Idelalisib and rituximab in relapsed chronic lymphocytic leukemia

New England Journal of Medicine

Volumn 370, Issue 11, 2014, Pages 997-1007

  Furman, Richard R ^a   Sharman, Jeff P ^d   Coutre, Steven E ^e   Cheson, Bruce D ^g   Pagel, John M ^h   Hillmen, Peter ⁱ   Barrientos, Jacqueline C ^k   Zelenetz, Andrew D ^b   Kipps, Thomas J ^l   Flinn, Ian ^m   Ghia, Paolo ⁿ   Eradat, Herbert ^o   Ervin, Thomas ^p   Lamanna, Nicole ^c   Coiffier, Bertrand ^q   Pettitt, Andrew R ^j   Ma, Shuo ^r   Stilgenbauer, Stephan ^s   Cramer, Paula ^t   Aiello, Maria ^f   Johnson, Dave M ^f   Miller, Langdon L ^f   Li, Daniel ^f   Jahn, Thomas M ^f   Dansey, Roger D ^f   Hallek, Michael ^t   O'Brien, Susan M ^u   more..

^a WEILL CORNELL MEDICAL COLLEGE   (United States)

^b MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^c NewYork Presbyterian Hospital   (United States)

^d US Oncology   (United States)

^e STANFORD UNIVERSITY SCHOOL OF MEDICINE   (United States)

^f GILEAD SCIENCES   (United States)

^g GEORGETOWN UNIVERSITY HOSPITAL   (United States)

^h UNIVERSITY OF WASHINGTON   (United States)

ⁱ ST JAMES S UNIVERSITY HOSPITAL   (United Kingdom)

^j ROYAL LIVERPOOL UNIVERSITY HOSPITAL   (United Kingdom)

^k DONALD AND BARBARA ZUCKER SCHOOL OF MEDICINE AT HOFSTRA NORTHWELL   (United States)

^l UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^m SARAH CANNON RESEARCH INSTITUTE   (United States)

ⁿ VITA SALUTE SAN RAFFAELE UNIVERSITY   (Italy)

^o UNIVERSITY OF CALIFORNIA   (United States)

^p Florida Cancer Specialists   (United States)

^q CENTRE HOSPITALIER LYON SUD   (France)

^r NORTHWESTERN UNIVERSITY   (United States)

^s UNIVERSITY OF ULM   (Germany)

^t UNIVERSITY OF COLOGNE   (Germany)

^u UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

more..

Author keywords

[No Author keywords available]

Indexed keywords

IDELALISIB; PLACEBO; RITUXIMAB;

ADULT; AGED; ANEMIA; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER MORTALITY; CANCER SURVIVAL; CELLULITIS; CHILL; CHRONIC LYMPHATIC LEUKEMIA; CONSTIPATION; CONTROLLED STUDY; COUGHING; DECREASED APPETITE; DIARRHEA; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DRUG WITHDRAWAL; DYSPNEA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FEVER; GASTROINTESTINAL DISEASE; HUMAN; HYPERTRANSAMINASEMIA; INFUSION RELATED REACTION; KIDNEY FUNCTION; LEUKEMIA RELAPSE; MAJOR CLINICAL STUDY; MALE; MONOTHERAPY; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; NIGHT SWEAT; OVERALL SURVIVAL; PHASE 3 CLINICAL TRIAL; PNEUMOCYSTIS PNEUMONIA; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RANDOMIZED CONTROLLED TRIAL; RASH; SEPSIS; SKIN DISEASE; THROMBOCYTOPENIA; TREATMENT OUTCOME; VERY ELDERLY; VOMITING;

AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CLASS IA PHOSPHATIDYLINOSITOL 3-KINASE; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; KIDNEY DISEASES; LEUKEMIA, LYMPHOCYTIC, CHRONIC, B-CELL; LYMPH NODES; MALE; MIDDLE AGED; PURINES; QUINAZOLINONES; RECURRENCE;

EID: 84896692766     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1315226     Document Type: Article

References (30)

1. Gribben JG, O'Brien S. Update on therapy of chronic lymphocytic leukemia. J Clin Oncol 2011;29:544-50.
2. Eichhorst B, Goede V, Hallek M. Treatment of elderly patients with chronic lymphocytic leukemia. Leuk Lymphoma 2009;50:171-8.
3. National Comprehensive Cancer Network. NCCN clinical practice guidelines in oncology: non-Hodgkin's lymphomas, version 2. 2013 (http://www.nccn.org/ professionals/physician-gls/pdf/nhl.pdf).
4. Itälä M, Geisler CH, Kimby E, et al. Standard-dose anti-CD20 antibody rituximab has efficacy in chronic lymphocytic leukaemia: results from a Nordic multicentre study. Eur J Haematol 2002;69:129-34. (Pubitemid 35335149)
5. O'Brien SM, Kantarjian H, Thomas DA, et al. Rituximab dose-escalation trial in chronic lymphocytic leukemia. J Clin Oncol 2001;19:2165-70. (Pubitemid 32366970)
6. Byrd JC, Murphy T, Howard RS, et al. Rituximab using a thrice weekly dosing schedule in B-cell chronic lymphocytic leukemia and small lymphocytic lymphoma demonstrates clinical activity and acceptable toxicity. J Clin Oncol 2001;19:2153-64. (Pubitemid 32366969)
7. Huhn D, von Schilling C, Wilhelm M, et al. Rituximab therapy of patients with B-cell chronic lymphocytic leukemia. Blood 2001;98:1326-31.
8. Chiorazzi N, Rai KR, Ferrarini M. Chronic lymphocytic leukemia. N Engl J Med 2005;352:804-15.
9. Bernal A, Pastore RD, Asgary Z, et al. Survival of leukemic B cells promoted by engagement of the antigen receptor. Blood 2001;98:3050-7.
10. Chen L, Widhopf G, Huynh L, et al. Expression of ZAP-70 is associated with increased B-cell receptor signaling in chronic lymphocytic leukemia. Blood 2002;100:4609-14. (Pubitemid 35429705)
11. Herishanu Y, Pérez-Galán P, Liu D, et al. The lymph node microenvironment promotes B-cell receptor signaling, NF-kappaB activation, and tumor proliferation in chronic lymphocytic leukemia. Blood 2011;117:563-74.
12. Okkenhaug K, Vanhaesebroeck B. PI3K in lymphocyte development, differentiation and activation. Nat Rev Immunol 2003;3:317-30. (Pubitemid 37328684)
13. Herman SE, Gordon AL, Wagner AJ, et al. Phosphatidylinositol 3-kinase-δ inhibitor CAL-101 shows promising preclinical activity in chronic lymphocytic leukemia by antagonizing intrinsic and extrinsic cellular survival signals. Blood 2010;116:2078-88.
14. Hoellenriegel J, Meadows SA, Sivina M, et al. The phosphoinositide 3′-kinase delta inhibitor, CAL-101, inhibits B-cell receptor signaling and chemokine networks in chronic lymphocytic leukemia. Blood 2011;118:3603-12.
15. Lannutti BJ, Meadows SA, Herman SE, et al. CAL-101, a p110delta selective phosphatidylinositol-3-kinase inhibitor for the treatment of B-cell malignancies, inhibits PI3K signaling and cellular viability. Blood 2011;117:591-4.
16. Burger JA, Burger M, Kipps TJ. Chronic lymphocytic leukemia B cells express functional CXCR4 chemokine receptors that mediate spontaneous migration beneath bone marrow stromal cells. Blood 1999;94:3658-67.
17. Furman RR, Asgary Z, Mascarenhas JO, Liou HC, Schattner EJ. Modulation of NF-kappa B activity and apoptosis in chronic lymphocytic leukemia B cells. J Immunol 2000;164:2200-6. (Pubitemid 30108780)
18. Gattei V, Bulian P, Del Principe MI, et al. Relevance of CD49d protein expression as overall survival and progressive disease prognosticator in chronic lymphocytic leukemia. Blood 2008;111:865-73.
19. Brown JR, Furman RR, Flinn I, et al. Final results of a phase I study of idelalisib (GS-1101) a selective inhibitor of PI3Kδ, in patients with relapsed or refractory CLL. J Clin Oncol 2013;31:7003. abstract.
20. Barrientos JC, Furman RR, Leonard J, et al. Update on a phase I study of the selective PI3Kδ inhibitor idelalisib (GS-1101) in combination with rituximab and/or bendamustine in patients with relapsed or refractory CLL. J Clin Oncol 2013;31:7017. abstract.
21. Extermann M, Overcash J, Lyman GH, Parr J, Balducci L. Comorbidity and functional status are independent in older cancer patients. J Clin Oncol 1998;16:1582-7. (Pubitemid 28175784)
22. 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;111:5446-56. [Erratum, Blood 2008;112:5259.]
23. Cheson BD, Byrd JC, Rai KR, et al. Novel targeted agents and the need to refine clinical end points in chronic lymphocytic leukemia. J Clin Oncol 2012;30:2820-2.
24. 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 (http://bloodjournal.hematologylibrary. org/content/111/12/5446.long/reply#bloodjournal-el-6920).
25. Kröber A, Seiler T, Benner A, et al. V(H) mutation status, CD38 expression level, genomic aberrations, and survival in chronic lymphocytic leukemia. Blood 2002;100:1410-6. (Pubitemid 34864299)
26. Döhner H, Stilgenbauer S, Benner A, et al. Genomic aberrations and survival in chronic lymphocytic leukemia. N Engl J Med 2000;343:1910-6. (Pubitemid 32064784)
27. Zenz T, Eichhorst B, Busch R, et al. TP53 mutation and survival in chronic lymphocytic leukemia. J Clin Oncol 2010;28:4473-9.
28. Wierda WG, Kipps TJ, Mayer J, et al. Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia. J Clin Oncol 2010;28:1749-55. [Erratum, J Clin Oncol 2010;28:3670.]
29. 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.
30. Souers AJ, Leverson JD, Boghaert ER, et al. ABT-199, a potent and selective BCL-2 inhibitor, achieves antitumor activity while sparing platelets. Nat Med 2013;19:202-8.