Chemoimmunotherapy with ofatumumab in combination with CHOP in previously untreated follicular lymphoma

British Journal of Haematology

Volumn 157, Issue 4, 2012, Pages 438-445

  Czuczman, Myron S ^a   Hess, Georg ^b   Gadeberg, Ole V ^c   Pedersen, Lars M ^d   Goldstein, Nancy ^e   Gupta, Ira ^e   Jewell, Roxanne C ^e   Lin, Thomas S ^e   Lisby, Steen ^f   Strange, Claus ^f   Windfeld, Kristian ^f   Viardot, Andreas ^g  

^a ROSWELL PARK CANCER INSTITUTE   (United States)

^b UNIVERSITY MEDICAL CENTER MAINZ   (Germany)

^c LILLEBAELT HOSPITAL   (Denmark)

^d ODENSE UNIVERSITY HOSPITAL   (Denmark)

^e GLAXOSMITHKLINE   (United States)

^f Genmab   (Denmark)

^g UNIVERSITY HOSPITAL ULM   (Germany)

Author keywords

Chemotherapy; Haematological malignancies; Immunotherapy; Lymphoid malignancies; Non Hodgkin lymphoma

Indexed keywords

CYCLOPHOSPHAMIDE; DOXORUBICIN; OFATUMUMAB; PREDNISONE; VINCRISTINE;

ADULT; AGED; ALOPECIA; AREA UNDER THE CURVE; ARTICLE; CANCER COMBINATION CHEMOTHERAPY; CANCER IMMUNOTHERAPY; CANCER PROGNOSIS; CANCER STAGING; CANCER SURVIVAL; CHEMOTHERAPY INDUCED EMESIS; CLINICAL EFFECTIVENESS; CONSTIPATION; CONTROLLED STUDY; COUGHING; DIARRHEA; DISEASE DURATION; DOSE RESPONSE; DRUG BLOOD LEVEL; DRUG DISTRIBUTION; DRUG DOSE COMPARISON; DRUG EFFECT; DRUG EFFICACY; DRUG FATALITY; DRUG HALF LIFE; DRUG SAFETY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DYSGEUSIA; DYSPEPSIA; DYSPNEA; FATIGUE; FEMALE; FEVER; FOLLICULAR LYMPHOMA; FOLLOW UP; HEADACHE; HUMAN; INFECTION; INJECTION SITE REACTION; LEUKOPENIA; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NAUSEA; NEUTROPENIA; OUTCOME ASSESSMENT; PERIPHERAL EDEMA; PHASE 2 CLINICAL TRIAL; POLYNEUROPATHY; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RASH; RESPIRATORY TRACT INFECTION; SIDE EFFECT; SORE THROAT; SURVIVAL RATE; TIME TO MAXIMUM PLASMA CONCENTRATION; TREATMENT DURATION; URTICARIA;

ADULT; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; CYCLOPHOSPHAMIDE; DOXORUBICIN; FEMALE; HUMANS; LYMPHOMA, FOLLICULAR; MALE; MIDDLE AGED; POSITRON-EMISSION TOMOGRAPHY; PREDNISONE; TREATMENT OUTCOME; VINCRISTINE;

EID: 84860006054     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/j.1365-2141.2012.09086.x     Document Type: Article

References (19)

1. Buske, C., Hoster, E., Dreyling, M., Hasford, J., Unterhalt, M. & Hiddemann, W. (2006) The Follicular Lymphoma International Prognostic Index (FLIPI) separates high-risk from intermediate- or low-risk patients with advanced-stage follicular lymphoma treated front-line with rituximab and the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) with respect to treatment outcome. Blood, 108, 1504-1508.
2. Cheson, B.D., Horning, S.J., Coiffier, B., Shipp, M.A., Fisher, R.I., Connors, J.M., Lister, T.A., Vose, J., Grillo-Lopez, A., Hagenbeek, A., Cabanillas, F., Klippensten, D., Hiddemann, W., Castellino, R., Harris, N.L., Armitage, J.O., Carter, W., Hoppe, R. & Canellos, G.P. (1999) Report of an international workshop to standardize response criteria for non-Hodgkin's lymphomas. NCI Sponsored International Working Group. Journal of Clinical Oncology, 17, 1244.
3. Friedberg, J.W. (2008) Treatment of follicular non-Hodgkin's lymphoma: the old and the new. Seminars in Hematology, 45, S2-6.
4. Hagenbeek, A., Gadeberg, O., Johnson, P., Pedersen, L.M., Walewski, J., Hellmann, A., Link, B.K., Robak, T., Wojtukiewicz, M., Pfreundschuh, M., Kneba, M., Engert, A., Sonneveld, P., Flensburg, M., Petersen, J., Losic, N. & Radford, J. (2008) First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial. Blood, 111, 5486-5495.
5. Hagenbeek, A., Fayad, L., Delwail, V., Rossi, J.F., Jacobsen, E., Kuliczkowski, K., Link, B.K., Pinter-Brown, L., Radford, J., Hellmann, A., Gallop-Evans, E., Gupta, I., Arning, M., Begtrup, K., Schultz, M., Bang, B., Russell, C.A. & Czuczman, M.S. (2009) Evaluation of ofatumumab, a novel human CD20 monoclonal antibody, as single agent therapy in rituximab-refractory follicular lymphoma. Blood (ASH Annual Meeting Abstracts), 114, 935.
6. Herold, M., Haas, A., Srock, S., Neser, S., Al-Ali, K.H., Neubauer, A., Dolken, G., Naumann, R., Knauf, W., Freund, M., Rohrberg, R., Hoffken, K., Franke, A., Ittel, T., Kettner, E., Haak, U., Mey, U., Klinkenstein, C., Assmann, M. & von Grunhagen, U. (2007) Rituximab added to first-line 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. Journal of Clinical Oncology, 25, 1986-1992.
7. Hiddemann, W., Kneba, M., Dreyling, M., Schmitz, N., Lengfelder, E., Schmits, R., Reiser, M., Metzner, B., Harder, H., Hegewisch-Becker, S., Fischer, T., Kropff, M., Reis, H.E., Freund, M., Wormann, B., Fuchs, R., Planker, M., Schimke, J., Eimermacher, H., Trumper, L., Aldaoud, A., Parwaresch, R. & Unterhalt, M. (2005) Frontline therapy with rituximab added to the combination of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) significantly improves the outcome for patients with advanced-stage follicular lymphoma compared with therapy with CHOP alone: results of a prospective randomized study of the German Low-Grade Lymphoma Study Group. Blood, 106, 3725-3732.
8. Marcus, R., Imrie, K., Belch, A., Cunningham, D., Flores, E., Catalano, J., Solal-Celigny, P., Offner, F., Walewski, J., Raposo, J., Jack, A. & Smith, P. (2005) CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood, 105, 1417-1423.
9. Marcus, R., Imrie, K., Solal-Celigny, P., Catalano, J.V., Dmoszynska, A., Raposo, J.C., Offner, F.C., Gomez-Codina, J., Belch, A., Cunningham, D., Wassner-Fritsch, E. & Stein, G. (2008) Phase III study of R-CVP compared with cyclophosphamide, vincristine, and prednisone alone in patients with previously untreated advanced follicular lymphoma. Journal of Clinical Oncology, 26, 4579-4586.
10. Pawluczkowycz, A.W., Beurskens, F.J., Beum, P.V., Lindorfer, M.A., van de Winkel, J.G., Parren, P.W. & Taylor, R.P. (2009) Binding of submaximal C1q promotes complement-dependent cytotoxicity (CDC) of B cells opsonized with anti-CD20 mAbs ofatumumab (OFA) or rituximab (RTX): considerably higher levels of CDC are induced by OFA than by RTX. Journal of Immunology, 183, 749-758.
11. Rummel, M.J., Niederle, N., Maschmeyer, G., Banat, A., Gruenhagen, U.v., Losem, C., Heil, G., Welslau, M., Balser, C., Kaiser, U., Ballo, H., Weidmann, E., Duerk, H.A., Kofahl-Krause, D., Roller, F., Barth, J., Hoelzer, D., Hinke, A. & Brugger, W. (2009) Bendamustine plus rituximab is superior in respect of progression-free survival and CR rate when compared to CHOP plus rituximab as first-line treatment of patients with advanced follicular, indolent, and mantle cell lymphomas: final results of a randomized phase III study of the StiL (Study Group Indolent Lymphomas, Germany). Blood (ASH Annual Meeting Abstracts), 114, 405.
12. Rummel, M.J., Kaiser, U., Balser, C., Stauch, M.B., Brugger, W., Welslau, M., Niederle, N., Losem, C., Ballo, H., Weidmann, E., von Gruenhagen, U., Mueller, L., Sandherr, M., Vereschagina, J., Hinke, A. & Barth, J. (2010) Bendamustine Plus Rituximab Versus Fludarabine Plus Rituximab In Patients with Relapsed Follicular, Indolent and Mantle Cell Lymphomas - Final Results of the Randomized Phase III Study NHL 2-2003 on Behalf of the StiL (Study Group Indolent Lymphomas, Germany). Blood (ASH Annual Meeting Abstracts), 116, 856.
13. Salles, G., Mounier, N., de Guibert, S., Morschhauser, F., Doyen, C., Rossi, J.F., Haioun, C., Brice, P., Mahe, B., Bouabdallah, R., Audhuy, B., Ferme, C., Dartigeas, C., Feugier, P., Sebban, C., Xerri, L. & Foussard, C. (2008) Rituximab combined with chemotherapy and interferon in follicular lymphoma patients: results of the GELA-GOELAMS FL2000 study. Blood, 112, 4824-4831.
14. Salles, G.A., Catalano, J., Feugier, P., Offner, F.C., Bouabdallah, R., Caballero, D., Brice, P., Pedersen, L.M., Haioun, C., Belada, D., Delmer, A., Simpson, D., Tilly, H., Leppa, S., Soubeyran, P., Hagenbeek, A., Casasnovas, O., Intragumtornchai, T., Ferme, C., Silva, M.G.d., Sebban, C., Lister, A., Estell, J.A., Milone, G., Sonet, A., Lopez-Guillermo, A., Seymour, J.F. & Xerri, L. (2010) Updated results of the PRIMA study confirms the benefit of 2-years rituximab maintenance in follicular lymphoma patients responding to immunochemotherapy. Blood (ASH Annual Meeting Abstracts), 116, 1788.
15. Solal-Celigny, P., Roy, P., Colombat, P., White, J., Armitage, J.O., Arranz-Saez, R., Au, W.Y., Bellei, M., Brice, P., Caballero, D., Coiffier, B., Conde-Garcia, E., Doyen, C., Federico, M., Fisher, R.I., Garcia-Conde, J.F., Guglielmi, C., Hagenbeek, A., Haioun, C., LeBlanc, M., Lister, A.T., Lopez-Guillermo, A., McLaughlin, P., Milpied, N., Morel, P., Mounier, N., Proctor, S.J., Rohatiner, A., Smith, P., Soubeyran, P., Tilly, H., Vitolo, U., Zinzani, P.L., Zucca, E. & Montserrat, E. (2004) Follicular lymphoma international prognostic index. Blood, 104, 1258-1265.
16. Teeling, J.L., French, R.R., Cragg, M.S., van den Brakel, J., Pluyter, M., Huang, H., Chan, C., Parren, P.W., Hack, C.E., Dechant, M., Valerius, T., van de Winkel, J.G. & Glennie, M.J. (2004) Characterization of new human CD20 monoclonal antibodies with potent cytolytic activity against non-Hodgkin lymphomas. Blood, 104, 1793-1800.
17. Teeling, J.L., Mackus, W.J., Wiegman, L.J., van den Brakel, J.H., Beers, S.A., French, R.R., van Meerten, T., Ebeling, S., Vink, T., Slootstra, J.W., Parren, P.W., Glennie, M.J. & van de Winkel, J.G. (2006) The biological activity of human CD20 monoclonal antibodies is linked to unique epitopes on CD20. Journal of Immunology, 177, 362-371.
18. Trotman, J., Fournier, M., Lamy, T., Estell, J.A., Sonet, A., Janikova, A., Tilly, H., Decaudin, D., Gabarre, J., Seymour, J.F., Garin, E., Forsyth, C., Fulham, M., Borght, T.V., Shpilberg, O. & Salles, G. (2010) Result of FDG PET-CT Imaging After Immunochemotherapy Induction Is a Powerful and Independent Prognostic Indicator of Outcome for Patients with Follicular Lymphoma: an Analysis From the PRIMA Study. Blood (ASH Annual Meeting Abstracts), 116, 855.
19. WHO (2001) World Health Organization Classification of Tumours: Pathology and Genetics of Tumours of Haematopoietic and Lymphoid Tissues. IARC Press, Lyon, France.