Adjuvant Therapy of Cancer V

Edited by

Sydney E. Salmon, M.D.

Professor of MedicineSection of Hematology and Oncology

Department of Internal MedicineDirector, Arizona Cancer Center

University of Arizona College of MedicineTucson, Arizona

Grune & Stratton, Inc.Harcourt Brace Jovanovich, Publishers

Orlando San Diego New York LondonSan Francisco Tokyo Sydney Toronto

Contents

Preface xvii

Contributors xix

PART I Perspectives on Adjuvant Therapy

Drug Resistance and Adjuvant Therapy of CancerSydney E. Salmon 3

The Effect of Dose Intensity in Adjuvant ChemotherapyWilliam M. Hryniuk, Gianni Bonadonna, and PinucciaValagussa 13

Adjuvant Radiotherapy in Chemosensitive TumorsM. Tubiana, R. Arriagada, P. Carde, J.M. Cosset, andT. Le Chevalier 25

Current Status of Hyperthermia as an Adjuvant Therapeutic Modality/ . Robert Cassady 35

The Potential Role of Immunotherapy and Biological Therapyin the Adjuvant Therapy of Cancer

Evan M. Hersh 47

NCI/Extramural Clinical Trials of Interleukin-2 andLymphokine-Activated Killer Cells for Cancer Treatment

Geoffrey R. Weiss, David H. Boldt, and Charles A. Coltman, Jr. 57

The Concept of Neoadjuvant ChemotherapyEmil Frei III, John R. Clark, and Daniel Miller 67

PART II Head and Neck Cancer

The Role of Induction Chemotherapy in the Treatment of AdvancedHead and Neck Cancer

Waun Ki Hong, Isaiah W. Dimery, Alan M. Kramer, JosephineParedes, K. Thomas Robbins, and Bruce Campbell 79

vi Contents

Adjuvant Chemotherapy for Patients with Locally Advanced Headand Neck Cancer: RTOG and Wayne State University Experiences

Muhyi Al-Safraf, Bruce Reading, Julie A. Kish, John F. Ensley,Efstathios Tapazoglou, Thomas Pajak, Victor Marcial, andGeorge Laramore 89

Strategies for Improvements in Complete Response Rate withAdjuvant Combination Chemotherapy in Advanced Head and NeckCancer (SCC of H&N)

John F. Ensley, Julie A. Kish, Efstathios Tapazoglou,and Muhyi Al-Sarraf 101

The Significance of Primary Site in Assessing Chemotherapy Responseand Survival in Advanced Squamous Cell Carcinomas of the Head andNeck Treated with Initial Combination Chemotherapy without Cisplatin:Analyses at Nine Years

Bridget T. Hill and hen A. Price 111

Long Term Survival following Induction Chemotherapy for SquamousCell Carcinoma of the Head and Neck: A Ten Year Follow-Up

Daniel D. Karp, Charles W. Vaughan, Bernard Willett, TimothyHeeren, Nancy A. DiMartino, Miriam E. Vincent, Marie E. Picardi,andWaunKiHong 119

Neoadjuvant Chemotherapy and Irradiation for Stages HI and IV Headand Neck Cancer: Is Radical Surgery Necessary?

Sidney P. Kadish, Neil Cohen, H. William Conway, David M.Sherman, Joel H. Schwartz, Gary M. Strauss, and Paul A.Ricciardi 129

Etoposide/Platinum Neoadjuvant Chemotherapy for Infants withPrimary Malignant CNS Tumors

John J. Hutter, Jr., Paul S. Meltzer, and J. Robert Cassady 139

PART m Lung Cancer

Adjuvant Chemotherapy Approaches in Non-Small Cell Lung CancerRichard J. Gralla, Mark G. Kris, Nael Martini, Laura V.Stampleman, and M. Thomasine Burke 147

Effectiveness of Adjuvant Chemotherapy in Operable Non-Small CellLung Cancer (NSCLC)

Joseph Ayoub, Andre Duranceau, Gilles Lorange, Andre Robidoux,James Hanley, Arthur Page, Alfred Joassin, Daniel Doyle, Edwin

Contents vii

Richard Lafontaine, Pierre Delvecchio, Rita Jean-Francois, Jean-Jacques Gauthier, Jacques Lemay, Anne-Marie Nutini, GeorgesArjane, Robert Lesage, Walter Schurch, Nicole Cave, JeanneDionne, and Participating RICUM Investigators 157

Neoadjuvant Mitomycin, Cisplatin, and Infusion Vinblastine withReduced Pulmonary Toxicity in Stage III Non-Small Cell Lung Cancer

Robert C. Spain, James Jost, Tobias Kircher, John F. Speer, Paul N.Anderson, Charles J. Zinn, Dudley Kersey, and John Schiller 165

Long Term Follow-Up after Induction Chemotherapy with or withoutChest Radiation in Limited Small Cell Lung Cancer

Cynthia A. Radosevich, Merrill S. Kies, David J. Bannon, JoaquinG. Mira, JohnJ. Crowley, and Robert B. Livingston, for theSouthwest Oncology Group 179

Combined Modality Treatment after Surgery for Cure for Small CellBronchial Carcinoma at TNM-Stage I

Karl Karrer, Helmuth Denck, Hanna Karnicka-Mlodkowska, PeterDrings, Janez Erzen, Yan Sun, Michael Thermann, Bulent Berkarda,Mei-lin Liao, Davide Dell'Amore, and Johannes Rothmundjor theISC-Lung Cancer Study Group 189

Prospective Clinical Trial of Individualized Chemotherapy Based onIn Vitro Drug Sensitivity Testing in Extensive Stage Small Cell LungCancer

Daniel C. Ihde, Edward K. Russell, Herbert K. Oie, R. Ilona Linnoila,Seth M. Steinberg, Bimal C. Ghosh, Harold R. Schumacher, John D.Minna, and Adi F. Gazdar 201

PART IV BREAST CANCER CHEMOTHERAPY: STAGES I-n

Milan Adjuvant Trials for Stage I-II Breast CancerG. Bonadonna, P. Valagussa, M. Zambetti, R. Buzzoni, and A.Moliterni 211

Adjuvant Chemotherapy in Node-Negative Breast Cancer PatientsR. Jakesz, R. Kolb, G. Reiner, M. Schemper, H. Rainer, C. Dittrich,and A. Reiner 223

Adjuvant Chemotherapy for Tl-2, NO, MO Estrogen Receptor NegativeBreast Cancer: Preliminary Results of a Randomised Trial

C.J. Williams, R.B. Buchanan, V. Hall, I. Taylor, T. Cooke, R.Nicholson, and K. Griffiths 233

viii Contents

Update of Swiss Adjuvant Trials with LMF and CMF in OperableBreast Cancer

Hans-Jorg Senn and Regula Barett-Mahler, for the OSAKO- andSAKK Groups 243

Neoadjuvant Chemotherapy in Breast Cancer: As Single PerioperativeTreatment and with Supplementary Long-Term Chemotherapy

Roar Nissen-Meyer, Herman H0st, Kjell Kjellgren, Bror Mdnsson,and Torsten Norin 253

Breast Cancer Adjuvant Therapy Trials at the Arizona Cancer CenterUsing Adriamycin and Cyclophosphamide

W.S. Dalton, RJ. Brooks, S.E. Jones, S.E. Salmon, S.J. Ketchel,G.F. Giordano, RA. Jackson, K. Mosley, andDJ. Slymen 263

Consistencies and Variations of Observations during Serial Analysesof a Trial of Adjuvant Chemotherapy in Breast Cancer

G. Mathe, R. Plagne, V. Morice, andJL. Missetjor theOncoFrance Breast Cancer Trial Group 2 71

PART V BREAST CANCER STAGE II:CHEMOTHERAPY AND COMBINED MODALITY

Long Term Results from NSABP Trials of Adjuvant Therapy forBreast Cancer

Bernard Fisher, Carol K. Redmond, Norman Wolmark, andNSABP Investigators 283

Adjuvant Therapy for Breast Cancer: The Ludwig Breast CancerTrials 1987

Aron Goldhirsch and Richard D. Gelberjor the Ludwig BreastCancer Study Group 297

The West Midlands Oncology Association Trials of AdjuvantChemotherapy for Operable Breast Cancer

John Michael Morrison, Anthony Howell, Robert J. Grieve, IanJ. Monypenny, Rosemary Walker, KrysA. Kelly, and John A.Waterhouse 311

Adjuvant Chemotherapy Trials of Breast Cancer: A Progress Reportfrom the Multicentre Cancer Chemotherapy Group (U.K.)

Bridget T. Hill, Margaret F. Spittle, M.J. Ostrowski, K.D. MacRae,andThelmaD. Bates 319

Contents ix

Adjuvant Chemotherapy for Breast Carcinoma Using CMFVP versusCMF versus CMF-MER: The Nine Year Results for Patients with1-3 Axillary Nodes

Raymond B. Weiss, Ann H. Korzun, Douglas C. Tormey, James F.Holland, Mary Alice Rice, William C. Wood, and ParticipatingCALGB Investigators 327

Adjuvant Systemic Risk Adapted Cytotoxic ± Tamoxifen Therapy inWomen with Node Positive Breast Cancer

Manfred Kaufmann, Walter Jonat, Hans Caffier, RolfKreienberg,Jbrn Hilfrich, Ulrich Abel, Heinrich Maass, and Fred Kubli, forthe Gynecological Adjuvant Breast Group (GABG) 337

Postsurgical Adjuvant Chemotherapy with or without Radiotherapy inWomen with Breast Cancer and Positive Axillary Nodes: Progress Reportof a Southeastern Cancer Study Group (SEG) Trial

Enrique Velez-Garcia, John T. Carpenter, Jr., Melvin Moore, CharlesL. Vogel, Victor Marcial, Alfred Ketcham, Marilyn Raney, andRichard Smalley 347

The Effect of Post-Operative Radiotherapy on Adjuvant Chemotherapyfor Stage II and HI Breast Carcinoma

Simon G. Tang, Fang-Jen Lin, and Ming-Shen Chen 357

Influence of the Sequencing of Chemotherapy and Radiation Therapy inNode-Negative Breast Cancer Patients Treated by Conservative Surgeryand Radiation Therapy

Stacey M. Gore, Steven E. Come, Katherine Griem, Mary Ann Rose,Abram Recht, Leslie E. Botnick, Christopher Rose, Geoffrey Beadle,Barbara Silver, I. Craig Henderson, and JayR. Harris 365

PART VI: BREAST CANCER: HORMONAL THERAPY

The Role of Adjuvant Endocrine Therapy in Primary Breast CancerMichael Baum, Alan J. Wilson, and Stephen R. Ebbs 377

Adjuvant Tamoxifen in Postmenopausal Women with Axillary NodePositive Breast Cancer: An Update

Kathleen I. Pritchard, J. William Meakin, Norman F. Boyd, GerritDeBoer, Alexander H.G. Paterson, Ulo Ambus, Alon J. Dembo,Donald J.A. Sutherland, Robert H. Wilkinson, Alan A. Bassett, WilliamK. Evans, Francis A. Beale, Roy M. Clark, and Thomas J. Keane,for the Toronto-Edmonton Breast Cancer Study Group 391

x Contents

PART VII BREAST CANCER STAGE ni : CHEMOTHERAPY ANDCOMBINED MODALITY

Neo-Adjuvant Chemotherapy in the Conservative Management of BreastCancer: A Study of 205 Patients

Claude Jacquillat, Marise Weil, Gerard Auclerc, Marie-FrangoiseAuclerc, David Khayat, and Frangois Baillet 403

Breast Cancer Adjuvant Therapy Trials of M. D. Anderson Hospital:Results of Three Studies

Aman U. Buzdar, Gabriel N. Hortobagyi, Shu-Wan Kau, Terry L.Smith, Giuseppe Fraschini, Frankie Ann Holmes, Verena Hug, Luis T.Campos, Frederick C. Ames, and Richard G. Martin 411

Induction Chemotherapy for Stage in Primary Breast CancerGabriel N. Hortobagyi, Shu Wan Kau, Aman U. Buzdar, Frederick C.Ames, Marsha D. McNeese, Debra Frye, Frankie Ann Holmes,Giuseppe Fraschini, Verena Hug, Richard G. Martin, andEleanor D.Montague 419

Neo-Adjuvant Chemotherapy with Estrogenic Recruitment in LocallyAdvanced Breast Cancer

Paolo Pronzato, Pier Franco Conte, Angela Alama, GiuseppeCanavese, Giovanni Gardin, Angelo Nicolin, andRiccardo Rosso 429

PART VIII BREAST CANCER: BIOLOGICAL FACTORS ANDNEW ANALYTIC APPROACHES

The Importance of DNA Flowcytometry for Adjuvant Studies, inParticular in Node Negative Patients

G.H. Blijham, B. Schutte, M. Reynders, and L. Schouten 439

Long-Term Tamoxifen Therapy to Control Transplanted Human BreastTumor Growth in Athymic Mice

Marco M. Gottardis, Mary K. Martin, and V. Craig Jordan 447

Time without Symptoms and Toxicity (TWiST): A Quality-of-Life-Oriented Endpoint to Evaluate Adjuvant Therapy

Richard D. Gelber, Arori Goldhirsch, Monica Castiglione, KarenPrice, Mary Is ley, and Alan Coates.for the Ludwig Breast Cancer.Study Group 455

Meta-Analysis: Considerations of Its Worth and Its LimitationsCarol K. Redmond and Howard E. Rockette 467

Contents xi

PART IX GASTROINTESTINAL CANCER

Adjuvant Therapy of Gastrointestinal CancerJohn S. Macdonald 479

Neoadjuvant Chemoradiotherapy for Resectable GastroesophagealJunction Adenocarcinoma

Paul L. Weiden, Lucius D. Hill, Richard A. Kozarek, Mark D.Hafermann, John A. Ryan, Jr., and David J. Patterson, for theVirginia Mason Medical Center 497

Adjuvant Chemotherapy in Gastric CarcinomaR. Jakesz, C. Dittrich, J. Funovics, H. Rainer, M. Schemper, andR. Schiessel 507

Postoperative Immunochemotherapy with Mitomycin C, Futraful, andPSK for Curatively Resected Cases of Gastric Cancer

Minoru Niimoto, Takao Hattori, Ryuichiro Tamada, KeizoSugimachi, Kiyoshi Inokuchi, and Nobuya Ogawa 515

Confirmation by the Gastrointestinal Tumor Study Group that SurvivalFollowing Potentially Curative Resection of Pancreatic Cancer isImproved by Multidisciplinary Postoperative Therapy

Harold O. Douglass, Jr., Donald M. Stablein, Martin H. Kaiser,Donald W. Weaver, John C. Marsh, Paul V. Woolley, Howard W.Bruckner, Bernard Levin, Arthur H. Knowlton, and SethM. Steinberg 525

Adjuvant Therapy in Carcinoma of the Colon: Five Year Results ofNSABP Protocol C-01

Norman Wolmark, Bernard Fisher, and Howard E. Rockette \ 531

The Australia and New Zealand Trial of Adjuvant Chemotherapy inColon Cancer

Bruce N. Gray, Jill deZwart, Richard Fisher, Ivon Burns, RonaldHurley, William Isbister, Hedy Mameghan, Graeme Newstead, andPhillip Reasbeck,for the Gastrointestinal Group of the ClinicalOncological Society of Australia 537

Adjuvant Chemotherapy or Postoperative Radiation for Rectal Cancer:5 Year Results of NSABP R-01

Bernard Fisher, Norman Wolmark, Howard E. Rockette, and Carol K.Redmond 547

xii Contents

PART X GENITOURINARY CANCER

Neoadjuvant and Adjuvant Chemotherapy for Urothelial Tract TumorsAlan Yagoda 555

Adjuvant CISCA for Patients with High Risk Bladder CancerChristopher J. Logothetis, Douglas E. Johnson, Clayton Chong,Francisco H. Dexeus, Sheryl Ogden, Andrew C. von Eschenbach,and Alberto G. Ayala 565

Long-Term Control of Locally Advanced Transitional Cell BladderCancer (TCCB) by High-Dose Intensity, Circadian-Based AdjuvantChemotherapy

Reinhard V. Roemeling, William J.M. Hrushesky, and Elwin E.Fraley 571

Adjuvant Medroxyprogesterone Acetate to Radical Nephrectomy inRenal Cell Carcinoma

Giorgio Pizzocaro, Luigi Piva, Giovanni di Fronzo, AlbertoCozzoli, Augusto Giongo, Silvano Minervini, Enrico Dormia,Umberto Fontanella, Alberto Zanollo, Giovanni Longo, andAugusto Maggioni 581

Early Stage Testis Cancer: The Testicular Cancer Intergroup StudiesStephen D. Williams, Donald Stablein, Franco Muggia, Lawrence H.Einhorn, Richard Hahn, John P. Donohue, Kurt Brunner, WilliamDe Wys, David Crawford, Joseph Spaulding, Raymond B. Weiss, RobertGolbey, Edwin Mark Jacobs, and David Paulson 587

Long-Term Survival Rates in Stage I and Stage II Germ Cell Tumorsof the Testis

Davor Vugrin, Amy Chen, and Polly Feigl 593

Stage II Nonseminomatous Testicular Tumours: Necessity and Extent ofAdjuvant Chemotherapy

Joachim H. Hartlapp, Lothar Weifibach, and Bettina Horstmann-Dubral, for the Testicular Tumour Study Group Bonn 603

Adjuvant and Neoadjuvant Vincristine, Bleomycin, and Methotrexate(VBM) for Inguinal Metastases of Penile Cancer

Giorgio Pizzocaro and Luigi Piva 613

Contents xiii

PART XI GYNECOLOGIC CANCER

Adjuvant Therapy in Gynecologic Cancer: The GOG Experience/ . Tate Thigpen and Brian Bundyjor The Gynecologic OncologyGroup 619

Stage III Optimal Disease Ovarian Cancer Relatively Resistant toAdjuvant Cisplatin Chemotherapy In Vitro and In Vivo

David S. Alberts, Nancy Mason-Liddil, Earl A. Surwit, Robert V.O'Toole, Richard Kronmal, Donald J. Slymen, and Sydney E.Salmon 629

Survival of Patients with Small Volume, Refractory Ovarian CarcinomaTreated with Intraperitoneal Cisplatin-Based Chemotherapy

Solomon Zimm, Maurie Markman, Stephen M. Cleary, IanAbramson, William Lucas, and Stephen B. Howell 637

PART XH MELANOMA

Improvement in Disease-Free Survival of Melanoma Patients inConjunction with Serological Response in a Phase Ia/Ib SEG Trialof Vaccinia Melanoma Oncolysate (VMO)

Marc K. Wallack, Jerry A. Bash, Evelyn S. Darnell, and Alfred A.Bartolucci 647

Adjuvant Immunotherapy of M.D. Anderson Stage III-B MalignantMelanoma with Newcastle Disease Viral Oncolysate

Carl Plager, James M. Bowen, Claudia J. Fenoglio, Nicholas E.J.Papadopoulos, Lee Murray, Sant P. Chawla, Robert S. Benjamin,HE. Savage, R D. Rossen, and E.M. Hersh 657

Randomized Trial of BCG ± Vitamin A for Stages I and II CutaneousMalignant Melanoma

Frank L. Meyskens, Jr., Ann E. Booth, Paula Goff, and Thomas E.Moon 665

Adjuvant Perfusion Chemotherapy of Cutaneous Malignant Melanoma:With Minimum 5 Year Follow-Up

Vishram B. Rege, Louis A. Leone, Clarence H. Soderberg, George V.Coleman, Henry J. Robidoux, Ruben Fijman, Jeanne Brown, andCyrus R. Mehta 671

xiv Contents

In Vitro Bioassay for Testing Perfusate Toxicity in Isolation Perfusion forExtremity Melanoma

K.H. Link, W. Kuehn, K.R. Aigner, and H. Voigt 679

PART XHI SARCOMA

A Randomized Prospective Trial of Adjuvant Chemotherapyfor Osteosarcoma

Frederick R. Eilber, Armando E. Giuliano, Jeffrey Eckardt, KarenPatterson, H. Stephens Moseley, and James Goodnight, Jr. 691

Preoperative Intra-Arterial Cisplatin and Limb-Salvage Surgery forPatients with High-Grade Osteosarcoma of the Extremities

Sant P. Chawla, Robert S. Benjamin, Norman Jaffe, Cesar H. Carrasco,A. Kevin Raymond, Alberto Ayala, Sidney Wallace, Terri Armen,Nicholas EJ. Papadopoulos, Carl Plager, and John A. Murray 701

Neoadjuvant Chemotherapy for Localized Osteosarcoma ofthe Extremities: Experience Related to 112 Cases Treated betweenMarch 1983 and June 1986

Piero Pied, Gaetano Bacci, Rodolfo Capanna, Mario Mercuri, NicolaBaldini, Giovanni Pignatti, Pietro Ruggieri, Roberto Biagini, Mad-dalena Avella, Mario Campanacci, Enrico Madon, Adalberto Brach delPrever, Guido Paolucci, andAntonia Mancini 711

Postoperative Adjuvant Chemotherapy (Adriamycin) in High GradeExtremity Soft Tissue Sarcoma: A Randomized Prospective Trial

Frederick R. Eilber, Armando E. Giuliano, James F. Huth, andDonald L. Morton 719

A Preliminary Analysis of a Randomized Intergroup (SWOG, ECOG,CALGB, NCOG) Trial of Adjuvant Doxorubicin for Soft TissueSarcomas

Karen Antman, David Amato, Michael Pilepich, Harvey Lerner,Stanley Balcerzak, Ernest Borden, and Laurence Baker 725

The Importance of Combination Chemotherapy for Adjuvant Treatmentof High-Risk Patients with Soft-Tissue Sarcomas of the Extremities

Roberts. Benjamin, Terenij O. Terjanian, Claudia J. Fenoglio,Howard T Barkley, Harry L. Evans, William K. Murphy, andRichard G. Martin 735

Contents xv

Prospective Randomized Trial Examining the Cardiac Toxicity ofAdjuvant Doxorubicin in High Grade Extremity Sarcomas

Murray F. Brennan, Claudia Friedrich, LoisAlmadrones, andGordon Magill 745

PART XIV LYMPHOMA

Chemotherapy with or without Adjuvant Radiotherapy for Stage Iand II Large Cell Lymphoma

Stephen E. Jones, Thomas P. Miller, Joseph M. Connors, andDenise Roe 755

Chemotherapy Plus Radiotherapy for Hodgkin's Disease: ClinicalStages IA and IIA

Jean-Marie Andrieu, Philippe Casassus, Bernard Desablens, Jean-Luc Harousseau, Jean Briere, Jean-Marc Tourani, Annick Lemevel,Norbert Ifrah, Max Dana, Yvan Coscas, and Claude Jacquillat 763

Two Cycles of MOPP as Adjuvant Therapy for Stage I-JJ Hodgkin'sDisease

Frederick B. Hagemeister, Lillian M. Fuller, William S. Velasquez,Peter McLaughlin, and Fernando Cabanillas 773

Adjuvant Radiotherapy for Advanced Hodgkin's Disease: 15 YearSurvival Data

Leonard R. Prosnitz, Leonard R. Farber, Joseph R. Bertino, SamuelN. Bobrow, Arthur L. Levy, and W. Bruce Lundberg 783

PART XV CONFERENCE SUMMARY

Conference SummaryLawrence H. Einhorn 795

Index 803