Consensus definitions of 14 severe acute toxic effects for childhood lymphoblastic leukaemia treatment: a Delphi consensus

K. Schmiegelow; Andishe Attarbaschi; Shlomit Barzilai; Gabriele Escherich; Thomas Leth Frandsen; Christina Halsey; Rachael Hough; Sima Jeha; Motohiro Kato; Der-Cherng Liang; Torben Stamm Mikkelsen; Anja Möricke; Riitta Niinimäki; Caroline Piette; Maria Caterina Putti; Elizabeth Raetz; Lewis B Silverman; Roderick Skinner; Ruta Tuckuviene; Inge van der Sluis; Ester Zapotocka; on behalf of the Ponte di Legno toxicity working group

doi:10.1016/S1470-2045(16)30035-3

Consensus definitions of 14 severe acute toxic effects for childhood lymphoblastic leukaemia treatment: a Delphi consensus

K. Schmiegelow, Andishe Attarbaschi, Shlomit Barzilai, Gabriele Escherich, Thomas Leth Frandsen, Christina Halsey, Rachael Hough, Sima Jeha, Motohiro Kato, Der-Cherng Liang, Torben Stamm Mikkelsen, Anja Möricke, Riitta Niinimäki, Caroline Piette, Maria Caterina Putti, Elizabeth Raetz, Lewis B Silverman, Roderick Skinner, Ruta Tuckuviene, Inge van der SluisEster Zapotocka, on behalf of the Ponte di Legno toxicity working group

Department of Clinical Medicine

98 Citations (Scopus)

Abstract

Although there are high survival rates for children with acute lymphoblastic leukaemia, their outcome is often counterbalanced by the burden of toxic effects. This is because reported frequencies vary widely across studies, partly because of diverse definitions of toxic effects. Using the Delphi method, 15 international childhood acute lymphoblastic leukaemia study groups assessed acute lymphoblastic leukaemia protocols to address toxic effects that were to be considered by the Ponte di Legno working group. 14 acute toxic effects (hypersensitivity to asparaginase, hyperlipidaemia, osteonecrosis, asparaginase-associated pancreatitis, arterial hypertension, posterior reversible encephalopathy syndrome, seizures, depressed level of consciousness, methotrexate-related stroke-like syndrome, peripheral neuropathy, high-dose methotrexate-related nephrotoxicity, sinusoidal obstructive syndrome, thromboembolism, and Pneumocystis jirovecii pneumonia) that are serious but too rare to be addressed comprehensively within any single group, or are deemed to need consensus definitions for reliable incidence comparisons, were selected for assessment. Our results showed that none of the protocols addressed all 14 toxic effects, that no two protocols shared identical definitions of all toxic effects, and that no toxic effect definition was shared by all protocols. Using the Delphi method over three face-to-face plenary meetings, consensus definitions were obtained for all 14 toxic effects. In the overall assessment of outcome of acute lymphoblastic leukaemia treatment, these expert opinion-based definitions will allow reliable comparisons of frequencies and severities of acute toxic effects across treatment protocols, and facilitate international research on cause, guidelines for treatment adaptation, preventive strategies, and development of consensus algorithms for reporting on acute lymphoblastic leukaemia treatment.

Original language	English
Journal	The Lancet Oncology
Volume	17
Issue number	6
Pages (from-to)	e231-e239
ISSN	1470-2045
DOIs	https://doi.org/10.1016/S1470-2045(16)30035-3
Publication status	Published - 1 Jun 2016

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Schmiegelow, K., Attarbaschi, A., Barzilai, S., Escherich, G., Frandsen, T. L., Halsey, C., Hough, R., Jeha, S., Kato, M., Liang, D-C., Mikkelsen, T. S., Möricke, A., Niinimäki, R., Piette, C., Putti, M. C., Raetz, E., Silverman, L. B., Skinner, R., Tuckuviene, R., ... on behalf of the Ponte di Legno toxicity working group (2016). Consensus definitions of 14 severe acute toxic effects for childhood lymphoblastic leukaemia treatment: a Delphi consensus. The Lancet Oncology, 17(6), e231-e239. https://doi.org/10.1016/S1470-2045(16)30035-3

Schmiegelow, K, Attarbaschi, A, Barzilai, S, Escherich, G, Frandsen, TL, Halsey, C, Hough, R, Jeha, S, Kato, M, Liang, D-C, Mikkelsen, TS, Möricke, A, Niinimäki, R, Piette, C, Putti, MC, Raetz, E, Silverman, LB, Skinner, R, Tuckuviene, R, van der Sluis, I, Zapotocka, E & on behalf of the Ponte di Legno toxicity working group 2016, 'Consensus definitions of 14 severe acute toxic effects for childhood lymphoblastic leukaemia treatment: a Delphi consensus', The Lancet Oncology, vol. 17, no. 6, pp. e231-e239. https://doi.org/10.1016/S1470-2045(16)30035-3

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title = "Consensus definitions of 14 severe acute toxic effects for childhood lymphoblastic leukaemia treatment: a Delphi consensus",

abstract = "Although there are high survival rates for children with acute lymphoblastic leukaemia, their outcome is often counterbalanced by the burden of toxic effects. This is because reported frequencies vary widely across studies, partly because of diverse definitions of toxic effects. Using the Delphi method, 15 international childhood acute lymphoblastic leukaemia study groups assessed acute lymphoblastic leukaemia protocols to address toxic effects that were to be considered by the Ponte di Legno working group. 14 acute toxic effects (hypersensitivity to asparaginase, hyperlipidaemia, osteonecrosis, asparaginase-associated pancreatitis, arterial hypertension, posterior reversible encephalopathy syndrome, seizures, depressed level of consciousness, methotrexate-related stroke-like syndrome, peripheral neuropathy, high-dose methotrexate-related nephrotoxicity, sinusoidal obstructive syndrome, thromboembolism, and Pneumocystis jirovecii pneumonia) that are serious but too rare to be addressed comprehensively within any single group, or are deemed to need consensus definitions for reliable incidence comparisons, were selected for assessment. Our results showed that none of the protocols addressed all 14 toxic effects, that no two protocols shared identical definitions of all toxic effects, and that no toxic effect definition was shared by all protocols. Using the Delphi method over three face-to-face plenary meetings, consensus definitions were obtained for all 14 toxic effects. In the overall assessment of outcome of acute lymphoblastic leukaemia treatment, these expert opinion-based definitions will allow reliable comparisons of frequencies and severities of acute toxic effects across treatment protocols, and facilitate international research on cause, guidelines for treatment adaptation, preventive strategies, and development of consensus algorithms for reporting on acute lymphoblastic leukaemia treatment.",

author = "K. Schmiegelow and Andishe Attarbaschi and Shlomit Barzilai and Gabriele Escherich and Frandsen, {Thomas Leth} and Christina Halsey and Rachael Hough and Sima Jeha and Motohiro Kato and Der-Cherng Liang and Mikkelsen, {Torben Stamm} and Anja M{\"o}ricke and Riitta Niinim{\"a}ki and Caroline Piette and Putti, {Maria Caterina} and Elizabeth Raetz and Silverman, {Lewis B} and Roderick Skinner and Ruta Tuckuviene and {van der Sluis}, Inge and Ester Zapotocka and {on behalf of the Ponte di Legno toxicity working group}",

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T1 - Consensus definitions of 14 severe acute toxic effects for childhood lymphoblastic leukaemia treatment

T2 - a Delphi consensus

AU - Schmiegelow, K.

AU - Attarbaschi, Andishe

AU - Barzilai, Shlomit

AU - Escherich, Gabriele

AU - Frandsen, Thomas Leth

AU - Halsey, Christina

AU - Hough, Rachael

AU - Jeha, Sima

AU - Kato, Motohiro

AU - Liang, Der-Cherng

AU - Mikkelsen, Torben Stamm

AU - Möricke, Anja

AU - Niinimäki, Riitta

AU - Piette, Caroline

AU - Putti, Maria Caterina

AU - Raetz, Elizabeth

AU - Silverman, Lewis B

AU - Skinner, Roderick

AU - Tuckuviene, Ruta

AU - van der Sluis, Inge

AU - Zapotocka, Ester

AU - on behalf of the Ponte di Legno toxicity working group

PY - 2016/6/1

Y1 - 2016/6/1

N2 - Although there are high survival rates for children with acute lymphoblastic leukaemia, their outcome is often counterbalanced by the burden of toxic effects. This is because reported frequencies vary widely across studies, partly because of diverse definitions of toxic effects. Using the Delphi method, 15 international childhood acute lymphoblastic leukaemia study groups assessed acute lymphoblastic leukaemia protocols to address toxic effects that were to be considered by the Ponte di Legno working group. 14 acute toxic effects (hypersensitivity to asparaginase, hyperlipidaemia, osteonecrosis, asparaginase-associated pancreatitis, arterial hypertension, posterior reversible encephalopathy syndrome, seizures, depressed level of consciousness, methotrexate-related stroke-like syndrome, peripheral neuropathy, high-dose methotrexate-related nephrotoxicity, sinusoidal obstructive syndrome, thromboembolism, and Pneumocystis jirovecii pneumonia) that are serious but too rare to be addressed comprehensively within any single group, or are deemed to need consensus definitions for reliable incidence comparisons, were selected for assessment. Our results showed that none of the protocols addressed all 14 toxic effects, that no two protocols shared identical definitions of all toxic effects, and that no toxic effect definition was shared by all protocols. Using the Delphi method over three face-to-face plenary meetings, consensus definitions were obtained for all 14 toxic effects. In the overall assessment of outcome of acute lymphoblastic leukaemia treatment, these expert opinion-based definitions will allow reliable comparisons of frequencies and severities of acute toxic effects across treatment protocols, and facilitate international research on cause, guidelines for treatment adaptation, preventive strategies, and development of consensus algorithms for reporting on acute lymphoblastic leukaemia treatment.

AB - Although there are high survival rates for children with acute lymphoblastic leukaemia, their outcome is often counterbalanced by the burden of toxic effects. This is because reported frequencies vary widely across studies, partly because of diverse definitions of toxic effects. Using the Delphi method, 15 international childhood acute lymphoblastic leukaemia study groups assessed acute lymphoblastic leukaemia protocols to address toxic effects that were to be considered by the Ponte di Legno working group. 14 acute toxic effects (hypersensitivity to asparaginase, hyperlipidaemia, osteonecrosis, asparaginase-associated pancreatitis, arterial hypertension, posterior reversible encephalopathy syndrome, seizures, depressed level of consciousness, methotrexate-related stroke-like syndrome, peripheral neuropathy, high-dose methotrexate-related nephrotoxicity, sinusoidal obstructive syndrome, thromboembolism, and Pneumocystis jirovecii pneumonia) that are serious but too rare to be addressed comprehensively within any single group, or are deemed to need consensus definitions for reliable incidence comparisons, were selected for assessment. Our results showed that none of the protocols addressed all 14 toxic effects, that no two protocols shared identical definitions of all toxic effects, and that no toxic effect definition was shared by all protocols. Using the Delphi method over three face-to-face plenary meetings, consensus definitions were obtained for all 14 toxic effects. In the overall assessment of outcome of acute lymphoblastic leukaemia treatment, these expert opinion-based definitions will allow reliable comparisons of frequencies and severities of acute toxic effects across treatment protocols, and facilitate international research on cause, guidelines for treatment adaptation, preventive strategies, and development of consensus algorithms for reporting on acute lymphoblastic leukaemia treatment.

U2 - 10.1016/S1470-2045(16)30035-3

DO - 10.1016/S1470-2045(16)30035-3

M3 - Review

AN - SCOPUS:84976910542

SN - 1470-2045

VL - 17

SP - e231-e239

JO - The Lancet Oncology

JF - The Lancet Oncology

IS - 6

ER -

Consensus definitions of 14 severe acute toxic effects for childhood lymphoblastic leukaemia treatment: a Delphi consensus

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