VcR-CVAD induction chemotherapy followed by maintenance rituximab in mantle cell lymphoma: A Wisconsin Oncology Network study

British Journal of Haematology

Volumn 155, Issue 2, 2011, Pages 190-197

  Chang, Julie E ^a   Peterson, Christopher ^b   Choi, Sangbum ^c   Eickhoff, Jens C ^d   Kim, Kyungmann ^d   Yang, David T ^d   Gilbert, Leslie A ^a   Rogers, Eric S ^a   Werndli, Jae E ^a   Huie, Michael S ^a   Mcfarland, Thomas A ^a   Volk, Michael ^e   Blank, Jules ^e   Callander, Natalie S ^a   Longo, Walter L ^a   Kahl, Brad S ^a  

^a UNIVERSITY OF WISCONSIN   (United States)

^b Aspirus Cancer Center   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^e Saint Vincent Regional Cancer Center   (United States)

Author keywords

Bortezomib; Chemotherapy; Mantle cell lymphoma; Non Hodgkin lymphoma; Rituximab

Indexed keywords

BORTEZOMIB; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DOXORUBICIN; RITUXIMAB; VINCRISTINE;

ADULT; ADVANCED CANCER; AGED; ARTICLE; BONE MARROW SUPPRESSION; CANCER SURVIVAL; CLINICAL ARTICLE; CLOSTRIDIUM DIFFICILE INFECTION; CONTINUOUS INFUSION; DEHYDRATION; DRUG DOSE REDUCTION; DRUG RESPONSE; DRUG WITHDRAWAL; ESOPHAGITIS; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; FOLLOW UP; HUMAN; HYPERGLYCEMIA; HYPONATREMIA; HYPOPHOSPHATEMIA; IMMUNOGLOBULIN BLOOD LEVEL; IMMUNOGLOBULIN DEFICIENCY; INFECTION; LUNG EMBOLISM; MALE; MANTLE CELL LYMPHOMA; MOOD CHANGE; MULTICENTER STUDY; MULTIPLE CYCLE TREATMENT; NEUTROPENIA; OVERALL SURVIVAL; PAIN; PNEUMOCOCCAL SEPSIS; PRIORITY JOURNAL; PROGNOSIS; PROGRESSION FREE SURVIVAL; RECURRENT INFECTION; RESPIRATORY TRACT INFECTION; SENSORY NEUROPATHY; SEPSIS; SIDE EFFECT; THROMBOCYTOPENIA;

AGED; ANTIBODIES, MONOCLONAL, MURINE-DERIVED; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORONIC ACIDS; CYCLOPHOSPHAMIDE; DEXAMETHASONE; DISEASE-FREE SURVIVAL; DOXORUBICIN; FEMALE; GRANULOCYTE COLONY-STIMULATING FACTOR; HEMATOLOGIC DISEASES; HUMANS; KAPLAN-MEIER ESTIMATE; LYMPHOMA, MANTLE-CELL; MALE; MIDDLE AGED; PERIPHERAL NERVOUS SYSTEM DISEASES; PROPORTIONAL HAZARDS MODELS; PROTEASE INHIBITORS; PYRAZINES; REMISSION INDUCTION; TREATMENT OUTCOME; VINCRISTINE;

EID: 80053567237     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/j.1365-2141.2011.08820.x     Document Type: Article

References (33)

1. 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.
2. Damon, L.E., Johnson, J.L., Niedzwiecki, D., Cheson, B.D., Hurd, D.D., Bartlett, N.L., Lacasce, A.S., Blum, K.A., Byrd, J.C., Kelly, M., Stock, W., Linker, C.A. & Canellos, G.P. (2009) Immunochemotherapy and autologous stem-cell transplantation for untreated patients with mantle-cell lymphoma: CALGB 59909. Journal of Clinical Oncology, 27, 6101-6108.
3. Delarue, R., Haioun, C., Ribrag, V., Brice, P., Delmer, A., Tilly, H., Salles, G., Van Hoof, A., Casasnovas, O., Brousse, N., Lefrere, F. & Hermine, O. (2008) RCHOP and RDHAP followed by autologous stem cell transplantation (ASCT) in mantle cell lymphoma (MCL): final results of a phase II study from the GELA. Blood (ASH Annual Meeting Abstracts), 112, 581.
4. Determann, O., Hoster, E., Ott, G., Wolfram Bernd, H., Loddenkemper, C., Leo Hansmann, M., Barth, T.E., Unterhalt, M., Hiddemann, W., Dreyling, M. & Klapper, W. (2008) Ki-67 predicts outcome in advanced-stage mantle cell lymphoma patients treated with anti-CD20 immunochemotherapy: results from randomized trials of the European MCL Network and the German Low Grade Lymphoma Study Group. Blood, 111, 2385-2387.
5. Dreyling, M., Hoster, E., van Hoof, A., Metzner, B., Gisselbrecht, C., Reiser, M., Pfreundschuh, M., Trumper, L., Steinhauer, H., Boiron, J., Boogaerts, M., Aldaoud, A., Silingardi, V., Kluin-Nelemans, H., Unterhalt, M. & Hiddemann, W. (2008) Early consolidation with myeloablative radiochemotherapy followed by autologous stem cell transplantion in first remission of mantle cell lymphoma. Blood (ASH Annual Meeting Abstracts), 112, 285.
6. Fayad, L., Thomas, D.A. & Romaguera, J. (2007) Update of the M.D. Anderson cancer center experience with HyperCVAD and rituximab for the treatment of mantle cell and burkitt-type lymphomas. Clincal Lymphoma & Myeloma, 8, S57-S62.
7. Fisher, R.I., Bernstein, S.H., Kahl, B.S., Djulbegovic, B., Robertson, M.J., de Vos, S., Epner, E., Krishnan, A., Leonard, J.P., Lonial, S., Stadtmauer, E.A., O'Connor, O.A., Shi, H., Boral, A.L. & Goy, A. (2006) Multicenter phase II study of bortezomib in patients with relapsed or refractory mantle cell lymphoma. Journal of Clinical Oncology, 24, 4867-4874.
8. Forstpointner, R., Unterhalt, M., Dreyling, M., Bock, H.P., Repp, R., Wandt, H., Pott, C., Seymour, J.F., Metzner, B., Hanel, A., Lehmann, T., Hartmann, F., Einsele, H. & Hiddemann, W. (2006) 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, 108, 4003-4008.
9. Furman, R.R., Martin, P., Ruan, J., Cheung, Y.K., Vose, J.M., Lacasce, A.S., Elstrom, R., Coleman, M. & Leonard, J.P. (2010) Phase 1 trial of bortezomib plus R-CHOP in previously untreated patients with aggressive non-Hodgkin lymphoma. Cancer, 116, 5432-5439.
10. Geisler, C.H., Kolstad, A., Laurell, A., Andersen, N.S., Pedersen, L.B., Jerkeman, M., Eriksson, M., Nordstrom, M., Kimby, E., Boesen, A.M., Kuittinen, O., Lauritzsen, G.F., Nilsson-Ehle, H., Ralfkiaer, E., Akerman, M., Ehinger, M., Sundstrom, C., Langholm, R., Delabie, J., Karjalainen-Lindsberg, M.L., Brown, P. & Elonen, E. (2008) Long-term progression-free survival of mantle cell lymphoma after intensive front-line immunochemotherapy with in vivo-purged stem cell rescue: a nonrandomized phase 2 multicenter study by the Nordic Lymphoma Group. Blood, 112, 2687-2693.
11. Ghielmini, M., Schmitz, S.F., Cogliatti, S., Bertoni, F., Waltzer, U., Fey, M.F., Betticher, D.C., Schefer, H., Pichert, G., Stahel, R., Ketterer, N., Bargetzi, M. & Cerny, T. (2005) Effect of single-agent rituximab given at the standard schedule or as prolonged treatment in patients with mantle cell lymphoma: a study of the Swiss Group for Clinical Cancer Research (SAKK). Journal of Clinical Oncology, 23, 705-711.
12. Goy, A., Younes, A., McLaughlin, P., Pro, B., Romaguera, J.E., Hagemeister, F., Fayad, L., Dang, N.H., Samaniego, F., Wang, M., Broglio, K., Samuels, B., Gilles, F., Sarris, A.H., Hart, S., Trehu, E., Schenkein, D., Cabanillas, F. & Rodriguez, A.M. (2005) Phase II study of proteasome inhibitor bortezomib in relapsed or refractory B-cell non-Hodgkin's lymphoma. Journal of Clinical Oncology, 23, 667-675.
13. Habermann, T.M., Weller, E.A., Morrison, V.A., Gascoyne, R.D., Cassileth, P.A., Cohn, J.B., Dakhil, S.R., Woda, B., Fisher, R.I., Peterson, B.A. & Horning, S.J. (2006) Rituximab-CHOP versus CHOP alone or with maintenance rituximab in older patients with diffuse large B-cell lymphoma. Journal of Clinical Oncology, 24, 3121-3127.
14. Herrmann, A., Hoster, E., Zwingers, T., Brittinger, G., Engelhard, M., Meusers, P., Reiser, M., Forstpointner, R., Metzner, B., Peter, N., Wormann, B., Trumper, L., Pfreundschuh, M., Einsele, H., Hiddemann, W., Unterhalt, M. & Dreyling, M. (2009) Improvement of overall survival in advanced stage mantle cell lymphoma. Journal of Clinical Oncology, 27, 511-518.
15. Hochster, H.S., Weller, E., Ryan, T., Habermann, T.M., Gascyone, R., Frankel, S.R. & Horning, S.J. (2004) Results of E1496: a phase III trial of CVP with or without maintenance rituximab in advanced indolent lymphoma (NHL) [abstract 6502]. Journal of Clinical Oncology, 22, 556.
16. Hoster, E., Dreyling, M., Klapper, W., Gisselbrecht, C., van Hoof, A., Kluin-Nelemans, H.C., Pfreundschuh, M., Reiser, M., Metzner, B., Einsele, H., Peter, N., Jung, W., Wormann, B., Ludwig, W.D., Duhrsen, U., Eimermacher, H., Wandt, H., Hasford, J., Hiddemann, W. & Unterhalt, M. (2008) A new prognostic index (MIPI) for patients with advanced-stage mantle cell lymphoma. Blood, 111, 558-565.
17. Kahl, B., Longo, W., Eickhoff, J., Zehnder, J., Jones, C., Blank, J., McFarland, T., Bottner, W., Rezazedeh, H., Werndli, J. & Bailey, H. (2006) Maintenance rituximab following induction chemoimmunotherapy may prolong progression-free survival in mantle cell lymphoma: a pilot study from the Wisconsin Oncology Network. Annals of Oncology, 17, 1418-1423.
18. Kahl, B.S., Li, H., Smith, M.R., Gascoyne, R.D., Paietta, E.P., Advani, R. & Horning, S.J. (2009) The VcR-CVAD regimen produces a high complete response rate in untreated Mantle Cell Lymphoma (MCL): first analysis of E1405 - A phase II study of VcR-CVAD with maintenance rituximab for MCL. Blood, 114, 663, abstract 1661.
19. Koyama, T. & Chen, H. (2008) Proper inference from Simon's two-stage designs. Statistics in Medicine, 27, 3145-3154.
20. Martin, P., Chadburn, A., Christos, P., Furman, R., Ruan, J., Joyce, M.A., Fusco, E., Glynn, P., Elstrom, R., Niesvizky, R., Feldman, E.J., Shore, T.B., Schuster, M.W., Ely, S., Knowles, D.M., Chen-Kiang, S., Coleman, M. & Leonard, J.P. (2008) Intensive treatment strategies may not provide superior outcomes in mantle cell lymphoma: overall survival exceeding 7years with standard therapies. Annals of Oncology, 19, 1327-1330.
21. Mitsiades, N., Mitsiades, C.S., Richardson, P.G., Poulaki, V., Tai, Y.T., Chauhan, D., Fanourakis, G., Gu, X., Bailey, C., Joseph, M., Libermann, T.A., Schlossman, R., Munshi, N.C., Hideshima, T. & Anderson, K.C. (2003) The proteasome inhibitor PS-341 potentiates sensitivity of multiple myeloma cells to conventional chemotherapeutic agents: therapeutic applications. Blood, 101, 2377-2380.
22. National Cancer Institute. (2006) Common terminology criteria for adverse events v3.0. Available at: .
23. National Comprehensive Cancer Network (2008) NCCN clinical practice guidelines in oncology. Non-Hodgkin's lymphomas. Available at: .
24. O'Connor, O.A., Wright, J., Moskowitz, C., Muzzy, J., MacGregor-Cortelli, B., Stubblefield, M., Straus, D., Portlock, C., Hamlin, P., Choi, E., Dumetrescu, O., Esseltine, D., Trehu, E., Adams, J., Schenkein, D. & Zelenetz, A.D. (2005) Phase II clinical experience with the novel proteasome inhibitor bortezomib in patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma. Journal of Clinical Oncology, 23, 676-684.
25. van Oers, M.H., Klasa, R., Marcus, R.E., Wolf, M., Kimby, E., Gascoyne, R.D., Jack, A., Van't Veer, M., Vranovsky, A., Holte, H., van Glabbeke, M., Teodorovic, I., Rozewicz, C. & Hagenbeek, A. (2006) 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, 108, 3295-3301.
26. Paoluzzi, L. & O'Connor, O.A. (2006) Mechanistic rationale and clinical evidence for the efficacy of proteasome inhibitors against indolent and mantle cell lymphomas. BioDrugs, 20, 13-23.
27. Ribrag, V., Gisselbrecht, C., Haioun, C., Salles, G., Golfier, J.B., Ertault, M., Ferme, C., Briere, J., Brice, P. & Mounier, N. (2009) Efficacy and toxicity of 2 schedules of frontline rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone plus bortezomib in patients with B-cell lymphoma: a randomized phase 2 trial from the French Adult Lymphoma Study Group (GELA). Cancer, 115, 4540-4546.
28. Robinson, K.S., Williams, M.E., van der Jagt, R.H., Cohen, P., Herst, J.A., Tulpule, A., Schwartzberg, L.S., Lemieux, B. & Cheson, B.D. (2008) Phase II multicenter study of bendamustine plus rituximab in patients with relapsed indolent B-cell and mantle cell non-Hodgkin's lymphoma. Journal of Clinical Oncology, 26, 4473-4479.
29. Romaguera, J.E., Fayad, L., Rodriguez, M.A., Broglio, K.R., Hagemeister, F.B., Pro, B., McLaughlin, P., Younes, A., Samaniego, F., Goy, A., Sarris, A.H., Dang, N.H., Wang, M., Beasley, V., Medeiros, L.J., Katz, R.L., Gagneja, H., Samuels, B.I., Smith, T.L. & Cabanillas, F.F. (2005) High rate of durable remissions after treatment of newly diagnosed aggressive mantle-cell lymphoma with rituximab plus hyper-CVAD alternating with rituximab plus high-dose methotrexate and cytarabine. Journal of Clinical Oncology, 23, 7013-7023.
30. Rummel, M.J., Al-Batran, S.E., Kim, S.Z., Welslau, M., Hecker, R., Kofahl-Krause, D., Josten, K.M., Durk, H., Rost, A., Neise, M., von Grunhagen, U., Chow, K.U., Hansmann, M.L., Hoelzer, D. & Mitrou, P.S. (2005) Bendamustine plus rituximab is effective and has a favorable toxicity profile in the treatment of mantle cell and low-grade non-Hodgkin's lymphoma. Journal of Clinical Oncology, 23, 3383-3389.
31. Salles, G., Seymour, J.F., Offner, F., Lopez-Guillermo, A., Belada, D., Xerri, L., Feugier, P., Bouabdallah, R., Catalano, J.V., Brice, P., Caballero, D., Haioun, C., Pedersen, L.M., Delmer, A., Simpson, D., Leppa, S., Soubeyran, P., Hagenbeek, A., Casasnovas, O., Intragumtornchai, T., Ferme, C., da Silva, M.G., Sebban, C., Lister, A., Estell, J.A., Milone, G., Sonet, A., Mendila, M., Coiffier, B. & Tilly, H. (2011) Rituximab maintenance for 2years in patients with high tumour burden follicular lymphoma responding to rituximab plus chemotherapy (PRIMA): a phase 3, randomised controlled trial. Lancet, 377, 42-51.
32. The Non-Hodgkin's Lymphoma Classification Project. (1997) A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. The Non-Hodgkin's Lymphoma Classification Project. Blood, 89, 3909-3918.
33. Ye, F. & Shyr, Y. (2007) Balanced two-stage designs for phase II clinical trials. Clincal Trials, 4, 514-524.