Ibrutinib for previously untreated and relapsed or refractory chronic lymphocytic leukaemia with TP53 aberrations: A phase 2, single-arm trial

The Lancet Oncology

Volumn 16, Issue 2, 2015, Pages 169-176

  Farooqui, Mohammed Z H ^a   Valdez, Janet ^a   Martyr, Sabrina ^a   Aue, Georg ^a   Saba, Nakhle ^a   Niemann, Carsten U ^a   Herman, Sarah E M ^a   Tian, Xin ^a   Marti, Gerald ^a   Soto, Susan ^a   Hughes, Thomas E ^a   Jones, Jade ^a   Lipsky, Andrew ^a   Pittaluga, Stefania ^b   Stetler Stevenson, Maryalice ^b   Yuan, Constance ^b   Lee, Yuh Shan ^a   Pedersen, Lone B ^d   Geisler, Christian H ^d   Calvo, Katherine R ^c   Arthur, Diane C ^b   Maric, Irina ^c   Childs, Richard ^a   Young, Neal S ^a   Wiestner, Adrian ^a   more..

^a NATIONAL HEART LUNG AND BLOOD INSTITUTE   (United States)

^b NATIONAL CANCER INSTITUTE   (United States)

^c NATIONAL INSTITUTES OF HEALTH   (United States)

^d University of Copenhagen   (Denmark)

Author keywords

[No Author keywords available]

Indexed keywords

IBRUTINIB; PROTEIN P53; PYRAZOLE DERIVATIVE; PYRIMIDINE DERIVATIVE; TP53 PROTEIN, HUMAN;

ADULT; AGED; ALOPECIA; ANEMIA; ANOREXIA; ARTHRALGIA; ARTICLE; CANCER CONTROL; CANCER GROWTH; CANCER RECURRENCE; CHILL; CHRONIC LYMPHATIC LEUKEMIA; COGNITIVE DEFECT; CONJUNCTIVAL HEMORRHAGE; CONSTIPATION; DIARRHEA; DRUG ACTIVITY; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRY EYE; DRY SKIN; DYSPEPSIA; EPISTAXIS; FATIGUE; FEMALE; FEVER; FOLLOW UP; GENE DELETION; GENE MUTATION; GENETIC ASSOCIATION; GENETIC DISORDER; HEADACHE; HEART ATRIUM FIBRILLATION; HEART PALPITATION; HIGH RISK PATIENT; HOARSENESS; HUMAN; INTENTION TO TREAT ANALYSIS; LONG TERM SURVIVAL; LUNG INFILTRATE; LYMPHOCYTOSIS; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MUSCLE CRAMP; MUSCLE SPASM; MYALGIA; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; OVERALL SURVIVAL; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PROGRESSION FREE SURVIVAL; PRURITUS; PURPURA; RASH; SINUSITIS; SKIN BRUISING; SKIN ULCER; TENDINITIS; THROMBOCYTOPENIA; TREATMENT DURATION; TUMOR SUPPRESSOR GENE; TUMOR VOLUME; UNSPECIFIED SIDE EFFECT; URINARY TRACT INFECTION; CANCER STAGING; CLINICAL TRIAL; DRUG RESISTANCE; GENETICS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MIDDLE AGED; MORTALITY; MUTATION; PATHOLOGY; PROGNOSIS; SINGLE BLIND PROCEDURE; SURVIVAL RATE; TUMOR RECURRENCE; VERY ELDERLY;

ADULT; AGED; AGED, 80 AND OVER; DRUG RESISTANCE, NEOPLASM; FEMALE; FOLLOW-UP STUDIES; HUMANS; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; MALE; MIDDLE AGED; MUTATION; NEOPLASM RECURRENCE, LOCAL; NEOPLASM STAGING; PROGNOSIS; PYRAZOLES; PYRIMIDINES; SINGLE-BLIND METHOD; SURVIVAL RATE; TUMOR SUPPRESSOR PROTEIN P53;

EID: 84921740802     PISSN: 14702045     EISSN: 14745488     Source Type: Journal    
DOI: 10.1016/S1470-2045(14)71182-9     Document Type: Article

References (30)

1. Hallek M, Fischer K, Fingerle-Rowson G, et al. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet 2010, 376:1164-1174.
2. Strati P, Keating MJ, O'Brien SM, et al. Outcomes of first-line treatment for chronic lymphocytic leukemia with 17p deletion. Haematologica 2014, 99:1350-1355.
3. Schnaiter A, Stilgenbauer S 17p deletion in chronic lymphocytic leukemia: risk stratification and therapeutic approach. Hematol Oncol Clin North Am 2013, 27:289-301.
4. Gonzalez D, Martinez P, Wade R, et al. Mutational status of the TP53 gene as a predictor of response and survival in patients with chronic lymphocytic leukemia: results from the LRF CLL4 trial. J Clin Oncol 2011, 29:2223-2229.
5. Stilgenbauer S, Schnaiter A, Paschka P, et al. Gene mutations and treatment outcome in chronic lymphocytic leukemia: results from the CLL8 trial. Blood 2014, 123:3247-3254.
6. Badoux XC, Keating MJ, Wierda WG What is the best frontline therapy for patients with CLL and 17p deletion?. Curr Hematol Malig Rep 2011, 6:36-46.
7. Dreger P, Dohner H, Ritgen M, et al. Allogeneic stem cell transplantation provides durable disease control in poor-risk chronic lymphocytic leukemia: long-term clinical and MRD results of the German CLL Study Group CLL3X trial. Blood 2010, 116:2438-2447.
8. Hillmen P, Skotnicki AB, Robak T, et al. Alemtuzumab compared with chlorambucil as first-line therapy for chronic lymphocytic leukemia. J Clin Oncol 2007, 25:5616-5623.
9. Pettitt AR, Jackson R, Carruthers S, et al. Alemtuzumab in combination with methylprednisolone is a highly effective induction regimen for patients with chronic lymphocytic leukemia and deletion of TP53: final results of the national cancer research institute CLL206 trial. J Clin Oncol 2012, 30:1647-1655.
10. Byrd JC, Brown JR, O'Brien S, et al. Ibrutinib versus ofatumumab in previously treated chronic lymphoid leukemia. N Engl J Med 2014, 371:213-223.
11. Byrd JC, Furman RR, Coutre SE, et al. Targeting BTK with ibrutinib in relapsed chronic lymphocytic leukemia. N Engl J Med 2013, 369:32-42.
12. Furman RR, Sharman JP, Coutre SE, et al. Idelalisib and rituximab in relapsed chronic lymphocytic leukemia. N Engl J Med 2014, 370:997-1007.
13. Dreger P, Schetelig J, Andersen N, et al. Managing high-risk chronic lymphocytic leukemia during transition to a new treatment era: stem cell transplantation or novel agents?. Blood 2014, published online Oct 9. http://dx.doi.org/10.1182/blood-2014-07-586826.
14. Buggy JJ, Elias L Bruton tyrosine kinase (BTK) and its role in B-cell malignancy. Int Rev Immunol 2012, 31:119-132.
15. Herman SE, Mustafa RZ, Gyamfi JA, et al. Ibrutinib inhibits BCR and NF-kappaB signaling and reduces tumor proliferation in tissue-resident cells of patients with CLL. Blood 2014, 123:3286-3295.
16. Hallek M, Cheson BD, Catovsky D, et al. Guidelines for the diagnosis and treatment of chronic lymphocytic leukemia: a report from the International Workshop on Chronic Lymphocytic Leukemia updating the National Cancer Institute-Working Group 1996 guidelines. Blood 2008, 111:5446-5456.
17. Hallek M, Cheson BD, Catovsky D, et al. Response assessment in chronic lymphocytic leukemia treated with novel agents causing an increase of peripheral blood lymphocytes. Blood June 4, 2012, (accessed Dec 18, 2014). http://www.bloodjournal.org/content/111/12/5446.e-letters.
18. Herman SE, Niemann CU, Farooqui M, et al. Ibrutinib-induced lymphocytosis in patients with chronic lymphocytic leukemia: correlative analyses from a phase II study. Leukemia 2014, 28:2188-2196.
19. Badoux XC, Keating MJ, Wen S, et al. Lenalidomide as initial therapy of elderly patients with chronic lymphocytic leukemia. Blood 2011, 118:3489-3498.
20. Lin TS, Ruppert AS, Johnson AJ, et al. Phase II study of flavopiridol in relapsed chronic lymphocytic leukemia demonstrating high response rates in genetically high-risk disease. J Clin Oncol 2009, 27:6012-6018.
21. Tam CS, O'Brien S, Wierda W, et al. Long-term results of the fludarabine, cyclophosphamide, and rituximab regimen as initial therapy of chronic lymphocytic leukemia. Blood 2008, 112:975-980.
22. O'Brien S, Furman RR, Coutre SE, et al. Ibrutinib as initial therapy for elderly patients with chronic lymphocytic leukaemia or small lymphocytic lymphoma: an open-label, multicentre, phase 1b/2 trial. Lancet Oncol 2014, 15:48-58.
23. Cheng S, Ma J, Guo A, et al. BTK inhibition targets in vivo CLL proliferation through its effects on B-cell receptor signaling activity. Leukemia 2013, 28:649-657.
24. Woyach JA, Smucker K, Smith LL, et al. Prolonged lymphocytosis during ibrutinib therapy is associated with distinct molecular characteristics and does not indicate a suboptimal response to therapy. Blood 2014, 123:1810-1817.
25. Caligaris-Cappio F, Bertilaccio MT, Scielzo C How the microenvironment wires the natural history of chronic lymphocytic leukemia. Semin Cancer Biol 2014, 24:43-48.
26. Dal Bo M, Tissino E, Benedetti D, et al. Microenvironmental interactions in chronic lymphocytic leukemia: the master role of CD49d. Semin Hematol 2014, 51:168-176.
27. Wiestner A Emerging role of kinase-targeted strategies in chronic lymphocytic leukemia. Blood 2012, 120:4684-4691.
28. Furman RR, Cheng S, Lu P, et al. Ibrutinib resistance in chronic lymphocytic leukemia. N Engl J Med 2014, 370:2352-2354.
29. Woyach JA, Furman RR, Liu TM, et al. Resistance mechanisms for the Bruton's tyrosine kinase inhibitor ibrutinib. N Engl J Med 2014, 370:2286-2294.
30. Burger JA, Keating MJ, Wierda WG, et al. Safety and activity of ibrutinib plus rituximab for patients with high-risk chronic lymphocytic leukaemia: a single-arm, phase 2 study. Lancet Oncol 2014, 15:1090-1099.