PI3Kδ inhibition by idelalisib in patients with relapsed indolent lymphoma

New England Journal of Medicine

Volumn 370, Issue 11, 2014, Pages 1008-1018

  Gopal, Ajay K ^a,b   Kahl, Brad S ^d   Vos, Svende ^e   Wagner Johnston, Nina D ^f   Schuster, Stephen J ^g   Jurczak, Wojciech J ^h   Flinn, Ian W ⁱ   Flowers, Christopher R ^j   Martin, Peter ^k   Viardot, Andreas ^l   Blum, Kristie A ⁿ   Goy, Andre H ^o   Davies, Andrew J ^p   Zinzani, Pier Luigi ^q   Dreyling, Martin ^m   Johnson, Dave ^c   Miller, Langdon L ^c   Holes, Leanne ^c   Li, Daniel ^c   Dansey, Roger D ^c   Godfrey, Wayne R ^c   Salles, Gilles A ^r   more..

^a UNIVERSITY OF WASHINGTON SCHOOL OF MEDICINE   (United States)

^b Fred Hutchinson Cancer Research Center   (United States)

^c Oncology   (United States)

^d UNIVERSITY OF WISCONSIN   (United States)

^e UNIVERSITY OF CALIFORNIA   (United States)

^f WASHINGTON UNIVERSITY SCHOOL OF MEDICINE   (United States)

^g UNIVERSITY OF PENNSYLVANIA   (United States)

^h JAGIELLONIAN UNIVERSITY   (Poland)

ⁱ SARAH CANNON RESEARCH INSTITUTE   (United States)

^j EMORY UNIVERSITY SCHOOL OF MEDICINE   (United States)

^k WEILL CORNELL MEDICAL COLLEGE   (United States)

^l UNIVERSITY HOSPITAL ULM   (Germany)

^m LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

ⁿ THE OHIO STATE UNIVERSITY WEXNER MEDICAL CENTER   (United States)

^o HACKENSACK UNIVERSITY MEDICAL CENTER   (United States)

^p UNIVERSITY OF SOUTHAMPTON   (United Kingdom)

^q UNIVERSITY OF BOLOGNA   (Italy)

^r UNIVERSITÉ LYON 1   (France)

more..

Author keywords

[No Author keywords available]

Indexed keywords

IDELALISIB; PHOSPHATIDYLINOSITOL 3 KINASE; PHOSPHATIDYLINOSITOL 3 KINASE DELTA; UNCLASSIFIED DRUG;

ABDOMINAL PAIN; ABNORMAL LABORATORY RESULT; ADULT; AGED; ARTICLE; ASTHENIA; BODY WEIGHT DISORDER; CANCER RECURRENCE; CANCER SURVIVAL; COUGHING; DECREASED APPETITE; DIARRHEA; DRUG EFFICACY; DRUG RESPONSE; DRUG SAFETY; DYSPNEA; ENZYME INHIBITION; FATIGUE; FEMALE; FEVER; FOLLICULAR LYMPHOMA; HEADACHE; HUMAN; HYPERTRANSAMINASEMIA; LYMPHOCYTOMA; MAJOR CLINICAL STUDY; MALE; MARGINAL ZONE LYMPHOMA; MULTICENTER STUDY; NAUSEA; NEUTROPENIA; NIGHT SWEAT; NONHODGKIN LYMPHOMA; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; PNEUMONIA; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RASH; SURVIVAL TIME; UPPER RESPIRATORY TRACT INFECTION; VERY ELDERLY; VOMITING; WALDENSTROEM MACROGLOBULINEMIA;

ADULT; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS; CLASS IA PHOSPHATIDYLINOSITOL 3-KINASE; DISEASE-FREE SURVIVAL; DOUBLE-BLIND METHOD; FEMALE; HUMANS; KAPLAN-MEIER ESTIMATE; LYMPH NODES; LYMPHOCYTE COUNT; LYMPHOMA, NON-HODGKIN; MALE; MIDDLE AGED; NEOPLASM GRADING; PURINES; QUINAZOLINONES; RECURRENCE;

EID: 84896693794     PISSN: 00284793     EISSN: 15334406     Source Type: Journal    
DOI: 10.1056/NEJMoa1314583     Document Type: Article

References (35)

1. Shankland KR, Armitage JO, Hancock BW. Non-Hodgkin lymphoma. Lancet 2012;380:848-57.
2. Horning SJ. Natural history of and therapy for the indolent non-Hodgkin's lymphomas. Semin Oncol 1993;20:Suppl 5:75-88. (Pubitemid 23319044)
3. Swerdlow S, Campo E, Harris NL, et al., eds. WHO classification of tumours of haematopoietic and lymphoid tissues. 4th ed. Lyon, France: IARC Press, 2008.
4. Siegel R, Naishadham D, Jemal A. Cancer statistics, 2012. CA Cancer J Clin 2012;62:10-29.
5. National Cancer Institute. Estimated new cancer causes and deaths for 2013. Bethesda, MD: National Institutes of Health, 2013 (http://seer.cancer.gov/ csr/1975-2010/results-single/sect-01-table.01.pdf).
6. Lunning MA, Vose JM. Management of indolent lymphoma: where are we now and where are we going. Blood Rev 2012;26:279-88.
7. Gribben JG. How I treat indolent lymphoma. Blood 2007;109:4617-26. (Pubitemid 46830597)
8. National Comprehensive Cancer Network. Treatment guidelines for lymphoma. 2013 (http://www.nccn.org/professionals/physician-gls/f-guidelines.asp).
9. Leonard JP, Gregory SA, Maloney DG, Vose JM, Younes A, Zelenetz AD. Optimizing the treatment of patients with rituximab-pretreated recurrent indolent non-Hodgkin lymphoma. Clin Adv Hematol Oncol 2008;6:437-45.
10. Cheson BD, Rummel MJ. Bendamustine: rebirth of an old drug. J Clin Oncol 2009;27:1492-501. [Erratum, J Clin Oncol 2009;27:2892.]
11. Tomblyn M. Radioimmunotherapy for B-cell non-Hodgkin lymphomas. Cancer Control 2012;19:196-203.
12. William BM, Bierman PJ. I-131 tositumomab. Expert Opin Biol Ther 2010;10:1271-8.
13. Johnston PB, Bondly C, Micallef IN. Ibritumomab tiuxetan for non-Hodgkin's lymphoma. Expert Rev Anticancer Ther 2006;6:861-9. (Pubitemid 44192873)
14. GSK to discontinue manufacture and sale of the BEXXAR therapeutic regimen (tositumomab and iodine I 131 tositumomab). GSK press release of GlaxoSmithKline, Brentford, Middlesex, United Kingdom, August 7, 2013.
15. Vanhaesebroeck B, Stephens L, Hawkins P. PI3K signalling: the path to discovery and understanding. Nat Rev Mol Cell Biol 2012;13:195-203.
16. Vanhaesebroeck B, Guillermet-Guibert J, Graupera M, Bilanges B. The emerging mechanisms of isoform-specific PI3K signalling. Nat Rev Mol Cell Biol 2010;11:329-41.
17. Durand CA, Hartvigsen K, Fogelstrand L, et al. Phosphoinositide 3-kinase p110 delta regulates natural antibody production, marginal zone and B-1 B cell function, and autoantibody responses. J Immunol 2009;183:5673-84.
18. Bilancio A, Okkenhaug K, Camps M, et al. Key role of the p110delta isoform of PI3K in B-cell antigen and IL-4 receptor signaling: comparative analysis of genetic and pharmacologic interference with p110delta function in B cells. Blood 2006;107:642-50. (Pubitemid 43076389)
19. 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.
20. 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.
21. Herman SE, Lapalombella R, Gordon AL, et al. The role of phosphatidylinositol 3-kinase-δ in the immunomodulatory effects of lenalidomide in chronic lymphocytic leukemia. Blood 2011;117:4323-7.
22. Benson DM, Kahl BS, Furman RR, et al. Final results of a phase I study of idelalisib, a selective inhibitor of PI3Kδ, in patients with relapsed or refractory indolent non-Hodgkin lymphoma (iNHL). J Clin Oncol 2013;31:Suppl:8526. abstract.
23. Brown JR, Furman RR, Flinn I, et al. Final results of a phase I study of idelalisib (GSE-1101) a selective inhibitor of PI3Kδ, in patients with relapsed or refractory CLL. J Clin Oncol 2013;31:Suppl:7003. abstract.
24. Schag CC, Heinrich RL, Ganz PA. Karnofsky performance status revisited: reliability, validity, and guidelines. J Clin Oncol 1984;2:187-93. (Pubitemid 14138407)
25. Cheson BD, Pfistner B, Juweid ME, et al. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-86. (Pubitemid 350002966)
26. Owen RG, Kyle RA, Stone MJ, et al. Response assessment in Waldenström macroglobulinaemia: update from the VIth International Workshop. Br J Haematol 2013;160:171-6.
27. Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Cancer Therapy Evaluation Program, common terminology for adverse events, version 30. Bethesda, MD: National Cancer Institute, 2009 (http://evs.nci.nih.gov/ftp1/ CTCAE/CTCAE-4.03-2010-06-14-QuickReference-5x7.pdf).
28. Simon R. Optimal two-stage designs for phase II clinical trials. Control Clin Trials 1989;10:1-10. (Pubitemid 19099520)
29. Witzig TE, Flinn IW, Gordon LI, et al. Treatment with ibritumomab tiuxetan radioimmunotherapy in patients with rituximab-refractory follicular non-Hodgkin's lymphoma. J Clin Oncol 2002;20:3262-9. (Pubitemid 34831524)
30. Horning SJ, Younes A, Jain V, et al. Efficacy and safety of tositumomab and iodine-131 tositumomab (Bexxar) in B-cell lymphoma, progressive after rituximab. J Clin Oncol 2005;23:712-9. (Pubitemid 46224170)
31. Kahl BS, Bartlett NL, Leonard JP, et al. Bendamustine is effective therapy in patients with rituximab-refractory, indolent B-cell non-Hodgkin lymphoma: results from a multicenter study. Cancer 2010;116:106-14.
32. Di Bella N, Taetle R, Kolibaba K, et al. Results of a phase 2 study of bortezomib in patients with relapsed or refractory indolent lymphoma. Blood 2010;115:475-80.
33. Friedberg JW, Sharman J, Sweetenham J, et al. Inhibition of Syk with fostamatinib disodium has significant clinical activity in non-Hodgkin lymphoma and chronic lymphocytic leukemia. Blood 2010;115:2578-85.
34. Advani RH, Buggy JJ, Sharman JP, et al. Bruton tyrosine kinase inhibitor ibrutinib (PCI-32765) has significant activity in patients with relapsed/refractory B-cell malignancies. J Clin Oncol 2013;31:88-94.
35. Witzig TE, Wiernik PH, Moore T, et al. Lenalidomide oral monotherapy produces durable responses in relapsed or refractory indolent non-Hodgkin's Lymphoma. J Clin Oncol 2009;27:5404-9.