A phase 2 trial of fludarabine and mitoxantrone chemotherapy followed by yttrium-90 ibritumomab tiuxetan for patients with previously untreated, indolent, nonfollicular, non-Hodgkin lymphoma

Cancer

Volumn 112, Issue 4, 2008, Pages 856-862

  Zinzani, Pier Luigi ^a,e   Tani, Monica ^a   Fanti, Stefano ^b   Stefoni, Vittorio ^a   Musuraca, Gerardo ^a   Vitolo, Umberto ^c   Perrotti, Alessio ^d   Fina, Mariapaola ^a   Derenzini, Enrico ^a   Baccarani, Michele ^a  

^a UNIVERSITY OF BOLOGNA   (Italy)

^b UNIVERSITY OF BOLOGNA   (Italy)

^c San Giovanni Battista Health and Hospital Corporation   (Italy)

^d S EUGENIO HOSPITAL   (Italy)

^e L and A Seràgnoli Hematology and Oncological Sciences Institute   (Italy)

Author keywords

Chemotherapy; Efficacy; Indolent; Nonfollicular non Hodgkin lymphoma; Radioimmunotherapy; Tolerability

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; FLUDARABINE; IBRITUMOMAB TIUXETAN; MITOXANTRONE; RITUXIMAB;

ADULT; AGED; ANEMIA; ARTICLE; BLOOD TOXICITY; BONE MARROW; CANCER INFILTRATION; CANCER PATIENT; CANCER REGRESSION; CLINICAL ARTICLE; CLINICAL TRIAL; CONTINUOUS INFUSION; DRUG EFFICACY; DRUG SAFETY; DRUG TOLERABILITY; ERYTHROCYTE TRANSFUSION; FEASIBILITY STUDY; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HUMAN; MALE; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; NONHODGKIN LYMPHOMA; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; SECOND CANCER; SIDE EFFECT; SURVIVAL RATE; THROMBOCYTE COUNT; THROMBOCYTE TRANSFUSION; THROMBOCYTOPENIA; THYROTROPIN BLOOD LEVEL; TREATMENT RESPONSE; WORLD HEALTH ORGANIZATION;

AGED; AGED, 80 AND OVER; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; FEMALE; HUMANS; LYMPHOMA, NON-HODGKIN; MALE; MIDDLE AGED; MITOXANTRONE; NEUTROPENIA; RADIOIMMUNOTHERAPY; SURVIVAL ANALYSIS; TREATMENT OUTCOME; VIDARABINE; YTTRIUM RADIOISOTOPES;

EID: 39049091866     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.23236     Document Type: Article

References (41)

1. Wothersspoon AC, Dogliosi C, Diss TC, et al. Regression of primary low-grade B cell gastric lymphoma of mucosa-associated lymphoid tissue type after eradication of Helicobacter pilori. Lancet. 1993;342:575-577.
2. Schechter NR, Portolock CS, Yahalom J. Treatment of mucosa-associated lymphoid tissue lymphoma of the stomach with radiation alone. J Clin Oncol. 1998;16:1916-1921.
3. Zinzani PL, Tani M, Barbieri E, et al. Utility of surgical resection with or without radiation therapy in patients with low-grade gastric mucosa-associated lymphoid tissue lymphoma. Haematologica. 2003;88:830-831.
4. Podock CS, Rosenberg SA, Glatstein E, et al. Treatment of advanced non-Hodgkin's lymphomas with favourable histologies: preliminary results of a prospective trial. Blood. 1976;47:747-756.
5. Hoppe RT, Kushlan P, Kaplan HS, et al. The treatment of advanced stage favourable histology non-Hodgkin's lymphoma: a preliminary report of a randomized trial comparing single agent chemotherapy, combination chemotherapy, and whole body irradiation. Blood. 1981;58:592-598.
6. Horning SJ, Rosenberg SA. The natural history of initially untreated low-grade non-Hodgkin's lymphomas. N Engl J Med. 1984;311:1471-1475.
7. Redmann JR, Cabanillas F, Velasquez WS, et al. Phase II trial of fludarabine phosphate in lymphoma: an effective new agent in low-grade lymphoma. J Clin Oncol. 1992;109:790-794.
8. Hochster HS, Kim K, Green MD, et al. Activity of fludarabine in previously treated non-Hodgkin's low-grade lymphoma: results of an Eastern Cooperative Oncology Group study. J Clin Oncol. 1992;10:28-32.
9. Zinzani PL, Lauria F, Rondelli D, et al. Fludarabine: an active agent in the treatment of previously-treated and untreated low-grade non-Hodgkin's lymphoma. Ann Oncol. 1993;4:575-578.
10. Hiddemann W, Unterhalt M, Pott C, et al. Fludarabine single-agent therapy for relapsed low-grade non-Hodgkin's lymphomas: a phase II study of the German Low-Grade Non-Hodgkin's Lymphoma Study Group. Semin Oncol. 1993;20:28-31.
11. McLaughlin P, Hagemeister FB, Swan F, et al. Phase I study of the combination of fludarabine, mitoxantrone, and dexamethasone in low-grade lymphoma. J Clin Oncol. 1994;12:575-579.
12. Zinzani PL, Bendandi M, Tura S. FMP regimen (fludarabine, mitoxantrone, prednisone) as therapy in recurrent low-grade non-Hodgkin's lymphoma. Eur J Haematol. 1995;55:262-266.
13. McLaughlin P, Hagemeister FB, Ramaguerra JE, et al. Fludarabine, mitoxantrone, and dexamethasone: an effective new regimen for indolent lymphoma. J Clin Oncol. 1996;14:1262-1268.
14. Zinzani PL, Bendandi M, Magagnoli M, et al. Fludarabine-mitoxantrone combination-containing regimen in recurrent low-grade non-Hodgkin's lymphoma. Ann Oncol. 1997;8:379-383.
15. Zinzani PL, Magagnoli M, Bendandi M, et al. Efficacy of fludarabine and mitoxantrone (FN) combination regimen in untreated indolent non-Hodgkin's lymphomas. Ann Oncol. 2000;11:363-365.
16. Zinzani PL, Pulsoni A, Perrotti A, et al. Fludarabine plus mitoxantrone with and without rituximab versus CHOP with and without rituximab as front-line treatment for patients with follicular lymphoma. J Clin Oncol. 2004;22:2654-2661.
17. Zinzani PL, Bendandi M, Gherlinzoni F, et al. FLU-ID (fludarabine and idarubicin) regimen as salvage therapy in pre-treated low-grade non-Hodgkin's lymphoma. Haematologica. 1996;81:168-171.
18. Zinzani PL, Magagnoli M, Moretti L, et al. Randomized trial of fludarabine versus fludarabine and idarubicin as frontline treatment in patients with indolent or mantle cell lymphoma. J Clin Oncol. 2000;18:773-779.
19. Zinzani PL, Pulsoni A, Gentilini P, et al. Effectiveness of fludarabine, idarubicin and cyclophosphamide (FLUIC) combination regimen for young patients with untreated non-follicular low-grade non-hodgkin's lymphoma. Leuk Lymphoma. 2004;45:1815-1819.
20. Hochster HS, Oken MM, Winter JN, et al. Phase I study of fludarabine plus cyclophosphamide in patients with previously untreated low-grade lymphoma: results and long-term follow-up: a report from the Eastern Cooperative Oncology Group. J Clin Oncol. 2000;18:987-994.
21. Flinn IW, Byrd JC, Morrison C, et al. Fludarabine and cyclophosphamide with filgrastim support in patients with previously untreated indolent lymphoid malignancies. Blood. 2000;96:71-75.
22. Lazzarino M, Orlandi E, Montillo M, et al. Fludarabine, cyclophosphamide, and dexamethasone (FluCyD) combination is effective in pretreated low-grade non-Hodgkin's lymphoma. Ann Oncol. 1999;10:59-64.
23. Forstpointner R, Dreyling M, Repp R, et al. The addition of rituximab of fludarabine, cyclophosphamide, mitoxantrone (FCM) significantly increases the response rate and prolongs survival as compared with FCM alone in patients with relapsed and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of German Low-Grade Lymphoma Study Group. Blood. 2004;104:3064-3071.
24. Forstpointner R, Unterhalt M, Dreyling M, et al. Maintenance therapy with rituximab leads to a significant prolongation of response duration after salvage therapy with a combination of rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) in patients with recurring and refractory follicular and mantle cell lymphomas: results of a prospective randomized study of the German Low Grade Lymphoma Study Group (GLSG). Blood. 2006;108:4003-4008.
25. Foran JM, Rohatiner AZS, Cunningham D, et al. European phase II study of rituximab (chimeric anti-CD20 monoclonal antibody) for patients with newly diagnosed mantle-cell lymphoma and previously treated mantie-cell lymphoma, immunocytoma, and small B-cell lymphocytic lymphoma. J Clin Oncol. 2000;18:317-324.
26. Hainsworth JD, Litchy S, Barton JH, et al. Single-agent rituximab as first line and maintenance treatment for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma: a phase II trial of the Minnie Pearl Cancer Research Network. J Clin Oncol. 2003;21:1746-1751.
27. Anderson KC, Bates MP, Slaughenhoupt BL, et al. Expression of human B cell-associated antigens on leukemias and lymphomas: a model of human B cell differentiation. Blood. 1984;63:1424-1433.
28. Press OW. Radiolabeled antibody therapy of B-cell lymphomas. Semin Oncol. 1999;26:58-65.
29. Witzig TE, White CA, Wiseman GA, et al. Phase I/II trial of IDEC-Y2B8 radioimmunotherapy for treatment of relapsed or refractory CD20(+) B-cell non-Hodgkin's lymphoma. J Clin Oncol. 1999;17:3793-3803.
30. 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. 2000;20:2453-2463.
31. Wiseman GW, Gordon LI, Multani PS, et al. Ibritumomab tiuxetan radioimmunotherapy for patients with relapsed or refractory non-Hodgkin's lymphoma and mild thrombocytopenia: a phase II multicenter trial. Blood. 2002;99:4336-4342.
32. Witzig TE, Flinn IF, Gordon LI, et al. Treatment with ibritumomab tiuxetan radioimmunotherapy in patients with rituximab refractory follicular non-Hodgkin's lymphoma. J Clin Oncol. 2002;20:3262-3269.
33. Harris NL, Jaffe ES, Diebold J, et al. World Health Organization classification of neoplastic diseases of the hematopoietic and lymphoid tissues: report of the Clinical Advisory Committee Meeting-Airlie House, Virginia, November 1997. J Clin Oncol. 1999;17:3835-3849.
34. Cheson BD, Horning SJ, Coiffier B, et al. Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas.NCI Sponsored International Working Group. J Clin Oncol. 1999;17:1244-1253.
35. Fleming TR. One-sample multiple testing procedure for phase II clinical trials. Biometrics. 1982;38:143-151.
36. Machin D, Campbell MJ. Statisticaltables for design of clinical trials. Oxford, United Kingdom: Blackwell; 1987.
37. A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001;20:859-866.
38. Kaplan EL, Meier P. Non-parametric estimation from incomplete observations. J Am Stat Assoc. 1958;53:457-481.
39. Plunkett W, Ghandi V, Huang P, et al. Fludarabine: pharmacokinetics, mechanisms of action, and rationales for combination therapies. Semin Oncol. 1993;20:2-12.
40. Leonard JP, Coleman M, Kostakoglu L, et al. Abbreviated chemotherapy with fludarabine followed by tositumomab and iodine I 131 tositumomab for untreated follicular lymphoma. J Clin Oncol. 2005;23:5696-5704.
41. Press OW, Unger JM, Braziel RM, et al. Phase II trial of CHOP chemotherapy followed by tositumomab/iodine I-131 tositumomab for previously untreated follicular non-Hodgkin's lymphoma: 5-year follow-up of Southwest Group protocol S9911. J Clin Oncol. 2006;24:4143-4149.