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The Treatment of Low-Grade B-Cell Non-Hodgkin's Lymphomas With

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The Treatment of Low-Grade B-Cell Non-Hodgkin's Lymphomas With THE UNIVERSITY OF NEW MEXICO HEALTH SCIENCES CENTER COLLEGE OF PHARMACY ALBUQUERQUE, NEW MEXICO Correspondence Continuing Education Courses For Nuclear Pharmacists and Nuclear Medicine Professionals VOLUME IX, NUMBER 5 The Treatment of Low-Grade B-Cell Non-Hodgkin’s Lymphomas with Radiopharmaceuticals By: Samuel C. Augustine, RPh, PharmD, BCNP, FAPhA, and Jeffrey P. Norenberg, MS, PharmD, BCNP, FASHP The University of New Mexico Health Sciences Center College of Pharmacy is approved by the American Council on Pharmaceutical Education as a provider of continuing pharmaceutical education. Program No. 039-000-01-002-H04. 2.5 Contact Hours or .25 CEUs The Treatment of Low Grade B-Cell Non-Hodgkin’s Lymphomas with Radiopharmaceuticals By: Samuel C. Augustine, RPh, PharmD, BCNP, FAPhA, Jeffrey P. Norenberg, MS, PharmD, BCNP, FASHP Coordinating Editor and Director of Pharmacy Continuing Education William B. Hladik III, MS, RPh College of Pharmacy University of New Mexico Health Sciences Center Managing Editor Julliana Newman, ELS Wellman Publishing, Inc. Albuquerque, New Mexico Editorial Board George H. Hinkle, MS, RPh, BCNP Jeffrey P. Norenberg, MS, PharmD, BCNP Laura L. Boles Ponto, PhD, RPh Timothy M. Quinton, PharmD, MS, RPh, BCNP Guest Reviewers Neil A. Petry, RPh, MS, BCNP, FAPhA Assistant Professor of Radiology Director, Radiopharmacy and Nuclear Medicine Laboratory Duke University Medical Center Durham, NC 27710 While the advice and information in this publication are believed to be true and accurate at press time, the author(s), editors, or the publisher cannot accept any legal responsibility for any errors or omissions that may be made. The publisher makes no warranty, express or implied, with respect to the material contained herein. Copyright 2002 University of New Mexico Health Sciences Center Pharmacy Continuing Education Albuquerque, New Mexico THE TREATMENT OF LOW-GRADE B-CELL NON-HODGKIN’S LYMPHOMAS WITH RADIOPHARMACEUTICALS STATEMENT OF OBJECTIVES Upon completion of this continuing education module, the reader should be able to: 1. Describe the natural history of non-Hodgkin’s lymphoma (NHL). 2. List the signs and symptoms of NHL. 3. Discuss the clinical classification systems used in NHL. 4. List the current treatment options for patients with NHL. 5. Explain the rationale for molecular targeting in the therapy of NHL. 6. Describe the patient treatment schema for Bexxar and ZevalinTM therapies. 7. Calculate the therapeutic dose of 131I-tositumomab based upon patient-specific parameters. 8. Compare the results of the pivotal clinical trials for Bexxar and ZevalinTM 9. Describe the appropriate acquisition, storage and preparation of Bexxar and ZevalinTM. 10. Discuss measurement considerations for pure beta emitters such as 90Y and the importance of geometric dependency in ionization chambers. 11. Describe the radiation safety procedures necessary to minimize personnel exposure when working with Bexxar and ZevalinTM. 12. List the NRC-recognized dose-based limits used for the “early release” of patients treated with therapeutic radiopharmaceuticals. 13. Explain the pharmacoeconomic and outcomes analysis of RituxanTM. 14. Discuss the expanded role for radiopharmacists in caring for patients receiving radioimmonotherapy for NHL. COURSE OUTLINE c) Therapeutic Dose Procedure d) Results of Clinical Trials I. BASIC FACTS OF with Bexxar NON-HODGKIN’S LYMPHOMA A. Etiology of Non-Hodgkin’s III. RADIOPHARMACY Lymphoma PRACTICE ISSUES B. Signs and Symptoms A. Supply and Storage of Bexxar C. Classification of Non-Hodgkin’s B. Supply, Storage, and Preparation Lymphoma of Zevalin™ D. Indolent Lymphomas 1. Zevalin™ Kit Preparation II. THERAPEUTIC OPTIONS 2. Quality Control Procedures A. Molecular Targeting for Zevalin™ 1. Antigen Targets in B-Cell Lymphoma C. Measurement of 90Yttrium 2. CD 20 D. Radiation Safety and Regulatory 3. MAb Nomenclature Issues B. Nonradiolabeled Antibody Therapy 1. Precautions with Bexxar 1. Mechanisms of Action 2. Precautions with Zevalin™ 2. Rituxan Dosage and 3. Licensing Administration 4. Patient Release C. Radiolabeled Antibody Therapy IV. PHARMACOECONOMIC AND 1. Radioimmunotherapy – Zevalin™ a) Biodistribution Procedure OUTCOMES ANALYSIS FOR b) Therapeutic Administration RITUXIMAB Procedure V. EXPANDED ROLE FOR THE c) Results of Clinical Trials RADIOPHARMACIST with Zevalin™ VI. CONCLUSION 2. Radioimmunotherapy –Bexxar VII. REFERENCES a) Dosimetric Dose Procedure VIII. QUESTIONS b) Calculation of the Therapeutic Dose of Bexxar 1 THE TREATMENT OF LOW-GRADE B- 10-year survival rates after diagnosis for non- CELL NON-HODGKIN’S LYMPHOMAS Hodgkin’s disease decline to 41 percent; the 15-year WITH RADIOPHARMACEUTICALS survival rate is 35 percent.2 Most patients with NHL will achieve remissions after chemotherapy. But, By: generally, patients diagnosed with intermediate- or Samuel C. Augustine, high-grade NHL can achieve a cure. Patients in the RPh, PharmD, BCNP, FAPhA, low-grade category are rarely cured having a and median survival rate of 6-10 years from initial Jeffrey P. Norenberg, diagnosis. These types of low-grade B-Cell MS, PharmD, BCNP, FASHP lymphomas are indolent and refractory to therapy and are the focus of this review. BASIC FACTS OF NON-HODGKIN’S LYMPHOMA Etiology of Non-Hodgkin’s Lymphoma Non-Hodgkin’s lymphomas are the fifth The etiology of NHL is unknown but an leading cause of cancer morbidity and mortality. increased incidence is seen with certain infectious Since the early 1970s, the incidence of non- agents; in immunodeficiency syndromes that are Hodgkin’s lymphoma has nearly doubled, although congenital, acquired, or autoimmune in nature; with during the 1990s the rate of increase appeared to environmental exposures; and there are also genetic slow.1 The estimated numbers of new cases of non- predisposing factors (see Table 3). Hodgkin’s lymphoma by state are given in Table 1. Risk factors for NHL are largely unknown The deaths for males and females from non- but in part involve reduced immune function and Hodgkin’s lymphoma in the year 2001 were exposure to certain agents. Human estimated at 13,800 and 12,500, respectively. This immunodeficiency virus and human T-Cell represents approximately 5% of all cancer deaths leukemia lymphoma virus are associated with an for both men and women. Estimated deaths by state increased risk of NHL. Persons with organ are given in Table 2. Survival rates for non- transplants have a more than 100 times higher risk Hodgkin’s lymphoma vary widely based upon the due to altered immune function. Other possible risk histopathology and the stage of disease. The one- factors include occupational exposures to herbicides year survival rate for non-Hodgkin’s lymphoma is and perhaps other chemicals. 70 percent; the five-year rate is 51 percent. Relative Table 1. Estimated New Kansas 500 Oklahoma 700 Non-Hodgkin’s Lymphoma Kentucky 900 Oregon 800 by State in 2001* Louisiana 900 Pennsylvania 3000 Maine 300 Rhode Island 300 Alabama 800 Maryland 900 South Carolina 700 Alaska 100 Massachusetts 1400 South Dakota 200 Arizona 1000 Michigan 2200 Tennessee 1200 Arkansas 600 Minnesota 1200 Texas 3600 California 5300 Mississippi 500 Utah 300 Colorado 700 Missouri 1200 Vermont 100 Connecticut 800 Montana 200 Virginia 1200 Delaware 200 Nebraska 300 Washington 1100 District of Columbia 100 Nevada 400 West Virginia 500 Florida 4200 New Hampshire 300 Wisconsin 1300 Georgia 1100 New Jersey 2000 Wyoming 100 Hawaii 300 New Mexico 300 United States 56,200 Idaho 200 New York 3700 * From Cancer Facts and Figures Illinois 2500 North Carolina 1400 1 Indiana 1300 North Dakota 100 2001. American Cancer Society Iowa 700 Ohio 2700 2 Table 2. Estimated Deaths Kansas 200 Oklahoma 300 from Non-Hodgkin’s Kentucky 400 Oregon 400 Lymphoma by State in 2001* Louisiana 400 Pennsylvania 1400 Maine 200 Rhode Island 100 Alabama 400 Maryland 400 South Carolina 300 Alaska <50 Massachusetts 700 South Dakota 100 Arizona 500 Michigan 1000 Tennessee 600 Arkansas 300 Minnesota 500 Texas 1700 California 2500 Mississippi 200 Utah 200 Colorado 300 Missouri 600 Vermont 100 Connecticut 400 Montana 100 Virginia 600 Delaware 100 Nebraska 200 Washington 500 District of Columbia <50 Nevada 200 West Virginia 200 Florida 2000 New Hampshire 100 Wisconsin 600 Georgia 500 New Jersey 900 Wyoming <50 Hawaii 100 New Mexico 100 United States 26,300 Idaho 100 New York 1700 Illinois 1200 North Carolina 700 * From Cancer Facts and Figures Indiana 600 North Dakota 100 2001. American Cancer Society1 Iowa 300 Ohio 1300 Table 3. Etiology of Non-Hodgkin’s Lymphoma Predisposing Factors Agent/Condition Lymphoma Infectious Agents EBV Burkitt’s HTLV-1 ATL/L Helicobacter pylori MALT Immunodeficiency Ataxia Suspected Syndrome - Congenital Telangiectasia Suspected Immunodeficiency AIDS CNS B-Cell Lymphoma Syndrome - Acquired Acquired Hypogammaglobulinemia Suspected Graft-versus-host disease Suspected Immunodeficiency Hashimoto’s Thyroiditis MALT Syndrome - Sjögren’s Syndrome MALT Autoimmune Systemic Lupus Erythematosis Suspected Rheumatoid Arthritis Suspected Environmental High Dose Radiation Leukemia and Exposure lymphoma Chemicals -Dyes & Solvents Suspected -Phenoxyherbacides Suspected -Organophosphates Suspected Genetic Wiskott-Aldrich syndrome Suspected Klinefelter’s Syndrome Suspected Chediak-Higashi syndrome Suspected EBV=Epstein Barr Virus; HTLV-1=Human T-cell Leukemia/lymphoma virus; ATL/L =Adult T-cell leukemia/lymphoma; and MALT=Marginal zone B-cell of mucosa-associated lymphoid tissue. 3 Signs and Symptoms lymphoma classification
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