Phase i trial of bortezomib in combination with rituximab-HyperCVAD alternating with rituximab, methotrexate and cytarabine for untreated aggressive mantle cell lymphoma

British Journal of Haematology

Volumn 151, Issue 1, 2010, Pages 47-53

  Romaguera, Jorge E ^a,b   Fayad, Luis E ^a,b   McLaughlin, Peter ^a,b   Pro, Barbara ^a,b   Rodriguez, Alma ^a,b   Wang, Michael ^a,b   Weaver, Pamela ^a,b   Hartig, Kimberly ^a,b   Kwak, Larry W ^a,b   Feldman, Tatyana ^a,b   Smith, Judy ^a,b   Ford, Peggy ^a,b   Goldberg, Stuart ^a,b   Pecora, Andrew ^a,b   Goy, Andre ^a,b  

^a UNIVERSITY OF TEXAS   (United States)

^b HACKENSACK UNIVERSITY MEDICAL CENTER   (United States)

Author keywords

bortezomib; hyper CVAD; mantle cell lymphoma; toxicity

Indexed keywords

BORTEZOMIB; CYCLOPHOSPHAMIDE; CYTARABINE; DEXAMETHASONE; DOXORUBICIN; METHOTREXATE; RITUXIMAB; VINCRISTINE; ANTINEOPLASTIC AGENT; BORONIC ACID DERIVATIVE; MONOCLONAL ANTIBODY; PYRAZINE DERIVATIVE;

ADULT; AGED; ANEMIA; ANXIETY; ARTICLE; ATELECTASIS; BLOOD TOXICITY; BONE MARROW SUPPRESSION; BRADYCARDIA; CELLULITIS; CLINICAL ARTICLE; CLINICAL TRIAL; CLOSTRIDIUM DIFFICILE INFECTION; COLITIS; CONTROLLED STUDY; DEHYDRATION; DOSE RESPONSE; DRUG DOSE INCREASE; DRUG DOSE REDUCTION; DRUG SAFETY; DRUG WITHDRAWAL; DYSARTHRIA; FATIGUE; FEBRILE NEUTROPENIA; FEMALE; HUMAN; HYPERTENSION; INFECTION; LEUKOPENIA; LUNG TOXICITY; MALE; MANIA; MANTLE CELL LYMPHOMA; MAXIMUM TOLERATED DOSE; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; NEUROPATHY; NEUTROPENIA; PERICARDIAL EFFUSION; PHASE 1 CLINICAL TRIAL; PLEURA EFFUSION; PRIORITY JOURNAL; PSYCHOSIS; SENSORY NEUROPATHY; SIDE EFFECT; STOMATITIS; TACHYCARDIA; THROMBOCYTOPENIA; WOUND INFECTION; AGE; DRUG ADMINISTRATION; LYMPHOMA, MANTLE-CELL; MIDDLE AGED; MULTICENTER STUDY; PATHOLOGY;

ADULT; AGE FACTORS; AGED; ANTIBODIES, MONOCLONAL; ANTINEOPLASTIC COMBINED CHEMOTHERAPY PROTOCOLS; BORONIC ACIDS; CYCLOPHOSPHAMIDE; CYTARABINE; DEXAMETHASONE; DOXORUBICIN; DRUG ADMINISTRATION SCHEDULE; FEMALE; HUMANS; LYMPHOMA, MANTLE-CELL; MALE; METHOTREXATE; MIDDLE AGED; PYRAZINES; VINCRISTINE; ANTIBODIES, MONOCLONAL, MURINE-DERIVED;

EID: 77956853122     PISSN: 00071048     EISSN: 13652141     Source Type: Journal    
DOI: 10.1111/j.1365-2141.2010.08315.x     Document Type: Article

References (22)

1. Attar, E.C., Learner, E. Amrein, P.C. (2004) In vitro studies of bortezomib with daunorubicin and cytarabine: sequence of administration affects leukemia cell chemosensitivity. Blood (ASH Annual Meeting Abstracts), 104, 4464.
2. Cella, D.F., Tulsky, D.S., Gray, G., Sarafian, B., Linn, E., Bonomi, A., Silberman, M., Yellen, S.B., Winicour, P. Brannon, J. (1993) The functional assessment of cancer therapy (FACT) scale: development and validation of the general measure. Journal of Clinical Oncology, 11, 570 579.
3. Cloos, J., Vink, J., van Miltenburg, M., Oerlemans, R., van der Heijden, J., Dijkmans, B., Jansen, G. Kaspers, G. (2004) Sensitization of leukemic cells for glucocorticoids by inhibition of NFKB activation. Blood (ASH Annual Meeting Abstracts), 104, 3395.
4. 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.
5. Gotoh, A., Ohyashiki, K., Oshimi, K., Usui, N., Hotta, T., Dan, K. Ikeda, Y. (2006) Lung injury associated with bortezomib therapy in relapsed/refractory multiple myeloma in Japan: a questionnaire-based report from the "lung injury by bortezomib" Joint Committee of the Japanese Society of Hematology and the Japanese Society of Clinical Hematology. International Journal of Hematology, 84, 406 412.
6. Goy, A., Remache, Y., Barkoh, B., Jiang, Y., Hart, S. Gilles, F. (2004) Sensitivity, schedule-dependence and molecular effects of the proteasome inhibitor bortezomib in non-Hodgkin's lymphoma cells. Blood (ASH Annual Meeting Abstracts), 104, 1387.
7. Herrmann, A., Hoster, E., Zwingers, T., Brittinger, G., Engelhard, M., Meusers, P., Reiser, M., Forstpointner, R., Metzner, B., Peter, N., Wörmann, B., Trümper, 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.
8. Jaffe, E.S., Harris, N.L., Stein, H. Vardiman, J.W. (2001) World Health Organization Classification of Tumours: Pathology and Genetics of Turnouts of Haematopoietic and Lymphoid Tissues. IARC Press, Lyon.
9. Kahl, B.S., Li, H., Smith, M.R., Gascoyne, R.D., Paietta, E., 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 (ASH Annual Meeting Abstracts), 114, 1661.
10. Katz, R.L., Caraway, N.P., Gu, J., Jiang, F., Pasco-Miller, L., Glassman, A.B., Luthra, R., Hayes, K.J., Romaguera, J.E., Cabanillas, F.F. Medeiros, J. (2000) Detection of chromosome 11q13 breakpoints by interphase fluorescence in situ hybridization: a useful ancillary method for the diagnosis of mantle cell lymphoma. American Journal of Clinical Pathology, 114, 248 257.
11. Leonard, J.P., Furman, R.R., Cheung, Y.K.K., Feldman, E., Cho, H.O., Vose, J.M., Nichols, G., Glynn, P.W., Joyce, M.A., Ketas, J., Ruan, J., Carew, J., Niesvizky, R., LaCasce, A., Chadburn, A., Cesarman, E. Coleman, M. (2005) Phase I/II trial of bortezomib + CHOP-rituximab in diffuse large B cell (DLBCL) and mantle cell lymphoma (MCL): phase I results. Blood (ASH Annual Meeting Abstracts), 106, 491.
12. Luthra, R., Sarris, A.H., Hai, S., Paladugu, A.V., Romaguera, J.E., Cabanillas, F.F. Medeiros, L.J. (1999) Real-time 5 3 exonuclease-based PCR assay for detection of the (11; 14) (q13;q32). American Journal of Clinical Pathology, 112, 524 530.
13. Martin, P., Chadburn, A., Christos, P., Weil, K., Furman, R., Ruan, J., Elstrom, R., Niesvizky, R., Ely, S., DiLiberto, M., Melnick, A., Knowles, D., Chen-Kiang, S., Coleman, M. Leonard, J.P. (2009) Outcome of deferred initial therapy in mantle-cell lymphoma. Journal of Clinical Oncology, 27, 1209 1213.
14. Miyakoshi, S., Kami, M., Yuji, K., Matsumura, T., Takatoku, M., Sasaki, M., Narimatsu, H., Fujii, T., Kawabata, M., Taniguchi, S., Ozawa, K. Oshimi, K. (2006) Severe pulmonary complications in Japanese patients after bortezomib treatment for refractory multiple myeloma. Blood, 107, 3492 3494.
15. O'Connor, O., Toner, L., Smith, E., Srinivasan, S., Hernandez, F., Rolf, M., Frankel, S. Chanan-Khan, A. (2004) Combined targeting of the proteasome and Bcl-2 sensitizes human B-cell lymphoma and multiple myeloma to cyclophosphamide in vitro and in vivo models of these diseases. Blood (ASH Annual Meeting Abstracts), 104, 2484.
16. Ohri, A. Arena, F.P. (2006) Severe pulmonary complications in African-American patient after bortezomib therapy. American Journal of Therapeutics, 13, 553 555.
17. Oken, M.M., Creech, R.H., Tormey, D.C., Horton, J., Davis, T.E., McFadden, E.T. Carbone, P.P. (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. American Journal of Clinical Oncology, 5, 649 655.
18. 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., 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 retreatment 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.
19. Romaguera, J.E., Fayad, L., Rodriguez, A., Hagemeister, F.B., Pro, B., McLaughlin, P., Younes, A., Samaniego, F., Shah, J., Weaver, P., Hartig, K., Cabanillas, F., Kwak, L., Kantarjian, H. Wang, M. (2008) Rituximab (R) + HyperCVAD alternating with R-methotrexate/cytarabine after 9 Years: continued high rate of failure-free survival in untreated mantle cell lymphoma (MCL). Blood (ASH Annual Meeting Abstracts), 112, 833.
20. Smolewski, P., Duechler, M., Linke, A., Cebula, B., Grzybowska- Izydorczyk, O., Shehata, M. Robak, T. (2006) Additive cytotoxic effect of bortezomib in combination with anti-CD20 or anti-CD52 monoclonal antibodies on chronic lymphocytic leukemia cells. Leukemia Research, 30, 521 529.
21. Weigert, O., Pastore, A., Rieken, M., Lang, N., Hiddemann, W. Dreyling, M. (2007) Sequence-dependent synergy of the proteasome inhibitor bortezomib and cytarabine in mantle cell lymphoma. Leukemia, 21, 524 528.
22. Weigert, O., Weidmann, E., Mueck, R., Bentz, M., von Schilling, C., Rohrberg, R., Jentsch-Ullrich, K., Hiddemann, W. Dreyling, M. (2009) A novel regimen combining high dose cytarabine and bortezomib has activity in multiply relapsed and refractory mantle cell lymphoma - long-term results of a multicenter observation study. Leukemia & Lymphoma, 50, 716 722.