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Assessment of imatinib as first-line treatment of chronic myeloid leukemia

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Assessment of imatinib as first-line treatment of chronic myeloid leukemia : 10-year survival results of the randomized CML study IV and impact of non-CML determinants. / Hehlmann, R; Lauseker, M; Saußele, S; Pfirrmann, M; Krause, S; Kolb, H J; Neubauer, A; Hossfeld, D K; Nerl, C; Gratwohl, A; Baerlocher, G M; Heim, D; Brümmendorf, T H; Fabarius, A; Haferlach, C; Schlegelberger, B; Müller, M C; Jeromin, S; Proetel, U; Kohlbrenner, K; Voskanyan, A; Rinaldetti, S; Seifarth, W; Spieß, B; Balleisen, L; Goebeler, M C; Hänel, M; Ho, A; Dengler, J; Falge, C; Kanz, L; Kremers, S; Burchert, A; Kneba, M; Stegelmann, F; Köhne, C A; Lindemann, H W; Waller, C F; Pfreundschuh, M; Spiekermann, K; Berdel, W E; Müller, L; Edinger, M; Mayer, J; Beelen, D W; Bentz, M; Link, H; Hertenstein, B; Fuchs, R; Wernli, M; Schlegel, F; Schlag, R; de Wit, M; Trümper, L; Hebart, H; Hahn, M; Thomalla, J; Scheid, C; Schafhausen, P; Verbeek, W; Eckart, M J; Gassmann, W; Pezzutto, A; Schenk, M; Brossart, P; Geer, T; Bildat, S; Schäfer, E; Hochhaus, A; Hasford, J.

In: LEUKEMIA, Vol. 31, No. 11, 11.2017, p. 2398-2406.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Hehlmann, R, Lauseker, M, Saußele, S, Pfirrmann, M, Krause, S, Kolb, HJ, Neubauer, A, Hossfeld, DK, Nerl, C, Gratwohl, A, Baerlocher, GM, Heim, D, Brümmendorf, TH, Fabarius, A, Haferlach, C, Schlegelberger, B, Müller, MC, Jeromin, S, Proetel, U, Kohlbrenner, K, Voskanyan, A, Rinaldetti, S, Seifarth, W, Spieß, B, Balleisen, L, Goebeler, MC, Hänel, M, Ho, A, Dengler, J, Falge, C, Kanz, L, Kremers, S, Burchert, A, Kneba, M, Stegelmann, F, Köhne, CA, Lindemann, HW, Waller, CF, Pfreundschuh, M, Spiekermann, K, Berdel, WE, Müller, L, Edinger, M, Mayer, J, Beelen, DW, Bentz, M, Link, H, Hertenstein, B, Fuchs, R, Wernli, M, Schlegel, F, Schlag, R, de Wit, M, Trümper, L, Hebart, H, Hahn, M, Thomalla, J, Scheid, C, Schafhausen, P, Verbeek, W, Eckart, MJ, Gassmann, W, Pezzutto, A, Schenk, M, Brossart, P, Geer, T, Bildat, S, Schäfer, E, Hochhaus, A & Hasford, J 2017, 'Assessment of imatinib as first-line treatment of chronic myeloid leukemia: 10-year survival results of the randomized CML study IV and impact of non-CML determinants', LEUKEMIA, vol. 31, no. 11, pp. 2398-2406. https://doi.org/10.1038/leu.2017.253

APA

Hehlmann, R., Lauseker, M., Saußele, S., Pfirrmann, M., Krause, S., Kolb, H. J., Neubauer, A., Hossfeld, D. K., Nerl, C., Gratwohl, A., Baerlocher, G. M., Heim, D., Brümmendorf, T. H., Fabarius, A., Haferlach, C., Schlegelberger, B., Müller, M. C., Jeromin, S., Proetel, U., ... Hasford, J. (2017). Assessment of imatinib as first-line treatment of chronic myeloid leukemia: 10-year survival results of the randomized CML study IV and impact of non-CML determinants. LEUKEMIA, 31(11), 2398-2406. https://doi.org/10.1038/leu.2017.253

Vancouver

Hehlmann R, Lauseker M, Saußele S, Pfirrmann M, Krause S, Kolb HJ et al. Assessment of imatinib as first-line treatment of chronic myeloid leukemia: 10-year survival results of the randomized CML study IV and impact of non-CML determinants. LEUKEMIA. 2017 Nov;31(11):2398-2406. https://doi.org/10.1038/leu.2017.253

Bibtex

@article{2a0c2a851a8a470e95d7bb84a982ba8a,
title = "Assessment of imatinib as first-line treatment of chronic myeloid leukemia: 10-year survival results of the randomized CML study IV and impact of non-CML determinants",
abstract = "Chronic myeloid leukemia (CML)-study IV was designed to explore whether treatment with imatinib (IM) at 400 mg/day (n=400) could be optimized by doubling the dose (n=420), adding interferon (IFN) (n=430) or cytarabine (n=158) or using IM after IFN-failure (n=128). From July 2002 to March 2012, 1551 newly diagnosed patients in chronic phase were randomized into a 5-arm study. The study was powered to detect a survival difference of 5% at 5 years. After a median observation time of 9.5 years, 10-year overall survival was 82%, 10-year progression-free survival was 80% and 10-year relative survival was 92%. Survival between IM400 mg and any experimental arm was not different. In a multivariate analysis, risk group, major-route chromosomal aberrations, comorbidities, smoking and treatment center (academic vs other) influenced survival significantly, but not any form of treatment optimization. Patients reaching the molecular response milestones at 3, 6 and 12 months had a significant survival advantage. For responders, monotherapy with IM400 mg provides a close to normal life expectancy independent of the time to response. Survival is more determined by patients' and disease factors than by initial treatment selection. Although improvements are also needed for refractory disease, more life-time can currently be gained by carefully addressing non-CML determinants of survival.",
keywords = "Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Dose-Response Relationship, Drug, Female, Hematopoietic Stem Cell Transplantation, Humans, Imatinib Mesylate, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Male, Middle Aged, Survival Analysis, Young Adult, Journal Article, Randomized Controlled Trial",
author = "R Hehlmann and M Lauseker and S Sau{\ss}ele and M Pfirrmann and S Krause and Kolb, {H J} and A Neubauer and Hossfeld, {D K} and C Nerl and A Gratwohl and Baerlocher, {G M} and D Heim and Br{\"u}mmendorf, {T H} and A Fabarius and C Haferlach and B Schlegelberger and M{\"u}ller, {M C} and S Jeromin and U Proetel and K Kohlbrenner and A Voskanyan and S Rinaldetti and W Seifarth and B Spie{\ss} and L Balleisen and Goebeler, {M C} and M H{\"a}nel and A Ho and J Dengler and C Falge and L Kanz and S Kremers and A Burchert and M Kneba and F Stegelmann and K{\"o}hne, {C A} and Lindemann, {H W} and Waller, {C F} and M Pfreundschuh and K Spiekermann and Berdel, {W E} and L M{\"u}ller and M Edinger and J Mayer and Beelen, {D W} and M Bentz and H Link and B Hertenstein and R Fuchs and M Wernli and F Schlegel and R Schlag and {de Wit}, M and L Tr{\"u}mper and H Hebart and M Hahn and J Thomalla and C Scheid and P Schafhausen and W Verbeek and Eckart, {M J} and W Gassmann and A Pezzutto and M Schenk and P Brossart and T Geer and S Bildat and E Sch{\"a}fer and A Hochhaus and J Hasford",
year = "2017",
month = nov,
doi = "10.1038/leu.2017.253",
language = "English",
volume = "31",
pages = "2398--2406",
journal = "LEUKEMIA",
issn = "0887-6924",
publisher = "NATURE PUBLISHING GROUP",
number = "11",

}

RIS

TY - JOUR

T1 - Assessment of imatinib as first-line treatment of chronic myeloid leukemia

T2 - 10-year survival results of the randomized CML study IV and impact of non-CML determinants

AU - Hehlmann, R

AU - Lauseker, M

AU - Saußele, S

AU - Pfirrmann, M

AU - Krause, S

AU - Kolb, H J

AU - Neubauer, A

AU - Hossfeld, D K

AU - Nerl, C

AU - Gratwohl, A

AU - Baerlocher, G M

AU - Heim, D

AU - Brümmendorf, T H

AU - Fabarius, A

AU - Haferlach, C

AU - Schlegelberger, B

AU - Müller, M C

AU - Jeromin, S

AU - Proetel, U

AU - Kohlbrenner, K

AU - Voskanyan, A

AU - Rinaldetti, S

AU - Seifarth, W

AU - Spieß, B

AU - Balleisen, L

AU - Goebeler, M C

AU - Hänel, M

AU - Ho, A

AU - Dengler, J

AU - Falge, C

AU - Kanz, L

AU - Kremers, S

AU - Burchert, A

AU - Kneba, M

AU - Stegelmann, F

AU - Köhne, C A

AU - Lindemann, H W

AU - Waller, C F

AU - Pfreundschuh, M

AU - Spiekermann, K

AU - Berdel, W E

AU - Müller, L

AU - Edinger, M

AU - Mayer, J

AU - Beelen, D W

AU - Bentz, M

AU - Link, H

AU - Hertenstein, B

AU - Fuchs, R

AU - Wernli, M

AU - Schlegel, F

AU - Schlag, R

AU - de Wit, M

AU - Trümper, L

AU - Hebart, H

AU - Hahn, M

AU - Thomalla, J

AU - Scheid, C

AU - Schafhausen, P

AU - Verbeek, W

AU - Eckart, M J

AU - Gassmann, W

AU - Pezzutto, A

AU - Schenk, M

AU - Brossart, P

AU - Geer, T

AU - Bildat, S

AU - Schäfer, E

AU - Hochhaus, A

AU - Hasford, J

PY - 2017/11

Y1 - 2017/11

N2 - Chronic myeloid leukemia (CML)-study IV was designed to explore whether treatment with imatinib (IM) at 400 mg/day (n=400) could be optimized by doubling the dose (n=420), adding interferon (IFN) (n=430) or cytarabine (n=158) or using IM after IFN-failure (n=128). From July 2002 to March 2012, 1551 newly diagnosed patients in chronic phase were randomized into a 5-arm study. The study was powered to detect a survival difference of 5% at 5 years. After a median observation time of 9.5 years, 10-year overall survival was 82%, 10-year progression-free survival was 80% and 10-year relative survival was 92%. Survival between IM400 mg and any experimental arm was not different. In a multivariate analysis, risk group, major-route chromosomal aberrations, comorbidities, smoking and treatment center (academic vs other) influenced survival significantly, but not any form of treatment optimization. Patients reaching the molecular response milestones at 3, 6 and 12 months had a significant survival advantage. For responders, monotherapy with IM400 mg provides a close to normal life expectancy independent of the time to response. Survival is more determined by patients' and disease factors than by initial treatment selection. Although improvements are also needed for refractory disease, more life-time can currently be gained by carefully addressing non-CML determinants of survival.

AB - Chronic myeloid leukemia (CML)-study IV was designed to explore whether treatment with imatinib (IM) at 400 mg/day (n=400) could be optimized by doubling the dose (n=420), adding interferon (IFN) (n=430) or cytarabine (n=158) or using IM after IFN-failure (n=128). From July 2002 to March 2012, 1551 newly diagnosed patients in chronic phase were randomized into a 5-arm study. The study was powered to detect a survival difference of 5% at 5 years. After a median observation time of 9.5 years, 10-year overall survival was 82%, 10-year progression-free survival was 80% and 10-year relative survival was 92%. Survival between IM400 mg and any experimental arm was not different. In a multivariate analysis, risk group, major-route chromosomal aberrations, comorbidities, smoking and treatment center (academic vs other) influenced survival significantly, but not any form of treatment optimization. Patients reaching the molecular response milestones at 3, 6 and 12 months had a significant survival advantage. For responders, monotherapy with IM400 mg provides a close to normal life expectancy independent of the time to response. Survival is more determined by patients' and disease factors than by initial treatment selection. Although improvements are also needed for refractory disease, more life-time can currently be gained by carefully addressing non-CML determinants of survival.

KW - Adolescent

KW - Adult

KW - Aged

KW - Aged, 80 and over

KW - Antineoplastic Agents

KW - Dose-Response Relationship, Drug

KW - Female

KW - Hematopoietic Stem Cell Transplantation

KW - Humans

KW - Imatinib Mesylate

KW - Leukemia, Myelogenous, Chronic, BCR-ABL Positive

KW - Male

KW - Middle Aged

KW - Survival Analysis

KW - Young Adult

KW - Journal Article

KW - Randomized Controlled Trial

U2 - 10.1038/leu.2017.253

DO - 10.1038/leu.2017.253

M3 - SCORING: Journal article

C2 - 28804124

VL - 31

SP - 2398

EP - 2406

JO - LEUKEMIA

JF - LEUKEMIA

SN - 0887-6924

IS - 11

ER -