Bibliography
- THE NON-HODGKIN'S LYMPHOMA CLASSIFICATION PROJECT: A clinical evaluation of the International Lymphoma Study Group classification of non-Hodgkin's lymphoma. Blood (1997) 89:3909–3918.
- HORNING SJ: Natural history of and therapy for the indolent non-Hodgkin's lymphomas. Semin. Oncol. (1993) 20:75–88.
- GALLAGHER CJ, GREGORY WM, JONES AE et al: Follicular lymphoma: prognostic factors for response and survival. J. Clin. Oncol (1986) 4:1470–1480.
- JOHNSON PW, ROHATINER AZ, WHELAN J et al: Patterns of survival in patients with recurrent follicular lymphoma: a 20-year study from a single center. J. Clin. Oncol (1995) 13:140–147.
- MACMANUS MP, HOPPE RT: Is radiotherapy curative for stage I and II low-grade follicular lymphoma? Results of a long-term follow-up study of patients treated at Stanford University. J. Clin. Oncol (1996) 14:1282–1290.
- BRICE P, BASTION Y, LEPAGE E et al.:Comparison in low-tumor-burden follicular lymphomas between an initial no-treatment policy, prednimustine, or interferon alfa: a randomized study from the Groupe d'Etude des Lymphomes Folliculaires. Groupe d'Etude des Lymphomes de l'Adulte. Clin. Oncol. (1997) 15:1110–1117.
- ARDESHNA KM, SMITH P, NORTON A et al.: Long-term effect of a watch and wait policy versus immediate systemic treatment for asymptomatic advanced-stage non-Hodgkin lymphoma: a randomised controlled trial. Lancet (2003) 362:516–522.
- ADVANI R, ROSENBERG SA, HORNING SJ: Stage I and II follicular non-Hodgkin's lymphoma: long-term follow-up of no initial therapy. J. Clin. Oncol (2004) 22:1454–1459.
- HORNING SJ: Follicular lymphoma: have we made any progress? Ann. Oncol (2000) 11 (Suppl. 1):23–27.
- CABANILLAS F, HORNING S, KAMINSKI M, CHAMPLIN R: Managing indolent lymphomas in relapse: working our way through a plethora of options. Hematol (Am. Soc. Hematol Educ. Program) (2000):166–179.
- SOLAL-CELIGNY P, ROY P, COLOMBAT P et al.: Follicular lymphoma international prognostic index. Blood (2004) 104:1258–1265.
- DAVE SS, WRIGHT G, TAN B et al.: Prediction of survival in follicular lymphoma based on molecular features of tumor-infiltrating immune cells. N Engl. J. Med. (2004) 351:2159–2169.
- STASHENKO P, NADLER LM, HARDY R, SCHLOSSMAN SF: Characterization of a human B lymphocyte-specific antigen. J. Immunol (1980) 125:1678–1685.
- EINFELD DA, BROWN JP, VALENTINE MA, CLARK EA, LEDBETTER JA: Molecular cloning of the human B cell CD20 receptor predicts a hydrophobic protein with multiple transmembrane domains. EMBO J. (1988) 7:711–717.
- TEDDER TF, STREULI M, SCHLOSSMAN SF, SAITO H: Isolation and structure of a cDNA encoding the B1 (CD20) cell-surface antigen of human B lymphocytes. Proc. Natl Acad. Sci. USA (1988) 85:208–212.
- BUBIEN JK, ZHOU LJ, BELL PD, FRIZZELL RA, TEDDER TF: Transfection of the CD20 cell surface molecule into ectopic cell types generates a Ca2+ conductance found constitutively in B lymphocytes. J. Cell Biol. (1993) 121:1121–1132.
- LI H, AYER LM, LYTTON J, DEANS JP: Store-operated cation entry mediated by CD20 in membrane rafts. J. Biol. Chem. (2003) 278:42427–42434.
- ANDERSON KC, BATES MP, SLAUGHENHOUPT BL, PINKUS GS, SCHLOSSMAN SF, NADLER LM: Expression of human B cell-associated antigens on leukemias and lymphomas: a model of human B cell differentiation. Blood (1984) 63:1424–1433.
- MCLAUGHLIN P, GRILLO-LOPEZ AJ, LINK BK et al.: Rituximab chimeric anti-CD20 monoclonal antibody therapy for relapsed indolent lymphoma: half of patients respond to a four-dose treatment program. J. Clin. Oncol (1998) 16:2825–2833.
- HIDDEMANN W, DREYLING MH, FORSTPOINTNER R et al.: Combined immuno-chemotherapy (R-CHOP) significantly improves time to treatment failure in first line therapy of follicular lymphoma results of a prospective randomized trial of the German Low Grade Lymphoma Study Group (GLSG). Blood (2003) 102:104a (abstract).
- 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.
- MARCUS R, IMRIE K, BELCH A et al.:CVP chemotherapy plus rituximab compared with CVP as first-line treatment for advanced follicular lymphoma. Blood (2004) 105(4):1417–1423.
- TEDDER TF, FORSGREN A, BOYD AW, NADLER LM, SCHLOSSMAN SF: Antibodies reactive with the B1 molecule inhibit cell cycle progression but not activation of human B lymphocytes. Eur. J. Immunol (1986) 16:881–887.
- BUCHSBAUM DJ, WAHL RL, NORMOLLE DP, KAMINSKI MS: Therapy with unlabeled and 131I-labeled pan-B-cell monoclonal antibodies in nude mice bearing Raji Burkitt's lymphoma xenografts. Cancer Res. (1992) 52:6476–6481.
- SHAN D, LEDBETTER JA, PRESS OW:Apoptosis of malignant human B cells by ligation of CD20 with monoclonal antibodies. Blood (1998) 91: 1644-1652.
- CRAGG MS, GLENNIE MJ: Antibody specificity controls in vivo effector mechanisms of anti-CD20 reagents. Blood (2004) 103:2738–2743.
- SHAN D, LEDBETTER JA, PRESS OW:Signaling events involved in anti-CD20-induced apoptosis of malignant human B cells. Cancer Immunol Immunother. (2000) 48:673–683.
- DAVIS TA, KAMINSKI MS, LEONARD JP et al.: The radioisotope contributes significantly to the activity of radioimmunotherapy. Clin. Cancer Res. (2004) 10:7792–7798.
- •Randomised trial of unlabelled tositumomab versus tositumomab and 1131 tositumomab.
- FRAKER PJ, SPECK JC JR: Protein andcell membrane iodinations with a sparingly soluble chloroamide, 1,3,4,6-tetrachloro-3a,6a-diphrenylglycoluril. Biochem. Biophys. Res. Commun. (1978) 80:849–857.
- O'DONOGHUE J, BARDIES M, WHELDON T: Relationships between tumor size and curability for uniformly targeted therapy with beta-emitting radionuclides. J. Nucl. Med. (1995) 36:1902–1909.
- KASSIS A, ADELSTEIN S: Considerationsin the selection of Radionuclides for cancer therapy. In: Handbook of Radiopharmaceuticals: Radiochemistry and Applications. Welch M, Redvanly C (Eds), John Wiley Publishers, West Sussex, UK (2003):767–793.
- GLAXOSMITHKLINE: GlaxoSmithKline Announces Expanded Indication for Bexxar in Non-Hodgkin's Lymphoma. (2005) Press Release.
- KAMINSKI MS, ZASADNY KR, FRANCIS IR et al.: Radioimmunotherapy of B-cell lymphoma with [131I]anti-B1 (anti-CD20) antibody. N Engl. J. Med. (1993) 329:459–465.
- BUCHSBAUM DJ, WAHL RI,, GLENN SD, NORMOLLE DP, KAMINSKI MS: Improved delivery of radiolabeled anti-B1 monoclonal antibody to Raji lymphoma xenografts by predosing with unlabeled anti-B1 monoclonal antibody. Cancer Res. (1992) 52:637–642.
- KAMINSKI MS, ZASADNY KR, FRANCIS IR et al.: Iodine-131-anti-B1 radioimmunotherapy for B-cell lymphoma. Clin. Oncol. (1996) 14:1974–1981.
- MONES J, COLEMAN M, KOSTAKOGLU Let al.: A dose-escalation study of tositumomab and iodine I 131 tositumomab (Bexxar) in pts with previously treated non-Hodgkin's lymphoma (NHL) with 25% bone marrow involvement. Proc. Am. Soc. Clin. Oncol (2004) 23:574 (abstract).
- SIEGEL JA: Revised Nuclear Regulatory Commission regulations for release of patients administered radioactive materials: outpatient iodine-131 anti-Bl therapy. Nud Med. (1998) 39:28S–33S.
- WAHL RL: The clinical importance of dosimetry in radioimmunotherapy with tositumomab and iodine 1131 tositumomab. Semin. Oncol (2003) 30:31–38.
- GOLDSMITH SJ, KAMINSKI M, WAHL RL et al.: Dosimetry optimizes radiolabelled antibody dosing in patients with non-Hodgkin's lymphoma. Proc. Am. Soc. Clin. Oncol (2001) 19:1140 (abstract).
- KAMINSKI MS, ESTES J, ZASADNY KR et al.: Radioimmunotherapy with iodine (131)I tositumomab for relapsed or refractory B-cell non-Hodgkin lymphoma: updated results and long-term follow-up of the University of Michigan experience. Blood (2000) 96:1259–1266.
- ••Complete data and long-term follow-up ofthe Phase I/II study from a single centre.
- WAHL RL: Iodine-131 anti-Bl antibody therapy in non-Hodgkin's lymphoma: dosimetry and clinical implications. J. Nud Med. (1998) 39:1S.
- VOSE JM, WAHL RL, SALEH M et al.: Multicenter Phase II study of iodine-131 tositumomab for chemotherapy-relapsed/ refractory low-grade and transformed low-grade B-cell non-Hodgkin's lymphomas. Clin. Oncol (2000) 18:1316–1323.
- •First multi-centre study, demonstrates reproducibility of dosimetric methodology.
- KAMINSKI MS, ZELENETZ AD, PRESS OW et al: Pivotal study of iodine I 131 tositumomab for chemotherapy-refractory low-grade or transformed low-grade B-cell non-Hodgkin's lymphomas. J. Clin. Oncol (2001) 19:3918–3928.
- ••Pivotal study using patient as own control.Demonstrates that many patients have a longer duration of remission following tositumomab and 1131 tositumomab than from their previous chemotherapeutic regimen.
- KAMINSKI M, ZELENETZ A, PRESS OW et al.: Tositumomab and iodine 1131 tositumomab (the BEXXAR therapeutic regimen) produced ongoing, durable remissions of more than 4 years in 9 patients with non-Hodgkin's lymphoma (NHL) in a pivotal study of patients refractory to their last chemotherapy. Blood (2004) 104:720a (abstract).
- DAVIES AJ, ROHATINER AZ, HOWELL S et al: Tositumomab and iodine 1131 tositumomab for recurrent indolent and transformed B-cell non-Hodgkin's lymphoma. J. Clin. Oncol (2004) 22:1469–1479.
- LEONARD J, FRENETT G, DILLMAN RO, GREGORY SA: Interim safety and efficacy results of Bexxari'm in a large multicenter expanded access study. Blood (2001) 98:133a (abstract).
- ARMITAGE JO, LEONARD J, GREGORY SA et al.: The effectiveness of tositumomab and iodine I 131 tositumomab in relapsed/refractory follicular grade 1/2 and small lymphocytic non-Hodgkin's lymphoma (NHL). Proc. Am. Soc. Clin. Oncol. (2004) 23:573 (abstract).
- HORNING SJ, YOUNES A. JAIN V et al.: Efficacy and safety of tositumomab and iodine-131 tositumomab (Bexxar) in B-cell lymphoma, progressive after rituximab. J. Clin. Oncol (2004) 23(4):712–719.
- •Recent analysis of rituicimab-refractory patients.
- COLEMAN M, KAMINSKI M, KNOX SJ, ZELENETZ AD, VOSE JM: The BEXXAR therapeutic regimen (tositumomab and iodine 1131 tositumomab) produced durable complete remissions in heavily pretreated patients with non-Hodgkins lymphoma (NHL), rituximab-relapseci/refractory disease, and rituximab-naive disease. Blood (2003) 102:29a (abstract).
- LEONARD J, ZELENETZ A, VOSE JM, KAMINSKI M: Impact of course of therapy on response rate and duration with the Bexxar therapeutic regimen (tositumomab and iodine 1131 tositumomab) and with chemotherapy. Blood (2004) 104:41a (abstract).
- ARMITAGE JO, DICK FR, CORDER MP: Diffuse histiocytic lymphoma after histologic conversion: a poor prognostic variant. Cancer Treat. Rep. (1981) 65:413–418.
- ZELENETZ AD, SALEH M, VOSE JM, YOUNES A. KAMINSKI M: Patients with transformed low grade lymphoma attain durable responses following outpatient radioimmunotherapy with tositumomab and iodine 1131 tositumomab [Bexxar®]. Blood (2002) 100:357a (abstract).
- KAMINSKI MS, TUCK M, ESTES J et al.: 131I-tositumomab therapy as initial treatment for follicular lymphoma. N Engl. J. Med. (2005) 352(5):441–449.
- BENNETT JM, KAMINSKI M, KNOX SJ et al.: Assessment of treatment-related myelodysplastic syndromes (tMDS) and acute myeloid leukemia (tAML) in patients with low-grade non-Hodgkins lymphoma (LG-NHL) treated with tositumomab and iodine-131 tositumomab (the BEXXAR therapeutic regimen). Blood (2003) 102:30a (abstract).
- KAMINSKI M, KNOX SJ, RADFORD JA, GREGORY SA, LEONARD J: Re-treatment with tositumomab and iodine 1131 tositumomab (the BEXXAR therapeutic regimen) in patients with non-Hodgkins lymphoma (NHL) with a previous response to the BEXXAR therapeutic regimen. Blood (2003) 102:407a (abstract).
- CZUCZMAN MS, GRILLO-LOPEZ AJ, WHITE CA et al.: of patients with low-grade B-cell lymphoma with the combination of chimeric anti-CD20 monoclonal antibody and CHOP chemotherapy. J. Clin. Oncol. (1999) 17:268–276.
- LEONARD J, COLEMAN M, KOSTAKOGLU Let al.: Durable remissions from fluciarabine followed by the iodine I-131 tositumomab Bexxar therapeutic regimen for patients with previously untreated follicular non-Hodgkin's lymphoma (NHL). Proc. Am. Soc. Clin. Oncol. (2004) 23:560 (abstract).
- LINK B, KAMINSKI M, COLEMAN M, LEONARD J: Phase II study of CVP followed by tositumomab and iodine 1131 tositumomab (Bexxar therapeutic regimen) in patients with untreated follicular non-Hodgkin's lymphoma (NHL). Proc. Am. Soc. Clin. Oncol. (2004) 23:560 (abstract).
- ZELENETZ AD, DONNELLY G, HALAAS J et al.: Initial treatment of mantle cell lymphoma with sequential radioimmunotherapy with tositumoamb/ iodine 1131 I-tositumoamb followed by CHOP chemotherapy results in a high complete remission rate. Blood (2003) 102:406a (abstract).
- PRESS OW, EARY JF, APPELBAUM FR et al.: Radiolabeled-antibody therapy of B-cell lymphoma with autologous bone marrow support. N Engl. J. Med. (1993) 329:1219–1224.
- PRESS OW, EARY JF, APPELBAUM FR et al: Phase II trial of 131I-B1 (anti-CD20) antibody therapy with autologous stem cell transplantation for relapsed B cell lymphomas. Lancet (1995) 346:336–340.
- GOPAL AK, GOOLEY TA, MALONEY DG et al.: High-dose radioimmunotherapy versus conventional high-dose therapy and autologous hematopoietic stern cell transplantation for relapsed follicular non-Hodgkin lymphoma: a multivariable cohort analysis. Blood (2003) 102:2351–2357.
- PRESS OW, EARY JF, GOOLEY T et al.: A Phase I/II trial of iodine-131-tositumomab (anti-CD20), etoposide, cyclophosphamide, and autologous stern cell transplantation for relapsed B-cell lymphomas. Blood (2000) 96:2934–2942.
- VOSE JM, BIERMAN PJ, ENKE C et al.:Phase I trial of iodine-131 tositumomab with high-dose chemotherapy and autologous stern-cell transplantation for relapsed non-Hodgkin's lymphoma. J. Clin. Oncol (2004) 23(3):461–467.
- GLAXOSMITHKLINE: BEXXAR® Prescribing Information (2005).
- GREGORY SA, ZELENETZ AD, KNOX SJ, VOSE JM, MAGNUSON, KAMINSKI MS: BexxarTm is an effective and well tolerated therapy in elderly patients with non-Hodgkin's lymphoma (NHL). Proc. Am. Soc. Clin. Oncol. (2001) 20:285a (abstract).
- ARMITAGE JO, CARBONE PP, CONNORS JM, LEVINE A, BENNETT JM, KROLL S: Treatment-related myelodysplasia and acute leukemia in non-Hodgkin's lymphoma patients. J. Clin. Oncol. (2003) 21:897–906.
- GREGORY SA, LEONARD J, KNOX SJ, ZELENETZ AD, ARMITAGE JO, KAMINSKI M: The iodine 1–131 tositumomab therapeutic regimen: summary of safety in 995 patients with relapsed/refractory low grade (LG) and transformed LG non-Hodgkin's lymphoma (NHL). Proc. Am. Soc. Clin. Oncol (2004) 23:613 (abstract).
- KAMINSKI MS, TUCK M, FANG Y, COLCHER D, VALENTE NK, NIEDER M: Development of HAMA after BexxarTm does not preclude treatment with rituximab. Blood (2000) 96:734a (abstract).
- VALENTE NK, KAMINSKI M, KNOX SJ et al.: Subsequent therapy can be administered following treatment with iodine 131 anti-B1 antibody in patients with non-Hodgkin's lymphoma. Ann. Oncol (1999) 10:33 (abstract).
- RATANATHARATHORN V UBERTI JP, AYASH L, ESTES J, SILVERS, KAMINSKI MS: Haematopoietic stem cell transplantation in lymphoma patients receiving prior therapy with tositumomab and iodine P31 tositumomab (BexxarTm). Blood (2001) 98:200a (abstract).
- KAMINSKI MS, BAHM V ESTES J, RATANATHARATHORN V: Tolerance of treatment subsequent to frontline BexxarTm (tositumomab and I 131 tositumomab) in patients with follicular lymphoma. Blood (2001) 98:603a (abstract).
- CHESON BD: Some like it hot! J. Clin. Oncol (2001) 19:3908–3911.
- DILLMAN RO: Radiolabeled anti-CD20 monoclonal antibodies for the treatment of B-cell lymphoma. J. Clin. Oncol (2002) 20:3545–3557.
- CHESON BD: Radioimmunotherapy of non-Hodgkin lymphomas. Blood (2003) 101:391–398.
- •Comprehensive review of radioimmunotherapy of non-Hodgkin's lymphomas.
- CORIXA CORPORARTION: Corbca announces sale and transfer of BEXXAR development and marketing rights to GlaxoSmithKline. (2004). Press Release.
- SCHOUTEN HC, QIAN W, KVALOY S et al.: High-dose therapy improves progression-free survival and survival in relapsed follicular non-Hodgkin's lymphoma: results from the randomized European CUP trial. J. Clin. Oncol (2003) 21:3918–3927.
- KHOURI IF, SALIBA RM, GIRALT SA et al.: Nonablative allogeneic hematopoietic transplantation as adoptive immunotherapy for indolent lymphoma: low incidence of toxicity, acute graft-versus-host disease, and treatment-related mortality. Blood (2001) 98:3595–3599.
- 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.
- WITZIG TE, FLINN IW, 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.
- -WISEMAN GA, GORDON LI, MULTANI PS et al.: Ibritumomab tiuxetan radioimmunotherapy for patients with relapsed or refractory non-Hodgkin lymphoma and mild thrombocytopenia: a Phase II multicenter trial. Blood (2002) 99:4336–4342.
- 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 (2002) 20:2453–2463.
- VOSE JM, LINK BK, GROSSBARD ML et al.: Phase II study of rituximab in combination with chop chemotherapy in patients with previously untreated, aggressive non-Hodgkin's lymphoma. Clin. Oncol. (2001) 19:389–397.
Websites
- http://www.fda.gov/ohrms/dockets/ac/02/ briefing/3916b1.htm Corixa Corp.: Oncology Drugs Advisory Committee Briefing Document. Iodine 1131 tositumomab (2002).