Single-agent monoclonal antibody efficacy in bulky non-Hodgkin's lymphoma: Results of a phase II trial of rituximab

Journal of Clinical Oncology

Volumn 17, Issue 6, 1999, Pages 1851-1857

  Davis, Thomas A ^a   White, C A ^a   Grillo Lopez A J ^a   Velasquez W S ^a   Link, B ^a   Maloney, D G ^a   Dillman, R O ^a   Williams, M E ^a   Mohrbacher, A ^a   Weaver, R ^a   Dowden, S ^a   Levy, R ^a  

^a STANFORD UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTIBODY; MONOCLONAL ANTIBODY; RITUXIMAB;

ADULT; AGED; ANTIBODY BLOOD LEVEL; ARTICLE; CHILL; CLINICAL ARTICLE; CLINICAL TRIAL; DISEASE ACTIVITY; DISEASE COURSE; DRUG EFFICACY; DRUG SAFETY; FEMALE; FEVER; HUMAN; INTRAVENOUS DRUG ADMINISTRATION; LEUKOPENIA; MALE; NAUSEA; NONHODGKIN LYMPHOMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; TUMOR VOLUME; VERTIGO;

EID: 0033067232     PISSN: 0732183X     EISSN: None     Source Type: Journal    
DOI: 10.1200/jco.1999.17.6.1851     Document Type: Article

References (42)

1. Maloney D, Smith B, Appelbaum F: The anti-tumor effect of monoclonal anti-CD20 antibody (MAB) therapy includes direct anti-proliferative activity and induction of apoptosis in CD20 positive non-Hodgkin's lymphoma (NHL) cell lines. Blood 88:637a, 1996 (abstr)
2. Reff M, Carner K, Chambers K, et al: Depletion of B cells in vivo by a chimeric mouse human monoclonal antibody to CD20. Blood 83:435-445, 1994
3. Demidem A, Lam T, Alas S, et al: Chimeric anti-CD20 (IDEC-C2B8) monoclonal antibody sensitizes a B cell lymphoma cell line to cell killing by cytotoxic drugs. Cancer Biother Radiopharm 12:177-186, 1997
4. LoBuglio A, Wheeler R, Trang J, et al: Mouse/human chimeric monoclonal antibody in man: Kinetics and immune response. Proc Natl Acad Sci USA 86:4220-4224, 1989
5. Grossbard M, Press O, Appelbaum F, et al: Monoclonal antibody-based therapies of leukemia and lymphoma. Blood 80:863-878, 1992
6. Colnaghi M: Generation of monoclonal antibodies for in vivo approaches. Nucl Med Biol 18:15-18, 1991
7. Press O, Appelbaum F, Ledbetter J, et al: Monoclonal antibody 1F5 (anti-CD20) serotherapy of human B-cell lymphomas. Blood 69:584-591, 1987
8. Stashenko P, Nadler L, Hardy R, et al: Characterization of a human B lymphocyte-specific antigen. J Immunol 125:1678-1685, 1980
9. Einfeld D, Brown J, Valentine M, et al: Molecular cloning of the human B cell CD20 receptor predicts a hydrophobic protein with multiple transmembrane domains. EMBO J 7:711-717, 1988
10. Maloney D, Liles T, Czerwinski D, et al: Phase I clinical trial using escalating single-dose infusion of chimeric anti-CD20 monoclonal antibody (IDEC-C2B8) in patients with recurrent B-cell lymphoma. Blood 84:2457-2466, 1994
11. Maloney D, Grillo-López A, Bodkin D, et al: IDEC-C2B8 anti-CD20 antibody: Results of long-term followup of relapsed NHL phase II trial patients. Blood 86:54a, 1995 (abstr)
12. McLaughlin P, Grillo-López A, Link B, et al: Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: Half of patients respond to a 4-dose treatment program. J Clin Oncol 16:2825-2833, 1998
13. Piro L, White C, Grillo-López A, et al: Rituxan (rituximab, IDEC-C2B8): Interim analysis of a phase II study of once weekly times 8 dosing in patients with relapsed low-grade or follicular non-Hodgkin's lymphoma. Blood 90:510(a), 1997 (abstr)
14. Piro L, White C, Grillo-López A, et al: Extended Rituxan (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol (in press)
15. Czuczman M, Grillo-López A, Jonas C, et al: IDEC-C2B8 and CHOP chemotherapy of low-grade lymphoma. Blood 86:54a, 1995 (abstr)
16. Link B, Grossbard M, Fisher R, et al: Phase II pilot study of the safety and efficacy of rituximab in combination with CHOP chemotherapy in patients with previously untreated-or high- grade NHL. Proc Am Soc Clin Oncol 17:3a, 1998 (abstr)
17. Davis T, Maloney D, White C, et al: Combination immunotherapy of low grade or follicular (LG/F) non-Hodgkins lymphoma (NHL) with rituximab and alpha interferon: Interim analysis. Proc Am Soc Clin Oncol 17:11a, 1998 (abstr 39)
18. Coiffier B, Ketterer N, Haioun C, et al: A multicenter, randomized phase II study of rituximab (chimeric anti-CD20 mAb) at two dosages in patients with relapsed or refractory intermediate or high grade NHL or in elderly patients in first-line therapy. Am Soc Hematol 90:510a, 1997 (abstr)
19. Maloney D, Grillo-López A, White C, et al: IDEC-C2B8 (rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood 90:2188-2195, 1997
20. Maloney D, Grillo-López A, Bodkin D, et al: IDEC-C2B8: Results of a phase I multiple-dose trial in patients with relapsed non-Hodgkin's lymphoma. J Clin Oncol 15:3266-3274, 1997
21. Horning S, Cheson B, Peterson B, et al: Response criteria and quality assurance of responses in the evaluation of new therapies for patients with low-grade lymphoma. Proc Am Soc Clin Oncol 16:18a, 1997 (abstr)
22. Grillo-López A, Horning S, Cheson B, et al: Development of response criteria for low-grade or follicular lymphomas and application in a 166 patient study. Exp Hematol 25:732, 1997 (abstr)
23. Food and Drug Administration: Coding Symbols for Thesaurus of Adverse Reaction Terms (ed 5). Rockville, MD, United States Food and Drug Administration, 1995
24. Weisdorf D, Andersen J, Glick J, et al: Survival after relapse of low-grade non-Hodgkin's lymphoma: Implications for marrow transplantation. J Clin Oncol 10:942-947, 1992
25. Shipp M, Harrington D: A predictive model for aggressive non-Hodgkin's lymphoma. The International Non-Hodgkin's Lymphoma Prognostic Factors Project. N Engl J Med 329:987-994, 1993
26. López-Guillermo A, Montserrat E, Bosch F, et al: Applicability of the International Index for Aggressive Lymphomas to patients with low-grade lymphoma. J Clin Oncol 12:1343-1348, 1994
27. Hermans J, Krol A, van Groningen K, et al: International prognostic index for aggressive non-Hodgkin's lymphoma is valid for all malignancy grades. Blood 86:1460-1463, 1995
28. Jeffery G, Mead G, Whitehouse J, et al: Involved field radiotherapy or chemotherapy in the management of stage I nodal intermediate grade non-Hodgkin's lymphoma. Br J Cancer 64:933-937, 1991
29. Coiffier B, Gisselbrecht C, Vose J, et al: Prognostic factors in aggressive malignant lymphomas: Description and validation of a prognostic index that could identify patients requiring a more intensive therapy. J Clin Oncol 9:211-219, 1991
30. Coiffier B, Gisselbrecht C, Herbrecht R, et al: LNH-84 regimen: A multicenter study of intensive chemotherapy in 737 patients with aggressive malignant lymphoma. J Clin Oncol 7:1018-1026, 1989
31. Velasquez W, Jagannath S, Tucker S, et al: Risk classification as the basis for clinical staging of diffuse large-cell lymphoma derived from 10-year survival data. Blood 74:551-557, 1989
32. Zuckerman K, LoBuglio A, Reeves J: Chemotherapy of intermediate- and high-grade non-Hodgkin's lymphomas with a high-dose doxorubicin-containing regimen. J Clin Oncol 8:248-256, 1990
33. Shipp M: Aggressive Non-Hodgkin's Lymphoma: Identification and Treatment of High-Risk Patients. Thousand Oaks, CA, Amgen, Inc.
34. Shipp M, Neuberg D, Janicek M, et al: High-dose CHOP as initial therapy for patients with poor-prognosis aggressive non-Hodgkin's lymphoma: A dose-finding pilot study. J Clin Oncol 13:2916-2923, 1995
35. Shipp M, Harrington D, Klatt M, et al: Identification of major prognostic subgroups of patients with large-cell lymphoma treated with m-BACOD or M-BACOD. Ann Intern Med 104:757-765, 1986
36. Jagannath S, Velásquez W, Tucker S, et al: Tumor burden assessment and its implication for a prognostic model in advanced diffuse large-cell lymphoma. J Clin Oncol 4:859-865, 1986
37. Rapoport A, Rowe J, Kouides P, et al: One hundred autotransplants for relapsed or refractory Hodgkin's disease and lymphoma: Value of pretransplant disease status for predicting outcome. J Clin Oncol 11:2351-2361, 1993
38. Velásquez W, McLaughlin P, Tucker S, et al: ESHAP - An effective chemotherapy regimen in refractory and relapsing lymphoma: A 4-year follow-up study. J Clin Oncol 12:1169-1176, 1994
39. Coiffier B, Lepage E: Prognosis of aggressive lymphomas: A study of five prognostic models with patients included in the LNH-84 regimen. Blood 74:558-564, 1989
40. Shipp M: Prognostic factors in aggressive non-Hodgkin's lymphoma: Who has "high-risk" disease? Blood 83:1165-1173, 1994
41. Berinstein N, Grillo-López A, White C, et al: Association of serum rituximab (IDEC-C2B8) concentration and anti-tumor response in the treatment of recurrent low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol 9:1-7, 1998
42. Byrd J, Waselenko J, Maneatis T, et al: Rituximab therapy in hematologic malignancy patients with circulating blood tumor cells: Association with increased infusion-related side effects and rapid tumor lysis. Blood 92:106a, 1998 (abstr) (suppl 1)