeneic and autologous SCT were comparable in the main pre-treatment ALL characteristics and the rate of response to therapy. Intention-to-treat analysis showed no differences between patients according to whether they had or did not have a donor in disease-free survival (39%, 95% CI 30-48% vs. 33%, 95% CI 23-41%) and overall survival (44%, 95% CI 35-52% vs. 35%, 95% CI 25-44%), as well as for autologous SCT vs. chemotherapy comparisons (disease-free survival: 40%, 95% CI 28-52% vs. 51%, 95% CI 37-67%; overall survival: 43%, 95% CI 29-58% vs. 52%, 95% CI 39-65%). No differences were observed when the analysis was made on the basis of the treatment actually performed. INTERPRETATION AND CONCLUSIONS: This study failed to prove that, when a family donor is available, allogeneic SCT produces a better outcome than autologous SCT or chemotherapy in adults with high-risk ALL.
RCT Entities:
BACKGROUND AND OBJECTIVES: The optimal post-remission therapy for adults with high-risk acute lymphoblastic leukemia (ALL) is not well established. This multicenter randomized trial by the Spanish PETHEMA Group was addressed to compare three options of post-remission therapy in adults with high-risk ALL: chemotherapy, allogeneic stem cell transplantation (SCT) and autologous SCT. DESIGN AND METHODS: A total of 222 valid high-risk ALL patients entered the trial. All received a standard five-drug/five-week induction course. Patients in complete remission with an HLA-identical family donor were assigned to allogeneic SCT (n=84) and the remaining were randomized to autologous SCT (n=50) or to delayed intensification followed by maintenance chemotherapy up to 2 years in complete remission (n=48). RESULTS: Overall, 183 patients achieved complete remission (82%). With a median follow-up of 70 months, the median disease-free survival and overall survival were 17 and 23 months, respectively. The 5-year disease-free survival and overall survival were 35% (95% CI, 30%-41%) and 34% (95% CI, 28%-39%), respectively. Patients allocated to the chemotherapy, allogeneic and autologous SCT were comparable in the main pre-treatment ALL characteristics and the rate of response to therapy. Intention-to-treat analysis showed no differences between patients according to whether they had or did not have a donor in disease-free survival (39%, 95% CI 30-48% vs. 33%, 95% CI 23-41%) and overall survival (44%, 95% CI 35-52% vs. 35%, 95% CI 25-44%), as well as for autologous SCT vs. chemotherapy comparisons (disease-free survival: 40%, 95% CI 28-52% vs. 51%, 95% CI 37-67%; overall survival: 43%, 95% CI 29-58% vs. 52%, 95% CI 39-65%). No differences were observed when the analysis was made on the basis of the treatment actually performed. INTERPRETATION AND CONCLUSIONS: This study failed to prove that, when a family donor is available, allogeneic SCT produces a better outcome than autologous SCT or chemotherapy in adults with high-risk ALL.
Authors: L Tucunduva; A Ruggeri; G Sanz; S Furst; G Socié; M Michallet; W Arcese; N Milpied; I Yakoub-Agha; W Linkesch; J Cornelissen; L Mannone; A P Iori; J-M Ribera; J Sanz; P Montesinos; D Purtill; M Labopin; E Gluckman; M Mohty; V Rocha Journal: Bone Marrow Transplant Date: 2014-07 Impact factor: 5.483
Authors: Steven Z Pavletic; Shaji Kumar; Mohamad Mohty; Marcos de Lima; James M Foran; Marcelo Pasquini; Mei-Jie Zhang; Sergio Giralt; Michael R Bishop; Daniel Weisdorf Journal: Biol Blood Marrow Transplant Date: 2010-04-24 Impact factor: 5.742
Authors: Nicholas J Short; Hagop M Kantarjian; Koji Sasaki; Jorge E Cortes; Farhad Ravandi; Deborah A Thomas; Guillermo Garcia-Manero; Issa Khouri; Partow Kebriaei; Richard E Champlin; Sherry Pierce; Ghayas C Issa; Marina Konopleva; Tapan M Kadia; Carlos Bueso-Ramos; Joseph D Khoury; Nitin Jain; Susan M O'Brien; Elias Jabbour Journal: Cancer Date: 2016-08-10 Impact factor: 6.860
Authors: Jenna D Goldberg; Alex Linker; Deborah Kuk; Ravin Ratan; Joseph Jurcic; Juliet N Barker; Hugo Castro-Malaspina; Sergio Giralt; Katharine Hsu; Ann A Jakubowski; Robert Jenq; Guenther Koehne; Esperanza B Papadopoulos; Marcel R M van den Brink; James W Young; Farid Boulad; Nancy A Kernan; Richard J O'Reilly; Susan E Prockop; Joachim Yahalom; Glenn Heller; Miguel-Angel Perales Journal: Biol Blood Marrow Transplant Date: 2012-09-13 Impact factor: 5.742
Authors: N Kröger; M Bornhäuser; M Stelljes; U Pichlmeier; R Trenschel; C Schmid; R Arnold; H Martin; M Heinzelmann; C Wolschke; R G Meyer; W Bethge; G Kobbe; F Ayuk; N Gökbuget; D Hölzer; A Zander; D Beelen Journal: Bone Marrow Transplant Date: 2015-09-14 Impact factor: 5.483