Efficacy and safety of the combination of rituximab, fludarabine, and mitoxantrone for rituximab-naive, recurrent/refractory follicular non-Hodgkin lymphoma with high tumor burden: A multicenter phase 2 trial by the Groupe d'Etude des Lymphomes de l'Adulte (GELA) and Groupe Ouest Est des Leucémies et Autres Maladies du Sang (GOELAMS)

Cancer

Volumn 116, Issue 18, 2010, Pages 4299-4308

  Morschhauser, Franck ^a   Mounier, Nicolas ^b   Sebban, Catherine ^c   Brice, Pauline ^d   Solal Celigny, Phillippe ^e   Tilly, Herve ^f   Feugier, Pierre ^g   Fermé, Christophe ^h   Copin, Marie Christine ^a   Lamy, Thierry ^i,j  

^a LILLE UNIVERSITY HOSPITAL   (France)

^b UNIVERSITY HOSPITAL OF NICE   (France)

^c University Hospital Center of Lyon   (France)

^d SAINT LOUIS HOSPITAL   (France)

^e Clinique Victor Hugo   (France)

^f CENTRE HENRI BECQUEREL   (France)

^g UNIVERSITY HOSPITAL OF NANCY   (France)

^h INSTITUT GUSTAVE ROUSSY   (France)

ⁱ INSTITUT PAOLI CALMETTES   (France)

^j PONTCHAILLOU UNIVERSITY HOSPITAL   (France)

more..

Author keywords

Fludarabine based combination; Follicular lymphoma; High tumor burden; Immunochemotherapy

Indexed keywords

ALPHA INTERFERON; CISPLATIN; CYCLOPHOSPHAMIDE; CYTARABINE; DOXORUBICIN; FLUDARABINE; MITOXANTRONE; PREDNISONE; RECOMBINANT GRANULOCYTE COLONY STIMULATING FACTOR; RITUXIMAB; VINCRISTINE; VINDESINE; ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; VIDARABINE;

ADULT; AGED; ALOPECIA; ANEMIA; ARTHRITIS; ARTICLE; ASTHMA; CARDIOTOXICITY; CHYLOUS ASCITES; CLINICAL ARTICLE; CLINICAL TRIAL; DIARRHEA; DRUG EFFICACY; DRUG SAFETY; EVENT FREE SURVIVAL; FEBRILE NEUTROPENIA; FEMALE; FEVER; FOLLICULAR LYMPHOMA; HUMAN; INFECTION; KIDNEY DISEASE; LIVER TOXICITY; MALE; MULTICENTER STUDY; NEUROLOGIC DISEASE; NEUTROPENIA; NONHODGKIN LYMPHOMA; OVERALL SURVIVAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; RECURRENT CANCER; THROMBOCYTOPENIA; TREATMENT RESPONSE; TUMOR VOLUME; ANALOGS AND DERIVATIVES; DRUG ADMINISTRATION; DRUG RESISTANCE; LYMPHOMA, FOLLICULAR; MIDDLE AGED; NEOPLASMS, SECOND PRIMARY; RECURRENT DISEASE;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; DRUG ADMINISTRATION SCHEDULE; DRUG RESISTANCE, NEOPLASM; FEMALE; HUMANS; LYMPHOMA, FOLLICULAR; MALE; MIDDLE AGED; MITOXANTRONE; NEOPLASMS, SECOND PRIMARY; RECURRENCE; TUMOR BURDEN; VIDARABINE;

EID: 77957337432     PISSN: 0008543X     EISSN: 10970142     Source Type: Journal    
DOI: 10.1002/cncr.25280     Document Type: Article

References (43)

1. Marcus R, Imrie K, Belch A, et al. CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood. 2005;105:1417-1423.
2. Hiddemann W, Buske C, Dreyling M, et al. Treatment strategies in follicular lymphomas: current status and future perspectives. J Clin Oncol. 2005;23:6394-6399.
3. Herold M, Haas A, Srock S, et al. Rituximab added to firstline mitoxantrone, chlorambucil, and prednisolone chemotherapy followed by interferon maintenance prolongs survival in patients with advanced follicular lymphoma: an East German Study Group Hematology and Oncology Study. J Clin Oncol. 2007;25:1986-1992.
4. Salles G, Mounier N, de Guibert S, et al. Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study. Blood. 2008;112:4824-4831.
5. Bellosillo B, Villamor N, Colomer D, Pons G, Montserrat E, Gil J. In vitro evaluation of fludarabine in combination with cyclophosphamide and/or mitoxantrone in B-cell chronic lymphocytic leukemia. Blood. 1999;94:2836-2843.
6. Zinzani PL, Bendandi M, Tura S. FMP regimen (fludarabine, mitoxantrone, prednisone) as therapy in recurrent lowgrade non-Hodgkin's lymphoma. Eur J Haematol. 1995;55: 262-266.
7. McLaughlin P, Hagemeister FB, Romaguera JE, et al. Fludarabine, mitoxantrone, and dexamethasone: an effective new regimen for indolent lymphoma. J ClinOncol. 1996;14:1262-1268.
8. Gregory SA, Vose J, Modiano M, et al. Mitoxantrone and fludarabine in the treatment of patients with non-Hodgkin's lymphoma failing primary therapy with a doxorubicin or mitoxantrone-containing regimen. Leuk Lymphoma. 2001; 40:315-324.
9. Armitage JO. The role of mitoxantrone in non-Hodgkin's lymphoma. Oncology (Williston Park). 2002;16:490-502, 507-508; discussion 511-512, 514.
10. Hagemeister F, Cabanillas F, Coleman M, Gregory SA, Zinzani PL. The role of mitoxantrone in the treatment of indolent lymphomas. Oncologist. 2005;10:150-159.
11. Lenz G, Hiddemann W, Dreyling M. The role of fludarabine in the treatment of follicular and mantle cell lymphoma. Cancer. 2004;101:883-893. (Pubitemid 39100419)
12. Tam CS, Wolf M, Prince HM, et al. Fludarabine, cyclophosphamide, and rituximab for the treatment of patients with chronic lymphocytic leukemia or indolent non-Hodgkin lymphoma. Cancer. 2006;106:2412-2420.
13. Montoto S, Moreno C, Domingo-Domenech E, et al. High clinical and molecular response rates with fludarabine, cyclophosphamide and mitoxantrone in previously untreated patients with advanced stage follicular lymphoma. Haematologica. 2008;93:207-214.
14. Bosch F, Ferrer A, Villamor N, et al. Fludarabine, cyclophosphamide, and mitoxantrone as initial therapy of chronic lymphocytic leukemia: high response rate and disease eradication. Clin Cancer Res. 2008;14:155-161.
15. Santini G, Chisesi T, Nati S, et al. Fludarabine, cyclophosphamide and mitoxantrone for untreated follicular lymphoma: a report from the non-Hodgkin's Lymphoma Co- Operative Study Group. Leuk Lymphoma. 2004;45:1141-1147.
16. Dreyling M, Forstpointner R, Repp R, et al. Combined immuno-chemotherapy (R-FCM) results in superior remission and survival rates in recurrent follicular and mantle cell lymphoma. Final results of a prospective randomized trial of the German Low-Grade Lymphoma Study Group (GLSG) [abstract]. Blood. 2003;102:103a. Abstract 351.
17. McLaughlin P, Hagemeister FB, Rodriguez MA, et al. Safety of fludarabine, mitoxantrone, and dexamethasone combined with rituximab in the treatment of stage IV indolent lymphoma. Semin Oncol. 2000;27:37-41.
18. Sarris AH, Jiang Y, Tsimberidou AM, et al. Quantitative real-time polymerase chain reaction for monitoring minimal residual disease in patients with advanced indolent lymphomas treated with rituximab, fludarabine, mitoxantrone, and dexamethasone. Semin Oncol. 2002;29:48-55.
19. 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.
20. Seymour JF, Grigg AP, Szer J, Fox RM. Fludarabine and mitoxantrone: effective and well-tolerated salvage therapy in relapsed indolent lymphoproliferative disorders. Ann Oncol. 2001;12:1455-1460.
21. Forstpointner R, Dreyling M, Repp R, et al. The addition of rituximab to a combination 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 the German Low-Grade Lymphoma Study Group. Blood. 2004;104:3064-3071.
22. Solal-Celigny P, Lepage E, Brousse N, et al. Recombinant interferon alfa-2b combined with a regimen containing doxorubicin in patients with advanced follicular lymphoma. Groupe d'Etude des Lymphomes de l'Adulte. N Engl J Med. 1993;329:1608-1614.
23. Swerdlow SH, Campo E, Harris NL, et al. Classification of Tumours of Haematopoietic and Lymphoid Tissues. In: Press I, ed. Lyon, France: Elsevier; 2008:2.
24. Solal-Celigny P, Roy P, Colombat P, et al. Follicular lymphoma international prognostic index. Blood. 2004;104:1258-1265.
25. 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;17:1244-1244.
26. McLaughlin P, Hagemeister FB, Swan F Jr, et al. Phase I study of the combination of fludarabine, mitoxantrone, and dexamethasone in low-grade lymphoma. J Clin Oncol. 1994; 12:575-579.
27. Piro LD, White CA, Grillo-Lopez AJ, et al. Extended rituximab (anti-CD20 monoclonal antibody) therapy for relapsed or refractory low-grade or follicular non-Hodgkin's lymphoma. Ann Oncol. 1999;10:655-661.
28. Czuczman MS, Koryzna A, Mohr A, et al. Rituximab in combination with fludarabine chemotherapy in low-grade or follicular lymphoma. J Clin Oncol. 2005;23:694-704.
29. Sacchi S, Pozzi S, Marcheselli R, et al. Rituximab in combination with fludarabine and cyclophosphamide in the treatment of patients with recurrent follicular lymphoma. Cancer. 2007;110:121-128. (Pubitemid 46992032)
30. Tsimberidou AM, Younes A, Romaguera J, et al. Immunosuppression and infectious complications in patients with stage IV indolent lymphoma treated with a fludarabine, mitoxantrone, and dexamethasone regimen. Cancer. 2005; 104:345-353.
31. Sebban C, Mounier N, Brousse N, et al. Standard chemotherapy with interferon compared with CHOP followed by high-dose therapy with autologous stem cell transplantation in untreated patients with advanced follicular lymphoma: the GELF-94 randomized study from the Groupe d'Etude des Lymphomes de l'Adulte (GELA). Blood. 2006;108: 2540-2544.
32. Deconinck E, Foussard C, Milpied N, et al. High-dose therapy followed by autologous purged stem-cell transplantation and doxorubicin-based chemotherapy in patients with advanced follicular lymphoma: a randomized multicenter study by GOELAMS. Blood. 2005;105:3817-3823.
33. Foussard C, Colombat P, Maisonneuve H, et al. Long-term follow-up of a randomized trial of fludarabine-mitoxantrone, compared with cyclophosphamide, doxorubicin, vindesine, prednisone (CHVP), as first-line treatment of elderly patients with advanced, low-grade non-Hodgkin's lymphoma before the era of monoclonal antibodies. Ann Oncol. 2005;16:466-472.
34. Maloney DG, Grillo-Lopez AJ, White CA, et al. IDECC2B8 (rituximab) anti-CD20 monoclonal antibody therapy in patients with relapsed low-grade non-Hodgkin's lymphoma. Blood. 1997;90:2188-2195.
35. van Oers MH, Klasa R, Marcus RE, et al. Rituximab maintenance improves clinical outcome of relapsed/resistant follicular non-Hodgkin lymphoma in patients both with and without rituximab during induction: results of a prospective randomized phase 3 intergroup trial. Blood. 2006;108:3295-3301.
36. Morschhauser F, Brice P, Ferme C, et al. Risk-adapted salvage treatment with single or tandem autologous stem-cell transplantation for first relapse/refractory Hodgkin's lymphoma: results of the prospective multicenter H96 trial by the GELA/SFGM Study Group. J Clin Oncol. 2008;26: 5980-5987.
37. 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.
38. Vitolo U, Ladetto M, Boccomini C, et al. Brief chemoimmunotherapy rituximab (R)-FND ± R maintenance is effective and safe in newly diagnosed follicular lymphoma elderly patients: an Intergruppo Italiano Linfomi (IIL) randomized trial [abstract]. Haematologica. 2009;94:417. Abstract 1041.
39. McLaughlin P, Neelapu S, Fanale M, et al. R-FND followed by radioimmunotherapy for high-risk follicular lymphoma [abstract]. Blood. 2008;112:1050. Abstract 3056.
40. Tournilhac O, Cazin B, Lepretre S, et al. Impact of frontline fludarabine and cyclophosphamide combined treatment on peripheral blood stem cell mobilization in B-cell chronic lymphocytic leukemia. Blood. 2004;103:363-365.
41. Laszlo D, Galieni P, Raspadori D, Tozzi M, Lauria F, Martinelli G. Fludarabine combination regimen severely affected peripheral blood stem cell mobilization. Acta Haematol. 2004;111:228-229.
42. Hagemeister F, McLaughlin P, Fayad L, et al. Rituximab, fludarabine, mitoxantrone, and dexamethasone (R-FND) for relapsed indolent lymphomas (RIL) [abstract]. Blood. 2005; 106:277a. Abstract 941.
43. Dreyling M, Forstpointner R, Bock H, et al. Combined immuno-chemotherapy followed by rituximab maintenance is an effective salvage treatment after prior rituximab containing therapy: results of a GLSG-subgroup analysis in patients with relapsed indolent lymphoma [abstract]. Blood. 2006;108:784a. Abstract 2769.