Bortezomib reinduction chemotherapy in high‐risk ALL in first relapse: a report from the Children's Oncology Group
Summary While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome inhibition with chemotherapy improves relapse ALL response rates. This phase 2 Children's Oncology Group study tested the hypothesis tha...
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| Vydáno v: | British journal of haematology Ročník 186; číslo 2; s. 274 - 285 |
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| Hlavní autoři: | , , , , , , , , , |
| Médium: | Journal Article |
| Jazyk: | angličtina |
| Vydáno: |
England
Blackwell Publishing Ltd
01.07.2019
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| Témata: | |
| ISSN: | 0007-1048, 1365-2141, 1365-2141 |
| On-line přístup: | Získat plný text |
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| Abstract | Summary
While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome inhibition with chemotherapy improves relapse ALL response rates. This phase 2 Children's Oncology Group study tested the hypothesis that adding the proteasome inhibitor bortezomib to chemotherapy increases complete response rates (CR2). Evaluable patients (n = 135, 103 B‐ALL, 22 T‐ALL, 10 T‐lymphoblastic lymphoma) were treated with reinduction chemotherapy plus bortezomib. Overall CR2 rates were 68 ± 5% for precursor B‐ALL patients (<21 years of age), 63 ± 7% for very early relapse (<18 months from diagnosis) and 72 ± 6% for early relapse (18–36 months from diagnosis). Relapsed T‐ALL patients had an encouraging CR2 rate of 68 ± 10%. End of induction minimal residual disease (MRD) significantly predicted survival. MRD negative (MRDneg; MRD <0·01%) rates increased from 29% (post‐cycle 1) to 64% following cycle 3. Very early relapse, end‐of‐induction MRDneg precursor B‐ALL patients had 70 ± 14% 3‐year event‐free (EFS) and overall survival (OS) rates, vs. 3‐year EFS/OS of 0–3% (P = 0·0001) for MRDpos (MRD ≥0·01) patients. Early relapse patients had similar outcomes (MRDneg 3‐year EFS/OS 58–65% vs. MRDpos 10–19%, EFS P = 0·0014). These data suggest that adding bortezomib to chemotherapy in certain ALL subgroups, such as T‐cell ALL, is worthy of further investigation. This study is registered at http://www.clinical.trials.gov as NCT00873093. |
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| AbstractList | While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome inhibition with chemotherapy improves relapse ALL response rates. This phase 2 Children's Oncology Group study tested the hypothesis that adding the proteasome inhibitor bortezomib to chemotherapy increases complete response rates (CR2). Evaluable patients (n = 135, 103 B-ALL, 22 T-ALL, 10 T-lymphoblastic lymphoma) were treated with reinduction chemotherapy plus bortezomib. Overall CR2 rates were 68 ± 5% for precursor B-ALL patients (<21 years of age), 63 ± 7% for very early relapse (<18 months from diagnosis) and 72 ± 6% for early relapse (18-36 months from diagnosis). Relapsed T-ALL patients had an encouraging CR2 rate of 68 ± 10%. End of induction minimal residual disease (MRD) significantly predicted survival. MRD negative (MRDneg; MRD <0·01%) rates increased from 29% (post-cycle 1) to 64% following cycle 3. Very early relapse, end-of-induction MRDneg precursor B-ALL patients had 70 ± 14% 3-year event-free (EFS) and overall survival (OS) rates, vs. 3-year EFS/OS of 0-3% (P = 0·0001) for MRDpos (MRD ≥0·01) patients. Early relapse patients had similar outcomes (MRDneg 3-year EFS/OS 58-65% vs. MRDpos 10-19%, EFS P = 0·0014). These data suggest that adding bortezomib to chemotherapy in certain ALL subgroups, such as T-cell ALL, is worthy of further investigation. This study is registered at http://www.clinical.trials.gov as NCT00873093.While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome inhibition with chemotherapy improves relapse ALL response rates. This phase 2 Children's Oncology Group study tested the hypothesis that adding the proteasome inhibitor bortezomib to chemotherapy increases complete response rates (CR2). Evaluable patients (n = 135, 103 B-ALL, 22 T-ALL, 10 T-lymphoblastic lymphoma) were treated with reinduction chemotherapy plus bortezomib. Overall CR2 rates were 68 ± 5% for precursor B-ALL patients (<21 years of age), 63 ± 7% for very early relapse (<18 months from diagnosis) and 72 ± 6% for early relapse (18-36 months from diagnosis). Relapsed T-ALL patients had an encouraging CR2 rate of 68 ± 10%. End of induction minimal residual disease (MRD) significantly predicted survival. MRD negative (MRDneg; MRD <0·01%) rates increased from 29% (post-cycle 1) to 64% following cycle 3. Very early relapse, end-of-induction MRDneg precursor B-ALL patients had 70 ± 14% 3-year event-free (EFS) and overall survival (OS) rates, vs. 3-year EFS/OS of 0-3% (P = 0·0001) for MRDpos (MRD ≥0·01) patients. Early relapse patients had similar outcomes (MRDneg 3-year EFS/OS 58-65% vs. MRDpos 10-19%, EFS P = 0·0014). These data suggest that adding bortezomib to chemotherapy in certain ALL subgroups, such as T-cell ALL, is worthy of further investigation. This study is registered at http://www.clinical.trials.gov as NCT00873093. While survival in paediatric acute lymphoblastic leukaemia ( ALL ) is excellent, survival following relapse is poor. Previous studies suggest proteasome inhibition with chemotherapy improves relapse ALL response rates. This phase 2 Children's Oncology Group study tested the hypothesis that adding the proteasome inhibitor bortezomib to chemotherapy increases complete response rates ( CR 2). Evaluable patients ( n = 135, 103 B‐ ALL , 22 T‐ ALL , 10 T‐lymphoblastic lymphoma) were treated with reinduction chemotherapy plus bortezomib. Overall CR 2 rates were 68 ± 5% for precursor B‐ ALL patients (<21 years of age), 63 ± 7% for very early relapse (<18 months from diagnosis) and 72 ± 6% for early relapse (18–36 months from diagnosis). Relapsed T‐ ALL patients had an encouraging CR 2 rate of 68 ± 10%. End of induction minimal residual disease ( MRD ) significantly predicted survival. MRD negative ( MRD neg; MRD <0·01%) rates increased from 29% (post‐cycle 1) to 64% following cycle 3. Very early relapse, end‐of‐induction MRD neg precursor B‐ ALL patients had 70 ± 14% 3‐year event‐free ( EFS ) and overall survival ( OS ) rates, vs. 3‐year EFS / OS of 0–3% ( P = 0·0001) for MRD pos ( MRD ≥0·01) patients. Early relapse patients had similar outcomes ( MRD neg 3‐year EFS / OS 58–65% vs. MRD pos 10–19%, EFS P = 0·0014). These data suggest that adding bortezomib to chemotherapy in certain ALL subgroups, such as T‐cell ALL , is worthy of further investigation. This study is registered at http://www.clinical.trials.gov as NCT 00873093. While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome inhibition with chemotherapy improves relapse ALL response rates. This phase 2 Children's Oncology Group study tested the hypothesis that adding the proteasome inhibitor bortezomib to chemotherapy increases complete response rates (CR2). Evaluable patients (n = 135, 103 B-ALL, 22 T-ALL, 10 T-lymphoblastic lymphoma) were treated with reinduction chemotherapy plus bortezomib. Overall CR2 rates were 68 ± 5% for precursor B-ALL patients (<21 years of age), 63 ± 7% for very early relapse (<18 months from diagnosis) and 72 ± 6% for early relapse (18-36 months from diagnosis). Relapsed T-ALL patients had an encouraging CR2 rate of 68 ± 10%. End of induction minimal residual disease (MRD) significantly predicted survival. MRD negative (MRDneg; MRD <0·01%) rates increased from 29% (post-cycle 1) to 64% following cycle 3. Very early relapse, end-of-induction MRDneg precursor B-ALL patients had 70 ± 14% 3-year event-free (EFS) and overall survival (OS) rates, vs. 3-year EFS/OS of 0-3% (P = 0·0001) for MRDpos (MRD ≥0·01) patients. Early relapse patients had similar outcomes (MRDneg 3-year EFS/OS 58-65% vs. MRDpos 10-19%, EFS P = 0·0014). These data suggest that adding bortezomib to chemotherapy in certain ALL subgroups, such as T-cell ALL, is worthy of further investigation. This study is registered at http://www.clinical.trials.gov as NCT00873093. Summary While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome inhibition with chemotherapy improves relapse ALL response rates. This phase 2 Children's Oncology Group study tested the hypothesis that adding the proteasome inhibitor bortezomib to chemotherapy increases complete response rates (CR2). Evaluable patients (n = 135, 103 B‐ALL, 22 T‐ALL, 10 T‐lymphoblastic lymphoma) were treated with reinduction chemotherapy plus bortezomib. Overall CR2 rates were 68 ± 5% for precursor B‐ALL patients (<21 years of age), 63 ± 7% for very early relapse (<18 months from diagnosis) and 72 ± 6% for early relapse (18–36 months from diagnosis). Relapsed T‐ALL patients had an encouraging CR2 rate of 68 ± 10%. End of induction minimal residual disease (MRD) significantly predicted survival. MRD negative (MRDneg; MRD <0·01%) rates increased from 29% (post‐cycle 1) to 64% following cycle 3. Very early relapse, end‐of‐induction MRDneg precursor B‐ALL patients had 70 ± 14% 3‐year event‐free (EFS) and overall survival (OS) rates, vs. 3‐year EFS/OS of 0–3% (P = 0·0001) for MRDpos (MRD ≥0·01) patients. Early relapse patients had similar outcomes (MRDneg 3‐year EFS/OS 58–65% vs. MRDpos 10–19%, EFS P = 0·0014). These data suggest that adding bortezomib to chemotherapy in certain ALL subgroups, such as T‐cell ALL, is worthy of further investigation. This study is registered at http://www.clinical.trials.gov as NCT00873093. While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome inhibition with chemotherapy improves relapse ALL response rates. This phase 2 Children’s Oncology Group study tested the hypothesis that adding the proteasome inhibitor bortezomib to chemotherapy increases complete response rates (CR2). Evaluable patients (n=135, 103 B-ALL, 22 T-ALL, 10 T-lymphoblastic lymphoma) were treated with reinduction chemotherapy plus bortezomib. Overall CR2 rates were 68%±5% for precursor B-ALL patients (<21 years of age), 63%±7% for very early relapse (<18 months from diagnosis) and 72%±6% for early relapse (18–36 months from diagnosis). Relapsed T-ALL patients had an encouraging CR2 rate of 68%±10%. End of induction minimal residual disease (MRD) significantly predicted survival. MRD negative (MRDneg; MRD <0.01%) rates increased from 29% (post-cycle 1) to 64% following cycle 3. Very early relapse, end-of-induction MRDneg precursor B-ALL patients had 70%±14% 3-year event-free (EFS) and overall survival (OS) rates, vs. 3-year EFS/OS of 0–3% (p=0.0001) for MRDpos (MRD ≥0.01) patients. Early relapse patients had similar outcomes (MRDneg 3-year EFS/OS 58–65% vs. MRDpos 10–19%, EFS p=0.0014). These data suggest that adding bortezomib to chemotherapy in certain ALL subgroups, such as T-cell ALL, is worthy of further investigation. This study is registered at http://www.clinical.trials.gov as NCT00873093. While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome inhibition with chemotherapy improves relapse ALL response rates. This phase 2 Children's Oncology Group study tested the hypothesis that adding the proteasome inhibitor bortezomib to chemotherapy increases complete response rates (CR2). Evaluable patients (n = 135, 103 B‐ALL, 22 T‐ALL, 10 T‐lymphoblastic lymphoma) were treated with reinduction chemotherapy plus bortezomib. Overall CR2 rates were 68 ± 5% for precursor B‐ALL patients (<21 years of age), 63 ± 7% for very early relapse (<18 months from diagnosis) and 72 ± 6% for early relapse (18–36 months from diagnosis). Relapsed T‐ALL patients had an encouraging CR2 rate of 68 ± 10%. End of induction minimal residual disease (MRD) significantly predicted survival. MRD negative (MRDneg; MRD <0·01%) rates increased from 29% (post‐cycle 1) to 64% following cycle 3. Very early relapse, end‐of‐induction MRDneg precursor B‐ALL patients had 70 ± 14% 3‐year event‐free (EFS) and overall survival (OS) rates, vs. 3‐year EFS/OS of 0–3% (P = 0·0001) for MRDpos (MRD ≥0·01) patients. Early relapse patients had similar outcomes (MRDneg 3‐year EFS/OS 58–65% vs. MRDpos 10–19%, EFS P = 0·0014). These data suggest that adding bortezomib to chemotherapy in certain ALL subgroups, such as T‐cell ALL, is worthy of further investigation. This study is registered at http://www.clinical.trials.gov as NCT00873093. |
| Author | Whitlock, James A. Devidas, Meenakshi Hunger, Stephen P. Horton, Terzah M. O'Brien, Maureen M. Carroll, William L. Lu, Xiaomin Borowitz, Michael J. Raetz, Elizabeth A. Brown, Patrick A. |
| AuthorAffiliation | 4 Cincinnati Children’s Hospital Medical Center, Cincinnati, OH 1 Texas Children’s Cancer and Hematology Centers at Baylor College of Medicine, Houston TX 7 Division of Pediatric Hematology Oncology, Department of Pediatrics, Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY, USA 8 Department of Pediatrics and the Center for Childhood Cancer Research, Children’s Hospital of Philadelphia, and The Perelman School of Medicine at the University of Pennsylvania, Philadelphia PA 6 Division of Pediatric Oncology, Primary Children’s Hospital, Salt Lake City, UT 5 Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, MD 2 Division of Pediatric Oncology, Hospital for Sick Children, Toronto ON, Canada 3 Children’s Oncology Group – Operations Center, Monrovia, CA |
| AuthorAffiliation_xml | – name: 6 Division of Pediatric Oncology, Primary Children’s Hospital, Salt Lake City, UT – name: 1 Texas Children’s Cancer and Hematology Centers at Baylor College of Medicine, Houston TX – name: 8 Department of Pediatrics and the Center for Childhood Cancer Research, Children’s Hospital of Philadelphia, and The Perelman School of Medicine at the University of Pennsylvania, Philadelphia PA – name: 7 Division of Pediatric Hematology Oncology, Department of Pediatrics, Perlmutter Cancer Center, NYU Langone Medical Center, New York, NY, USA – name: 2 Division of Pediatric Oncology, Hospital for Sick Children, Toronto ON, Canada – name: 3 Children’s Oncology Group – Operations Center, Monrovia, CA – name: 5 Johns Hopkins University/Sidney Kimmel Cancer Center, Baltimore, MD – name: 4 Cincinnati Children’s Hospital Medical Center, Cincinnati, OH |
| Author_xml | – sequence: 1 givenname: Terzah M. orcidid: 0000-0001-8293-4242 surname: Horton fullname: Horton, Terzah M. email: tmhorton@txch.org organization: Texas Children's Cancer and Hematology Centers at Baylor College of Medicine – sequence: 2 givenname: James A. surname: Whitlock fullname: Whitlock, James A. organization: Hospital for Sick Children – sequence: 3 givenname: Xiaomin surname: Lu fullname: Lu, Xiaomin organization: Children's Oncology Group – Operations Center – sequence: 4 givenname: Maureen M. surname: O'Brien fullname: O'Brien, Maureen M. organization: Cincinnati Children's Hospital Medical Center – sequence: 5 givenname: Michael J. surname: Borowitz fullname: Borowitz, Michael J. organization: Johns Hopkins University/Sidney Kimmel Cancer Center – sequence: 6 givenname: Meenakshi surname: Devidas fullname: Devidas, Meenakshi organization: Children's Oncology Group – Operations Center – sequence: 7 givenname: Elizabeth A. surname: Raetz fullname: Raetz, Elizabeth A. organization: Primary Children's Hospital – sequence: 8 givenname: Patrick A. surname: Brown fullname: Brown, Patrick A. organization: Johns Hopkins University/Sidney Kimmel Cancer Center – sequence: 9 givenname: William L. surname: Carroll fullname: Carroll, William L. organization: NYU Langone Medical Center – sequence: 10 givenname: Stephen P. surname: Hunger fullname: Hunger, Stephen P. organization: The Perelman School of Medicine at the University of Pennsylvania |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/30957229$$D View this record in MEDLINE/PubMed |
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| ContentType | Journal Article |
| Copyright | 2019 British Society for Haematology and John Wiley & Sons Ltd 2019 British Society for Haematology and John Wiley & Sons Ltd. Copyright © 2019 John Wiley & Sons Ltd |
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| Keywords | proteasome inhibition acute lymphocytic leukaemia minimal residual disease acute lymphoblastic leukaemia paediatric leukaemia |
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| Notes | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Feature-1 content type line 23 Authorship: Terzah Horton, James Whitlock, Meena Devidas, Xioamin Lu and Stephen Hunger designed and analysed the research study. The clinical trial was conducted by COG; Terzah Horton was the principle investigator for the trial. Data Analysis was conducted by Terzah Horton, Meena Devidas, Xiaomin Lu, Michael Borowitz and Stephen Hunger. The manuscript was written by Terzah Horton and critical revisions were provided by James Whitlock, Xiaomin Lu, Maureen M. O’Brien, Michael Borowitz, Meenakshi Devidas, Elizabeth Raetz, Patrick Brown, William Carroll and Stephen Hunger. Final approval of manuscript was provided by Terzah Horton, James Whitlock, Xiaomin Lu, Maureen M. O’Brien, Michael Borowitz, Meenakshi Devidas, Elizabeth Raetz, Patrick Brown, William Carroll and Stephen Hunger. |
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While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome... While survival in paediatric acute lymphoblastic leukaemia ( ALL ) is excellent, survival following relapse is poor. Previous studies suggest proteasome... While survival in paediatric acute lymphoblastic leukaemia (ALL) is excellent, survival following relapse is poor. Previous studies suggest proteasome... |
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| SubjectTerms | acute lymphoblastic leukaemia Acute lymphoblastic leukemia acute lymphocytic leukaemia Adolescent Adult Bortezomib Bortezomib - administration & dosage Bortezomib - adverse effects Chemotherapy Child Child, Preschool Children Clinical trials Diagnosis Disease-Free Survival Female Hematology Humans Infant Leukemia Lymphoma Male Minimal residual disease Neoplasm, Residual Oncology paediatric leukaemia Precursor Cell Lymphoblastic Leukemia-Lymphoma - blood Precursor Cell Lymphoblastic Leukemia-Lymphoma - drug therapy Precursor Cell Lymphoblastic Leukemia-Lymphoma - mortality proteasome inhibition Proteasome inhibitors Recurrence Survival Rate Time Factors |
| Title | Bortezomib reinduction chemotherapy in high‐risk ALL in first relapse: a report from the Children's Oncology Group |
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