Biotherapy : a comprehensive overview / edited by Paula Trahan Rieger.

Format:

Book

Contributor:

Rieger, Paula Trahan.

Series:

Jones and Bartlett series in oncology

Language:

English

Subjects (All):

Biological response modifiers--Therapeutic use.

Biological response modifiers.

Cancer--Immunotherapy.

Cancer.

Neoplasms--therapy.

Immunotherapy.

Biological Products--therapeutic use.

Medical Subjects:

Neoplasms--therapy.

Immunotherapy.

Biological Products--therapeutic use.

Physical Description:

xxiv, 807 pages : illustrations ; 24 cm.

Edition:

Second edition.

Place of Publication:

Boston, Ma : Jones and Bartlett, 2001.

Contents:

Part I Biotherapy: Principles and Foundations 1

Chapter 1 Biotherapy: An Overview / Paula Trahan Rieger 3

Historical Perspective 3

Biotechnology 6

Definition and Classification of Biotherapy 8

Clinical Development of Biological Agents 9

Steps in the Drug Development Process 10

The Cost of Drug Development 11

Maximum Tolerated Dose Versus Optimal Biological Dose 13

The Role of Nurses in the Development of Biological Agents 13

Biological Agents 14

Interferons 15

Interleukins 15

Hematopoietic Growth Factors 16

Monoclonal Antibodies 16

Retinoids 17

Vaccines 17

Tumor Necrosis Factor 18

Immunomodulators 18

Cellular Therapy 23

Chapter 2 The Immune System / Scott Solomon, Krishna Komanduri 39

Overview of the Immune System 39

Innate Immunity 42

Complement System 42

Phagocytic Cells 43

Natural Killer Cells 44

Adaptive Immunity 44

Major Histocompatibility Complex and Antigen Presentation 45

T Cells and Thymic Education 46

Antigen-Presenting Cells 48

Helper and Cytotoxic T Lymphocytes 49

T-Cell Receptor Complex 50

CD4 and CD8 Receptors 50

Costimulation 51

Helper T-Cell Subsets 51

Mechanisms of Cytotoxic T-Lymphocyte Killing 52

T-Cell Receptor Diversity 52

B Lymphocytes and Antibodies 54

B-Cell Activation 54

Immunoglobulins 54

Distribution of Lymphoid Cells 56

Cancer and the Immune System 57

Tumor Biology 57

Immune Surveillance 58

Immune Responses to Tumors 59

Cell-Mediated Cytotoxity 59

Antitumor Antibodies 60

Cytokines as Cancer Therapy 60

Tumor Escape Mechanisms 61

Chapter 3 Normal Cell Biology and the Biology of Cancer / Deborah L. Volker 65

Normal Cell Biology 65

Structural and Functional Elements 65

Cell Metabolism 66

Cell Proliferation and Regulation 69

Cancer Biology 73

The Molecular Basis of Cancer 74

Characteristics of Cancer Cells 77

The Biology of Tumor Growth: Invasion and Spread of Disease 78

Chapter 4 Optimizing the Dose and Schedule of Biological Agents / Paula Trahan Rieger 85

Drug Development 85

Optimal Biological Dosing 87

Diversity and Selectivity 87

The Cytokine Cascade 87

Toxicity of Natural Products 88

Measurement of Biological Effects in Clinical Trials 88

Drug Activity and Dosing 88

Pharmaceutical Phase 88

Pharmacokinetic Phase 89

Pharmacodynamic Phase 94

Scheduling 100

Biotherapy in Combination Therapy Regimens 102

Goals of Combination Therapy 102

Combinations of Biological Agents 103

Biological Agents and Chemotherapy 105

Outcomes of Therapy 113

Future Directions 115

Part II Major Categories of Biological Agents 123

Chapter 5 The Interferons / Linda Cuaron, John Thompson 125

Biological Activity 127

Antiviral Effects 128

Intercellular Protein Changes 128

Antiproliferative Effects 128

Immunomodulatory Effects 129

Antiangiogenesis 131

Clinical Experience: Interferon-[alpha] 132

Hematologic Malignancies and Lymphomas 132

B-Cell Malignancies 139

T-Cell Malignancies 145

Solid Tumors 146

Non-oncologic Indications for Interferon-[alpha] Therapy 159

Toxicity Profile of Interferon-[alpha] 165

Fever and Flu-like Syndrome 165

Fatigue 166

Anorexia 167

Myalgia and Arthralgia 167

Hematological Effects 167

Neurological Effects 168

Retinal Changes 169

Hypertriglyceridemia 169

Autoimmune Effects 169

Cutaneous Effects 170

Renal and Hepatic Effects 170

Antibody Development 170

Psychosocial Issues During Therapy 170

Nursing Issues 171

Clinical Experience: Interferon-[beta] 172

Multiple Sclerosis 172

Side Effect Management 173

Clinical Experience: Interferon-[gamma] 174

Regulatory Approvals 176

Chapter 6 The Interleukins / Danielle M. Gale, Patricia Sorokin 195

Interleukin-1 198

Biological Actions 198

Clinical Trials 200

Regulatory Approval 203

Side Effects 203

Future Directions 203

Interleukin-2 203

Biological Actions 204

Clinical Trials 204

Regulatory Approval 211

Side Effects 211

Nursing Considerations 213

Future Directions 214

Interleukin-4 215

Biological Actions 215

Clinical Trials 216

Regulatory Approval 217

Side Effects 217

Future Directions 217

Interleukin-6 218

Biological Actions 218

Clinical Trials 219

Regulatory Approval 220

Side Effects 220

Nursing Considerations 221

Future Directions 221

Interleukin-10 221

Biological Actions 222

Physiological Activities 222

Regulatory Approval 224

Nursing Considerations 224

Future Directions 224

Interleukin-12 225

Biological Actions 225

Clinical Trials 225

Regulatory Approval 226

Side Effects 227

Nursing Considerations 227

Future Directions 227

Chapter 7 Hematopoietic Growth Factors / Debra Wujcik 245

Classification 246

Lineage-Restricted Hematopoietic Growth Factors 246

Multilineage Hematopoietic Growth Factors 248

Biological Actions 249

Hematopoiesis 249

Hematopoietic Growth Factors in Hematopoiesis 252

Cell Surface Receptors 252

Genetics 252

Animal Studies 253

Clinical Trials 254

Erythropoietin 254

Granulocyte-Macrophage Colony-Stimulating Factor 255

Granulocyte Colony-Stimulating Factor 258

Interleukin-11 and Thrombopoietin 259

Interleukin-11 259

Regulatory-Approved Agents 260

Granulocyte Colony-Stimulating Factor 260

Granulocyte-Macrophage Colony-Stimulating Factor 261

Erythropoietin 262

Interleukin-11 263

Side Effects 263

Clinical Issues 264

Investigational Agents 267

Stem Cell Factor 267

Macrophage Colony-Stimulating Factor 268

Interleukin-3 268

Novel Erythropoiesis-Stimulating Protein 269

Combinations of Hematopoietic Growth Factors 269

Future Directions 270

Chapter 8 Monoclonal Antibodies: Overview and Use in Hematologic Malignancies / Janet E. DiJulio 283

Hybridoma Technology 284

Biological Actions 286

Clinical Studies 289

Clinical Studies of the Leukemias and Lymphomas 292

Adverse Effects 300

Obstacles to Treatment 304

Human Antimurine Antibodies 304

Antigenic Modulation 305

Antigen Blockade 305

Tumor Heterogeneity 306

Cost 306

Other Uses of Monoclonal Antibodies 306

Regulatory Approval 307

Future Directions 307

Chapter 9 Monoclonal Antibodies: Applications in Solid Tumors and Other Diseases / Paula Trahan Rieger, Marjorie Green, James Lee Murray 317

Biological Actions 318

Unconjugated Antibody Therapy: Direct and Indirect Effects 318

Conjugated Antibody Therapy: Isotopes, Immunotoxins, and More 320

Targeting Antibodies for Clinical Use 321

Overcoming Barriers to Effective Treatment 322

Clinical Trials of Unconjugated Antibodies 323

Growth Factor Receptor Blockade: A Model for Antibody Development 323

Breast Cancer: Other Options for Therapy 328

Colon Cancer 329

Lung Cancer 330

Malignant Melanoma 331

Vaccines 331

Monoclonal Antibodies as Biological Response Modifiers 332

Conjugate Therapy 332

Radioimmunoconjugates 332

Immunotoxins 339

Chemoimmunoconjugates 340

Adverse Effects 341

The Use of MABs Outside of Cancer 342

Regulatory Approvals 345

Future Directions 346

Chapter 10 Cancer Vaccines / Donna M. Kinzler, Charles K.

Brown 357

Rationale for the Use of Cancer Vaccines 357

Historical Overview of the Use and Development of Cancer Vaccines 359

Antigen Formulations 360

Antigen-Specific Preparations 361

Cellular Preparations 364

Cancer Vaccine Clinical Trials 366

Immunoadjuvants 367

Adjuvant Formulations 368

Clinical Studies Using Immunoadjuvants 371

Dendritic Cells 372

Dendritic Cell Biology 372

Dendritic Cell Clinical Studies 373

Regulatory Approval 374

Administration and Side Effects 374

Nursing Management 374

Obstacles to Therapy 375

Chapter 11 Tumor Necrosis Factor / Lynne Brophy 383

Biological Actions 384

Vascular Changes 384

Effects on Hematopoietic Cells 384

Activation of Immune Mechanisms 384

Inflammation 385

Immunologic Surveillance 386

Lipid Metabolism 386

Clinical Studies in Patients With Cancer 387

Tumor Necrosis Factor as a Single Agent 387

Tumor Necrosis Factor in Combination Therapy 391

Isolated Limb Perfusion 392

Regulatory Status 394

Adverse Effects 394

Future Directions 396

Chapter 12 The Retinoids / Paula Trahan Rieger, Fadlo R. Khuri 407

Biological Activity 408

Clinical Studies 411

Chemoprevention 411

Treatment of Cancer 419

Regulatory Approval 421

Toxicity 422

Future Directions 423

Chapter 13 Gene Therapy / Yvette Payne, Patricia Brusso 431

What is Gene Therapy? 432

Gene Therapy Strategies 432

Drug-Resistance Genes 436

Drug-Sensitivity Genes 437

Immunomodulatory Genes 438

Tumor-Suppressor Gene Replacement and Oncogene Inactivation 439

Delivery Methods 440

Viral Vectors 441

Retroviral Vectors 441

Adenoviral Vectors 442

Herpes Simplex Virus Vectors 443

Adeno-Associated and Vaccinia Virus 443

Nonviral Vectors 444

Liposomes 444

Molecular Conjugates 444

Naked DNA 445

Comparison 445

Side-Effect Profile 445

Ethical Considerations 447

Nursing Considerations 450

The Role of the Nurse in Gene Therapy 450

Safety Issues 450

Education 451

Future Directions 451

Part III Nursing Management and Future Perspectives 459

Chapter 14 Patient Management / Paula Trahan Rieger 461

Nursing Standards: A Foundation for Practice 462

Nursing Assessment 462

Pretherapy Assessment 462

Assessment During Therapy 465

Post-Therapy Assessment 466

Cultural Assessment 467

Psychosocial Assessment 467

Administration of Biotherapy 472

Administration Routes, Modalities, and Techniques 472

Handling and Disposal of Biological Agents 475

Management of Side Effects 477

Symptom Management Model 478

Pathophysiology of Biotherapy-Related Side Effects 481

Nursing Interventions 481

Radiation Precautions 488

Sexuality Concerns 489

Special Issues for Nursing Consideration 489

Novel Therapies 489

Alternative and Complementary Therapies 490

Natural Therapies 490

Unconventional or Questionable Therapies 491

Nurse Stress 491

Ambulatory Care 491

Nursing Research 493

Chapter 15 Upside Down: Life With Lymphoma / Brian Stabler 507

Life Before Lymphoma 507

Hitting the Wall 508

Facing Fears 509

Overcoming the Dread 509

Accepting the Role of "Patient" 510

Round One 511

Listening to Hear 512

Accepting Help 513

Round Two 514

After the "Novelty" Wears Off 515

Accommodating Illness 516

Looking Back: How Health Professionals Can Help 517

Providing Information 517

Raising Hope 517

Cancer Survival: More Than a Simple Act of Fate 517

Chapter 16 Flu-Like Syndrome / Brenda K. Shelton 519

Characteristics and Effects of the Flu-Like Syndrome 519

Impact of FLS on Physical and Emotional Well-Being 520

Presenting Symptoms 520

Pathophysiology of the Flu-Like Syndrome 523

Alterations in the Thermoregulatory Set Point 523

Action of Pyrogens 523

Stimulation of Inflammatory-Immune Response and Immunostimulatory Effects 524

Agent-Specific Patterns of Flu-Like Syndrome Presentation and Severity 526

Interferons 526

Hematopoietic Growth Factors 526

Interleukin-2 528

Monoclonal Antibodies 529

Tumor Necrosis Factor 529

Retinoids 530

Levamisole 530

Immunoconjugates 530

Assessment and Management of Biotherapy-Induced Flu-Like Syndrome 530

Assessment 530

Management 532

Research 537

Chapter 17 Fatigue / Grace E. Dean 547

Definition of Fatigue 549

Theoretical Frameworks for Fatigue 551

Presentation and Pathophysiology of Fatigue 553

Interferon 553

Interleukin-2 556

Tumor Necrosis Factor 558

Hematopoietic Growth Factors 558

Monoclonal Antibodies 559

Measurements of Fatigue 561

Assessment and Management of Biotherapy-Related Fatigue 561

Assessment 561

Management Strategies 562

Research on Fatigue 568

Chapter 18 Anorexia as a Side Effect of Biotherapy / Linda Cuaron 579

Presentation of Anorexia 580

The Role of Nutrients in Immune Function 581

The Role of Cytokines in Altering Metabolism 583

Presentation of Cachexia 584

Occurrence of Anorexia 585

Pathophysiology of Anorexia 586

Central Nervous System Mediators of Anorexia 586

The Role of Cytokines in the Development of Anorexia 587

Depression and Anorexia 589

The Hypothalamic-Pituitary-Adrenal Axis 590

The Influence of Tumor on the Development of Anorexia and Cachexia 590

The Neurobiology of Food Intake and Anorexia 591

Serotonergic Mechanistic Hypothesis 591

Gastrointestinal Factors Related to Anorexia 592

Assessment and Management of Anorexia 593

Nursing Assessment 593

Management of Anorexia 595

Directions for Research 599

Agents That Inhibit Cytokine Production 599

Agents That Counteract Cytokine-Induced Metabolic Changes 600

Chapter 19 Mental Status Changes Associated with Biotherapy / Christina A. Meyers 605

Assessment of Neurobehavioral Functioning 606

Presentation of Mental Status Changes 607

Interferon-[alpha] 608

Interleukin-2 609

Tumor Necrosis Factor 610

Route of Administration 610

Irreversible and Delayed Neurotoxicity 610

Pathophysiology of Mental Status Changes 611

Cerebrovascular Alterations 611

Hypothalamic Actions 612

Induction of Secondary Cytokines 612

Neuroendocrine Alterations 612

Neurotransmitter Alterations 613

Nursing Intervention Strategies 613

Research 615

Future Directions 615

Chapter 20 Patient Education / Kimberly A. Rumsey 623

The Process of Patient Education 624

Assessment 625

Planning 627

Implementation 640

Evaluation 640

Future Directions 642

Chapter 21 The Role of Disease Management in Reimbursement for Biotherapy / Alma Yvette DeJesus 647

The Impact of Health Care Financing on Biotherapy 648

Reimbursement Issues 649

Effects of Reimbursement on Clinical Trials 651

Insurance Coverage of "Off-Label" Use of Approved Drugs 653

Reimbursement in the Setting of Managed Care 655

Reimbursement in the Setting of Federal Programs 656

Disease Management 657

Strategies for Obtaining Reimbursement 661

Chapter 22 The Future of Cancer Therapy / Paula Trahan Rieger 669

Discovery of New Agents 672

New Developments in Interleukins 672

Chemokines 673

Advances in Dosing, Delivery, and Development of Drugs 673

Liposomes as Novel-Drug Delivery Systems 673

Polymer Conjugates 675

Combination Therapies 675

Pharmacogenomics 676

Drug Design 676

New Developments in Genetically Engineered Molecules 676

Denileukin Difitox 677

Etanercept 678

Bifunctional Monoclonal Antibodies 679

Receptor-Based Therapy 680

New Developments in Understanding the Biology of Cancer 680

Risk Assessment 682

Chemoprevention 683

Detection 684

Treatment 685

Biological Agents in Other Diseases 691

Appendix A Biotherapy Care Pathway Advocate Health Care 701

Appendix C Plans of Care for Patients Receiving Biological Agents 771

Appendix D Normograms for Determination of Body Surface Area 781.

Notes:

Includes bibliographical references and index.

ISBN:

0763714283

OCLC:

44811806