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Cancer Chemotherapy by Infusion PDF

761 Pages·1987·14.171 MB·English
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Cancer Chemotherapy by Infusion Cancer Chemotherapy by Infusion Jacob J. Lokich, M.D. MTP PRESS LIMITED .... ~ ~ a member of the KLUWER ACADEMIC PUBLISHERS GROUP -_ n .' LANCASTER / BOSTON / THE HAGUE / DORDRECHT Published in the USA by Precept Press, Inc. 160 East Illinois Street Chicago, Illinois 60611 Published in the UK and Europe by MTP Press Limited Falcon House Lancaster, England British Library Cataloguing in Publication Data Cancer chemotherapy by infusion. 1. Cancer-Chemotherapy I. Lokich, Jacob J. 616.99'4061 RC271.C5 ISBN-13: 978-94-010-7932-7 e-ISBN-13: 978-94-009-3193-0 DOl: 10.1007/978-94-009-3193-0 © 1987 by Precept Press, Inc. All Rights Reserved Softcover reprint ofthe hardcover 1s t edition 1987 Except for appropriate use in critical reviews or works of scholarship, the reproduction or use of this work in any form or by any electronic, mechanical or other means now known or hereafter invented, including photocopying and recording, and in any information storage and retrieval system is forbidden without the written permission of the publisher. Library of Congress Catalog Card Number: 86-62057 International Standard Book Number: 0-931028-68-X 91 90 89 88 87 5 4 3 2 1 For my colleagues and collaborators on the nursing team who make medicine possible, and for my children, who make my life meaningful CONTENTS Preface xix SECTION I - RATIONALE AND TECHNICAL ASPECTS 1. Introduction to the Concept and Practice of Infusion Chemotherapy 3 Jacob J. Lokich, M.D. Categories of Infusion Chemotherapy 5 Rationale for Systemic Infusional Chemotherapy 7 Technologic Impetus to Infusional Chemotherapy 9 Current Clinical Status of Infusional Chemotherapy 10 Summary 11 2. Experimental Rationale for Continuous Infusion Chemotherapy 12 Mark J. Ratain, M.D., and Nicholas J. Vogelzang, M.D. Introduction 12 Antimetabolites 14 Plant Alkaloids 19 Alkylating Agents 22 Antineoplastic Antibiotics 25 Miscellaneous Agents 31 Summary 32 3. The Clinical Pharmacology of Infusional Chemotherapy 35 Gregory A. Curt, M.D., and Jerry M. Collins, Ph.D. Pharmacokinetics of Infusional Therapy 36 Regional Therapy 37 4. Drug Administration Systems for Infusion Chemotherapy 41 Elton M. Tucker, B.S.M.E. Introduction 41 Patient Worn Extracorporal Systems 43 vii viii CONTENTS Implantable Infusion Systems 51 Alarms and Performance Status Information 57 5. Technical Aspects of Vascular Access for Infusional Chemotherapy 59 Albert Bothe, Jr., M.D., and John M. Daly, M.D. Introduction-Venous Access 59 Arterial Access 68 Summary 73 6. Nursing Management of Infusion Catheters 74 Cheryl L. Moore, R.N. Hickman Catheters 75 Subclavian Catheters 77 Implantable Venous Access Portals 78 Special Considerations 81 Management of Local Skin Effects 82 Complications Associated with Subclavian Catheters 84 Detection and Management of Infection 85 Hepatic Artery Catheters 91 Implantable Infusion Pump 94 Pump Complications 97 Conclusion 99 7. Pharmaceutical Issues in Infusion Chemotherapy Stability and Compatibility 100 John A. Benvenuto, Ph.D., Stephen C. Adams, Pharm.D., Harish M. Vyas, Ph.D., and Roger W. Anderson, M.S. Concepts and Definitions 100 Procedures for Study of Stability 102 Short-Term Stability 103 Long-Term Stability 109 Admixtures III Conclusion 113 SECTION II - CHEMOTHERAPEUTIC AGENTS 8. Antipyrimidines: 5-Fluorouracil and 5-Fluoro-2' -Deoxyuridine 117 Michael J. O'Connell, M.D. Clinical Trials of Fluorinated Pyrimidines Given by Short- and Long-Term Intravenous Infusions 118 Studies of Protracted Venous Infusion of the Fluorinated Pyrimidines 120 Contents ix 9. Mexthotrexate 123 Carmen J. Allegra, M.D., and Gregory A. Curt, M.D. Introduction 123 Theoretical Considerations 124 Clinical Investigations 126 Summary 129 10. Anthracyclines 130 Sewa S. Legha, M.D., Gabriel N. Hortobagyi, M.D., and Robert S. Benjamin, M.D. Introduction 130 General Considerations 131 Methods of Doxorubicin Infusion 132 Therapeutic Implications of Continuous Venous Infusion of Doxorubicin 137 Anthracycline Analogues 138 11. Cisplatin, Platinum Analogues, and Other Heavy Metal Complexes 145 Stephen P. Ackland, M.B., B.S., F.R.A.C.P., and Nicholas J. Vogelzang, M.D. Cisplatin 145 Intra-Arterial Cisplatin 153 Platinum Analogues 155 Gallium Nitrate (Ga(NOl)l) 157 Spirogermanium 159 12. Cytosine Arabinoside 161 Gregory A. Curt, M.D., Carmen J. Allegra, M.D., and Bruce D. Cheson, M.D. Background 161 Clinical Research 162 13. Periwinkle Alkaloids I: Vinblastine and Vindesine 167 Mark J. Ratain, M.D., Nicholas J. Vogelzang, M.D., and Gerald P. Bodey, M.D. Background 167 Rationale for Infusion 168 Vinblastine (Phase 1 Trials) 169 Vinblastine (Phase 2 Trials) 171 Vindesine (Phase 1 Trials) 174 Vindesine (Phase 2 Trials) 176 Conclusions 180 X CONTENTS 14. Periwinkle Alkaloids II: Vincristine 181 Don V. Jackson, Jr., M.D. Clinical Trials 185 Results 191 Discussion 195 15. Bleomycin 200 Robert B. Catalano, Pharm.D., and Robert L. Comis, M.D. Introduction 200 Mechanism of Action 200 Pharmacology 201 Bleomycin Toxicology 202 Animal Studies 202 Pharmaceutical Data 203 Clinical Trials in Humans 204 Testicular Cancer 204 Head and Neck Cancer 205 Cervical Cancer 205 Lymphomas 206 Other Tumors 207 Discussion 209 16. The Epipodophyllotoxins: VP-16 and VM-26 211 Nancy Phillips, R.Ph., and Robert L. Comis, M.D. Mechanism of Action 211 Clinical Pharmacology 212 Schedule Dependency 215 Pharmaceutical Data 215 Clinical Trials 215 Discussion 219 17. Alkylating Drugs and Other Agents 221 Jacob J. Lokich, M.D. Alkylating Agents 222 Antimetabolites 226 Miscellaneous Cytotoxic Agents 227 Summary 230 Contents xi 18. Investigational Agents 231 Merrill J. Egorin, M.D., F.A.C.P. 19. Protracted Infusional Chemotherapy 243 Jacob J. Lokich, M.D. Preclinical Pharmaceutical Studies 244 Phase 1 Studies 245 Summary of Phase 1 Trials of Protracted Infusion Chemotherapy 254 Phase 2 Studies 256 Phase 3 Trials 261 SECTION III - SYSTEMIC INFUSION BY TUMOR CATEGORY 20. Head and Neck Cancer 265 Efstathios Tapazoglou, M.D., and Muhyi AI-Sarraf, M.D., F.R.C.P.(C), F.A.C.P. Background 265 Rationale of Infusion Chemotherapy 269 Clinical Trials 271 Summary 279 21. Esophageal and Anal Cancer 281 Lawrence Leichman, M.D., Jacob J. Lokich, M.D., and Cynthia Leichman, M.D. Preoperative Versus Postoperative Therapeutic Concepts 281 Anal Canal Tumors 282 Squamous Cell Cancer of the Esophagus 285 Present and Future Status of Anal and Esophageal Cancer Therapy 289 22. Colorectal Cancer 291 Jacob J. Lokich, M.D. Standard Bolus 5-Fluorouracil 292 5-Fluorouracil and FUDR Continuous Infusion 294 Other Agents 300 Infusional 5-FU Concomitant with Radiation 301 Adjuvant Infusional Chemotherapy 302 Summary 302 xii CONTENTS 23. Gastric, Pancreas, and Biliary Tract Cancer 304 Geoffrey Falkson, M.D., and Baruch Klein, M.D. Conventional Treatment 304 Chemotherapy by Infusion for Stomach, Pancreas, and Biliary Tract Carcinoma 310 Intra-Arterial Therapy 312 Discussion 313 24. Breast Cancer 316 Sewa S. Legha, M.D. Infusion Studies of Doxorubicin 317 Continuous Infusion of Vinca Alkaloids 319 Continuous Venous Infusion Trials with Other Drugs 320 25. Infusion for Hematologic Malignancies 322 Murray M. Bern, M.D. Vinca Alkaloids 323 Epipodophyllotoxins 324 Antibiotics 325 Alkylating Agents 326 Antimetabolites 327 Metals 329 New Drugs 330 Combination Chemotherapy 332 Conclusions 337 26. Lung Cancer 338 Lucien Israel, Jean-Luc Breau, M.D., and Jean Franrois Morere, M.D. Theory and Background 338 Modalities of Administration of DDP-BLM and Associated Drugs 339 Modalities of Administration of 1 or 2 Complementary Drugs 340 Secondary Therapy Protocols in Relation to Clinical Situations 341 Results 345 Discussion 348 Other Trials of Infusion Chemotherapy 351 Summary 352 27. Testicular Cancer and Other Tumors of the Male Genitourinary Tract 353 Christopher J. Logothetis, M.D. Vinblastine and Bleomycin Combination in the Management of Germ Cell Tumors 353

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