Phase II trial of short-course R-Chop followed by 90Y- ibritumomab tiuxetan in previously untreated high-risk elderly diffuse large B-cell lymphoma patients

Clinical Cancer Research

Volumn 16, Issue 15, 2010, Pages 3998-4004

  Zinzani, Pier Luigi ^a   Rossi, Giuseppe ^b   Franceschetti, Silvia ^c   Botto, Barbara ^d   Di Rocco, Alice ^f   Cabras, Maria Giuseppina ^e   Petti, Maria Concetta ^g   Stefoni, Vittorio ^a   Broccoli, Alessandro ^a   Fanti, Stefano ^a   Pellegrini, Cinzia ^a   Montini, Gian Carlo ^a   Gandolfi, Letizia ^a   Derenzini, Enrico ^a   Argnani, Lisa ^a   Fina, Mariapaola ^a   Tucci, Alessandra ^b   Bottelli, Chiara ^b   Pileri, Stefano ^a   Baccarani, Michele ^a  

^a UNIVERSITY OF BOLOGNA   (Italy)

^b Division of Hematology   (Italy)

^c Novara Hospital   (Italy)

^d MOLINETTE HOSPITAL   (Italy)

^e Cagliari Hospital   (Italy)

^f SAPIENZA UNIVERSITY OF ROME   (Italy)

^g REGINA ELENA NATIONAL CANCER INSTITUTE   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; IBRITUMOMAB TIUXETAN; PREDNISONE; RITUXIMAB; VINCRISTINE; YTTRIUM 90;

ADULT; AGED; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER GRADING; CANCER REGRESSION; CLINICAL TRIAL; ERYTHROCYTE TRANSFUSION; FEMALE; HUMAN; HUMAN TISSUE; LARGE CELL LYMPHOMA; MAJOR CLINICAL STUDY; MALE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA; TREATMENT RESPONSE;

AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DISEASE-FREE SURVIVAL; DOXORUBICIN; FEMALE; HUMANS; KAPLAN-MEIERS ESTIMATE; LYMPHOMA, LARGE B-CELL, DIFFUSE; MALE; MIDDLE AGED; NEOPLASM STAGING; PREDNISONE; RISK FACTORS; TREATMENT OUTCOME; VINCRISTINE;

EID: 77955119703     PISSN: 10780432     EISSN: 15573265     Source Type: Journal    
DOI: 10.1158/1078-0432.CCR-10-0162     Document Type: Article

References (24)

1. Coiffier B, Lepage E, Briere J, et al. CHOP chemotherapy plus rituximab compared with CHOP alone in elderly patients with diffuse large-B-cell lymphoma. N Engl J Med 2002;346:235-42.
2. Pfreundschuh M, Schubert J, Ziepert M, et al. Six versus eight cycles of bi-weekly CHOP-14 with or without Rituximab in elderly patients with aggressive CD20+ B-Cell Lymphomas: a randomised controlled trial (RICOVER-60). Lancet Oncol 2008;9:105-16.
3. Pfreundschuh M, Trumper L, Osterborg A, et al. CHOP-like chemotherapy plus rituximab versus CHOP-like chemotherapy alone in young patients with good-prognosis diffuse large B-cell lymphoma: a randomised controlled trial by the MabThera International Trial (MInT) Group. Lancet Oncol 2006;7:379-91.
4. Feugier P, Van Hoof A, Sebban C, et al. Long-term results of the R-CHOP study in the treatment of elderly patients with diffuse large B-cell lymphoma: A study by the Groupe d'Etude des Lymphomes de l'Adulte. J Clin Oncol 2005;23:4117-23.
5. Cunningham D, Smith P, Mouncey P, et al. A phase III trial comparing R-CHOP 14 and R-CHOP 21 for the treatment of patients with newly diagnosed diffuse large B-cell non-Hodgkin's lymphoma [abstract]. J Clin Oncol 2009;27:8506.
6. Pfreundschuh M, Zeynalova S, Poeschel V, et al. Dose-denserituximab improves outcome of elderly patients with poor-prognosis diffuse large B-cell lymphoma (DLBCL): results of the DENSE-R-CHOP-14 trial of the German High-Grade Non-Hodgkin Lymphoma Study Group (DSHNHL) [abstract]. Blood 2007;110:789.
7. Witzig TE, Gordon LI, Cabanillas F, et al. Randomized controlled trial of yttrium-90-labeled ibritumomab tiuxetan radioimmunotherapy versus rituximab immunotherapy for patients with relapsed or refractory low-grade, follicular, or transformed B-cell non-Hodgkin's lymphoma. J Clin Oncol 2002;20:2453-63.
8. Morschhauser F, Illidge T, Huglo D, et al. Efficacy and safety of yttrium-90 ibritumomab tiuxetan in patients with relapsed or refractory diffuse large B-cell lymphoma not appropriate for autologous stem-cell transplantation. Blood 2007;110:54-8.
9. Witzig TE, Molina A, Gordon LI, et al. Long-term responses in patients with recurring or refractory B-cell non-Hodgkin lymphoma treated with yttrium 90 ibritumomab tiuxetan. Cancer 2007;109:1804-10. (Pubitemid 46668544)
10. Smith MR, Zhang L, Gordon LI, et al. Phase II study of R-CHOP followed by 90Y-ibritumomab tiuxetan in untreated mantle cell lymphoma: Eastern Cooperative Oncology Group Study E1499 [abstract]. Blood 2007;110:389.
11. Zinzani PL, Tani M, Fanti S, et al. A phase II trial of CHOP chemotherapy followed by yttrium 90 ibritumomab tiuxetan (Zevalin) for previously untreated elderly diffuse large B-cell lymphoma patients. Ann Oncol 2008;19:769-73.
12. Hamlin PA, Moskowitz CH, Wegner B, et al. Sequential RCHOP and yttrium-90 ibritumomab tiuxetan (RIT) is a highly effective regimen for high risk elderly patients with untreated DLBCL [abstract]. Ann Oncol 2008;19:54.
13. Shipp MA, Harrington DP. A predictive model for aggressive NHL: the international non-Hodgkin's lymphoma prognostic factors project. N Engl J Med 1993;329:987-94.
14. Harris NL, Jaffe ES, Stein H, et al. A revised European-American classification of lymphoid neoplasms: a proposal from the International Lymphoma Study Group. Blood 1994;84:1361-92.
15. Cheson BD, Pfistner B, Juweid ME, et al. International Harmonization Project on Lymphoma. Revised response criteria for malignant lymphoma. J Clin Oncol 2007;25:579-86.
16. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics 1982;38:143-51.
17. Machin D, Campbell MJ. Statistical tables for the design of clinical trials. Oxford: Blackwell; 1987.
18. A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med 2001;20:859-66.
19. Kaplan EL, Meier P. Non-parametric estimation from incomplete observations. J Am Stat Assoc 1958;53:457-81.
20. Delarue R, Tilly H, Salles G, et al. R-CHOP14 compared to R-CHOP21 in elderly patients with diffuse large B-cell lymphoma: results of the interim analysis of the LNH03-6B GELA study [abstract]. Blood 2009;114:169.
21. Coiffier B, Feugier P, Mounier N, et al. Long-term results of the GELA study comparing R-CHOP and CHOP chemotherapy in older patients with diffuse large B-cell lymphoma show good survival in poor-risk patients [abstract]. J Clin Oncol 2007;25:443.
22. Illidge T, Tolan S. Current treatment approaches for diffuse large B-cell lymphoma. Leuk Lymphoma 2008;49:663-76. (Pubitemid 351517211)
23. Habermann TM, Weller EA, Morrison VA, et al. Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. J Clin Oncol 2006;24:3121-7.
24. Pfreundschuh M, Zeynalova S, Poschel V, et al. Improved outcome of elderly patients with poor prognosis diffuse large B-cell lymphoma (DLBCL) after dose-dense rituximab: results of the dense-R-CHOP-14 trial of the german high-grade non-Hodgkin lymphoma study group (DSHNHL) [abstract]. Ann Oncol 2008;19:53.