Guidelines for the management of nilotinib (Tasigna®)-induced side effects in chronic myelogenous leukemia: Recommendations of French Intergroup of CML (Fi-LMC group);Recommandations du groupe Fi-LMC pour la gestion des effets indésirables du traitement par nilotinib (Tasigna®) au cours de la leucémie myéloïde chronique

Bulletin du Cancer

Volumn 97, Issue 8, 2010, Pages 997-1009

  Etienne G ^a,g   Milpied, B ^b   Rea D ^c,g   Rigal Huguet, F ^d,g   Tulliez, M ^e,g   Nicolini, F E ^f,g  

^a INSTITUT BERGONIÉ   (France)

^b HÔPITAL SAINT ANDRÉ   (France)

^c SAINT LOUIS HOSPITAL   (France)

^d CHU PURPAN   (France)

^e HENRI MONDOR HOSPITAL   (France)

^f EDOUARD HERRIOT HOSPITAL   (France)

^g POITIERS UNIVERSITY HOSPITAL   (France)

Author keywords

CML; Imatinib; Nilotinib; Side effects; TKI2

Indexed keywords

4-METHYL-N-(3-(4-METHYLIMIDAZOL-1-YL)-5-(TRIFLUOROMETHYL)PHENYL)-3-((4-PYRIDIN-3-YLPYRIMIDIN-2-YL)AMINO)BENZAMIDE; ANTINEOPLASTIC AGENT; BENZAMIDE DERIVATIVE; ERYTHROPOIETIN; GRANULOCYTE COLONY STIMULATING FACTOR; IMATINIB; PIPERAZINE DERIVATIVE; PROTEIN KINASE INHIBITOR; PROTEIN TYROSINE KINASE; PYRIMIDINE DERIVATIVE; RECOMBINANT PROTEIN;

ANTAGONISTS AND INHIBITORS; CHEMICALLY INDUCED; DRUG EFFECTS; DRUG ERUPTIONS; DRUG INTERACTION; DRUG RESISTANCE; FERTILITY; FOOD DRUG INTERACTION; FRANCE; HEART DISEASES; HUMAN; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; METABOLIC DISEASES; NEUTROPENIA; PRACTICE GUIDELINE;

ANTINEOPLASTIC AGENTS; BENZAMIDES; DRUG ERUPTIONS; DRUG INTERACTIONS; DRUG RESISTANCE, NEOPLASM; ERYTHROPOIETIN; FERTILITY; FOOD-DRUG INTERACTIONS; FRANCE; GRANULOCYTE COLONY-STIMULATING FACTOR; HEART DISEASES; HUMANS; LEUKEMIA, MYELOGENOUS, CHRONIC, BCR-ABL POSITIVE; METABOLIC DISEASES; NEUTROPENIA; PIPERAZINES; PROTEIN KINASE INHIBITORS; PROTEIN-TYROSINE KINASES; PYRIMIDINES; RECOMBINANT PROTEINS;

EID: 77956522879     PISSN: 00074551     EISSN: 17696917     Source Type: Journal    
DOI: 10.1684/bdc.2010.1136     Document Type: Review

References (23)

1. Labussière H, Hayette S, Tigaud I, Michallet M, Nicolini FE. Treatment of chronic myeloid leukemia in 2007. Bull Cancer 2007; 94: 863-9.
2. Kantarjian H, Giles F, Wunderle L, Bhalla K, O'Brien S, Wassmann B, et al. Nilotinib in imatinib-resistant CML and Philadelphia chromosome-positive ALL. NEJM 2006; 354: 2542-51.
3. Nicolini FE, Alimena G, Al-Ali HK, Turkina AT, Shen Z, Jootar S, et al. Final safety analysis of 1,793 cml patients from ENACT (expanding nilotinib access in clinical trials) study in adult patients with imatinib-resistant or intolerant Chronic myeloid leukemia. Haematologica 2009; 94 (suppl 2): 255, EHA abstract 0630.
4. Kantarjian HM, Giles F, Gattermann N, Bhalla K, Alimena G, Palandri F, et al. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine-kinase inhibitor, is effective in patients with Philadelphia chromosome-positive chronic myelogenous leukemia in chronic phase following imatinib resistance and intolerance. Blood 2007; 110: 3540-6.
5. Rosti G, Palandri F, Castagnetti F, Breccia M, Levato L, Gugliotta G, et al. Nilotinib for the frontline treatment of Ph+chronic myeloid leukemia. Blood 2009; 114: 4933-8.
6. Rosti G, Castagnetti F, Breccia M, Poerio A, Gugliotta G, Levato L, et al. Nilotinib 800 mg daily in early chronic phase chronic myeloid leukemia: 12-month results of a phase II trial of the GIMENA CML working party. Haematologica 2009; 94(suppl 2): 440 abstract 1090.
7. Quintás-Cardama A, Cortés JE, Kantarjian H. Practical management of toxicities associated with tyrosine-kinase inhibitors in chronic myeloid leukemia. Clin Lymphoma Myeloma 2008; 8(Suppl 3) S82-S8.
8. Singer JB, Shou Y, Giles F, Kantarjian HM, Hsu Y, Robeva AS, et al. UGT1A1 promoter polymorphism increases risk of nilotinib-induced hyperbilirubinemia. Leukemia 2007; 21: 2311-5.
9. Le Coutre P, Ottmann OG, Giles F, Kim DW, Cortes J, Gattermann N, et al. Nilotinib (formerly AMN107), a highly selective BCR-ABL tyrosine-kinase inhibitor, is active in patients with imatinib-resistant or intolerant accelerated-phase chronic myelogenous leukemia. Blood 2008; 111: 1834-9.
10. FDA, prescribing information, août 2009.
11. RCP nilotinib.
12. RCP dasatinib.
13. Rosti G, Castagnetti F, Poerio A, Breccia M, Levato L, Capucci A, et al. High and early rates of cytogenetic and molecular response with nilotinib 800 mg daily as first line treatment of Ph-positive chronic myeloid leukemia in chronic phase: results of a phase II Trial of the GIMEMA CML Working Party. Blood 2008; 112: 181.
14. Lichtman MA, Liesveld JN. Acute myelogenous leukemia. In: Beutler E, Lichtman MA, Coller BS, Kipps TJ, Seligsohn U, eds. Williams Hematology. New York: McGraw-Hill Book Company, 2001.
15. Conchon M, Sanabani SS, Bendit I, Santos FM, Serpa M, Dorliac-Llacer PE. Two successful pregnancies in a woman with chronic myeloid leukemia exposed to nilotinib during the first trimester of her second pregnancy: case study. J Hematol Oncol 2009; 2: 42.
16. Yin O, Gallagher N, Fischer D, Zhao L, Zhou W, Golor G, et al. No inhibition of warfarin pharmacokinetics and pharmacodynamics by nilotinib in human subjects. Haematologica 2009; 94(suppl 2): 345 EHA abstract 0857.
17. Yin O, Gallagher N, Fischer D, Zhao L, Demirhan E, Golor G, et al. Effect of the proton pump inhibitor esomeprazole on the oral absorption and pharmacokinetics of nilotinib. Haematologica 2009; 94(suppl 2): 345 EHA abstract 0863.
18. Jabbour E, Kantarjian HM, Baccarani M, le Coutre P, Haque A, Gallagher NJ, et al. Minimal cross-intolerance between nilotinib and imatinib in patients with imatinib-intolerant chronic myeloid leukemia in chronic phase or accelerated phase. Blood 2008; 112: 3215.
19. Khoury HJ, Goldberg SL, Mauro MJ, Stone RM, Matloub Y, Chen T, et al. Dasatinib lack of cross-intolerance to imatinib in patients with chronic myelogenous leukemia chronic phase intolerant to imatinib: a retrospective analysis of safety. J Clin Oncol 2008; 26: 7015.
20. Garg RJ, Kantarjian HM, O'Brien S, Quintas-Cardama A, Faderl S, Estrov Z, et al. The use of nilotinib or dasatinib after failure to two prior tyrosine-kinase inhibitors (TKI): long-term follow-up. Blood 2009; 114: 4361-8.
21. Rea D, Bergeron A, Fieschi C, Bengouga D, Oksenhendler E, Dombret H. Dasatinib-induced lupus. Lancet 2008; 372: 713-4.
22. Ault P, Kantarjian H, O'Brien S, Faderl S, Beran M, Rios M, et al. Pregnancy among patients with chronic myeloid treated with imatinib. J Clin Oncol 2006; 24: 1204.
23. Cony-Makhoul P, Bergeron A, Corm S, Dubruille V, Rea D, Rigal-Huguet F, et al. Guidelines for the management of dasatinib (Sprycel)-induced side effects in chronic myelogenous leukemia and Philadelphia positive acute lymphoblastic leukemias. Bull Cancer 2008; 95: 805-11.