Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-α in newly diagnosed chronic myeloid leukemia

PURPOSE: Treatment of chronic-phase (CP) chronic myeloid leukemia (CML) with imatinib 400 mg/d can be unsatisfactory. Optimization of treatment is warranted. - PATIENTS AND METHODS: In all, 1,014 newly diagnosed CP-CML patients were randomly assigned to imatinib 800 mg/d (n = 338), imatinib 400 mg/d...

Full description

Saved in:
Bibliographic Details
Main Authors: Hehlmann, Rüdiger (Author) , Lauseker, Michael (Author) , Jung-Munkwitz, Susanne (Author) , Leitner, Armin (Author) , Müller, Martin Christian (Author) , Pletsch, Nadine (Author) , Proetel, Ulrike (Author) , Haferlach, Claudia (Author) , Schlegelberger, Brigitte (Author) , Balleisen, Leopold (Author) , Hänel, Mathias (Author) , Pfirrmann, Markus (Author) , Krause, Stefan W. (Author) , Nerl, Christoph (Author) , Pralle, Hans (Author) , Gratwohl, Alois (Author) , Hossfeld, Dieter K. (Author) , Hasford, Joerg (Author) , Hochhaus, Andreas (Author) , Saußele, Susanne (Author)
Format: Article (Journal)
Language:English
Published: March 21, 2011
In: Journal of clinical oncology
Year: 2011, Volume: 29, Issue: 12, Pages: 1634-1642
ISSN:1527-7755
Online Access: Get full text
Author Notes:Rüdiger Hehlmann, Michael Lauseker, Susanne Jung-Munkwitz, Armin Leitner, Martin C. Müller, Nadine Pletsch, Ulrike Proetel, Claudia Haferlach, Brigitte Schlegelberger, Leopold Balleisen, Mathias Hänel, Markus Pfirrmann, Stefan W. Krause, Christoph Nerl, Hans Pralle, Alois Gratwohl, Dieter K. Hossfeld, Joerg Hasford, Andreas Hochhaus, and Susanne Saussele

MARC

LEADER 00000caa a2200000 c 4500
001 180073123X
003 DE-627
005 20220820173921.0
007 cr uuu---uuuuu
008 220503s2011 xx |||||o 00| ||eng c
024 7 |a 10.1200/JCO.2010.32.0598  |2 doi 
035 |a (DE-627)180073123X 
035 |a (DE-599)KXP180073123X 
035 |a (OCoLC)1341459386 
040 |a DE-627  |b ger  |c DE-627  |e rda 
041 |a eng 
084 |a 33  |2 sdnb 
100 1 |a Hehlmann, Rüdiger  |d 1941-  |e VerfasserIn  |0 (DE-588)1037003489  |0 (DE-627)751737879  |0 (DE-576)390939463  |4 aut 
245 1 0 |a Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-α in newly diagnosed chronic myeloid leukemia  |c Rüdiger Hehlmann, Michael Lauseker, Susanne Jung-Munkwitz, Armin Leitner, Martin C. Müller, Nadine Pletsch, Ulrike Proetel, Claudia Haferlach, Brigitte Schlegelberger, Leopold Balleisen, Mathias Hänel, Markus Pfirrmann, Stefan W. Krause, Christoph Nerl, Hans Pralle, Alois Gratwohl, Dieter K. Hossfeld, Joerg Hasford, Andreas Hochhaus, and Susanne Saussele 
264 1 |c March 21, 2011 
300 |a 9 
336 |a Text  |b txt  |2 rdacontent 
337 |a Computermedien  |b c  |2 rdamedia 
338 |a Online-Ressource  |b cr  |2 rdacarrier 
500 |a Gesehen am 03.05.2022 
520 |a PURPOSE: Treatment of chronic-phase (CP) chronic myeloid leukemia (CML) with imatinib 400 mg/d can be unsatisfactory. Optimization of treatment is warranted. - PATIENTS AND METHODS: In all, 1,014 newly diagnosed CP-CML patients were randomly assigned to imatinib 800 mg/d (n = 338), imatinib 400 mg/d (n = 325), or imatinib 400 mg/d plus interferon alfa (IFN-α; n = 351). Dose adaptation to avoid higher-grade toxicity was recommended. First primary end point was major molecular remission (MMR) at 12 months. - RESULTS: A higher rate of MMR at 12 months occurred with tolerability-adapted imatinib 800 mg/d than with imatinib 400 mg/d (59% [95% CI, 53% to 65%] v 44% [95% CI, 37% to 50%]; P < .001) or imatinib 400 mg/d plus IFN-α (59% v 46% [95% CI, 40% to 52%]; P = .002). Median dose in the 800-mg/d arm was 628 mg/d with a maximum dose of 737 mg/d during months 4 to 6 and a maintenance dose of 600 mg/d. All three treatment approaches were well tolerated with similar grade 3 and 4 adverse events. Independent of treatment approach, MMR at 12 months showed better progression-free survival (99% v 94%; P = .0023) and overall survival (99% v 93%; P = .0011) at 3 years when compared with > 1% on the international scale or no MMR but showed no difference in 0.1% to < 1% on the international scale, which closely correlates with complete cytogenetic remission. - CONCLUSION: Treatment of early-phase CML with imatinib can be optimized. Early high-dose therapy followed by rapid adaptation to good tolerability increases the rate of MMR at 12 months. Achievement of MMR by month 12 is directly associated with improved survival. 
650 4 |a Adolescent 
650 4 |a Adult 
650 4 |a Aged 
650 4 |a Aged, 80 and over 
650 4 |a Antineoplastic Combined Chemotherapy Protocols 
650 4 |a Benzamides 
650 4 |a Chi-Square Distribution 
650 4 |a Disease-Free Survival 
650 4 |a Dose-Response Relationship, Drug 
650 4 |a Female 
650 4 |a Germany 
650 4 |a Humans 
650 4 |a Imatinib Mesylate 
650 4 |a Interferon-alpha 
650 4 |a Kaplan-Meier Estimate 
650 4 |a Leukemia, Myelogenous, Chronic, BCR-ABL Positive 
650 4 |a Male 
650 4 |a Middle Aged 
650 4 |a Piperazines 
650 4 |a Protein Kinase Inhibitors 
650 4 |a Pyrimidines 
650 4 |a Remission Induction 
650 4 |a Risk Assessment 
650 4 |a Risk Factors 
650 4 |a Survival Rate 
650 4 |a Time Factors 
650 4 |a Treatment Outcome 
650 4 |a Young Adult 
700 1 |a Lauseker, Michael  |d 1981-  |e VerfasserIn  |0 (DE-588)1058710265  |0 (DE-627)79743223X  |0 (DE-576)414848438  |4 aut 
700 1 |a Jung-Munkwitz, Susanne  |d 1972-  |e VerfasserIn  |0 (DE-588)129818496  |0 (DE-627)481322361  |0 (DE-576)297851373  |4 aut 
700 1 |a Leitner, Armin  |d 1968-  |e VerfasserIn  |0 (DE-588)124123406  |0 (DE-627)706545435  |0 (DE-576)294029427  |4 aut 
700 1 |a Müller, Martin Christian  |d 1972-  |e VerfasserIn  |0 (DE-588)121360296  |0 (DE-627)705409236  |0 (DE-576)181482819  |4 aut 
700 1 |a Pletsch, Nadine  |e VerfasserIn  |0 (DE-588)1065689802  |0 (DE-627)816570841  |0 (DE-576)425385329  |4 aut 
700 1 |a Proetel, Ulrike  |e VerfasserIn  |0 (DE-588)106568956X  |0 (DE-627)816570523  |0 (DE-576)425384837  |4 aut 
700 1 |a Haferlach, Claudia  |e VerfasserIn  |0 (DE-588)1206213272  |0 (DE-627)1691999199  |4 aut 
700 1 |a Schlegelberger, Brigitte  |d 1956-  |e VerfasserIn  |0 (DE-588)133666115  |0 (DE-627)550183779  |0 (DE-576)30001029X  |4 aut 
700 1 |a Balleisen, Leopold  |d 1943-  |e VerfasserIn  |0 (DE-588)1146399782  |0 (DE-627)1007913886  |0 (DE-576)186039204  |4 aut 
700 1 |a Hänel, Mathias  |d 1964-  |e VerfasserIn  |0 (DE-588)17362295X  |0 (DE-627)698532414  |0 (DE-576)134465970  |4 aut 
700 1 |a Pfirrmann, Markus  |d 1967-  |e VerfasserIn  |0 (DE-588)133124932  |0 (DE-627)534963617  |0 (DE-576)299639835  |4 aut 
700 1 |a Krause, Stefan W.  |e VerfasserIn  |4 aut 
700 1 |a Nerl, Christoph  |e VerfasserIn  |4 aut 
700 1 |a Pralle, Hans  |e VerfasserIn  |4 aut 
700 1 |a Gratwohl, Alois  |d 1947-  |e VerfasserIn  |0 (DE-588)1089795653  |0 (DE-627)853608105  |0 (DE-576)460543067  |4 aut 
700 1 |a Hossfeld, Dieter K.  |d 1938-  |e VerfasserIn  |0 (DE-588)1055746471  |0 (DE-627)793793335  |0 (DE-576)411243020  |4 aut 
700 1 |a Hasford, Joerg  |d 1950-2021  |e VerfasserIn  |0 (DE-588)109611675  |0 (DE-627)484973878  |0 (DE-576)289647487  |4 aut 
700 1 |a Hochhaus, Andreas  |d 1959-  |e VerfasserIn  |0 (DE-588)1107039339  |0 (DE-627)863321976  |0 (DE-576)474976130  |4 aut 
700 1 |a Saußele, Susanne  |d 1968-  |e VerfasserIn  |0 (DE-588)115839860  |0 (DE-627)69162786X  |0 (DE-576)29010694X  |4 aut 
773 0 8 |i Enthalten in  |t Journal of clinical oncology  |d Alexandria, Va. : American Society of Clinical Oncology, 1983  |g 29(2011), 12, Seite 1634-1642  |h Online-Ressource  |w (DE-627)313116962  |w (DE-600)2005181-5  |w (DE-576)090887018  |x 1527-7755  |7 nnas  |a Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-α in newly diagnosed chronic myeloid leukemia 
773 1 8 |g volume:29  |g year:2011  |g number:12  |g pages:1634-1642  |g extent:9  |a Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-α in newly diagnosed chronic myeloid leukemia 
776 0 8 |i Erscheint auch als  |n Druck-Ausgabe  |a Hehlmann, Rüdiger, 1941 -   |t Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-α in newly diagnosed chronic myeloid leukemia  |d 2011  |w (DE-627)730417913  |w (DE-576)9730417911 
951 |a AR 
992 |a 20220503 
993 |a Article 
994 |a 2011 
998 |g 115839860  |a Saußele, Susanne  |m 115839860:Saußele, Susanne  |d 60000  |d 61200  |e 60000PS115839860  |e 61200PS115839860  |k 0/60000/  |k 1/60000/61200/  |p 20  |y j 
998 |g 1107039339  |a Hochhaus, Andreas  |m 1107039339:Hochhaus, Andreas  |d 60000  |d 61200  |e 60000PH1107039339  |e 61200PH1107039339  |k 0/60000/  |k 1/60000/61200/  |p 19 
998 |g 106568956X  |a Proetel, Ulrike  |m 106568956X:Proetel, Ulrike  |d 60000  |d 61200  |e 60000PP106568956X  |e 61200PP106568956X  |k 0/60000/  |k 1/60000/61200/  |p 7 
998 |g 121360296  |a Müller, Martin Christian  |m 121360296:Müller, Martin Christian  |d 60000  |d 61200  |e 60000PM121360296  |e 61200PM121360296  |k 0/60000/  |k 1/60000/61200/  |p 5 
998 |g 124123406  |a Leitner, Armin  |m 124123406:Leitner, Armin  |d 60000  |d 61200  |e 60000PL124123406  |e 61200PL124123406  |k 0/60000/  |k 1/60000/61200/  |p 4 
998 |g 129818496  |a Jung-Munkwitz, Susanne  |m 129818496:Jung-Munkwitz, Susanne  |d 60000  |d 61200  |e 60000PJ129818496  |e 61200PJ129818496  |k 0/60000/  |k 1/60000/61200/  |p 3 
998 |g 1037003489  |a Hehlmann, Rüdiger  |m 1037003489:Hehlmann, Rüdiger  |d 60000  |d 61200  |d 60000  |e 60000PH1037003489  |e 61200PH1037003489  |e 60000PH1037003489  |k 0/60000/  |k 1/60000/61200/  |k 0/60000/  |p 1  |x j 
999 |a KXP-PPN180073123X  |e 4128459356 
BIB |a Y 
SER |a journal 
JSO |a {"relHost":[{"note":["Fortsetzung der Druck-Ausgabe","Gesehen am 22.05.23"],"id":{"eki":["313116962"],"zdb":["2005181-5"],"issn":["1527-7755"]},"recId":"313116962","pubHistory":["1.1983 -"],"type":{"bibl":"periodical","media":"Online-Ressource"},"disp":"Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-α in newly diagnosed chronic myeloid leukemiaJournal of clinical oncology","title":[{"title_sort":"Journal of clinical oncology","title":"Journal of clinical oncology","subtitle":"JCO : an American Society of Clinical Oncology journal"}],"physDesc":[{"extent":"Online-Ressource"}],"corporate":[{"role":"isb","display":"American Society of Clinical Oncology"}],"titleAlt":[{"title":"official journal of the American Society of Clinical Oncology"},{"title":"JCO"},{"title":"Journal of clinical oncology legacy archive (ASCO)"}],"language":["eng"],"origin":[{"publisher":"American Society of Clinical Oncology ; Lippincott Williams & Wilkins","dateIssuedDisp":"1983-","publisherPlace":"Alexandria, Va. ; Baltimore, Md. [u.a.]","dateIssuedKey":"1983"}],"part":{"text":"29(2011), 12, Seite 1634-1642","volume":"29","extent":"9","year":"2011","pages":"1634-1642","issue":"12"}}],"origin":[{"dateIssuedDisp":"March 21, 2011","dateIssuedKey":"2011"}],"person":[{"family":"Hehlmann","role":"aut","given":"Rüdiger","display":"Hehlmann, Rüdiger"},{"given":"Michael","role":"aut","family":"Lauseker","display":"Lauseker, Michael"},{"display":"Jung-Munkwitz, Susanne","given":"Susanne","family":"Jung-Munkwitz","role":"aut"},{"given":"Armin","role":"aut","family":"Leitner","display":"Leitner, Armin"},{"display":"Müller, Martin Christian","given":"Martin Christian","family":"Müller","role":"aut"},{"display":"Pletsch, Nadine","role":"aut","family":"Pletsch","given":"Nadine"},{"role":"aut","family":"Proetel","given":"Ulrike","display":"Proetel, Ulrike"},{"display":"Haferlach, Claudia","given":"Claudia","role":"aut","family":"Haferlach"},{"given":"Brigitte","family":"Schlegelberger","role":"aut","display":"Schlegelberger, Brigitte"},{"given":"Leopold","family":"Balleisen","role":"aut","display":"Balleisen, Leopold"},{"family":"Hänel","role":"aut","given":"Mathias","display":"Hänel, Mathias"},{"display":"Pfirrmann, Markus","role":"aut","family":"Pfirrmann","given":"Markus"},{"display":"Krause, Stefan W.","role":"aut","family":"Krause","given":"Stefan W."},{"given":"Christoph","family":"Nerl","role":"aut","display":"Nerl, Christoph"},{"display":"Pralle, Hans","given":"Hans","family":"Pralle","role":"aut"},{"given":"Alois","family":"Gratwohl","role":"aut","display":"Gratwohl, Alois"},{"display":"Hossfeld, Dieter K.","given":"Dieter K.","family":"Hossfeld","role":"aut"},{"role":"aut","family":"Hasford","given":"Joerg","display":"Hasford, Joerg"},{"given":"Andreas","family":"Hochhaus","role":"aut","display":"Hochhaus, Andreas"},{"display":"Saußele, Susanne","family":"Saußele","role":"aut","given":"Susanne"}],"language":["eng"],"recId":"180073123X","id":{"doi":["10.1200/JCO.2010.32.0598"],"eki":["180073123X"]},"note":["Gesehen am 03.05.2022"],"physDesc":[{"extent":"9 S."}],"title":[{"title_sort":"Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-α in newly diagnosed chronic myeloid leukemia","title":"Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-α in newly diagnosed chronic myeloid leukemia"}],"type":{"media":"Online-Ressource","bibl":"article-journal"},"name":{"displayForm":["Rüdiger Hehlmann, Michael Lauseker, Susanne Jung-Munkwitz, Armin Leitner, Martin C. Müller, Nadine Pletsch, Ulrike Proetel, Claudia Haferlach, Brigitte Schlegelberger, Leopold Balleisen, Mathias Hänel, Markus Pfirrmann, Stefan W. Krause, Christoph Nerl, Hans Pralle, Alois Gratwohl, Dieter K. Hossfeld, Joerg Hasford, Andreas Hochhaus, and Susanne Saussele"]}} 
SRT |a HEHLMANNRUTOLERABILI2120