Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma

Birgit Burkhardt; Wilhelm Woessmann; Martin Zimmermann; Udo Kontny; Josef Vormoor; Wolfgang Doerffel; Georg Mann; Guenter Henze; Felix Niggli; Wolf-Dieter Ludwig; Dirk Janssen; Hansjoerg Riehm; Martin Schrappe; Alfred Reiter

doi:10.1200/JCO.2005.02.2707

Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma

Birgit Burkhardt, Wilhelm Woessmann, Martin Zimmermann, Udo Kontny, Josef Vormoor, Wolfgang Doerffel, Georg Mann, Guenter Henze, Felix Niggli, Wolf-Dieter Ludwig, Dirk Janssen, Hansjoerg Riehm, Martin Schrappe, Alfred Reiter

Research output: Contribution to journal › Article › Academic › peer-review

Abstract

PURPOSE: In the Non-Hodgkin's Lymphoma-Berlin-Frankfurt-Munster (NHL-BFM) 95 trial, we tested, against the historical control of the combined trials NHL-BFM90 and NHL-BFM86, whether prophylactic cranial radiotherapy (PCRT) can be omitted for CNS-negative patients with stage III or IV lymphoblastic lymphoma (LBL) with sufficient early response.

PATIENTS AND METHODS: Apart from the removal of PCRT in NHL-BFM95, the chemotherapy of the three trials was identical except for the amount of l-asparaginase and daunorubicin during induction. The therapy in NHL-BFM95 was accepted to be noninferior when compared with trials NHL-BFM90/86 if the lower limit of the one-sided 95% CI for the difference in the 2-year probability of event-free-survival (pEFS) between target patients of NHL-BFM95 and the historical controls of NHL-BFM90/86 did not exceed -14%. The target patient group consisted of stage III and IV patients who were CNS negative and responded well to induction therapy.

RESULTS: The number of target patients was 156 in NHL-BFM95 (median age, 8.6 years; range, 0.2 to 19.5 years) and 163 in NHL-BFM90/86 (median age, 8.4 years; range, 0.6 to 16.6 years). For the target group, the pEFS rates at 2 and 5 years were 86% +/- 3% and 82% +/- 3%, respectively, in NHL-BFM95 (median follow-up time, 5.1 years; range, 2.1 to 9.1 years) compared with 91% +/- 2% and 88% +/- 3%, respectively in NHL-BFM90/86 (median follow-up time, 10.7 years; range, 5 to 15.4 years). The lower limit of the one-sided 95% CI for the difference in pEFS was -11% at 2 years and -13% at 5 years. In NHL-BFM95, one isolated and two combined CNS relapses occurred compared with one combined CNS relapse in NHL-BFM90/86. Five-year disease-free-survival rate was 88% +/- 3% in NHL-BFM95 compared with 91% +/- 2% in NHL-BFM90/86.

CONCLUSION: For CNS-negative patients with stage III or IV LBL and sufficient response to induction therapy, treatment without PCRT may be noninferior to treatment including PCRT.

Original language	English
Pages (from-to)	491-9
Number of pages	9
Journal	Journal of clinical oncology : official journal of the American Society of Clinical Oncology
Volume	24
Issue number	3
DOIs	https://doi.org/10.1200/JCO.2005.02.2707
Publication status	Published - 20 Jan 2006
Externally published	Yes

Keywords

Adolescent
Antineoplastic Combined Chemotherapy Protocols/therapeutic use
Asparaginase/administration & dosage
Brain Neoplasms/prevention & control
Child
Cranial Irradiation
Daunorubicin/administration & dosage
Disease-Free Survival
Female
Humans
Male
Neoplasm Staging
Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy
Remission Induction
Survival Analysis
Treatment Outcome

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10.1200/JCO.2005.02.2707

Cite this

Burkhardt, B., Woessmann, W., Zimmermann, M., Kontny, U., Vormoor, J., Doerffel, W., Mann, G., Henze, G., Niggli, F., Ludwig, W.-D., Janssen, D., Riehm, H., Schrappe, M., & Reiter, A. (2006). Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 24(3), 491-9. https://doi.org/10.1200/JCO.2005.02.2707

Burkhardt, Birgit ; Woessmann, Wilhelm ; Zimmermann, Martin et al. / Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma. In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2006 ; Vol. 24, No. 3. pp. 491-9.

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title = "Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma",

abstract = "PURPOSE: In the Non-Hodgkin's Lymphoma-Berlin-Frankfurt-Munster (NHL-BFM) 95 trial, we tested, against the historical control of the combined trials NHL-BFM90 and NHL-BFM86, whether prophylactic cranial radiotherapy (PCRT) can be omitted for CNS-negative patients with stage III or IV lymphoblastic lymphoma (LBL) with sufficient early response.PATIENTS AND METHODS: Apart from the removal of PCRT in NHL-BFM95, the chemotherapy of the three trials was identical except for the amount of l-asparaginase and daunorubicin during induction. The therapy in NHL-BFM95 was accepted to be noninferior when compared with trials NHL-BFM90/86 if the lower limit of the one-sided 95% CI for the difference in the 2-year probability of event-free-survival (pEFS) between target patients of NHL-BFM95 and the historical controls of NHL-BFM90/86 did not exceed -14%. The target patient group consisted of stage III and IV patients who were CNS negative and responded well to induction therapy.RESULTS: The number of target patients was 156 in NHL-BFM95 (median age, 8.6 years; range, 0.2 to 19.5 years) and 163 in NHL-BFM90/86 (median age, 8.4 years; range, 0.6 to 16.6 years). For the target group, the pEFS rates at 2 and 5 years were 86% +/- 3% and 82% +/- 3%, respectively, in NHL-BFM95 (median follow-up time, 5.1 years; range, 2.1 to 9.1 years) compared with 91% +/- 2% and 88% +/- 3%, respectively in NHL-BFM90/86 (median follow-up time, 10.7 years; range, 5 to 15.4 years). The lower limit of the one-sided 95% CI for the difference in pEFS was -11% at 2 years and -13% at 5 years. In NHL-BFM95, one isolated and two combined CNS relapses occurred compared with one combined CNS relapse in NHL-BFM90/86. Five-year disease-free-survival rate was 88% +/- 3% in NHL-BFM95 compared with 91% +/- 2% in NHL-BFM90/86.CONCLUSION: For CNS-negative patients with stage III or IV LBL and sufficient response to induction therapy, treatment without PCRT may be noninferior to treatment including PCRT.",

keywords = "Adolescent, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Asparaginase/administration & dosage, Brain Neoplasms/prevention & control, Child, Cranial Irradiation, Daunorubicin/administration & dosage, Disease-Free Survival, Female, Humans, Male, Neoplasm Staging, Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy, Remission Induction, Survival Analysis, Treatment Outcome",

author = "Birgit Burkhardt and Wilhelm Woessmann and Martin Zimmermann and Udo Kontny and Josef Vormoor and Wolfgang Doerffel and Georg Mann and Guenter Henze and Felix Niggli and Wolf-Dieter Ludwig and Dirk Janssen and Hansjoerg Riehm and Martin Schrappe and Alfred Reiter",

year = "2006",

month = jan,

day = "20",

doi = "10.1200/JCO.2005.02.2707",

language = "English",

volume = "24",

pages = "491--9",

journal = "Journal of clinical oncology : official journal of the American Society of Clinical Oncology",

issn = "0732-183X",

publisher = "Lippincott Williams & Wilkins",

number = "3",

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Burkhardt, B, Woessmann, W, Zimmermann, M, Kontny, U, Vormoor, J, Doerffel, W, Mann, G, Henze, G, Niggli, F, Ludwig, W-D, Janssen, D, Riehm, H, Schrappe, M & Reiter, A 2006, 'Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma', Journal of clinical oncology : official journal of the American Society of Clinical Oncology, vol. 24, no. 3, pp. 491-9. https://doi.org/10.1200/JCO.2005.02.2707

Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma. / Burkhardt, Birgit; Woessmann, Wilhelm; Zimmermann, Martin et al.
In: Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Vol. 24, No. 3, 20.01.2006, p. 491-9.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma

AU - Burkhardt, Birgit

AU - Woessmann, Wilhelm

AU - Zimmermann, Martin

AU - Kontny, Udo

AU - Vormoor, Josef

AU - Doerffel, Wolfgang

AU - Mann, Georg

AU - Henze, Guenter

AU - Niggli, Felix

AU - Ludwig, Wolf-Dieter

AU - Janssen, Dirk

AU - Riehm, Hansjoerg

AU - Schrappe, Martin

AU - Reiter, Alfred

PY - 2006/1/20

Y1 - 2006/1/20

N2 - PURPOSE: In the Non-Hodgkin's Lymphoma-Berlin-Frankfurt-Munster (NHL-BFM) 95 trial, we tested, against the historical control of the combined trials NHL-BFM90 and NHL-BFM86, whether prophylactic cranial radiotherapy (PCRT) can be omitted for CNS-negative patients with stage III or IV lymphoblastic lymphoma (LBL) with sufficient early response.PATIENTS AND METHODS: Apart from the removal of PCRT in NHL-BFM95, the chemotherapy of the three trials was identical except for the amount of l-asparaginase and daunorubicin during induction. The therapy in NHL-BFM95 was accepted to be noninferior when compared with trials NHL-BFM90/86 if the lower limit of the one-sided 95% CI for the difference in the 2-year probability of event-free-survival (pEFS) between target patients of NHL-BFM95 and the historical controls of NHL-BFM90/86 did not exceed -14%. The target patient group consisted of stage III and IV patients who were CNS negative and responded well to induction therapy.RESULTS: The number of target patients was 156 in NHL-BFM95 (median age, 8.6 years; range, 0.2 to 19.5 years) and 163 in NHL-BFM90/86 (median age, 8.4 years; range, 0.6 to 16.6 years). For the target group, the pEFS rates at 2 and 5 years were 86% +/- 3% and 82% +/- 3%, respectively, in NHL-BFM95 (median follow-up time, 5.1 years; range, 2.1 to 9.1 years) compared with 91% +/- 2% and 88% +/- 3%, respectively in NHL-BFM90/86 (median follow-up time, 10.7 years; range, 5 to 15.4 years). The lower limit of the one-sided 95% CI for the difference in pEFS was -11% at 2 years and -13% at 5 years. In NHL-BFM95, one isolated and two combined CNS relapses occurred compared with one combined CNS relapse in NHL-BFM90/86. Five-year disease-free-survival rate was 88% +/- 3% in NHL-BFM95 compared with 91% +/- 2% in NHL-BFM90/86.CONCLUSION: For CNS-negative patients with stage III or IV LBL and sufficient response to induction therapy, treatment without PCRT may be noninferior to treatment including PCRT.

AB - PURPOSE: In the Non-Hodgkin's Lymphoma-Berlin-Frankfurt-Munster (NHL-BFM) 95 trial, we tested, against the historical control of the combined trials NHL-BFM90 and NHL-BFM86, whether prophylactic cranial radiotherapy (PCRT) can be omitted for CNS-negative patients with stage III or IV lymphoblastic lymphoma (LBL) with sufficient early response.PATIENTS AND METHODS: Apart from the removal of PCRT in NHL-BFM95, the chemotherapy of the three trials was identical except for the amount of l-asparaginase and daunorubicin during induction. The therapy in NHL-BFM95 was accepted to be noninferior when compared with trials NHL-BFM90/86 if the lower limit of the one-sided 95% CI for the difference in the 2-year probability of event-free-survival (pEFS) between target patients of NHL-BFM95 and the historical controls of NHL-BFM90/86 did not exceed -14%. The target patient group consisted of stage III and IV patients who were CNS negative and responded well to induction therapy.RESULTS: The number of target patients was 156 in NHL-BFM95 (median age, 8.6 years; range, 0.2 to 19.5 years) and 163 in NHL-BFM90/86 (median age, 8.4 years; range, 0.6 to 16.6 years). For the target group, the pEFS rates at 2 and 5 years were 86% +/- 3% and 82% +/- 3%, respectively, in NHL-BFM95 (median follow-up time, 5.1 years; range, 2.1 to 9.1 years) compared with 91% +/- 2% and 88% +/- 3%, respectively in NHL-BFM90/86 (median follow-up time, 10.7 years; range, 5 to 15.4 years). The lower limit of the one-sided 95% CI for the difference in pEFS was -11% at 2 years and -13% at 5 years. In NHL-BFM95, one isolated and two combined CNS relapses occurred compared with one combined CNS relapse in NHL-BFM90/86. Five-year disease-free-survival rate was 88% +/- 3% in NHL-BFM95 compared with 91% +/- 2% in NHL-BFM90/86.CONCLUSION: For CNS-negative patients with stage III or IV LBL and sufficient response to induction therapy, treatment without PCRT may be noninferior to treatment including PCRT.

KW - Adolescent

KW - Antineoplastic Combined Chemotherapy Protocols/therapeutic use

KW - Asparaginase/administration & dosage

KW - Brain Neoplasms/prevention & control

KW - Child

KW - Cranial Irradiation

KW - Daunorubicin/administration & dosage

KW - Disease-Free Survival

KW - Female

KW - Humans

KW - Male

KW - Neoplasm Staging

KW - Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy

KW - Remission Induction

KW - Survival Analysis

KW - Treatment Outcome

U2 - 10.1200/JCO.2005.02.2707

DO - 10.1200/JCO.2005.02.2707

M3 - Article

C2 - 16421426

SN - 0732-183X

VL - 24

SP - 491

EP - 499

JO - Journal of clinical oncology : official journal of the American Society of Clinical Oncology

JF - Journal of clinical oncology : official journal of the American Society of Clinical Oncology

IS - 3

ER -

Burkhardt B, Woessmann W, Zimmermann M, Kontny U, Vormoor J, Doerffel W et al. Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma. Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2006 Jan 20;24(3):491-9. doi: 10.1200/JCO.2005.02.2707

Impact of cranial radiotherapy on central nervous system prophylaxis in children and adolescents with central nervous system-negative stage III or IV lymphoblastic lymphoma

Abstract

Keywords

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