Risks and untoward toxicities of antibody-based immunoconjugates

Advanced Drug Delivery Reviews

Volumn 64, Issue 15, 2012, Pages 1782-1799

  Litvak Greenfeld, Dana ^a   Benhar, Itai ^a  

^a TEL AVIV UNIVERSITY   (Israel)

Author keywords

Adverse events; Antibody drug conjugates; Immunotoxins; Monoclonal antibody; Radioimmunoconjugates; Targeted therapy; Toxicity

Indexed keywords

ADVERSE EVENTS; ANTIBODY-DRUG CONJUGATES; IMMUNOTOXINS; RADIOIMMUNOCONJUGATES; TARGETED THERAPY;

MOLECULES; MONOCLONAL ANTIBODIES;

TOXICITY;

ANTIBODY; ANTIBODY CONJUGATE; ANTINEOPLASTIC AGENT; BL 22; BR 96 DOXORUBICIN CONJUGATE; BRENTUXIMAB VEDOTIN; CAT 5001; CMB 401; DAUNORUBICIN; DENILEUKIN DIFTITOX; DOCETAXEL; ERB 38; GEMTUZUMAB OZOGAMICIN; IBRITUMOMAB TIUXETAN; IMMUNOTOXIN; IMMUNOTOXIN LMB2; INOTUZUMAB OZOGAMICIN; IODINE RITUXUMAB I 131; LEVOTHYROXINE; LMB 7; LMB 9; MOXETUMOMAB PASUDOTOX; RADIOIMMUNOCONJUGATE; RADIOPHARMACEUTICAL AGENT; RITUXIMAB; SGN 10; SS 1; SS 1P; THYROXINE; TOSITUMOMAB I 131; TRASTUZUMAB EMTANSINE; UNCLASSIFIED DRUG; UNINDEXED DRUG;

ABDOMINAL PAIN; ACUTE GRANULOCYTIC LEUKEMIA; ACUTE HEART INFARCTION; ACUTE LYMPHOBLASTIC LEUKEMIA; ADENOCARCINOMA; ADVANCED CANCER; ALLERGIC REACTION; AMYLASE BLOOD LEVEL; ANEMIA; ANOREXIA; ARTHRALGIA; ASCITES; ASTHENIA; BACKACHE; BLEEDING; BLOOD TOXICITY; BLURRED VISION; BONE MARROW SUPPRESSION; BONE PAIN; BRAIN HEMORRHAGE; BREAST CANCER; CANCER FATIGUE; CANCER PAIN; CARCINOMA; CARDIOMYOPATHY; CARDIOTOXICITY; CATHETER INFECTION; CAUSE OF DEATH; CHEMOTHERAPY INDUCED ANEMIA; CHEMOTHERAPY INDUCED EMESIS; CHEMOTHERAPY INDUCED NAUSEA AND VOMITING; CHILL; CHRONIC LYMPHATIC LEUKEMIA; CHRONIC PANCREATITIS; CONJUNCTIVITIS; COUGHING; CUTANEOUS T CELL LYMPHOMA; DEEP VEIN THROMBOSIS; DIARRHEA; DISEASE ASSOCIATION; DRUG APPROVAL; DRUG DOSE ESCALATION; DRUG DOSE REDUCTION; DRUG EFFICACY; DRUG ERUPTION; DRUG FATALITY; DRUG INDUCED HEADACHE; DRUG MECHANISM; DRUG RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; DRUG TREATMENT FAILURE; DRUG WITHDRAWAL; DRY EYE; DYSPNEA; EDEMA; EPIPHORA; EPISTAXIS; ESOPHAGUS CANCER; EVENT FREE SURVIVAL; EYE DISEASE; FEBRILE NEUTROPENIA; FEVER; FOOD AND DRUG ADMINISTRATION; GASTRITIS; GASTROINTESTINAL SYMPTOM; GASTROINTESTINAL TOXICITY; HAIRY CELL LEUKEMIA; HEART FAILURE; HEMATURIA; HEMOLYSIS; HEMOLYTIC UREMIC SYNDROME; HEMORRHOID HEMORRHAGE; HEPATOSPLENOMEGALY; HODGKIN DISEASE; HUMAN; HYPERBILIRUBINEMIA; HYPERTENSION; HYPOALBUMINEMIA; HYPOALBUNIMIA; HYPOKALEMIA; HYPOTENSION; HYPOTHYROIDISM; HYPOXIA; IMMUNOTOXICITY; INFECTION; INFUSION RELATED REACTION; KIDNEY FAILURE; LARGE CELL LYMPHOMA; LEG EDEMA; LIVER FAILURE; LIVER TOXICITY; LIVER VEIN OBSTRUCTION; LOADING DRUG DOSE; LUNG CANCER; LUNG EDEMA; LUNG HEMORRHAGE; LYMPHOCYTOPENIA; LYMPHOMA; MALIGNANT NEOPLASTIC DISEASE; MANTLE CELL LYMPHOMA; MESOTHELIOMA; METASTASIS; MOLECULAR DYNAMICS; MOTOR NEUROPATHY; MOUTH PAIN; MOUTH ULCER; MUCOSA INFLAMMATION; MULTIPLE CYCLE TREATMENT; MYALGIA; MYELODYSPLASTIC SYNDROME; NAUSEA; NAUSEA AND VOMITING; NEPHROTOXICITY; NEUTROPENIA; NONHODGKIN LYMPHOMA; NOSE OBSTRUCTION; OVARY CANCER; OVERALL SURVIVAL; PANCREAS CANCER; PERICARDIAL EFFUSION; PERIORBITAL EDEMA; PERIPHERAL NEUROPATHY; PERITONITIS; PLEURA EFFUSION; PLEURISY; PNEUMONIA; PRIORITY JOURNAL; PROTEINURIA; PRURITUS; RECTUM HEMORRHAGE; REVIEW; RIGOR; RISK ASSESSMENT; SEPSIS; SIDE EFFECT; STOMATITIS; SUBDURAL HEMATOMA; SUPERFICIAL THROMBOPHLEBITIS; T CELL LEUKEMIA; THIRST; THORAX PAIN; THROAT IRRITATION; THROMBOCYTOPENIA; THROMBOSIS; THYROTOXICOSIS; UPPER GASTROINTESTINAL BLEEDING; UREA NITROGEN BLOOD LEVEL; URTICARIA; VASCULAR DISEASE; VASCULAR LEAK SYNDROMDE; VASCULAR LEAK SYNDROME; VEIN THROMBOSIS; VISUAL IMPAIRMENT; WEIGHT GAIN; WHEEZING;

ANIMALS; ANTIBODIES, MONOCLONAL; DRUG DELIVERY SYSTEMS; DRUG DESIGN; HUMANS; IMMUNOCONJUGATES; IMMUNOTOXINS;

EID: 84869164607     PISSN: 0169409X     EISSN: 18728294     Source Type: Journal    
DOI: 10.1016/j.addr.2012.05.013     Document Type: Review

References (231)

1. Winau F., Westphal O., Winau R. Paul Ehrlich - in search of the magic bullet. Microbes Infect. 2004, 6(8):786-789.
2. Strebhardt K., Ullrich A. Paul Ehrlich's magic bullet concept: 100years of progress. Nat. Rev. Cancer 2008, 8(6):473-480.
3. Kohler G., Milstein C. Continuous cultures of fused cells secreting antibody of predefined specificity. Nature 1975, 256(5517):495-497.
4. Reichert J.M., et al. Monoclonal antibody successes in the clinic. Nat. Biotechnol. 2005, 23(9):1073-1078.
5. FDA approved monoclonal antibodies (mAbs) for cancer therapy Available from:. http://lifesciencedigest.com/2011/03/05/fda-approved-mabs-for-cancer-therapy/.
6. Wu A.M., Senter P.D. Arming antibodies: prospects and challenges for immunoconjugates. Nat. Biotechnol. 2005, 23(9):1137-1146.
7. Kovtun Y.V., Goldmacher V.S. Cell killing by antibody-drug conjugates. Cancer Lett. 2007, 255(2):232-240.
8. Chari R.V. Targeted cancer therapy: conferring specificity to cytotoxic drugs. Acc. Chem. Res. 2008, 41(1):98-107.
9. Morton D.L., et al. Demonstration of antibodies against human malignant melanoma by immunofluorescence. Surgery 1968, 64(1):233-240.
10. Old L.J. Cancer immunology: the search for specificity - G. H. A. Clowes Memorial lecture. Cancer Res. 1981, 41(2):361-375.
11. Dillman R.O. Monoclonal antibodies in the treatment of cancer. Crit. Rev. Oncol. Hematol. 1984, 1(4):357-385.
12. Boven E., Pinedo H.M. Monoclonal antibodies in cancer treatment: where do we stand after 10years?. Radiother. Oncol. 1986, 5(2):109-117.
13. Kipriyanov S.M., Little M. Generation of recombinant antibodies. Mol. Biotechnol. 1999, 12(2):173-201.
14. Reichert J.M. Antibody-based therapeutics to watch in 2011. MAbs 2011, 3(1):76-99.
15. Reichert J.M. Metrics for antibody therapeutics development. MAbs 2010, 2(6):695-700.
16. Pastan I., et al. Immunotoxin treatment of cancer. Annu. Rev. Med. 2007, 58:221-237.
17. Sharkey R.M., Goldenberg D.M. Perspectives on cancer therapy with radiolabeled monoclonal antibodies. J. Nucl. Med. 2005, 46(Suppl. 1):115S-127S.
18. Garnett M.C. Targeted drug conjugates: principles and progress. Adv. Drug Deliv. Rev. 2001, 53(2):171-216.
19. Saijo N. What are the reasons for negative phase III trials of molecular-target-based drugs?. Cancer Sci. 2004, 95(10):772-776.
20. Dubowchik G.M., Walker M.A. Receptor-mediated and enzyme-dependent targeting of cytotoxic anticancer drugs. Pharmacol. Ther. 1999, 83(2):67-123.
21. Pietersz G.A., et al. Chemoimmunoconjugates for the treatment of cancer. Adv. Immunol. 1994, 56:301-387.
22. Damle N.K. Tumour-targeted chemotherapy with immunoconjugates of calicheamicin. Expert Opin. Biol. Ther. 2004, 4(9):1445-1452.
23. Damle N.K., Frost P. Antibody-targeted chemotherapy with immunoconjugates of calicheamicin. Curr. Opin. Pharmacol. 2003, 3(4):386-390.
24. Doronina S.O., et al. Development of potent monoclonal antibody auristatin conjugates for cancer therapy. Nat. Biotechnol. 2003, 21(7):778-784.
25. Francisco J.A., et al. cAC10-vcMMAE, an anti-CD30-monomethyl auristatin E conjugate with potent and selective antitumor activity. Blood 2003, 102(4):1458-1465.
26. Lopus M., et al. Maytansine and cellular metabolites of antibody-maytansinoid conjugates strongly suppress microtubule dynamics by binding to microtubules. Mol. Cancer Ther. 2010, 9(10):2689-2699.
27. Zein N., et al. Calicheamicin gamma 1I: an antitumor antibiotic that cleaves double-stranded DNA site specifically. Science 1988, 240(4856):1198-1201.
28. Lopus M. Antibody-DM1 conjugates as cancer therapeutics. Cancer Lett. 2011, 307(2):113-118.
29. Maiese W.M., et al. Calicheamicins, a novel family of antitumor antibiotics: taxonomy, fermentation and biological properties. J. Antibiot. (Tokyo) 1989, 42(4):558-563.
30. Pettit G.R., et al. Antineoplastic agents 337. Synthesis of dolastatin 10 structural modifications. Anticancer Drug Des. 1995, 10(7):529-544.
31. Ducry L., Stump B. Antibody-drug conjugates: linking cytotoxic payloads to monoclonal antibodies. Bioconjug. Chem. 2010, 21(1):5-13.
32. Toki B.E., et al. Protease-mediated fragmentation of p-amidobenzyl ethers: a new strategy for the activation of anticancer prodrugs. J. Org. Chem. 2002, 67(6):1866-1872.
33. Dubowchik G.M., et al. Doxorubicin immunoconjugates containing bivalent, lysosomally-cleavable dipeptide linkages. Bioorg. Med. Chem. Lett. 2002, 12(11):1529-1532.
34. Willner D., et al. (6-Maleimidocaproyl)hydrazone of doxorubicin - a new derivative for the preparation of immunoconjugates of doxorubicin. Bioconjug. Chem. 1993, 4(6):521-527.
35. Kaneko T., et al. New hydrazone derivatives of adriamycin and their immunoconjugates - a correlation between acid stability and cytotoxicity. Bioconjug. Chem. 1991, 2(3):133-141.
36. Doronina S.O., et al. Enhanced activity of monomethylauristatin F through monoclonal antibody delivery: effects of linker technology on efficacy and toxicity. Bioconjug. Chem. 2006, 17(1):114-124.
37. Senter P.D. Potent antibody drug conjugates for cancer therapy. Curr. Opin. Chem. Biol. 2009, 13(3):235-244.
38. Bross P.F., et al. Approval summary: gemtuzumab ozogamicin in relapsed acute myeloid leukemia. Clin. Cancer Res. 2001, 7(6):1490-1496.
39. Cefalo M.G., et al. Hepatic veno-occlusive disease: a chemotherapy-related toxicity in children with malignancies. Paediatr. Drugs 2010, 12(5):277-284.
40. Ho V.T., et al. Hepatic veno-occlusive disease after hematopoietic stem cell transplantation: review and update on the use of defibrotide. Semin. Thromb. Hemost. 2007, 33(4):373-388.
41. Lee J.J., Swain S.M. Peripheral neuropathy induced by microtubule-stabilizing agents. J. Clin. Oncol. 2006, 24(10):1633-1642.
42. Swain S.M., Arezzo J.C. Neuropathy associated with microtubule inhibitors: diagnosis, incidence, and management. Clin. Adv. Hematol. Oncol. 2008, 6(6):455-467.
43. Jordan M.A., Wilson L. Microtubules as a target for anticancer drugs. Nat. Rev. Cancer 2004, 4(4):253-265.
44. McKnight J.A. Principles of chemotherapy. Clin. Tech. Small Anim. Pract. 2003, 18(2):67-72.
45. Bartelds G.M., et al. Development of antidrug antibodies against adalimumab and association with disease activity and treatment failure during long-term follow-up. JAMA 2011, 305(14):1460-1468.
46. Foyil K.V. Extended retreatment with brentuximab vedotin (SGN-35) maintains complete remission in patient with recurrent systemic anaplastic large-cell lymphoma. Leuk. Lymphoma 2011, 53(3):506-507.
47. Sagawa A. The efficacy and safety of reinstitution of tocilizumab in patients with relapsed active rheumatoid arthritis after long-term withdrawal of tocilizumab: retreatment of patients with rheumatoid arthritis with novel anti-IL-6 receptor antibody after a long-term interval following SAMURAI: the RONIN study. Mod. Rheumatol. 2011, 21(4):352-358.
48. Rutgeerts P., et al. Efficacy and safety of retreatment with anti-tumor necrosis factor antibody (infliximab) to maintain remission in Crohn's disease. Gastroenterology 1999, 117(4):761-769.
49. Koh L.P., Lim L.C., Thng C.H. Retreatment with chimeric CD 20 monoclonal antibody in a patient with nodal marginal zone B-cell lymphoma. Med. Oncol. 2000, 17(3):225-228.
50. Hamann P.R., et al. An anti-CD33 antibody-calicheamicin conjugate for treatment of acute myeloid leukemia. Choice of linker. Bioconjug. Chem. 2002, 13(1):40-46.
51. Andrews R.G., Singer J.W., Bernstein I.D. Precursors of colony-forming cells in humans can be distinguished from colony-forming cells by expression of the CD33 and CD34 antigens and light scatter properties. J. Exp. Med. 1989, 169(5):1721-1731.
52. Hamann P.R., et al. Gemtuzumab ozogamicin, a potent and selective anti-CD33 antibody-calicheamicin conjugate for treatment of acute myeloid leukemia. Bioconjug. Chem. 2002, 13(1):47-58.
53. Walker S., et al. Cleavage behavior of calicheamicin gamma 1 and calicheamicin T. Proc. Natl. Acad. Sci. U. S. A. 1992, 89(10):4608-4612.
54. Larson R.A., et al. Antibody-targeted chemotherapy of older patients with acute myeloid leukemia in first relapse using Mylotarg (gemtuzumab ozogamicin). Leukemia 2002, 16(9):1627-1636.
55. Sievers E.L. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukaemia in first relapse. Expert Opin. Biol. Ther. 2001, 1(5):893-901.
56. Sievers E.L., et al. Selective ablation of acute myeloid leukemia using antibody-targeted chemotherapy: a phase I study of an anti-CD33 calicheamicin immunoconjugate. Blood 1999, 93(11):3678-3684.
57. Sievers E.L., et al. Efficacy and safety of gemtuzumab ozogamicin in patients with CD33-positive acute myeloid leukemia in first relapse. J. Clin. Oncol. 2001, 19(13):3244-3254.
58. Wadleigh M., et al. Prior gemtuzumab ozogamicin exposure significantly increases the risk of veno-occlusive disease in patients who undergo myeloablative allogeneic stem cell transplantation. Blood 2003, 102(5):1578-1582.
59. Wadleigh M., et al. Hepatic veno-occlusive disease: pathogenesis, diagnosis and treatment. Curr. Opin. Hematol. 2003, 10(6):451-462.
60. Larson R.A., et al. Final report of the efficacy and safety of gemtuzumab ozogamicin (Mylotarg) in patients with CD33-positive acute myeloid leukemia in first recurrence. Cancer 2005, 104(7):1442-1452.
61. Giles F.J., et al. Mylotarg (gemtuzumab ozogamicin) therapy is associated with hepatic venoocclusive disease in patients who have not received stem cell transplantation. Cancer 2001, 92(2):406-413.
62. Rajvanshi P., et al. Hepatic sinusoidal obstruction after gemtuzumab ozogamicin (Mylotarg) therapy. Blood 2002, 99(7):2310-2314.
63. A phase III study of the addition of gemtuzumab ozogamicin (Mylotarg®) induction therapy versus standard induction with daunomycin and cytosine arabinoside followed by consolidation and subsequent randomization to post-consolidation therapy with gemtuzumab ozogamicin (Mylotarg®) or no additional therapy for patients under age 61 with previously untreated de novo acute myeloid leukemia (AML) Available from:. http://www.mhlw.go.jp/stf/shingi/2r9852000000vrz2-att/2r9852000000vs34.pdf.
64. Stephan J.P., Kozak K.R., Wong W.L. Challenges in developing bioanalytical assays for characterization of antibody-drug conjugates. Bioanalysis 2011, 3(6):677-700.
65. Mylotarg (gemtuzumab ozogamicin): market withdrawal Available from:. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm216458.htm.
66. New lease of life for gemtuzumab, now it shows survival advantage Available from:. http://www.medscape.com/viewarticle/755219.
67. FDA approves Adcetris to treat two types of lymphoma Available from:. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm268781.htm.
68. Chiarle R., et al. CD30 in normal and neoplastic cells. Clin. Immunol. 1999, 90(2):157-164.
69. Koblinski J.E., Ahram M., Sloane B.F. Unraveling the role of proteases in cancer. Clin. Chim. Acta 2000, 291(2):113-135.
70. Okeley N.M., et al. Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Clin. Cancer Res. 2010, 16(3):888-897.
71. Sun M.M., et al. Reduction-alkylation strategies for the modification of specific monoclonal antibody disulfides. Bioconjug. Chem. 2005, 16(5):1282-1290.
72. Younes A., et al. Brentuximab vedotin (SGN-35) for relapsed CD30-positive lymphomas. N. Engl. J. Med. 2010, 363(19):1812-1821.
73. Fanale M.A. A phase I weekly dosing study of brentuximab vedotin in patients with relapsed/refractory CD30-positive hematologic malignancies. Clin. Cancer Res. 2011, 18(1):248-255.
74. A pivotal open-label trial of brentuximab vedotin for Hodgkin lymphoma Available from:. http://www.clinicaltrials.gov/show/NCT00848926.
75. A phase 2 open label trial of brentuximab vedotin (SGN-35) for systemic anaplastic large cell lymphoma Available from:. http://clinicaltrials.gov/ct2/show/results/NCT00866047.
76. Brentuximab vedotin clinical trials Available from:. http://www.clinicaltrials.gov/ct2/results?term=Brentuximab+Vedotin&pg=1.
77. DiJoseph J.F., et al. Antibody-targeted chemotherapy with CMC-544: a CD22-targeted immunoconjugate of calicheamicin for the treatment of B-lymphoid malignancies. Blood 2004, 103(5):1807-1814.
78. Advani A., et al. Safety, pharmacokinetics, and preliminary clinical activity of inotuzumab ozogamicin, a novel immunoconjugate for the treatment of B-cell non-Hodgkin's lymphoma: results of a phase I study. J. Clin. Oncol. 2010, 28(12):2085-2093.
79. DiJoseph J.F., et al. Potent and specific antitumor efficacy of CMC-544, a CD22-targeted immunoconjugate of calicheamicin, against systemically disseminated B-cell lymphoma. Clin. Cancer Res. 2004, 10(24):8620-8629.
80. Inotuzumab ozogamicin clinical trials Available from:. http://www.clinicaltrials.gov/ct2/results?term=+Inotuzumab+ozogamicin.
81. Ricart A.D. Immunoconjugates against solid tumors: mind the gap. Clin. Pharmacol. Ther. 2011, 89(4):513-523.
82. Slamon D.J., et al. Studies of the HER-2/neu proto-oncogene in human breast and ovarian cancer. Science 1989, 244(4905):707-712.
83. Widdison W.C., et al. Semisynthetic maytansine analogues for the targeted treatment of cancer. J. Med. Chem. 2006, 49(14):4392-4408.
84. Remillard S., et al. Antimitotic activity of the potent tumor inhibitor maytansine. Science 1975, 189(4207):1002-1005.
85. Krop I.E., et al. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3weeks to patients with HER2-positive metastatic breast cancer. J. Clin. Oncol. 2010, 28(16):2698-2704.
86. LoRusso P.M., et al. Trastuzumab emtansine: a unique antibody-drug conjugate in development for human epidermal growth factor receptor 2-positive cancer. Clin. Cancer Res. 2011, 17(20):6437-6447.
87. Burris H.A., et al. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy. J. Clin. Oncol. 2011, 29(4):398-405.
88. Perez E.A., et al. Efficacy and safety of trastuzumab-DM1 versus trastuzumab plus docetaxel in HER2-positive metastatic breast cancer patients with no prior chemotherapy for metastatic disease: preliminary results of a randomized, multicenter, open-label phase 2 study. European Society of Medical Oncology 2010, Milan, Italy. p. abstract LBA3.
89. Krop I., et al. A phase II study of trastuzumab-DM1 (T-DM1), a novel HER2 antibody drug conjugate, in patients with HER2[U+200F] metastatic breast cancer who were previously treated with an anthracycline, a taxane, capecitabine, lapatinib, and trastuzumab. European Society for Medical Oncology Congress 2010, Milan, Italy. p. abstract 277O.
90. Krop I. A phase II study of trastuzumab-DM1 (T-DM1), a novel HER2 antibody-drug conjugate, in HER2+ metastatic breast cancer (MBC) patients previously treated with conventional chemotherapy, lapatinib and trastuzumab. Cancer Res. 2009, 69(24 Supplement 3). (p. Abstract #710).
91. Seidman A., et al. Cardiac dysfunction in the trastuzumab clinical trials experience. J. Clin. Oncol. 2002, 20(5):1215-1221.
92. de Azambuja E., et al. Cardiac toxicity with anti-HER-2 therapies: what have we learned so far?. Target. Oncol. 2009, 4(2):77-88.
93. Chan S.Y., et al. A phase 2 study of the cytotoxic immunoconjugate CMB-401 (hCTM01-calicheamicin) in patients with platinum-sensitive recurrent epithelial ovarian carcinoma. Cancer Immunol. Immunother. 2003, 52(4):243-248.
94. Tolcher A.W., et al. Randomized phase II study of BR96-doxorubicin conjugate in patients with metastatic breast cancer. J. Clin. Oncol. 1999, 17(2):478-484.
95. Weiss R.B. The anthracyclines: will we ever find a better doxorubicin?. Semin. Oncol. 1992, 19(6):670-686.
96. Pressman D., Korngold L. The in vivo localization of anti-Wagner-osteogenic-sarcoma antibodies. Cancer 1953, 6(3):619-623.
97. Pressman D. The zone of localization of antibodies; the in vivo disposition of anti-mouse-kidney serum and anti-mouse-plasma serum as determined by radioactive tracers. J. Immunol. 1949, 63(4):375-388.
98. Goldenberg D.M., et al. Clinical studies on the radioimmunodetection of tumors containing alpha-fetoprotein. Cancer 1980, 45(10):2500-2505.
99. Goldenberg D.M., et al. Use of radiolabeled antibodies to carcinoembryonic antigen for the detection and localization of diverse cancers by external photoscanning. N. Engl. J. Med. 1978, 298(25):1384-1386.
100. DeLand F.H., et al. In vivo radioimmunodetection of neoplasms. Compr. Ther. 1979, 5(2):31-36.
101. Goldenberg D.M., et al. Experimental radioimmunotherapy of a xenografted human colonic tumor (GW-39) producing carcinoembryonic antigen. Cancer Res. 1981, 41(11 Pt 1):4354-4360.
102. Carrasquillo J.A., et al. Diagnosis of and therapy for solid tumors with radiolabeled antibodies and immune fragments. Cancer Treat. Rep. 1984, 68(1):317-328.
103. Larson S.M., et al. Localization of 131I-labeled p97-specific Fab fragments in human melanoma as a basis for radiotherapy. J. Clin. Invest. 1983, 72(6):2101-2114.
104. Otsuka F.L., Welch M.J. Methods to label monoclonal antibodies for use in tumor imaging. Int. J. Rad. Appl. Instrum. B 1987, 14(3):243-249.
105. Gansow O.A., et al. Chelates and antibodies: current methods and new directions. Cancer Treat. Res. 1990, 51:153-171.
106. Mothersill C., Seymour C.B. Radiation-induced bystander effects - implications for cancer. Nat. Rev. Cancer 2004, 4(2):158-164.
107. Prise K.M., O'Sullivan J.M. Radiation-induced bystander signalling in cancer therapy. Nat. Rev. Cancer 2009, 9(5):351-360.
108. Morschhauser F., et al. Efficacy and safety of yttrium-90 ibritumomab tiuxetan in patients with relapsed or refractory diffuse large B-cell lymphoma not appropriate for autologous stem-cell transplantation. Blood 2007, 110(1):54-58.
109. Vose J.M. Bexxar: novel radioimmunotherapy for the treatment of low-grade and transformed low-grade non-Hodgkin's lymphoma. Oncologist 2004, 9(2):160-172.
110. Milenic D.E. Radioimmunotherapy: designer molecules to potentiate effective therapy. Semin. Radiat. Oncol. 2000, 10(2):139-155.
111. Knox S.J., Meredith R.F. Clinical radioimmunotherapy. Semin. Radiat. Oncol. 2000, 10(2):73-93.
112. Imam S.K. Status of radioimmunotherapy in the new millennium. Cancer Biother. Radiopharm. 2001, 16(3):237-256.
113. Goldenberg D.M. Advancing role of radiolabeled antibodies in the therapy of cancer. Cancer Immunol. Immunother. 2003, 52(5):281-296.
114. Jaffer F.A., Weissleder R. Molecular imaging in the clinical arena. JAMA 2005, 293(7):855-862.
115. Boswell C.A., Brechbiel M.W. Development of radioimmunotherapeutic and diagnostic antibodies: an inside-out view. Nucl. Med. Biol. 2007, 34(7):757-778.
116. Ansell S.M., et al. Antilymphoma treatments given subsequent to Yttrium 90 ibritumomab tiuxetan are feasible in patients with progressive non-Hodgkin's lymphoma: a review of the literature. Clin. Lymphoma 2004, 5(3):202-204.
117. Pedersen-Bjergaard J., et al. Risk of acute nonlymphocytic leukemia and preleukemia in patients treated with cyclophosphamide for non-Hodgkin's lymphomas. Comparison with results obtained in patients treated for Hodgkin's disease and ovarian carcinoma with other alkylating agents. Ann. Intern. Med. 1985, 103(2):195-200.
118. Leone G., et al. Therapy related leukemias: susceptibility, prevention and treatment. Leuk. Lymphoma 2001, 41(3-4):255-276.
119. Dillman R.O. Radiolabeled anti-CD20 monoclonal antibodies for the treatment of B-cell lymphoma. J. Clin. Oncol. 2002, 20(16):3545-3557.
120. Kaminski M.S., et al. 131I-tositumomab therapy as initial treatment for follicular lymphoma. N. Engl. J. Med. 2005, 352(5):441-449.
121. Leahy M.F., Turner J.H. Radioimmunotherapy of relapsed indolent non-Hodgkin lymphoma with 131I-rituximab in routine clinical practice: 10-year single-institution experience of 142 consecutive patients. Blood 2011, 117(1):45-52.
122. Bishton M.J., et al. Repeat treatment with iodine-131-rituximab is safe and effective in patients with relapsed indolent B-cell non-Hodgkin's lymphoma who had previously responded to iodine-131-rituximab. Ann. Oncol. 2008, 19(9):1629-1633.
123. Kaminski M.S., et al. Re-treatment with I-131 tositumomab in patients with non-Hodgkin's lymphoma who had previously responded to I-131 tositumomab. J. Clin. Oncol. 2005, 23(31):7985-7993.
124. Witzig T.E. Radioimmunotherapy for patients with relapsed B-cell non-Hodgkin lymphoma. Cancer Chemother. Pharmacol. 2001, 48(Suppl. 1):S91-S95.
125. McLaughlin P., 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(8):2825-2833.
126. Wiseman G.A., et al. Radiation dosimetry results and safety correlations from 90Y-ibritumomab tiuxetan radioimmunotherapy for relapsed or refractory non-Hodgkin's lymphoma: combined data from 4 clinical trials. J. Nucl. Med. 2003, 44(3):465-474.
127. Witzig T.E., et al. Safety of yttrium-90 ibritumomab tiuxetan radioimmunotherapy for relapsed low-grade, follicular, or transformed non-Hodgkin's lymphoma. J. Clin. Oncol. 2003, 21(7):1263-1270.
128. Friedberg J.W., Fisher R.I. Iodine-131 tositumomab (Bexxar): radioimmunoconjugate therapy for indolent and transformed B-cell non-Hodgkin's lymphoma. Expert Rev. Anticancer Ther. 2004, 4(1):18-26.
129. Kaminski M.S., 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(4):1259-1266.
130. Kaminski M.S., 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(19):3918-3928.
131. Holm L.E., et al. Cancer risk after iodine-131 therapy for hyperthyroidism. J. Natl. Cancer Inst. 1991, 83(15):1072-1077.
132. Bennett J.M., et al. Assessment of treatment-related myelodysplastic syndromes and acute myeloid leukemia in patients with non-Hodgkin lymphoma treated with tositumomab and iodine I131 tositumomab. Blood 2005, 105(12):4576-4582.
133. Le Beau M.M., et al. Clinical and cytogenetic correlations in 63 patients with therapy-related myelodysplastic syndromes and acute nonlymphocytic leukemia: further evidence for characteristic abnormalities of chromosomes no. 5 and 7. J. Clin. Oncol. 1986, 4(3):325-345.
134. Travis L.B., et al. Bladder cancer after chemotherapy for non-Hodgkin's lymphoma. N. Engl. J. Med. 1989, 321(8):544-545.
135. Jacene H.A., et al. Comparison of 90Y-ibritumomab tiuxetan and 131I-tositumomab in clinical practice. J. Nucl. Med. 2007, 48(11):1767-1776.
136. Leahy M.F., et al. Multicenter phase II clinical study of iodine-131-rituximab radioimmunotherapy in relapsed or refractory indolent non-Hodgkin's lymphoma. J. Clin. Oncol. 2006, 24(27):4418-4425.
137. Illidge T.M., et al. Phase 1/2 study of fractionated (131)I-rituximab in low-grade B-cell lymphoma: the effect of prior rituximab dosing and tumor burden on subsequent radioimmunotherapy. Blood 2009, 113(7):1412-1421.
138. Turner J.H., et al. 131I-Anti CD20 radioimmunotherapy of relapsed or refractory non-Hodgkins lymphoma: a phase II clinical trial of a nonmyeloablative dose regimen of chimeric rituximab radiolabeled in a hospital. Cancer Biother. Radiopharm. 2003, 18(4):513-524.
139. Shapiro W.R., et al. (131)I-chTNT-1/B mAb: tumour necrosis therapy for malignant astrocytic glioma. Expert Opin. Biol. Ther. 2006, 6(5):539-545.
140. Bobo R.H., et al. Convection-enhanced delivery of macromolecules in the brain. Proc. Natl. Acad. Sci. U. S. A. 1994, 91(6):2076-2080.
141. Laske D.W., et al. Chronic interstitial infusion of protein to primate brain: determination of drug distribution and clearance with single-photon emission computerized tomography imaging. J. Neurosurg. 1997, 87(4):586-594.
142. Patel S.J., et al. Safety and feasibility of convection-enhanced delivery of Cotara for the treatment of malignant glioma: initial experience in 51 patients. Neurosurgery 2005, 56(6):1243-1252. (discussion 1252-3).
143. van der Jagt R.H., et al. Localization of radiolabeled antimyeloid antibodies in a human acute leukemia xenograft tumor model. Cancer Res. 1992, 52(1):89-94.
144. Pagel J.M., et al. 131I-anti-CD45 antibody plus busulfan and cyclophosphamide before allogeneic hematopoietic cell transplantation for treatment of acute myeloid leukemia in first remission. Blood 2006, 107(5):2184-2191.
145. Dubel S. Recombinant therapeutic antibodies. Appl. Microbiol. Biotechnol. 2007, 74(4):723-729.
146. Love C., Palestro C.J. 99mTc-fanolesomab Palatin Technologies. IDrugs 2003, 6(11):1079-1085.
147. NeutroSpec withdrawn from market Available from:. http://jnm.snmjournals.org/content/47/2/36N.full.pdf.
148. Public health advisory: suspended marketing of NeutroSpec (Technetium (99m Tc) fanolesomab) Available from:. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/PublicHealthAdvisories/ucm051652.htm.
149. Shanthly N., et al. 99mTc-Fanolesomab: affinity, pharmacokinetics and preliminary evaluation. Q. J. Nucl. Med. Mol. Imaging 2006, 50(2):104-112.
150. Press O.W., et al. Radiolabeled-antibody therapy of B-cell lymphoma with autologous bone marrow support. N. Engl. J. Med. 1993, 329(17):1219-1224.
151. Mery C.M., Shafi B.M., Binyamin G. Molecular imaging and radioimmunoguided surgery. Semin. Pediatr. Surg. 2006, 15(4):259-266.
152. Meredith R., et al. Comparison of biodistribution, dosimetry, and outcome from clinical trials of radionuclide-CC49 antibody therapy. Cancer Biother. Radiopharm. 2003, 18(3):393-404.
153. Tempero M., et al. High-dose therapy with 90Yttrium-labeled monoclonal antibody CC49: a phase I trial. Clin. Cancer Res. 2000, 6(8):3095-3102.
154. Forero A., et al. Phase I study of 90Y-CC49 monoclonal antibody therapy in patients with advanced non-small cell lung cancer: effect of chelating agents and paclitaxel co-administration. Cancer Biother. Radiopharm. 2005, 20(5):467-478.
155. Pastan I.H. Recombinant immunotoxins: new therapeutic agents for cancer treatment. Cancer Detect. Prev. 1993, 17(2):289-293.
156. FitzGerald D., Pastan I. Targeted toxin therapy for the treatment of cancer. J. Natl. Cancer Inst. 1989, 81(19):1455-1463.
157. Vitetta E.S., Uhr J.W. Immunotoxins: redirecting nature's poisons. Cell 1985, 41(3):653-654.
158. Shapira A., Benhar I. Toxin-based therapeutic approaches. Toxins (Basel) 2010, 2(11):2519-2583.
159. Kreitman R.J. Immunotoxins for targeted cancer therapy. AAPS J. 2006, 8(3):E532-E551.
160. Kreitman R.J. Recombinant immunotoxins for the treatment of chemoresistant hematologic malignancies. Curr. Pharm. Des. 2009, 15(23):2652-2664.
161. FitzGerald D.J., et al. Treatment of hematologic malignancies with immunotoxins and antibody-drug conjugates. Cancer Res. 2011, 71(20):6300-6309.
162. Kreitman R.J. Recombinant immunotoxins containing truncated bacterial toxins for the treatment of hematologic malignancies. BioDrugs 2009, 23(1):1-13.
163. Menestrina G., Schiavo G., Montecucco C. Molecular mechanisms of action of bacterial protein toxins. Mol. Aspects Med. 1994, 15(2):79-193.
164. Falnes P.O., Sandvig K. Penetration of protein toxins into cells. Curr. Opin. Cell Biol. 2000, 12(4):407-413.
165. Chiron M.F., Fryling C.M., FitzGerald D. Furin-mediated cleavage of Pseudomonas exotoxin-derived chimeric toxins. J. Biol. Chem. 1997, 272(50):31707-31711.
166. Williams D.P., et al. Cellular processing of the interleukin-2 fusion toxin DAB486-IL-2 and efficient delivery of diphtheria fragment A to the cytosol of target cells requires Arg194. J. Biol. Chem. 1990, 265(33):20673-20677.
167. Van Ness B.G., Howard J.B., Bodley J.W. ADP-ribosylation of elongation factor 2 by diphtheria toxin. Isolation and properties of the novel ribosyl-amino acid and its hydrolysis products. J. Biol. Chem. 1980, 255(22):10717-10720.
168. Carroll S.F., Collier R.J. Active site of Pseudomonas aeruginosa exotoxin A. Glutamic acid 553 is photolabeled by NAD and shows functional homology with glutamic acid 148 of diphtheria toxin. J. Biol. Chem. 1987, 262(18):8707-8711.
169. de Virgilio M., et al. Ribosome-inactivating proteins: from plant defense to tumor attack. Toxins (Basel) 2010, 2(11):2699-2737.
170. Sandvig K., van Deurs B. Endocytosis and intracellular transport of ricin: recent discoveries. FEBS Lett. 1999, 452(1-2):67-70.
171. Endo Y., Tsurugi K. Mechanism of action of ricin and related toxic lectins on eukaryotic ribosomes. Nucleic Acids Symp. Ser. 1986, 17:187-190.
172. Endo Y., Tsurugi K. RNA N-glycosidase activity of ricin A-chain. Mechanism of action of the toxic lectin ricin on eukaryotic ribosomes. J. Biol. Chem. 1987, 262(17):8128-8130.
173. Olsen E., et al. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneous T-cell lymphoma. J. Clin. Oncol. 2001, 19(2):376-388.
174. Vitetta E.S. Immunotoxins and vascular leak syndrome. Cancer J. 2000, 6(Suppl. 3):S218-S224.
175. Baluna R., Vitetta E.S. Vascular leak syndrome: a side effect of immunotherapy. Immunopharmacology 1997, 37(2-3):117-132.
176. Kuan C.T., Pai L.H., Pastan I. Immunotoxins containing Pseudomonas exotoxin that target LeY damage human endothelial cells in an antibody-specific mode: relevance to vascular leak syndrome. Clin. Cancer Res. 1995, 1(12):1589-1594.
177. Soler-Rodriguez A.M., et al. Ricin A-chain and ricin A-chain immunotoxins rapidly damage human endothelial cells: implications for vascular leak syndrome. Exp. Cell Res. 1993, 206(2):227-234.
178. Siegall C.B., et al. Prevention of immunotoxin-mediated vascular leak syndrome in rats with retention of antitumor-activity. Proc. Natl. Acad. Sci. U. S. A. 1994, 91(20):9514-9518.
179. Baluna R., et al. Evidence for a structural motif in toxins and interleukin-2 that may be responsible for binding to endothelial cells and initiating vascular leak syndrome. Proc. Natl. Acad. Sci. U. S. A. 1999, 96(7):3957-3962.
180. Baluna R., et al. The effect of a monoclonal antibody coupled to ricin A chain-derived peptides on endothelial cells in vitro: insights into toxin-mediated vascular damage. Exp. Cell Res. 2000, 258(2):417-424.
181. Smallshaw J.E., et al. Genetic engineering of an immunotoxin to eliminate pulmonary vascular leak in mice. Nat. Biotechnol. 2003, 21(4):387-391.
182. Onda M., et al. Lowering the isoelectric point of the Fv portion of recombinant immunotoxins leads to decreased nonspecific animal toxicity without affecting antitumor activity. Cancer Res. 2001, 61(13):5070-5077.
183. Traini R., Kreitman R.J. Renal excretion of recombinant immunotoxins containing Pseudomonas exotoxin. Bioconjug. Chem. 2011, 22(4):736-740.
184. Jeyarajah D.R., Thistlethwaite J.R. General aspects of cytokine-release syndrome: timing and incidence of symptoms. Transplant. Proc. 1993, 25(2 Suppl. 1):16-20.
185. Moake J.L. Thrombotic microangiopathies. N. Engl. J. Med. 2002, 347(8):589-600.
186. Amirlak I., Amirlak B. Haemolytic uraemic syndrome: an overview. Nephrology (Carlton) 2006, 11(3):213-218.
187. Gadina M., et al. Humanized immunotoxins. Ther. Immunol. 1994, 1(1):59-64.
188. Kreitman R.J., Pastan I. Recombinant single-chain immunotoxins against T-cell and B-cell leukemias. Leuk. Lymphoma 1994, 13(1-2):1-10.
189. Kreitman R.J., et al. Phase I trial of recombinant immunotoxin anti-Tac(Fv)PE38 (LMB-2) in patients with hematologic malignancies. J. Clin. Oncol. 2000, 18(8):1622-1636.
190. Anti-Tac(Fv)-PE38 (LMB-2) to treat cutaneous T-cell lymphomas Available from:. http://clinicaltrials.gov/ct2/show/NCT00080535.
191. Amlot P.L., et al. A phase I study of an anti-CD22-deglycosylated ricin A chain immunotoxin in the treatment of B-cell lymphomas resistant to conventional therapy. Blood 1993, 82(9):2624-2633.
192. Vitetta E.S., et al. Phase I immunotoxin trial in patients with B-cell lymphoma. Cancer Res. 1991, 51(15):4052-4058.
193. Mansfield E., et al. Recombinant RFB4 single-chain immunotoxin that is cytotoxic towards CD22-positive cells. Biochem. Soc. Trans. 1997, 25(2):709-714.
194. Clark E.A. CD22, a B cell-specific receptor, mediates adhesion and signal transduction. J. Immunol. 1993, 150(11):4715-4718.
195. Du X., et al. Differential cellular internalization of anti-CD19 and -CD22 immunotoxins results in different cytotoxic activity. Cancer Res. 2008, 68(15):6300-6305.
196. Kreitman R.J., et al. Efficacy of the anti-CD22 recombinant immunotoxin BL22 in chemotherapy-resistant hairy-cell leukemia. N. Engl. J. Med. 2001, 345(4):241-247.
197. Kreitman R.J., et al. Phase I trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with B-cell malignancies. J. Clin. Oncol. 2005, 23(27):6719-6729.
198. Kreitman R.J., et al. Phase II trial of recombinant immunotoxin RFB4(dsFv)-PE38 (BL22) in patients with hairy cell leukemia. J. Clin. Oncol. 2009, 27(18):2983-2990.
199. Wayne A.S., et al. Anti-CD22 immunotoxin RFB4(dsFv)-PE38 (BL22) for CD22-positive hematologic malignancies of childhood: preclinical studies and phase I clinical trial. Clin. Cancer Res. 2010, 16(6):1894-1903.
200. Salvatore G., et al. Improved cytotoxic activity toward cell lines and fresh leukemia cells of a mutant anti-CD22 immunotoxin obtained by antibody phage display. Clin. Cancer Res. 2002, 8(4):995-1002.
201. Wayne A., et al. Complete remissions in 3 of 12 patients with pediatric acute lymphoblastic leukemia (ALL) during phase I testing of the anti-CD22 immunotoxin moxetumomab pasudotox 2010, 3246. Orlando, FL.
202. Frankel A.E., Tagge E.P., Willingham M.C. Clinical trials of targeted toxins. Semin. Cancer Biol. 1995, 6(5):307-317.
203. Pai-Scherf L.H., et al. Hepatotoxicity in cancer patients receiving erb-38, a recombinant immunotoxin that targets the erbB2 receptor. Clin. Cancer Res. 1999, 5(9):2311-2315.
204. Press M.F., Cordon-Cardo C., Slamon D.J. Expression of the HER-2/neu proto-oncogene in normal human adult and fetal tissues. Oncogene 1990, 5(7):953-962.
205. Chang K., Pastan I. Molecular cloning of mesothelin, a differentiation antigen present on mesothelium, mesotheliomas, and ovarian cancers. Proc. Natl. Acad. Sci. U. S. A. 1996, 93(1):136-140.
206. Argani P., et al. Mesothelin is overexpressed in the vast majority of ductal adenocarcinomas of the pancreas: identification of a new pancreatic cancer marker by serial analysis of gene expression (SAGE). Clin. Cancer Res. 2001, 7(12):3862-3868.
207. Hassan R., et al. Localization of mesothelin in epithelial ovarian cancer. Appl. Immunohistochem. Mol. Morphol. 2005, 13(3):243-247.
208. Ordonez N.G. Value of mesothelin immunostaining in the diagnosis of mesothelioma. Mod. Pathol. 2003, 16(3):192-197.
209. Chang K., Pastan I., Willingham M.C. Frequent expression of the tumor antigen CAK1 in squamous-cell carcinomas. Int. J. Cancer 1992, 51(4):548-554.
210. Hassan R., et al. Phase I study of SS1P, a recombinant anti-mesothelin immunotoxin given as a bolus I.V. infusion to patients with mesothelin-expressing mesothelioma, ovarian, and pancreatic cancers. Clin. Cancer Res. 2007, 13(17):5144-5149.
211. Pastan I., et al. Characterization of monoclonal antibodies B1 and B3 that react with mucinous adenocarcinomas. Cancer Res. 1991, 51(14):3781-3787.
212. Posey J.A., et al. A phase I trial of the single-chain immunotoxin SGN-10 (BR96 sFv-PE40) in patients with advanced solid tumors. Clin. Cancer Res. 2002, 8(10):3092-3099.
213. LeMaistre C.F., et al. Phase I trial of H65-RTA immunoconjugate in patients with cutaneous T-cell lymphoma. Blood 1991, 78(5):1173-1182.
214. Grossbard M.L., et al. Anti-B4-blocked ricin: a phase II trial of 7 day continuous infusion in patients with multiple myeloma. Br. J. Haematol. 1998, 102(2):509-515.
215. Grossbard M.L., et al. Anti-B4-blocked ricin: a phase I trial of 7-day continuous infusion in patients with B-cell neoplasms. J. Clin. Oncol. 1993, 11(4):726-737.
216. Sausville E.A., et al. Continuous infusion of the anti-CD22 immunotoxin IgG-RFB4-SMPT-dgA in patients with B-cell lymphoma: a phase I study. Blood 1995, 85(12):3457-3465.
217. Gould B.J., et al. Phase I study of an anti-breast cancer immunotoxin by continuous infusion: report of a targeted toxic effect not predicted by animal studies. J. Natl. Cancer Inst. 1989, 81(10):775-781.
218. LeMaistre C.F., et al. Phase I trial of a ligand fusion-protein (DAB389IL-2) in lymphomas expressing the receptor for interleukin-2. Blood 1998, 91(2):399-405.
219. Williams D.P., et al. Diphtheria toxin receptor binding domain substitution with interleukin-2: genetic construction and properties of a diphtheria toxin-related interleukin-2 fusion protein. Protein Eng. 1987, 1(6):493-498.
220. Bacha P., et al. Interleukin 2 receptor-targeted cytotoxicity. Interleukin 2 receptor-mediated action of a diphtheria toxin-related interleukin 2 fusion protein. J. Exp. Med. 1988, 167(2):612-622.
221. Shaughnessy P.J., et al. Denileukin diftitox for the treatment of steroid-resistant acute graft-versus-host disease. Biol. Blood Marrow Transplant. 2005, 11(3):188-193.
222. Wong B.Y., et al. De novo maintenance therapy with denileukin diftitox (Ontak) in a patient with peripheral T-cell lymphoma is associated with prolonged remission. Am. J. Hematol. 2008, 83(7):596-598.
223. Frankel A.E., et al. DAB389IL2 (ONTAK) fusion protein therapy of chronic lymphocytic leukaemia. Expert Opin. Biol. Ther. 2003, 3(1):179-186.
224. Frankel A.E., et al. A phase II study of DT fusion protein denileukin diftitox in patients with fludarabine-refractory chronic lymphocytic leukemia. Clin. Cancer Res. 2003, 9(10 Pt 1):3555-3561.
225. Martin A., et al. A multicenter dose-escalation trial with denileukin diftitox (ONTAK, DAB(389)IL-2) in patients with severe psoriasis. J. Am. Acad. Dermatol. 2001, 45(6):871-881.
226. Saleh M.N., et al. Antitumor activity of DAB389IL-2 fusion toxin in mycosis fungoides. J. Am. Acad. Dermatol. 1998, 39(1):63-73.
227. Dang N.H., et al. Phase II trial of denileukin diftitox for relapsed/refractory T-cell non-Hodgkin lymphoma. Br. J. Haematol. 2007, 136(3):439-447.
228. Dang N.H., et al. Phase II study of denileukin diftitox for relapsed/refractory B-Cell non-Hodgkin's lymphoma. J. Clin. Oncol. 2004, 22(20):4095-4102.
229. Changes in the Ontak (denileukin diftitiox) package insert to include a description of ophthalmologic adverse events Available from:. http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm095661.htm.
230. Ruddle J.B., et al. A denileukin diftitox (Ontak) associated retinopathy?. Br. J. Ophthalmol. 2006, 90(8):1070-1071.
231. Park M., et al. Vision loss following denileukin diftitox treatment: a case report of possible posterior ischemic optic neuropathy. Leuk. Lymphoma 2007, 48(4):808-811.