Safety and efficacy of the combination of pegylated interferon-α2b and dasatinib in newly diagnosed chronic-phase chronic myeloid leukemia patients

Leukemia

Volumn 30, Issue 9, 2016, Pages 1853-1860

  Hjorth Hansen, H ^a   Stentoft, J ^b   Richter, J ^c   Koskenvesa, P ^d   Hoglund M ^e   Dreimane, A ^f   Porkka, K ^d   Gedde Dahl, T ^g   Gjertsen, B T ^h   Gruber, F X ⁱ   Stenke, L ^j   Eriksson, K M ^k   Markevarn B ^l   Lubking A ^d   Vestergaard, H ^m   Udby, L ⁿ   Bjerrum, O W ^o   Persson, I ^p   Mustjoki, S ^d   Olsson Stromberg U ^e  

^a NORWEGIAN UNIVERSITY OF SCIENCE AND TECHNOLOGY   (Norway)

^b AARHUS UNIVERSITY HOSPITAL   (Denmark)

^c LUND UNIVERSITY HOSPITAL   (Sweden)

^d UNIVERSITY OF HELSINKI   (Finland)

^e UPPSALA UNIVERSITY HOSPITAL   (Sweden)

^f LINKÖPING UNIVERSITY   (Sweden)

^g OSLO UNIVERSITY HOSPITAL   (Norway)

^h HAUKELAND UNIVERSITY HOSPITAL   (Norway)

ⁱ UNIVERSITY HOSPITAL OF NORTH NORWAY   (Norway)

^j KAROLINSKA UNIVERSITY HOSPITAL   (Sweden)

^k Karolinska Institutet ^*  (Sweden)

^l UMEÅ UNIVERSITY HOSPITAL   (Sweden)

^m ODENSE UNIVERSITY HOSPITAL   (Denmark)

ⁿ ROSKILDE HOSPITAL   (Denmark)

^o Rigshospitalet   (Denmark)

^p UPPSALA UNIVERSITY   (Sweden)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ALANINE AMINOTRANSFERASE; BCR ABL PROTEIN; DASATINIB; PEGINTERFERON ALPHA2B; TRIACYLGLYCEROL LIPASE; ALPHA INTERFERON; ANTINEOPLASTIC AGENT; MACROGOL DERIVATIVE; RECOMBINANT PROTEIN;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANAPHYLAXIS; ANEMIA; ANGIONEUROTIC EDEMA; ANXIETY DISORDER; ARTICLE; ATRIAL FIBRILLATION; BRADYCARDIA; CANCER COMBINATION CHEMOTHERAPY; CANCER DIAGNOSIS; CANCER GROWTH; CHRONIC MYELOID LEUKEMIA; CHRONIC PHASE CHRONIC MYELOID LEUKEMIA; CLINICAL ARTICLE; CYTOGENETICS; DEPRESSION; DIAGNOSTIC VALUE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG SAFETY; DYSPNEA; EDEMA; FATIGUE; FEMALE; FEVER; FLU LIKE SYNDROME; FOLLOW UP; HEADACHE; HUMAN; HYPOPHOSPHATEMIA; HYPOTHYROIDISM; INFECTION; MALAISE; MALE; MULTICENTER STUDY; NEUTROPENIA; PHASE 2 CLINICAL TRIAL; PLEURA EFFUSION; PNEUMONIA; PRIORITY JOURNAL; RASH; SIDE EFFECT; THROMBOCYTOPENIA; URTICARIA; ADOLESCENT; CLINICAL TRIAL; LEUKEMIA, MYELOID, CHRONIC-PHASE; MIDDLE AGED; REMISSION; TREATMENT OUTCOME; YOUNG ADULT;

ADOLESCENT; ADULT; AGED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DASATINIB; FEMALE; HUMANS; INTERFERON-ALPHA; LEUKEMIA, MYELOID, CHRONIC-PHASE; MALE; MIDDLE AGED; PLEURAL EFFUSION; POLYETHYLENE GLYCOLS; RECOMBINANT PROTEINS; REMISSION INDUCTION; TREATMENT OUTCOME; YOUNG ADULT;

EID: 84973163267     PISSN: 08876924     EISSN: 14765551     Source Type: Journal    
DOI: 10.1038/leu.2016.121     Document Type: Article

References (50)

1. Hehlmann R. CML-Where do we stand in 2015? Ann Hematol 2015; 94(Suppl 2): S103-S105
2. Hoglund M, Sandin F, Hellstrom K, Bjoreman M, Bjorkholm M, Brune M et al. Tyrosine kinase inhibitor usage, treatment outcome, and prognostic scores in CML: report from the population-based Swedish CML registry. Blood 2013; 122: 1284-1292
3. Hochhaus A, O'Brien SG, Guilhot F, Druker BJ, Branford S, Foroni L et al. Six-year follow-up of patients receiving imatinib for the first-line treatment of chronic myeloid leukemia. Leukemia 2009; 23: 1054-1061
4. Jabbour E, Kantarjian HM, Saglio G, Steegmann JL, Shah NP, Boque C et al. Early response with dasatinib or imatinib in chronic myeloid leukemia: 3-year follow-up from a randomized phase 3 trial (DASISION). Blood 2014; 123: 494-500
5. Kantarjian H, Shah NP, Hochhaus A, Cortes J, Shah S, Ayala M et al. Dasatinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia. N Engl J Med 2010; 362: 2260-2270
6. Kantarjian HM, Hochhaus A, Saglio G, De SC, Flinn IW, Stenke L et al. Nilotinib versus imatinib for the treatment of patients with newly diagnosed chronic phase, Philadelphia chromosome-positive, chronic myeloid leukaemia: 24-month minimum follow-up of the phase 3 randomised ENESTnd trial. Lancet Oncol 2011; 12: 841-851
7. Hochhaus A, Saglio G, Hughes TP, Larson RA, Kim DW, Issaragrisil S et al. Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial. Leukemia 2016; 5: 1044-1054
8. Cortes JE, Baccarani M, Guilhot F, Druker BJ, Branford S, Kim DW et al. Phase III, randomized, open-label study of daily imatinib mesylate 400mg versus 800 mg in patients with newly diagnosed, previously untreated chronic myeloid leukemia in chronic phase using molecular end points: tyrosine kinase inhibitor optimization and selectivity study. J Clin Oncol 2010; 28: 424-430
9. Cortes JE, Kim DW, Kantarjian HM, Brummendorf TH, Dyagil I, Griskevicius L et al. Bosutinib versus imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: results from the BELA trial. J Clin Oncol 2012; 30: 3486-3492
10. Cortes JE, Kim DW, Pinilla-Ibarz J, le Coutre P, Paquette R, Chuah C et al. A phase 2 trial of ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med 2013; 369: 1783-1796
11. Cortes JE, Talpaz M, Kantarjian H. Ponatinib in Philadelphia chromosome-positive leukemias. N Engl J Med 2014; 370: 577
12. Hehlmann R, Müller MC, Lauseker M, Hanfstein B, Fabarius A, Schreiber A et al. Deep molecular response is reached by the majority of patients treated with imatinib, predicts survival, and is achieved more quickly by optimized high-dose imatinib: results from the randomized CML-Study IV. J Clin Oncol 2014; 32: 415-423
13. Hughes T. ENESTnd 5-year follow-up: continued benefit of frontline nilotinib vs imatinib in patients with CML in chronic phase. Haematologica 2014; 99(suppl 1): 877
14. Mahon FX, Rea D, Guilhot J, Guilhot F, Huguet F, Nicolini F et al. Discontinuation of imatinib in patients with chronic myeloid leukaemia who have maintained complete molecular remission for at least 2 years: the prospective, multicentre Stop Imatinib (STIM) trial. Lancet Oncol 2010; 11: 1029-1035
15. Ross DM, Branford S, Seymour JF, Schwarer AP, Arthur C, Yeung DT et al. Safety and efficacy of imatinib cessation for CML patients with stable undetectable minimal residual disease: results from the TWISTER study. Blood 2013; 122: 515-522
16. Rousselot P, Charbonnier A, Cony-Makhoul P, Agape P, Nicolini FE, Varet B et al. Loss of major molecular response as a trigger for restarting tyrosine kinase inhibitor therapy in patients with chronic-phase chronic myelogenous leukemia who have stopped imatinib after durable undetectable disease. J Clin Oncol 2014; 32: 424-430
17. Takahashi N, Kyo T, Maeda Y, Sugihara T, Usuki K, Kawaguchi T et al. Discontinuation of imatinib in Japanese patients with chronic myeloid leukemia. Haematologica 2012; 97: 903-906
18. Abboud C, Berman E, Cohen A, Cortes J, DeAngelo D, Deininger M et al. The price of drugs for chronic myeloid leukemia (CML) is a reflection of the unsustainable prices of cancer drugs: from the perspective of a large group of CML experts. Blood 2013; 121: 4439-4442
19. Cortes JE, Saglio G, Baccarani M, Kantarjian HM, Mayer J, Boqué C et al. Final study results of the phase 3 dasatinib versus imatinib in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP) trial (DASISION, CA180-056). Blood 2014; 124: 152-152
20. Hjorth-Hansen H, Stenke L, Soderlund S, Dreimane A, Ehrencrona H, Gedde-Dahl T et al. Dasatinib induces fast and deep responses in newly diagnosed chronic myeloid leukaemia patients in chronic phase: clinical results from a randomised phase-2 study (NordCML006). Eur J Haematol 2015; 94: 243-250
21. Kantarjian HM, Shah NP, Cortes JE, Baccarani M, Agarwal MB, Undurraga MS et al. Dasatinib or imatinib in newly diagnosed chronic-phase chronic myeloid leukemia: 2-year follow-up from a randomized phase 3 trial (DASISION). Blood 2012; 119: 1123-1129
22. Radich JP, Kopecky KJ, Appelbaum FR, Kamel-Reid S, Stock W, Malnassy G et al. A randomized trial of dasatinib 100 mg versus imatinib 400 mg in newly diagnosed chronic-phase chronic myeloid leukemia. Blood 2012; 120: 3898-3905
23. Interferon alfa versus chemotherapy for chronic myeloid leukemia: a metaanalysis of seven randomized trials: Chronic Myeloid Leukemia Trialists' Collaborative Group. J Natl Cancer Inst 1997; 89: 1616-1620
24. Simonsson B, Hjorth-Hansen H, Bjerrum OW, Porkka K. Interferon for treatment of chronic myeloid leukemia. Curr Drug Targets 2010; 12: 420-428
25. Talpaz M, Hehlmann R, Quintas-Cardama A, Mercer J, Cortes J. Re-emergence of interferon-alpha in the treatment of chronic myeloid leukemia. Leukemia 2013; 27: 803-812
26. Mahon FX, Delbrel X, Cony-Makhoul P, Faberes C, Boiron JM, Barthe C et al. Follow-up of complete cytogenetic remission in patients with chronic myeloid leukemia after cessation of interferon alfa. J Clin Oncol 2002; 20: 214-220
27. Bhattacharya S, Zheng H, Tzimas C, Carroll M, Baker DP, Fuchs SY. Bcr-abl signals to desensitize chronic myeloid leukemia cells to IFNalpha via accelerating the degradation of its receptor. Blood 2011; 118: 4179-4187
28. Hehlmann R, Lauseker M, Jung-Munkwitz S, Leitner A, Muller MC, Pletsch N et al. Tolerability-adapted imatinib 800 mg/d versus 400 mg/d versus 400 mg/d plus interferon-alpha in newly diagnosed chronic myeloid leukemia. J Clin Oncol 2011; 29: 1634-1642
29. Preudhomme C, Guilhot J, Nicolini FE, Guerci-Bresler A, Rigal-Huguet F, Maloisel F et al. Imatinib plus peginterferon alfa-2a in chronic myeloid leukemia. N Engl J Med 2010; 363: 2511-2521
30. Johnson-Ansah H, Guilhot J, Rousselot P, Rea D, Legros L, Rigal-Huguet F et al. Tolerability and efficacy of pegylated interferon-α-2a in combination with imatinib for patients with chronic-phase chronic myeloid leukemia. Cancer 2013; 119: 4284-4289
31. Simonsson B, Gedde-Dahl T, Markevarn B, Remes K, Stentoft J, Almqvist A et al. Combination of pegylated interferon-{alpha}2b with imatinib increases molecular response rates in patients with low or intermediate risk chronic myeloid leukemia. Blood 2011; 12: 3228-3235
32. Cortes J, Quintas-Cardama A, Jones D, Ravandi F, Garcia-Manero G, Verstovsek S et al. Immune modulation of minimal residual disease in early chronic phase chronic myelogenous leukemia: a randomized trial of frontline high-dose imatinib mesylate with or without pegylated interferon alpha-2b and granulocytemacrophage colony-stimulating factor. Cancer 2011; 117: 572-580
33. Baccarani M, Martinelli G, Rosti G, Trabacchi E, Testoni N, Bassi S et al. Imatinib and pegylated human recombinant interferon-alpha2b in early chronic-phase chronic myeloid leukemia. Blood 2004; 104: 4245-4251
34. Palandri F, Castagnetti F, Iacobucci I, Martinelli G, Amabile M, Gugliotta G et al. The response to imatinib and interferon-alpha is more rapid than the response to imatinib alone: a retrospective analysis of 495 Philadelphia-positive chronic myeloid leukemia patients in early chronic phase. Haematologica 2010; 95: 1415-1419
35. Palandri F, Iacobucci I, Castagnetti F, Testoni N, Poerio A, Amabile M et al. Front-line treatment of Philadelphia positive chronic myeloid leukemia with imatinib and interferon-alpha: 5-year outcome. Haematologica 2008; 93: 770-774
36. Nicolini FE, Etienne G, Dubruille V, Roy L, Huguet F, Legros L et al. Nilotinib and peginterferon alfa-2a for newly diagnosed chronic-phase chronic myeloid leukaemia (NiloPeg): a multicentre, non-randomised, open-label phase 2 study. Lancet Haematol 2015; 2: e37-e46
37. Giles FJ, Mauro MJ, Hong F, Ortmann CE, McNeill C, Woodman RC et al. Rates of peripheral arterial occlusive disease in patients with chronic myeloid leukemia in the chronic phase treated with imatinib, nilotinib, or non-tyrosine kinase therapy: a retrospective cohort analysis. Leukemia 2013; 27: 1310-1315
38. Kreutzman A, Juvonen V, Kairisto V, Ekblom M, Stenke L, Seggewiss R et al. Mono/oligoclonal T and NK cells are common in chronic myeloid leukemia patients at diagnosis and expand during dasatinib therapy. Blood 2010; 116: 772-782
39. Molldrem JJ, Lee PP, Wang C, Felio K, Kantarjian HM, Champlin RE et al. Evidence that specific T lymphocytes may participate in the elimination of chronic myelogenous leukemia. Nat Med 2000; 6: 1018-1023
40. Porkka K, Khoury HJ, Paquette RL, Matloub Y, Sinha R, Cortes JE. Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion. Cancer 2010; 116: 377-386
41. Burchert A, Wolfl S, Schmidt M, Brendel C, Denecke B, Cai D et al. Interferon-alpha, but not the ABL-kinase inhibitor imatinib (STI571), induces expression of myeloblastin and a specific T-cell response in chronic myeloid leukemia. Blood 2003; 101: 259-264
42. Cross NCP, White HE, Colomer D, Ehrencrona H, Foroni L, Gottardi E et al. Laboratory recommendations for scoring deep molecular responses following treatment for chronic myeloid leukemia. Leukemia 2015; 29: 999-1003
43. Hochhaus A, Rosti G, Cross NCP, Steegmann JL, le Coutre P, Ossenkoppele G et al. Frontline nilotinib in patients with chronic myeloid leukemia in chronic phase: results from the European ENEST1st study. Leukemia 2015; 30: 57-64
44. Cross NC, White HE, Muller MC, Saglio G, Hochhaus A. Standardized definitions of molecular response in chronic myeloid leukemia. Leukemia 2012; 26: 2172-2175
45. Baccarani M, Deininger MW, Rosti G, Hochhaus A, Soverini S, Apperley JF et al. European LeukemiaNet recommendations for the management of chronic myeloid leukemia. 2013Blood 2013; 122: 872-884
46. Kim TD, Rea D, Schwarz M, Grille P, Nicolini FE, Rosti G et al. Peripheral artery occlusive disease in chronic phase chronic myeloid leukemia patients treated with nilotinib or imatinib. Leukemia 2013; 27: 1316-1321
47. O'Brien SG, Hedgley C, Adams S, Foroni L, Apperley JF, Holyoake TL et al. Spirit 2: an NCRI randomised study comparing dasatinib with imatinib in patients with newly diagnosed CML. Blood 2014; 124. http://www.spirit-cml.org/media/99599/ ash-92014-s99592-slides.pdf
48. Rea D, Nicolini FE, Tulliez M, Rousselot P, Guilhot F, Gardembas M et al. Dasatinib or nilotinib discontinuation in chronic phase (CP)-chronic myeloid leukemia (CML) patients (pts) with durably undetectable BCR-ABL transcripts: interim analysis of the STOP 2G-TKI Study with a minimum follow-up of 12 months-on behalf of the French CML Group Filmc. Blood 2014; 124
49. Imagawa J, Tanaka H, Okada M, Nakamae H, Hino M, Murai K et al. Discontinuation of dasatinib in patients with chronic myeloid leukaemia who have maintained deep molecular response for longer than 1 year (DADI trial): a multicentre phase 2 trial. Lancet Haematol 2015; 2: e528-e535
50. Roy L, Chomel J-C, Guilhot J, Guerci-Bresler A, Escoffre-Barbe M, Giraudier P et al. Combination of dasatinib and Peg-interferon alpha 2b in chronic phase chronic myeloid leukemia (CP-CML) first line: preliminary results of a phase II trial, from the French Intergroup of CML (Fi-LMC). American Society of Hematology Annual meeting, Orlando, FL, USA, 2015, p. 134 Abstract