about this report - swog 1995/introduction.pdf · about this report john crowley, ph.d. statistical...

INTRODUCTION/

ADMINISTRATIVE

INFORMATION

Southwest Oncology Group Meeting

April 29 - May 1, 1995

APRIL 29 - MAY 1, 1995 SOUTHWEST ONCOLOGY GROUP INTRO/AI)MIN INFORM 1

CONTENTS

About This Report .................................. 3

Southwest Oncology Group Operations Office Staff ................ 4

Southwest Oncology Group Statistical Center Staff ................. 5

Statistical Center Disease and Discipline Committee Teams ............ 6

Southwest Oncology Group - Holiday Schedule .................. 7

Future Southwest Oncology Group Meetings .................... 7

Southwest Oncology Group Publications List .................... 8

2 INTRO/ADMIN INFORM SOUTHWEST ONCOLOGY GROUP APRIL 29 - MAY 1, 1995

About This Report

John Crowley, Ph.D.

Statistical Center Director

The tables and graphs of "Initial Registrations" in the Accrual Summary of this Report of Studies reflect one credit forthe INITIAL registration to any protocol, whether therapeutic, cancer control, or ancillary. "Therapeutic Credits" and"Cancer Control Credits" are those assigned by the Division of Cancer Prevention and Control of the National CancerInstitute. As a generalization, the initial registration to most therapeutic studies is assigned one credit, 1.5 credits areassigned to officially designated NCI high priority studies, and 2.0 credits are given to certain acute leukemia studies.Credits for cancer control studies vary widely but are generally less than one credit per registration.

The survival plots in this Report of Studies are derived according to the Kaplan-Meier method (1), also known as theproduct-limit method. Censored observations are marked on the curve with a tic representing the last follow-up time. Itshould be stressed that these curves are subject to statistical variability, especially in the right-hand tail where there arefew observations, and should be interpreted cautiously. The median survival (point where the curve crosses 50%) shown for each curve where appropriate, and confidence intervals for the median are given in the summary statements -Brookmeyer and Crowley (2). Formal statistical tests of the differences between curves may also be shown, the mostcommonly used test statistic being the logrank test (3). This is the statistic of choice when treatment differences arerelatively constant over time (as opposed to the situation where curves cross, or differences are predominantly early orlate in the study period). Treatment comparisons adjusted for prognostic factors may also be done and described in theSummary Statement; these are most often done using stratified logrank tests and/or modeling the influence of prog-nostic factors using Cox regression (4). More details on the use of these techniques of survival analysis can be found the review by Crowley and Breslow (5). Definitions used for toxicity grades and solid tumor response categories can found in Green and Weiss (6).

Distribution of the Report of Studies is changing, effective Spring 1995. Starting at the Phoenix meeting, boundReports will be available to everyone who attends the Group Meeting; they can be picked up at the Registration Desk.Head Data Managers will be mailed one bound and one unbound copy for local use and copying. PCPT Head DataManagers will get a report on SWOG-9217 only. These mailings should arrive before the meeting.

References:

(1) Nonparametric estimation from incomplete observations. Kaplan EL, Meier P. JASA, 53:457-481, 1958.

(2) A confidence interval for the median survival time. Brookmeyer R, Crowley J. Biometrics, 38:29-41,1982.

(3) Evaluation of survival data and two new rank order statistics arising in its consideration. Mantel N. CancerChemotherapy Reports, 50:163-170, 1966.

(4) Regression models and life tables. Cox DR. J R Star Soc Ser B, 34:187-202, 1972.

(5) Statistical analysis of survival data. Crowley J, Breslow N. Ann Rev Public Health, 5:395-411, 1984.

(6) Southwest Oncology Group standard response criteria, endpoint definitions and toxicity criteria. Green S, WeissGR. Invest New Drugs, 10:239-253, 1992.

APRIL 29 - MAY l, 1995 SOUTHWEST ONCOLOGY GROUP INTRO/ADMIN INFORM 3

Southwest Oncoiogy Group Operations Office Staff

Charles A. Coltman, Jr., M.D. Chairman

Mace L. Rothenberg, M.D. Executive Officer

Geoffrey R. Weiss, M.D. Associate Executive Officer

Marjorie A. Godfrey Director of Operations

Dee Daniel Public Relations Coordinator

Dana B. Sparks, M.A.T. Chief Protocol Coordinator: Breast, Melanoma, Lymphoma,GYN, [-lead & Neck and Women’s Health

Francine Fuentes Protocol Coordinator: GU; Surgery designate

Patricia Gotierrez Protocol Coordinator: Lung, Leukemia, Brain, and Myeloma;Bone Marrow Transplant; Radiotherapy designate, Pathologyand Flow Cytometry designate

Genevieve Lozano Protocol Coordinator: Cancer Control, GU, Sarcoma,Developmental Therapeutics, Stomatology

Dennis Cooper Quality Assurance Coordinator

Melinda Guerrero, M.B.A. Quality Assurance Associate Coordinator for PCPT

Elaine Armstrong Quality Assurance Auditor

Gina Atwood Adverse Drug Reaction/lnvestigational New Drug Specialist

Judy A. Attaway Programs Assistant

Myra Lewis, M.B.A. Financial Coordinator

Marilyn Cox Accounting Specialist

Iris Kohlleppel Accounting Specialist

Sue Davis, M.M.S. Projects Coordinator

Leticia Eltiott Projects Secretary

Kimberly Jacobs Meetings Manager

Connie Barnes Programs Manager

Marilyn Bourquin Protocol Word Processing Specialist

R.C. "Dick" Boward, Jr., M.S. Computer Specialist/596/310 Program

Lynne Beavers Membership/Assurance Specialist

Janet Graft Publication Specialist/Slide Development/Procurement

Jo Lynn Hall Receptionist

Juan "Tony" Santiago Mail Room Specialist


Southwest Oncology Group Statistical Center Staff

John Crowley, Ph.D., DirectorStephanie Green, Ph.D., Deputy Director

Brent Blumenstein, Ph.D., Deputy DirectorJacqueline Benedetti, Ph.D., Coordinating Statistician

Steve Dahlberg, M.S., Coordinating Statistician

Administration Biostatistics

Kathie Roth, B.S., Project Administrator Polly Feigl, Ph.D.Donna Wood, Administrative Coordinator Kenneth Kopecky, Ph.D.Anita Pang, Administrative Assistant Michael LeBlanc, Ph.D.Marcelle Aquino, Secretary PY Liu, Ph.D.Aletha Concepcion, Secretary Barbara McKnight, Ph.D.

Joth Jacobson, M.S.Danika Lew, M.A.

Data Operations Laura Loll, M.S.Janet O’Sullivan, M.A.

Evonne Mize, Data Operations Manager Cathryn Rankin, M.S.Laura Kingsbury, M.R.T., Data Operations Dorothy Rector, M.S.Technical Manager Joseph Unger, M.S.

Susan Carlin, B.A., Data CoordinatorSupervisor

Programming

Data Coordinators: Steve Condit, Ph.D., Data Base Manager

Kristie Beasley, A.R.T. Carl Benson, B.S.Lisa Bump, B.S. Kelly Landreth, B.S.Claire Chapdu, B.A., A.R.T. David Law, B.S.Eileen Hess, B.S. Laura McDonaldCole Johnson Jeanne-Marie Smith, M.A.Monica Lee, B.A. Andrea Spading, B.S.Diana Lowry, B.A. Debbie SpicerDona Marrah Ron West, B.A.Janet Quade, B.S.Angela Ribble, B.A.Kathy Sears Prostate Cancer Prevention TrialJohn VanDamme, B.S., B.A.Patricia Waldman Phyllis Goodman, M.S., Lead Statistician

Data Control Team: Anne-Marie Ryan, R.N., Project ManagerLynda Emel, Ph.D., Data Coordinator Lead

Marcia Foster, Office Worker Lori Filipcic, Data Coordinator

Gwen Morgan, File Room Secretary Nena Gannon, Data Coordinator

Sunga Rose, Receptionist Debbie Rupert, A.R.T., Data Coordinator

Millie Wisecup, Data Control Technician Trudi White, B.Ph., Data CoordinatorRichard Grassy, Data Control TechnicianRaquelle Samuels, Data Control Technician

Behavioral Scientist Christine Sargent, Data Control TechnicianCarol Sehmidt, B.A., Data Control

Carol Moinpour, Ph.D. Technician

Sandy Piheros, P.A., Research Assistant Shannon Hill, B.M., Program AssistantAnnie Brophy-Sitter, Data Entry Operator

APRIL 29 - MAY 1, 1995 SOUTHWEST ONCOLOGY GROUP INTRO/ADMIN INFORM 5

Statistical Center Disease and Discipline Committee Teams

Committee Data Coordinators Biostatisticians

Brain Angela Ribble Dorothy RectorLaura Loll

Breast Eileen Hess Stephanie GreenDiana Lowry Janet O’SullivanAngela RibblePatricia Waldman

Gastrointestinal Lisa Bump Jacqueline BenedettiJohn VanDamme Joth Jacobson

Genitourinary Dona Marrah Brent BlumensteinCole Johnson Danika LewKathy Sears

Gynecology Claire Chapdu PY LiuJanet Quade Janet O’Sullivan

Head & Neck Monica Lee Michael LeBlancDanika Lew

Leukemia Laura Kingsbury Kenneth KopeckyCathryn Rankin

Lung Kristie Beasley John CrowleyDorothy RectorLaura Loll

Lymphoma Susan Carlin Steve DahlbergEvonne Mize Danika LewDiana Lowry

Melanoma Claire Chapdu PY LiuJoseph Unger

Myeloma Angela Ribble John CrowleyJoth Jacobson

Sarcoma Eileen Hess Michael LeBlancCathryn Rankin

Cancer Control Research Monica Lee Polly FeiglDona Marrah Laura Loll

Barbara McKnightJanet O’Sullivan

Pathology Eileen Hess Cathryn RankinJohn VanDamme

Radiation Therapy Jan Quade Dorothy Rector

Surgery Lisa Bump Joth Jacobson

Bone Marrow Transplant -- Steve Dahlberg

Solid Tumor Cytogenetics -- Cathryn Rankin

Women’s Health -- Dorothy RectorJoth Jacobson


Southwest Oncology Group - Holiday Schedule

Statistical Center Holiday Operations Office

Battle of Flowers Fri - April 28, 1995

Mon - May 29, 1995 Memorial Day Mon - May 29, 1995

Tue - July 4, 1995 Independence Day Tue - July 4, 1995

Mon- Sept 4, 1995 Labor Day Mon - Sept 4, 1995

Future Southwest Oncology Group Meetings

Fri-Sun, Oct 27-29, 1995 Hyatt Regency New OrleansNew Orleans, Louisiana

Sat-Mon, Apt 27-29, 1996 Hyatt Regency San Francisco AirportBurllngame, California

Sat-Mon, Oct 19-21, 1996 Hyatt Regency at O’Hare AirportRosemont, Illinois

Fri-Sun, Apt 4-6, 1997 Loews Anatole HotelDallas, Texas


SOUTHWEST ONCOLOGY GROUPPUBLICATIONS LIST

1994

CommitteeStudy #

Brain8834 A phase II evaluation of fazarabine in high-grade gliomas: A Southwest

Oncology Group study. GB Selby, C Upchurch, J Townsend, HJ Eyre. CancerChemotherapy and Pharmacology 34(2):179-180, 1994.

Breast7827 Adjuvant CMFVP versus tamoxifen versus concurrent CMFVP and tamoxifen

for postmenopausal, node-positive and estrogen receptor-positive breast cancerpatients: A Southwest Oncology Group study. SE Rivkin, S Green, B Metch,AB Cruz, MD Abeloff, WR Jewell, JJ Costanzi, WB Farrar, JP Minton, CKOsborne. Journal of Clinical Oncology 12(10):2078-2085, 1994.

8608 Phase II evaluation of mitoxantrone plus CIS-platinum in patients withadvanced breast cancer: A Southwest Oneology Group study. JO Atiba, SJGreen, HE Hynes, CK Osborne, TP Miller, M Davidner. lnvestigational NewDru~5 12:129-132, 1994.

8746 Failure of GM-CSF to permit dose-escalation in an every other week dose-intensive regimen for advanced breast cancer. CK Osborne, MC Sunderland,JA Neidhart, PM Ravdin, MD Abeloff. Annals of Oncology 5:43-47, 1994.

8811 Phase II trial of 5-fiuorouracil and high-dose folinic acid as first or second-linetherapy for advanced breast cancer. KA Margolin, S Green, K Osborne, JHDoroshow, SA Akman, LA Leong, RJ Morgan, JW Raschko, G Somlo, LHutchins, C Upchurch. American Journal of Clinical Oncology 17(2):175-180,1994.

Multiple Current trials and future directions of the Southwest Oncology Group (SWOG)Studies Breast Cancer Committee. CK Osborne. Cancer 74(3):1135-1138, 1994.

None Breast cancer outcome and predictors of outcome: Are there age differentials?KS Albain, DC Allred, GM Clark. Journal of the National Cancer InstituteMonographs 16:35-42, 1994.

Gastrointestinal8411 Phase 11 trial of dimethyl triazeno imidazole carboxamide in patients with

metastatic carcinoid. A Southwest Ontology Group study. RM Bukowski, CMTangen, RF Peterson, SA Taylor, JJ Rinehart, HJ Eyre, SE Rivkin, T Fleming,JS Macdonald. Cancer 73(5):1505-1508, 1994.

8623 Phase 11 trial of trimetrexate in untreated advanced gastric carcinoma. ASouthwest Oncology Group study. A Hantel, CM Tangen, JS Macdonald, SPRichman, RP Pugh, T Pollock. lnvestigational New Drugs 12:155-157, 1994.

8 INTRO/ADMIN INFORM SOUTHWEST ONCOLOGY GROUP APRIL 29 - MAY I, 1995

Gastrointestinal (cont)8896 Improved adjuvant therapy for rectal cancer by combining protracted-infusion(INT-0114) fluorouracil with radiation therapy after curative surgery. MJ O’Connell, JA

Martensou, HS Wieand, JE Krook, JS Macdonald, DG Hailer, RJ Mayer, LLGunderson, TA Rich. New England Journal of Medicine 331(8):502-507, 1994.

8936 Phase II trial of piroxantrone in gastric carcinoma: A Southwest OncologyGroup study. A Hantel, C Tangen, WL Gluck, JS Macdonald. InvestigationalNew Drugs 12(2):159-161, 1994.

9006/9118 Association of iutratumoral pharmacokinetics of fluorouracil with clinicalresponse. CA Presant, W Wolf, V Waluch, C Wiseman, P Kennedy, D Blayney,RR Brechner. Lancet 343:1184-1187, 1994.

9006/9118 Measurement of human tumor pharmacokinetics in vivo noninvasively by 19-Fmagnetic resonance spectroscopy predicts clinical 5-FU sensitivity andresistance. CA Presant, W Wolf, V Waluch, R Brechncr, C Wiseman, DWBlayney, P Kennedy. Cancer Treatment, An Update 757-758, 1994.

Genitourinary8494 Prognostic factors in stage D2 prostate cancer; important implications for future(INT-0036) trials: Results of a cooperative intergroup study (INT.0036). MA Eisenberger,

ED Crawford, M Wolf, B Blumenstein, DG McLeod, R Beuson, FA Dorr, MBenson, JT Spaulding. Seminars in Oncology 21(5):613-619, 1994.

8509 Phase It trial of menogaril in metastatic adenocarcinoma of the prostate: ASouthwest Oncology Group study. SA Taylor, B Blumenstein, RL Stephens, EDCrawford, B Pistone, JB Hill. Investigational New Drugs 12:67-70, 1994.

8509/8708 Effects of continued androgen-deprivation therapy and other prognostic factors8719/8722 on response and survival in phase II chemotherapy trials for hormone-refractory8955 prostate cancer: A Southwest Oncology Group report. M Hussain, M Wolf, E

Marshall, ED Crawford, M Eisenberger. Journal of Clinical Oncology12(9):1868-1875, 1994.

8722 Phase I1 trial of amonafide for the treatment of advanced, hormonally refractorycarcinoma of the prostate. A Southwest Oncology Group study. ME Marshall,B Blumenstein, ED Crawford, IM Thompson, JB Craig, M Eisenberger, FAhmann. American Journal of Clinical Oncology 17(6):514-515, 1994.

8794 An opportunity to determine optimal treatment of pT3 prostate cancer: The(1NT-0086) window may be closing. IM Thompson, JC Paradelo, ED Crawford, CA

Coltman, B Blumenstein. Urology 44(6):804-811, 1994.

8926 Evaluation of low dose continuous infusion 5-fluorouracil in patients withadvanced and recurrent renal cell carcinoma: A Southwest Oncology Groupstudy. JA Kish, M Wolf, ED Crawford, JT Leimert, A Bueschen, JR Neefe, RCFlanigau. Cancer 74(3):916-919, 1994.


Genitourinary (cont)8929 Phase lI evaluation of merbarone in renal cell carcinoma. RC Flanigan, JH

Saiers, M Wolf, EH Kraut, AY Smith, B Blumenstein, ED Crawford.Investigational New Drugs 12(2):147-149, 1994.

9217 Prostate cancer prevention: Risk reduction through life-style, diet, andchemoprevention. KE Greco, L Kulawiak. Oncology NuLsing Forum21(9):1504-1511, 1994.

9217 The prostate cancer prevention trial. A low-risk, high-accrual study. JO’Connor. Oncology.!ssues 9(5):20-24, 1994.

Gynecology8412 Cisplatin versus carboplatin in advanced ovarian cancer: An economic analysis.

D Alberts, E Hannigan, R Cannetta, R O’Toole, V Malviya, E Surwit, WNahhas, C Jolles, J Jacobs, S Pashko. Pharmacy and Therapeutics 19(7):692-706, 1994.

8732 Phase II trial of amonafide in patients with advanced metastatic or recurrentendometrial adenocarcinoma: A Southwest Oncology Group study. VKMalviya, P Liu, R O’Toole, DS Alberts, E Surwit, S Rosenoff, JH Ward, A Yu, JO’Sullivan, JB Craig. American Journal of Clinical Oncolog~ 17(1):37-40,1994.

Head & Neck8590 Chemotherapy as predictor of compliance. JR Jacobs, RR Casiano, DE(iNT-0034) Schuller, TF Pajak, GE Laramore, M AI-Sarraf. Journal of SurgLcal Oncology

55:143-148, 1994.

8855 Clinical applications of DNA content parameters ill patients with squamous cellcarcinomas of the head and neck. JF Ensley, Z Maciorowski. Seminars inOncology 21(3):330-339, 1994.

Leukemia8417/8750 Detection of BCR-ABL fusion genes in adult acute lymphoblastic leukemia by

the polymerase chain reaction. JP Radich, KJ Kopecky, DH Boldt, D Head, MLSlovak, R Babu, J Kirk, A Lee, P Kessler, F Appelbaum, G Gehly. Leukemia8(10):1688-1695, 1994.

8600/8750 Consistent loss of the D5S89 locus mapping telomeric to the intel’leukin genecluster and centromeric to EGR-1 in patients with 5q- chromosome. LNagarjan, J Zavadil, D Claxton, X Lu, J Fairman, JA Warrington, JJ Wasmuth,AC Chinault, CE Sever, ML Slovak, CL Willman, AB Deisseroth. Blood83(1):199-208, 1994.

8600/8750 Deletion of the gene for multidrug resistance in acute myeloid leukemia withinversion chromosome 16: Prognositic implications. BJ Kuss, RG Deeley, SPCole, CL Willman, KJ Kopecky, SR Wolman, HJ Eyre, SA Lane, JKNancarrow, SA Whitmore, DF Callen. LglLcet 343:1531-1535, 1994.


Leukemia (cont)8600/8750 HLA-DR-, CD33+, CD56+, CD16’ myeloid/natural killer cell acute leukemia:8828/9007 A previously unrecognized form of acute leukemia potentially misdiagnosed as9031 FAIl AML-M3. AA Scott, DR Head, KJ Kopecky, FR Appelbaum, KS Theft,

MR Grever, IM Chen, MH Whittaker, BB Griffith, JD Licht, S Waxman, MMWhalen, AD Bankhurst, LC Richter, TM Grogan, CLWillman. Blood84(1):244-255, 1994.

Lung8012/8241 Current management of unresectable non-small cell lung cancer. RB8367 Livingston. Seminars in Oncolog¥ 21(5)(Suppl 10):4-13, 1994.

8805 Neoadjuvant therapy: A novel and effective treatment for stage IIIb non-smallcell lung cancer. VW Rusch, KS Albain, JJ Crowley, TW Rice, V Lonchyna, RMcKenna Jr, K Stelzer, RB Livingston. Annals of Thoracic Surgery 58:290-295,1994.

8836 Daily low-dose cisplatin plus concurrent high-dose thoracic irradiation inlocally advanced unreseetable non-small-cell lung cancer: Results of a phase IISouthwest Oncology Group study. MB Hazuka, JJ Crowley, PA Bunn Jr, MO’Rourke, TJ Braun, PA Bunn, RB Livingston. Journal of Clinical Oncology12(9):1814-1820, 1994.

None Vinorelbine (navelbine) - a new agent for the treatment of non-small cell lungcancer: A summary. CA Coltman Jr. Seminars in Oncology 21(5) (Suppl10):1-3, 1994.

Lymphoma7808 Low-dose involved field radiation after chemotherapy in advanced Hodgkin

disease. A Southwest Oncology Group randomized study. CJ Fabian, CMMansfield, S Dahlberg, SE Jones, TP Miller, EV Slyck, PN Grozea, FSMorrison, CA Coltman, RI Fisher. Annals of Internal Medicine 120(11):903-912, 1994.

8309 Autologous bone marrow transplantation in adults with non-Hodgkin’slymphoma: A Southwest Oncology Group study. R Saez, S Dahlberg, FRAppelbaum, RJ Hartsock, F LeMaistre, CA Coltman Jr, RI Fisher.Hematological Oncologv 12(2):75-85, 1994.

8516 A phase 11I comparison of CHOP vs. m-BACOD vs. Pro-MACE-CytaBOM vs.(INT-0067) MACOP-B in patients with intermediate or high-grade non-Hodgkin’s

lymphoma: Results of SWOG-8516 (Intergroup 0067), the national high-priority lymphoma study. RI Fisher, ER Gaynor, S Dahlberg, MM Oken, TMGrogan, EM Mize, JH Glick, CA Coltman Jr, TP Miller. Annals of Oncologv5(Suppl 2):S91-S95, 1994.

8516/8819 Prognostic significance of the Ki-67 associated proliferative antigen inaggressive non-Hodgkin’s lymphomas: A prospective Southwest OncologyGroup (SWOG) trial. TP Miller, TM Grogan, S Dahlberg, CM Spier, Braziel, PM Banks, K Foucar, CR Kjeldsberg, N Levy, BN Nathwani, BSchnitzer, RR Tubbs, ER Gaynor, RI Fisher. Blood 83(6):1460-1466, 1994.

APRIL 29 - MAY 1, 1995 SOUTHWEST ONCOLOGY GROUP INTRO/ADM1N INFORM 11

Lymphoma (cont)8819 The presence of bcl-1 and bcl-2 gene rearrangements in diffuse small cleaved

cell lymphoma: A disease with diverse molecular and immunophenotypicfindings. CP Leith, CL Willman, CM Spier, TP Miller, TM Grogan..Diagnostic Molecular Pathology 3(3): 178-183, 1994.

Melanoma8049 A randomized trial of vitamin A versus observation as adjuvant therapy in high

risk stage I malignant melanoma: A Southwest Oncology Group study. FLMeyskens Jr, PY Liu, RJ Tuthill, VK Sondak, WS Fletcher, WR JewelI, WSamlowski, SP Balcerzak, JJ Costanzi, DJ Rector. Journal of Clinical Oncology12(10):2060-2065, 1994.

8754 Didemnin B in metastatic malignant melanoma: A phase I1 trial of theSouthwest Oncology Group. VK Sondak, KJ Kopecky, PY Liu, WS Fletcher,WH Harvey, LR Laufman. Anti-Cancer Drugs 5:147-150, 1994.

Myeloma8530 Efficacy of prednisone in refractory multiple myeloma and measurement of

glucocorticoid receptors: A Southwest Oncology Group study. V Gupta, EBThompson, D Stock-Novack, SE Salmon, HI Pierce, JD Bonuet, D Chilton, JBeckord. lnvestigational New Drugs 12(2):121-128, 1994.

8624 Combination chemotherapy, glucocorticoids and interferon alfa in the treatmentof multiple myeloma: A Southwest Oncology Group study. SE Salmon, JJCrowley, TM Grogan, P Finley, RP Pugh, B Barlogie. Journal of ClinicalQncology 12(1 l):2405-2414, 1994.

8944 Phase II study of carboplatin (CBDCA) in refractory multiple myeloma: Southwest Oncology Group study. B Barlogie, J Crowley, SE Sahnon, J Bonnet,JK Weick, K Hayden. lnvestigatjopaJ_New_Drugs 12:53-55, 1994.

Multiple Hemopoietic stem cell transplants for multiple myeloma. S Jagannath, DHStudies Vesole, G Tricot, J Crowley, SE Salmon. Oncolt)gy 8(11):89-100, 1994

Sarcoma8322 A Southwest Oncology Group phase 11 evaluation of fludarabine monophosphate

in sarcoma. MR Grever, J Benedetti, SP Balcerzak, SA Taylor, TP Miller, SRDakhil. investigational New Drugs 12:259-261, 1994.

8715 Phase II evaluation of amonafide in advanced sarcoma: A Southwest OncologyGroup study. SS Buys, B Metch, SP Balcerzak, JR Neefe, WJ Stuckey. CancerInvestigation 12(4):399-402, 1994.

Miscellaneous8902 GM-CSF, carboplatin, doxorubicin: A phase 1 study. EA Poplin, DS Alberts, JJ

P, inehart, ltO Smith, JA Neidhart, EM Hersh. Cancer Chemotherapy andPharmacology 33:340-346, 1994.

None Data monitoring committees and early stopping guidelines: The SouthwestOncology Group experience. J Crowley, S Green, PY Liu, M Wolf. Statistics inMedicine 13:1391-1399, 1994.


Miscellaneous (cont)None Measuring quality of life: An emerging science. CM Moinpour. Seminars in

Oncologv 21(5)(Suppl 10):4g-63, 1994.

None Organizations and structures that facilitate community research. CA ColtmanJr. Seminars in Oncologv 21(4)(Suppl 7):107-111, 1994.

None The case against independent monitoring committees. D Harrington, JCrowley, SL George, T Pajak, C Redmond, S Wieand. Statistics in Medicine13:1411-1414, 1994.


SOUTHWEST ONCOLOGY GROUPPUBLICATIONS LIST

1993

CommitteeStudy #

Brain7983 A randomized trial of radiotherapy versus radiotherapy plus CCNU for incompletely

resected low grade gliomas: A Southwest Oncology Group study. HJ Eyre, JJCrowley, JJ Townsend, JR Eltringham, RA Morantz, SF Schulman, JM Quagliana, MAI-Sarraf. Journal of Neurosurgery 78:909-914, 1993.

8415 A phase lI evaluation of tamoxifen in unresectahle or refractory meningiomas: ASouthwest Oncology Group study. JW Goodwin, J Crowley, HJ Eyre, B Stafford, KAJaeckle, JJ Townsend. Journal of Neuro-Oncology 15:75-77, 1993.

8632 Phase I1 evaluation of echinomycin (NSC-526417) in patients with central nervoussystem malignancies: A Southwest Oncology Group study. SA Taylor, J Crowley, JTownsend, FS Vogel, H Eyre, TJ Braun, JW Goodwin. Journal of Neuro-Oncology15:181-184, 1993.

Breast7827 One versus 2 years of CMFVP adjuvant chemotherapy ill axillary node-positive and

estrogen receptor-negative patients: A Southwest Oncology Group study. SE Rivkin,S Green, B Metch, WR Jewel1, JJ Costanzi, SJ Altman, JP Minton, RM O’Bryan, CKOsborne. Journal of Clinical Oncology 11(9): 1710-1716, 1993.

8313 Pitfalls in quality-of-life assessment: Lessons from a Southwest Oncology Groupbreast cancer clinical trial. KA Hayden, CM Moinpour, B Metch, P Feigl, RMO’Bryan, S Green, CK Osborne. O0&’0Jggy Nursing Forum 20(9):1415-1419, 1993.

Gastrointestinal8040/8044 Evaluation of combination chemotherapy and phase 1I agents in pancreatic

adenocarcinoma: A Southwest Oncology Group study. RM Bukowski, TR Fleming,JS Macdonald, N Oishi, SA Taylor, LH Baker. Cancer 71(2):322-325, 1993.

8591 Testing against ordered alternatives for censored survival data. PY Liu, S Green, MlINT-0035 Wolf, J Crowley. JASA 88(421):153-160, 1993.

8591 An evaluation of the carcinoembryonic antigen (CEA) test for monitoring patientslINT-0035 with resected colon cancer. CG Moertel, TR Fleming, JS Macdonald, DG Hailer, JA

Laurie, C Tangen. JAMA 270(8):943-947, 1993.

8591 lfepatic toxicity associated with fluorouracil plus levamisole adjuvant therapy. CGlINT-0035 Moertel, TR Fleming, JS Macdonald, DG Hailer, JA Laurie. Journal of Clinical

0.ncoh~ 11(12):2386-2390, 1993.

8614 VM-26 in gastric cancer: A Southwest Oncology Group study. JL Berenberg, CTangen, JS Macdonald, B Barlogie, LR Laufman. Investigafiona/NeW D~ugs11:333-334, 1993.


Gastrointestinal (cont)8712 Phase lI study of trimetrexate in previously untreated patients with hepatocellular

carcinoma: A Southwest Oncology Group study, WH Harvey, TR Fleming, PJGoodman, JE Harkins, SE Rivkin, JS Macdonald, Investigationai New Drugs 11:45-46, 1993.

8714 Phase II trial of amonafide in advanced colorectal cancer: A Southwest OncologyGroup study. TD Brown, PJ Goodman, T Fleming, JS Macdonald, JB Craig, ABEinstein. Anti-Cancer Drugs 4:49-50, 1993.

8720 Phase II trial of amonafide in advanced pancreas cancer: A Southwest OncologyGroup study. CG Leichman, C Tangen, JS Macdonald, T Leimert, TR Fleming.Investigational New Drugs 11:219~221, 1993.

8730 Amonafide treatment of refractory esophageal cancer: A Southwest Oncology Groupstudy. E Poplin, T Fleming, JS Macdonald, R Rodvien, K Grant, RI Fisher, MEConrad. Investigational New Drugs 11:47-51, 1993.

8905 Selection designs for pilot studies based on survival. PY Liu, S Dahlherg, J Crowley.Biometrics 49:391-398, 1993.

8916 Phase II trial of merbarone in pancreatic carcinoma: A Southwest Oncology Groupstudy. EH Kraut, T Fleming, JS Macdonald, CH Spiridonidis, JE Bradof, LH Baker.American Journal of Clinical Oncology 16(4):327-328, 1993.

8933 A phase lI trial of piroxantrone in adenocarcinoma of the pancreas. A SouthwestOncology Group study. TR Jenkins, C Tangen, JS Macdonald, G Weiss, RChapman, A Hantel. Investigational New Drugs 11:329~331, 1993.

9006 Dynamic multinuclear chemical shift imaging of tumors (H-I, F-19, P-31) during fluorouracil chemotherapy. H Kim, V Waluch, M Singh, CA Present, W Wolf.IEEE 1316-1318, 1993.

Genitourinary8231 Alternating combination chemotherapy in patients with extragonadal germ cell

tumors: A Southwest Oncology Group study. RM Bukowski, M Wolf, BG Kulander,J Montie, ED Crawford, B Blumenstein. Cancer 71(8):2631-2638, 1993.

8302 Doxorubicin, mitomycin-C and 5-fluorouracil in the treatment of hormone refractoryadenocarcinoma of the prostate. A Southwest Oncology Group study. BBlumenstein, ED Crawford, JH Saiers, RL Stephens, SE Rivkin, CA Coltman Jr.Journal of Urology 150:411-413, 1993.

8325 Phase II trial of mitotane and eisplatin in patients with adrenal carcinoma: ASouthwest Oncology Group study. RM Bukowski, M Wolf, HS Levine, EDCrawford, RL Stephens, E Gaynor, WG Harker. Journal of Clinical Oncolog¥11:161-165, 1993.

8421 Cyclophosphamide, methotrexate and 5-fluorouracil in the treatment of metastaticprostate cancer: A Southwest Oncology Group study. AJ Wozniak, BABlumenstein, ED Crawford, M Boileau, SE Rivkin, WS Fletcher. Cancer71(12):3975-3978, 1993.


Genitourinary (cont)8494 The use of flutamide in hormone-refractory metastatic prostate cancer. DG McLeod,(INT-0036) RC Benson Jr, MA Eisenberger, ED Crawford, BA Blumenstein, D Spicer, JT

Spaulding. Cancer Supplement 72112):3870-3873, 1993.

8494/8894 Some statistical considerations for the interpretation of trials of combined androgen(INT-0036) therapy. BA Blumenstein. Cancer Supplement 72112):3834-3840, 1993.(INT-0105)

8789 Randomized trial of etoposide and cisplatin versus etoposide and carboplatin inpatients with good risk germ cell tumors: A multi-institutional study. DF Bajorin,MF Sarosdy, DG Pfister, M Mazumdar, RJ Motzer, HI Scher, NL Geller, WR Fair, HHerr, P Sogani, J Sheinfeld, P Russo, V Vlamis, R Carey, NJ Vogelzang, EDCrawford, GJ Bosi. Journal of Clinical Oncolog3~ 1114):598-606, 1993.

8802 Phase 11 trial of echinomycin for the treatment of advanced renal cell carcinoma: ASouthwest Oncology Group study. ME Marshall, MK Wolf, ED Crawford, S Taylor,B Blumenstein, R Flanigan, FJ Meyers, HE Hynes, B Barlogie, M Eisenberger.(nxestigational New Drugs 11:207-209, 1993.

9217 Chemoprevention of prostate cancer with finasteride. I Thompson, P Feigl, CColtman. Cancer Prevention Dec:l-15, 1993.

None ttow PSA testing has improved and complicated therapeutic decision-making. EDCrawford, IM Thompson, PT Scardino. Oncology 13:15-17, 1993.

Gynecology8412 Analysis of patient age as an independent prognostic factor for survival in a phase II1

study of cisplatin-cyclophosphamide versus carboplatin-cyclophosphamide in stages11i (suboptimal) and IV ovarian cancer. A Southwest Oncology Group study. Alberts, S Dahlberg, SJ Green, D Garcia, EV Hannigan, R O’Toole, D Stock-Novack, EA Surwit, VK Malviya, CJ Jolles. Ca_n~er 7112):618-627, 1993.

8412 Results of a Southwest Oncology Group phase II1 trial of carboplatin pluscyclophosphamide versus cisplatin plus cyclophosphamide in advanced ovariancancer. EV Hannigan, S Green, DS Alberts, R O’Toole, E Surwit. Oncology 50(Suppl 2):2-9, 1993.

9047 Localized ovarian cancer in the elderly. The Gynecologic Oncology Groupexperience. RC Young, MF Brady, LA Walton, HD Homesley, HE Averette, ItJLong. C’anc~r. Supplgment 7112):601-605, 1993.

Head & Neck8590 Implications of positive surgical margins. JR Jacobs, K Ahmad, R Casiano, DE(INT-0034) Schuller, C Scott, GE Laramore, M AI-Sarraf. Laryngoscopy 103:64-68, 1993.

8590 Is a surgical resection leaving positive margins of benefit to the patient with locally(INT-0034) advanced squamous cell carcinoma of the head and neck: A comparative study using

Intergroup study 0034 and the Radiation Therapy Oncology Group head and neckdatabase. GE Laramore, CB Scott, DE Schuller, RE Haselow, TJ Ervin, R Wheeler,M AI-Sarraf, RA Gahbauer, JR Jacobs, JG Schwade, BH Campbell. lnternationa!JournaL~’ R;,~0i0tiotl O~3col~Biology and Physics 27:1011-1016, 1993.


Head & Neck (cont)8855 The selection of patients with advanced squamous cell carcinomas of the head and

neck for clinical trials based on tumor DNA content parameters. J Ensley, HPietraszkiewicz, A Pear, W Sakr, M Alonso, Z Maciorowski. Adjuvant Therapy ofCancer VII, 99-107, 1993.

8932 Phase lI trial of piroxantrone in patients with recurrent and metastatic squamous cellcarcinoma of the head and neck: A Southwest Oncology Group trial. SA Taylor, JBenedetti, D Schuller, SP Richman, GO Broun, A Hantel. Investigational NewDrugs 11:227-229, 1993.

Leukemia8032 Mitoxantrone (dihydroxyanthracenedione) in acute leukemia: An evaluation of two

treatment schedules by the Southwest Oncology Group. JH Saiki, WJ Stuckey, JWAthens, BL Tranum, E Van Slyck, DD Von Hoff. Investigational New Drugs11:197-200, 1993.

8600/8750 An AML1/ETO fusion transcript is consistently detected by RNA-based polymerase9007/9031 chain reaction in acute myelogenous leukemia containing the t(8;21)(q22;q22). 9034 Downing, DR Head, AM Curcio-Brint, MG Hulshof, TA Motroni, SC Raimondi, AJ

Carroll, HA Drabkin, CL Witlman, KS Theil, CI Civin, P Erikson. Blood81(11):2860-2865, 1993.

8600/9007 HRX involvement in de novo and secondary leukemias with diverse chromosome9031/9034 11q23 abnormalities. SP Hunger, DC Tkachuk, MD Amylon, MP Link, AJ Carroll,

JL Welborn, CL Willman, ML Cleary. Blood 81(12):3197-3203, 1993.

8612 A prospective randomized comparison of total body irradiation-etoposide versusbusulfan-cyclophosphamide as preparatory regimens for bone marrowtransplantation in patients with recurrent leukemia who were not in first remission:A Southwest Oncology Group study. KG Blume, KJ Kopecky, JP Henslee-Downey,SJ Forman, PJ Stiff, CF LeMaistre, FR Appelbaum. Blood 81(8):2187-2193, 1993.

8833 A phase I trial of combination fludarabine monophosphate and chlorambucil inchronic lymphocytic leukemia: A Southwest Oncology Group study. L Elias, DStock-Novack, DR Head, MR Grever, JK Weick, RA Chapman, JE Godwin, ENMetz, FR Appelbaum. Leukemia 7(3):361-365, 1993.

9023/9126 Multidrug resistance: Clinical relevance in acute leukemia. AF List. Oncolog¥7(10):23-32, 1993.

Multiple Deletion of IRF-1, mapping to chromosome 5q31.1, in human leukemia andStudies preleukemic myelodysplasia. CL Willman, CE Sever, MG Pallavicini, H Harada, N

Tanaka, ML Slovak, H Yamamoto, K Harada, TC Meeker, AF List, T Taniguchi.Science 259:968-971, 1993.

Lung8009/8215 Predictors of survival following relapse or progression of small cell lung cancer:8605 Southwest Oncology Group study #8605 and an analysis of the recurrent disease data

base. KS Albain, JJ Crowley, L Hutchins, D Gandara, RM O’Bryan, D Von Hoff, BGriffin, RB Livingston. Cancer 72(4):1184-1191, 1993.


Lung (con08385 Mitogauzone, cisplatin, and vinblastine in advanced non-small cell lung cancer: A

Southwest Oncology Group study. R Chapman, J Crowley, JG Lucas, BL Hom, RBLivingston, CB Vaughn, HE Hynes. Investigational New Drugs 11(l):91-92, 1993.

8738 Evaluation of cisplatin intensity in metastatic non-small cell lung cancer: A phaseIII study of the Southwest Oncology Group. DR Gandara, J Crowley, RB Livingston,EA Perez, CW Taylor, G Weiss, JR Neefe, LF Hutchins, RW Roach, SM Grunberg,TJ Braun, RB Natale, SP Balcerzak. Journal of Clinical Oncology 11(5):873-878,1993.

8805 Surgical resection of stage Ilia and stage IIIB non-small cell lung cancer afterconcurrent induction chemoradiotherapy. VW Rusch, KS Albain, JJ Crowley, TWRice, V Lonchyna, R McKenna Jr, RB Livingston, BR Griffin, JR Benfield. Journalof Thoracic and Cardiovascular Sur~ 105(1):97-106, 1993.

8857 Prolonged, alternating chemotherapy for extensive small cell lung cancer: ASouthwest Oncology Group study. RB Livingston, JJ Crowley, T Thompson, SKWilliamson, FJ Meyers, T O’Rourke, JR Neefc. Cancer 81(11):3509-3513, 1993.

8915 Phase II trial of 6-thioguanine administered as 120 hour continuous infusion forrefractory or recurrent small cell lung cancer: A Southwest Oncology Group study.SK Williamson, J Crowley, RB Livingston, G Weiss. lnvestigational New Drugs11:81-83, 1993.

9038 Extended administration of oral etoposide and oral cyclophosphamide for thetreatment of advanced non-small cell lung cancer. A Southwest Oncology Groupstudy. SM Grunberg, J Crowley, R Livingston, [ Gill, SK Williamson, T O’Rourke,T Braun, ME Marshall, JK Weick, SP Balcerzak, RL Martino. Journal of ClinicalOncology 11(8):1598-1601, 1993.

None Incorporation of radiotherapy fractionation in the combined-modality treatment oflimited small-cell lung cancer. AT Turrisi III. Chest 103:418S-422S, 1993.

Lymphoma7204/7426 Long-term followup of patients with low-grade malignant lymphomas treated with7713 doxorubicin-based chemotherapy or chemoimmunotherapy. BW Dana, S Dahlberg,

BN Nathwani, E Chase, CA Coltman Jr, TP Miller, RI Fisher. Journal of ClinicalOncologv 11(4):644-651, 1993.

7204/7426 Treatment of diffuse large-cell lymphoma: A summary of outcome for patients7713 treated by the Southwest Oncology Group. TP Miller, S Dahlberg. In: Malignant

Lymphomas Including Hodgkin’s disease: Diagnosis, management and speciali/mblems, Dana BW, ed., Kluwer Academic Publishers, Boston, Vol.4, pp. 53-63,1993.

8410/8503 A predictive model for aggressive non-Hodgkin’s lymphoma. The international non-8508 Hodgkin’s lymphoma prognostic factors project. New England Journal of Medicine

329(14):987-994, 1993.

18 INTRO/ADMIN INFORM SOUTHWEST ONCOLOGY GROUP APRIL 29 - MAY l, 1995

Lymphoma (cont)8516 Comparison of a standard regimen (CHOP) with three intensive chemotherapy(INT-0067) regimens for advanced oon-Hodgkin’s lymphoma. RI Fisher, ER Gaynor, S

Dahlberg, MM Oken, TM Grogan, EM Mize, JH Glick, CA Coltman Jr, TP Miller.New England Journal of Medicine 328:1002-1006, 1993.

8819 Cytolytic (TIA-1 +) tumor infiltrating lymphocytes in B cell non-Hodgkin’slymphomas. J Diaz, R Tubbs, M Stoler, T Grogan. Leukemia and Lymphoma 9:91-94, 1993.

8819 lmmunobiologic correlates of prognosis in lymphoma. TM Grogan, TP Miller.Seminars in Oncologv 20:58-74, 1993.

8819 NCAM (CD56)-positive malignant lymphoma. WF Kern, CM Spier, TP Miller, Grogan. Leukemia and Lvmphoma 12:1-10, 1993.

Melanoma8393 Efficacy of 2-cm surgical margins for intermediate-thickness melanomas (1 to (INT-0013) ram): Results of a multi-institutional randomized surgical trial. CM Balch, MM

Urist, CP Karakousis, TJ Smith, WJ Temple, K Drzewiecki, WR Jewell, AABartolucci, MC Mihm Jr, R Barnhill, HJ Wanebo. Annals of Sur eg~y 218(3):262-269, 1993.

8723 Evaluation of amonafide in disseminated malignant melanoma: A SouthwestOncology Group study. M Slavik, KJ Kopecky, V Sondak, JB Craig, MK Samson.Investigational New Drugs 11:223-226, 1993.

8804 Evaluation of cisplatin and DTIC in inoperable stage III and IV melanoma: ASouthwest Oncology Group study. WS Fletcher, DS Daniels, VK Sondak, B Dana, RTownsend, HE Hynes, LF Hutchins, JR Pancoast. American Journal of ClinicalOncology 16(4):359-362, 1993.

Myeloma8624 P-glycoprotein expression in human plasma cell myeloma: Correlation with prior

chemotherapy. TM Grogan, CM Spier, SE Salmon, M Matzner, JA Rybski, RSWeinstein, RJ Scheper, WS Dalton. Blood 81(2):490-495, 1993.

Sarcoma8616 An intergroup phase IIl randomized study of doxorubicin and dacarbazine with or

without ifosfamide and mesna in advanced soft tissue and bone sarcomas. KAAntman, J Crowley, SP Balcerzak, SE Rivkin, GR Weiss, A Elias, RB Natale, RMCooper, B Barlogie, SL Trump, JH Doroshow, J Aisner, RP Pugh, RB Weiss, BACooper, GH Clamond, LH Baker. Journal of Clinical Oncology 11:1276-1285, 1993.

8641 Phase I1 trial of ifosfamide and cisplatin in the treatment of metastatic soft tissuesarcomas. A Southwest Oncology Group study. GT Budd, B Metch, SAW Weiss,JK Weick, C Fabian, RL Stephens, SP Balcerzak. Cancer Chemotherapy andPharmacology 31(Supp12):S213-S216, 1993.

8930 Phase II trial of piroxantrone for advanced or metastatic soft tissue sarcomas: ASouthwest Oncology Group Study. MM Zalupski, J Benedetti, SP Balcerzak, LFHutchins, RJ Belt, A Hantel, JW Goodwin. lnvestigational New Drugs 11:337-341,1993.


MiscellaneousMultiple Survival trees by goodness of split. M LeBlanc, J Crowley. JASA 88(422):457-467,Studies 1993.

None Data monitoring committees for Southwest Oncology Group clinical trials. S Green,J Crowley. Statistics in Medicine 12:451-455, 1993.

None Summary of a joint meeting between the Southwest Oncology Group and theJapanese Clinical Trials Consortium. ML Rothenberg, CA Coltman Jr, MFukushima. JCRCO 119:564-567, 1993.

None Verifying keyed medical research data. BA Blumenstein. Statistics in Medicine12:1535-1542, 1993.

None Sufficient conditions for treatment responders to have longer survival than non-responders. PY Liu, JO Voelkel, J Crowley, M Wolf. Stat & Prob Letters 18:205-208, 1993.


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