Phase II study of single-agent bortezomib for the treatment of patients with fludarabine-refractory B-cell chronic lymphocytic leukemia

Cancer

Volumn 107, Issue 5, 2006, Pages 916-924

  Faderl, Stefan ^a   Rai, Kanti ^b   Gribben, John ^c   Byrd, John C ^d   Flinn, Ian W ^e   O'Brien, Susan ^a   Sheng, Shihong ^f   Esseltine, Dixie Lee ^f   Keating, Michael J ^a  

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

^b LONG ISLAND JEWISH MEDICAL CENTER   (United States)

^c ST BARTHOLOMEW S HOSPITAL   (United Kingdom)

^d OHIO STATE UNIVERSITY   (United States)

^e JOHNS HOPKINS UNIVERSITY   (United States)

^f MILLENNIUM PHARMACEUTICALS INC   (United States)

Author keywords

Bortezomib; Chronic lymphocytic leukemia; Salvage therapy; Treatment failure

Indexed keywords

BETA 2 MICROGLOBULIN; BORTEZOMIB; COTRIMOXAZOLE; FAMCICLOVIR; FLUDARABINE; PROTEASOME;

ABDOMINAL PAIN; ADULT; AGED; ANEMIA; ANOREXIA; APHASIA; APOPTOSIS; B CELL LEUKEMIA; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL ARTICLE; CLINICAL TRIAL; CONFUSION; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; EDEMA; FEMALE; HEADACHE; HEMOLYTIC ANEMIA; HUMAN; HYPONATREMIA; INAPPROPRIATE VASOPRESSIN SECRETION; LEUKEMIA REMISSION; LYMPHADENOPATHY; LYMPHOCYTOSIS; MALE; MULTICENTER STUDY; MUSCLE WEAKNESS; NAUSEA; NEUROTOXICITY; NEUTROPENIA; PERIPHERAL NEUROPATHY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGNOSIS; RANDOMIZED CONTROLLED TRIAL; REVIEW; SALVAGE THERAPY; SENSORY NEUROPATHY; SPLENOMEGALY; THROMBOCYTOPENIA; VOMITING;

ANTINEOPLASTIC AGENTS; BORONIC ACIDS; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; LEUKEMIA, B-CELL, CHRONIC; MALE; MIDDLE AGED; PROTEASE INHIBITORS; PYRAZINES; TREATMENT OUTCOME; VIDARABINE;

EID: 33747875167     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.22097     Document Type: Review

References (62)

1. Byrd JC, Stilgenbauer S, Flinn IW. Chronic lymphocytic leukemia. Hematology (Am Soc Hematol Educ Program). 2004:163-183.
2. Zent CS, Kyasa MJ, Evans R, Schichman SA. Chronic lymphocytic leukemia incidence is substantially higher than estimated from tumor registry data. Cancer. 2001;92:1325-1330.
3. Oscier D, Fegan C, Hillmen P, et al. Guidelines on the diagnosis and management of chronic lymphocytic leukaemia. Br J Haematol. 2004;125:294-317.
4. Shanafelt TD, Call TG. Current approach to diagnosis and management of chronic lymphocytic leukemia. Mayo Clin Proc. 2004;79:388-398.
5. Bosch F, Ferrer A, Lopez-Guillermo A, et al. Fludarabine, cyclophosphamide and mitoxantrone in the treatment of resistant or relapsed chronic lymphocytic leukaemia. Br J Haematol. 2002;119:976-984.
6. O'Brien S, del Giglio A, Keating M. Advances in the biology and treatment of B-cell chronic lymphocytic leukemia. Blood. 1995;85:307-318.
7. O'Brien S, Kantarjian H, Beran M, et al. Results of fludarabine and prednisone therapy in 264 patients with chronic lymphocytic leukemia with multivariate analysis-derived prognostic model for response to treatment. Blood. 1993;82:1695-1700.
8. Wendtner CM, Eichhorst BF, Hallek MJ. Advances in chemotherapy for chronic lymphocytic leukemia. Semin Hematol. 2004;41:224-233.
9. Eichhorst BF, Busch R, Hopfinger G, et al. Fludarabine plus cyclophosphamide versus fludarabine alone in first line therapy of younger patients with chronic lymphocytic leukemia. Blood. 2005 Oct 11; [Epub ahead of print].
10. Keating MJ, O'Brien S, Kantarjian H, et al. Long-term follow-up of patients with chronic lymphocytic leukemia treated with fludarabine as a single agent. Blood. 1993;81:2878-2884.
11. Schulz H, Klein SK, Rehwald U, et al. Phase 2 study of a combined immunochemotherapy using rituximab and fludarabine in patients with chronic lymphocytic leukemia. Blood. 2002;100:3115-3120.
12. Keating MJ, O'Brien S, Albitar M, et al. Early results of a chemoimmunotherapy regimen of fludarabine, cyclophosphamide, and rituximab as initial therapy for chronic lymphocytic leukemia. J Clin Oncol. 2005;23:4079-4088.
13. Byrd JC, Rai K, Peterson BL, et al. Addition of rituximab to fludarabine may prolong progression-free survival and overall survival in patients with previously untreated chronic lymphocytic leukemia: an updated retrospective comparative analysis of CALGB 9712 and CALGB 9011. Blood. 2005;105:49-53.
14. Wierda W, O'Brien S, Wen S, et al. Chemoimmunotherapy with fludarabine, cyclophosphamide, and rituximab for relapsed and refractory chronic lymphocytic leukemia. J Clin Oncol. 2005;23:4070-4078.
15. Kowal M, Dmoszynska A, Lewandowski K, et al. Efficacy and safety of fludarabine and cyclophosphamide combined therapy in patients with refractory/recurrent B-cell chronic lymphocytic leukaemia (B-CLL)-Polish multicentre study. Leuk Lymphoma. 2004;45:1159-1165.
16. Hendry L, Bowen A, Matutes E, Swansbury J, Catovsky D. Fludarabine, cyclophosphamide and mitoxantrone in relapsed or refractory chronic lymphocytic leukemia and low grade non-Hodgkin's lymphoma. Leuk Lymphoma. 2004;45:945-950.
17. Stilgenbauer S, Winkler D, Krober A, et al. Subcutaneous Campath-1H (alemtuzumab) in fludarabine-refractory CLL: interim analysis of the CLL2h study of the German CLL Study Group (GCLLSG)]. Blood. 2004;104:140a.
18. Bowen AL, Zomas A, Emmett E, Matutes E, Dyer MJ, Catovsky D. Subcutaneous CAMPATH-1H in fludarabine-resistant/relapsed chronic lymphocytic and B-prolymphocytic leukaemia. Br J Haematol. 1997;96:617-619.
19. Wierda W, Faderl S, O'Brien S, et al. Combined cyclophosphamide, fludarabine, alemtuzumab, and rituximab (CFAR) is active for relapsed and refractory patients with CLL. Blood. 2004;104:101a.
20. Keating MJ, Flinn I, Jain V, et al. Therapeutic role of alemtuzumab (Campath-1H) in patients who have failed fludarabine: results of a large international study. Blood. 2002;99:3554-3561.
21. Rai KR, Freter CE, Mercier RJ, et al. Alemtuzumab in previously treated chronic lymphocytic leukemia patients who also had received fludarabine. J Clin Oncol. 2002;20:3891-3897.
22. Knauf W, Rieger K, Blau W, et al. Remission induction using alemtuzumab can permit chemotherapy-refractory chronic lymphocytic leukemia (CLL) patients to undergo allogeneic stem cell transplantation. Leuk Lymphoma, 2004;45:2455-2458.
23. Lin TS, Flinn IW, Lucas MS, et al. Filgrastim and alemtuzumab (Campath-1H) for refractory chronic lymphocytic leukemia. Leukemia. 2005;19:1207-1210.
24. Rai KR, Moore JO, Boyd TE, et al. Phase 3 randomized trial of fludarabine/cyclophosphamide chemotherapy with or without oblimersen sodium (Bcl-2 antisense; Genasense; G3139) for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Blood. 2004;104:150a.
25. Byrd JC, Peterson BL, Gabrilove J, et al. Treatment of relapsed chronic lymphocytic leukemia by 72-hour continuous infusion or 1-hour bolus infusion of flavopiridol: results from Cancer and Leukemia Group B study 19805. Clin Cancer Res. 2005;11:4176-4181.
26. Byrd JC, Lin TS, Dalton JT, et al. Flavopiridol administered as a pharmacologically-derived schedule demonstrates marked clinical activity in refractory, genetically high risk, chronic lymphocytic leukemia (CLL). Blood. 2004;104:101a.
27. Flinn IW, Byrd JC, Bartlett N, et al. Flavopiridol administered as a 24-hour continuous infusion in chronic lymphocytic leukemia lacks clinical activity. Leuk Res. 2005;29:1253-1257.
28. O'Brien S, Kantarjian H, Estey E, et al. Lack of effect of 2-chlorodeoxyadenosine therapy in patients with chronic lymphocytic leukemia refractory to fludarabine therapy. N Engl J Med. 1994;330:319-322.
29. Sorror ML, Maris MB, Sandmaier BM, et al. Hematopoietic cell transplantation after nonmyeloablative conditioning for advanced chronic lymphocytic leukemia. J Clin Oncol. 2005;23:3819-3829.
30. Adams J, Kauffman M. Development of the proteasome inhibitor Velcade (bortezomib). Cancer Invest. 2004;22:304-311.
31. Myung J, Kim KB, Crews CM. The ubiquitin-proteasome pathway and proteasome inhibitors. Med Res Rev. 2001;21:245-273.
32. Voorhees PM, Dees EC, O'Neil B, Orlowski RZ. The proteasome as a target for cancer therapy. Clin Cancer Res. 2003;9:6316-6325.
33. Adams J. Potential for proteasome inhibition in the treatment of cancer. Drug Discov Today. 2003;8:307-315.
34. Adams J, Palombella VJ, Elliott PJ. Proteasome inhibition: a new strategy in cancer treatment. Invest New Drugs. 2000;18:109-121.
35. Fahy BN, Schlieman MG, Mortenson MM, Virudachalam S, Bold RJ. Targeting BCL-2 overexpression in various human malignancies through NF-kappaB inhibition by the proteasome inhibitor bortezomib. Cancer Chemother Pharmacol. 2005;56:46-54.
36. Delic J, Masdehors P, Omura S, et al. The proteasome inhibitor lactacystin induces apoptosis and sensitizes chemo- and radioresistant human chronic lymphocytic leukaemia lymphocytes to TNF-alpha-initiated apoptosis. Br J Cancer. 1998;77:1103-1107.
37. Masdehors P, Omura S, Merle-Beral H, et al. Increased sensitivity of CLL-derived lymphocytes to apoptotic death activation by the proteasome-specific inhibitor lactacystin. Br J Haematol 1999;105:752-757.
38. Masdehors P, Merle-Beral H, Maloum K, Omura S, Magdelenat H, Delic J. Deregulation of the ubiquitin system and p53 proteolysis modify the apoptotic response in B-CLL lymphocytes. Blood. 2000;96:269-274.
39. Almond JB, Snowden RT, Hunter A, Dinsdale D, Cain K, Cohen GM. Proteasome inhibitor-induced apoptosis of B-chronic lymphocytic leukaemia cells involves cytochrome c release and caspase activation, accompanied by formation of an approximately 700 kDa Apaf-1 containing apoptosome complex. Leukemia. 2001;15:1388-1397.
40. Bogner C, Schneller F, Hipp S, Ringshausen I, Peschel C, Decker T. Cycling B-CLL cells are highly susceptible to inhibition of the proteasome: involvement of p27, early D-type cyclins, Bax, and caspase-dependent and -independent pathways. Exp Hematol. 2003;31:218-225.
41. Kelley TW, Alkan S, Srkalovic G, Hsi ED. Treatment of human chronic lymphocytic leukemia cells with the proteasome inhibitor bortezomib promotes apoptosis. Leuk Res. 2004;28:845-850.
42. Duechler M, Linke A, Cebula B, et al. In vitro cytotoxic effect of proteasome inhibitor bortezomib in combination with purine nucleoside analogues on chronic lymphocytic leukaemia cells. Eur J Haematol. 2005;74:407-417.
43. Pahler JC, Ruiz S, Niemer I, et al. Effects of the proteasome inhibitor, bortezomib, on apoptosis in isolated lymphocytes obtained from patients with chronic lymphocytic leukemia. Clin Cancer Res. 2003;9:4570-4577.
44. Chandra J, Niemer I, Gilbreath J, et al. Proteasome inhibitors induce apoptosis in glucocorticoid-resistant chronic lymphocytic leukemic lymphocytes. Blood. 1998;92:4220-4229.
45. Orlowski RZ, Stinchcombe TE, Mitchell BS, et al. Phase I trial of the proteasome inhibitor PS-341 in patients with refractory hematologic malignancies. J Clin Oncol. 2002;20:4420-4427.
46. Jagannath S, Barlogie B, Berenson J, et al. A phase 2 study of two doses of bortezomib in relapsed or refractory myeloma. Br J Haematol. 2004;127:165-172.
47. Goy A, Younes A, McLaughlin P, et al. Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. J Clin Oncol. 2005;23:667-675.
48. O'Connor O, Wright J, Moskowitz C, et al. A multicenter experience with single agent bortezomib in non-Hodgkin's lymphoma reveals marked differences in sub-type sensitivity to proteasome inhibition. Blood. 2004;104:175a.
49. Richardson PG, Barlogie B, Berenson J, et al. A phase 2 study of bortezomib in relapsed, refractory myeloma. N Engl J Med. 2003;348:2609-2617.
50. Richardson PG, Sonneveld P, Schuster MW, et al. Bortezomib or high-dose dexamethasone for relapsed multiple myeloma. N Engl J Med. 2005;352:2487-2498.
51. Cheson BD, Bennett JM, Grever M, et al. National Cancer Institute-sponsored Working Group guidelines for chronic lymphocytic leukemia: revised guidelines for diagnosis and treatment. Blood. 1996;87:4990-4997.
52. Rai KR, Sawitsky A, Cronkite EP, Chanana AD, Levy RN, Pasternack BS. Clinical staging of chronic lymphocytic leukemia. Blood. 1975;46:219-234.
53. Lightcap ES, McCormack TA, Pien CS, Chau V, Adams J, Elliott PJ. Proteasome inhibition measurements: clinical application. Clin Chem. 2000;46:673-683.
54. Blaney SM, Bernstein M, Neville K, et al. Phase I study of the proteasome inhibitor bortezomib in pediatric patients with refractory solid tumors: a Children's Oncology Group study (ADVL0015). J Clin Oncol. 2004;22:4804-4809.
55. Papandreou CN, Daliani DD, Nix D, et al. Phase I trial of the proteasome inhibitor bortezomib in patients with advanced solid tumors with observations in androgen-independent prostate cancer. J Clin Oncol. 2004;22:2108-2121.
56. Aghajanian C, Soignet S, Dizon DS, et al. A phase I trial of the novel proteasome inhibitor PS341 in advanced solid tumor malignancies. Clin Cancer Res. 2002;8:2505-2511.
57. Hamilton AL, Eder JP, Pavlick AC, et al. Proteasome inhibition with bortezomib (PS-341): a phase I study with pharmacodynamic end points using a day 1 and day 4 schedule in a 14-day cycle. J Clin Oncol. 2005;23:6107-6116.
58. Keating MJ, O'Brien S, Albitar M. Emerging information on the use of rituximab in chronic lymphocytic leukemia. Semin Oncol. 2002;29:70-74.
59. O'Brien SM, Kantarjian H, Thomas DA, et al. Rituximab dose-escalation trial in chronic lymphocytic leukemia. J Clin Oncol. 2001;19:2165-2170.
60. Byrd JC, Peterson BL, Morrison VA, et al. Randomized phase 2 study of fludarabine with concurrent versus sequential treatment with rituximab in symptomatic, untreated patients with B-cell chronic lymphocytic leukemia: results from Cancer and Leukemia Group B 9712 (CALGB 9712). Blood. 2003;101:6-14.
61. Berenson J, Yang H, Swift R, et al. Bortezomib in combination with melphalan in the treatment of relapsed or refractory multiple myeloma: a phase I/II study. Blood. 2004;104:64a.
62. Orlowski RZ, Voorhees PM, Garcia RA, et al. Phase 1 trial of the proteasome inhibitor bortezomib and pegylated liposomal doxorubicin in patients with advanced hematologic malignancies. Blood. 2005;105:3058-3065.