High single-drug activity of nelarabine in relapsed T-lymphoblastic leukemia/lymphoma offers curative option with subsequent stem cell transplantation.
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High single-drug activity of nelarabine in relapsed T-lymphoblastic leukemia/lymphoma offers curative option with subsequent stem cell transplantation. / Gökbuget, Nicola; Basara, Nadezda; Baurmann, Herrad; Beck, Joachim; Brüggemann, Monika; Diedrich, Helmut; Güldenzoph, Björn; Hartung, Gernot; Horst, Heinz-August; Hüttmann, Andreas; Kobbe, Guido; Naumann, Ralph; Ratei, Richard; Reichle, Albrecht; Serve, Hubert; Stelljes, Matthias; Viardot, Andreas; Wattad, Mohammed; Hoelzer, Dieter.
in: BLOOD, Jahrgang 118, Nr. 13, 13, 2011, S. 3504-3511.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - High single-drug activity of nelarabine in relapsed T-lymphoblastic leukemia/lymphoma offers curative option with subsequent stem cell transplantation.
AU - Gökbuget, Nicola
AU - Basara, Nadezda
AU - Baurmann, Herrad
AU - Beck, Joachim
AU - Brüggemann, Monika
AU - Diedrich, Helmut
AU - Güldenzoph, Björn
AU - Hartung, Gernot
AU - Horst, Heinz-August
AU - Hüttmann, Andreas
AU - Kobbe, Guido
AU - Naumann, Ralph
AU - Ratei, Richard
AU - Reichle, Albrecht
AU - Serve, Hubert
AU - Stelljes, Matthias
AU - Viardot, Andreas
AU - Wattad, Mohammed
AU - Hoelzer, Dieter
PY - 2011
Y1 - 2011
N2 - Nelarabine, a purine analog with T-cell specific action, has been approved for relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (ALL/LBL). This is a report of a single-arm phase 2 study conducted in adults (18-81 years of age) with relapsed/refractory T-ALL/LBL. After 1 or 2 cycles, 45 of 126 evaluable patients (36%) achieved complete remission (CR), 12 partial remission (10%), and 66 (52%) were refractory. One treatment-related death was observed, and 2 patients were withdrawn before evaluation. A total of 80% of the CR patients were transferred to stem cell transplantation (SCT). Overall survival was 24% at 1 year (11% at 6 years). After subsequent SCT in CR, survival was 31% and relapse-free survival 37% at 3 years. Transplantation-related mortality was 11%. Neurologic toxicities of grade I-IV/grade III-IV were observed in 13%/4% of the cycles and 16%/7% of the patients. This largest study so far with nelarabine in adults showed impressive single-drug activity in relapsed T-ALL/T-LBL. The drug was well tolerated, even in heavily pretreated patients. A high proportion of CR patients were transferred to SCT with low mortality but a high relapse rate. Exploration of nelarabine in earlier stages of relapse (eg, increasing minimal residual disease), in front-line therapy, and in combination is warranted.
AB - Nelarabine, a purine analog with T-cell specific action, has been approved for relapsed/refractory T-cell acute lymphoblastic leukemia/lymphoma (ALL/LBL). This is a report of a single-arm phase 2 study conducted in adults (18-81 years of age) with relapsed/refractory T-ALL/LBL. After 1 or 2 cycles, 45 of 126 evaluable patients (36%) achieved complete remission (CR), 12 partial remission (10%), and 66 (52%) were refractory. One treatment-related death was observed, and 2 patients were withdrawn before evaluation. A total of 80% of the CR patients were transferred to stem cell transplantation (SCT). Overall survival was 24% at 1 year (11% at 6 years). After subsequent SCT in CR, survival was 31% and relapse-free survival 37% at 3 years. Transplantation-related mortality was 11%. Neurologic toxicities of grade I-IV/grade III-IV were observed in 13%/4% of the cycles and 16%/7% of the patients. This largest study so far with nelarabine in adults showed impressive single-drug activity in relapsed T-ALL/T-LBL. The drug was well tolerated, even in heavily pretreated patients. A high proportion of CR patients were transferred to SCT with low mortality but a high relapse rate. Exploration of nelarabine in earlier stages of relapse (eg, increasing minimal residual disease), in front-line therapy, and in combination is warranted.
KW - Adult
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Aged, 80 and over
KW - Adolescent
KW - Young Adult
KW - Treatment Outcome
KW - Recurrence
KW - Chemotherapy, Adjuvant
KW - Remission Induction
KW - Antineoplastic Agents/therapeutic use
KW - Arabinonucleosides/therapeutic use
KW - Leukemia-Lymphoma, Adult T-Cell/drug therapy/pathology
KW - Precursor T-Cell Lymphoblastic Leukemia-Lymphoma/drug therapy/pathology
KW - Prodrugs/therapeutic use
KW - Stem Cell Transplantation/methods
KW - Adult
KW - Humans
KW - Male
KW - Aged
KW - Female
KW - Middle Aged
KW - Aged, 80 and over
KW - Adolescent
KW - Young Adult
KW - Treatment Outcome
KW - Recurrence
KW - Chemotherapy, Adjuvant
KW - Remission Induction
KW - Antineoplastic Agents/therapeutic use
KW - Arabinonucleosides/therapeutic use
KW - Leukemia-Lymphoma, Adult T-Cell/drug therapy/pathology
KW - Precursor T-Cell Lymphoblastic Leukemia-Lymphoma/drug therapy/pathology
KW - Prodrugs/therapeutic use
KW - Stem Cell Transplantation/methods
M3 - SCORING: Journal article
VL - 118
SP - 3504
EP - 3511
JO - BLOOD
JF - BLOOD
SN - 0006-4971
IS - 13
M1 - 13
ER -