TWENTY-FIRST
`
`Annual Meeting of the
`
`American Society of Clinical Oncology
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`May 19-21, 1985
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`PROCEEDINGS
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`Houston, Texas
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`
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`Scientific Proceedings
`
`Abstracts
`
`NUS
`
`Biomarkers, Diagnosis, Etiology, Epidemiology
`Cancer Prevention
`
`Clinical Pharmacology (Adult and Pediatric)
`Clinical Trials
`Breast
`Gastrointestinal Tract
`Genitourinary Tract (Other Than Gynecology)
`Gynecological Tumors
`Head and Neck, Sarcoma, Melanoma, and Other Solid
`Tumors
`
`Leukemia (Adult and Pediatric)
`Lung
`Lymphoma (Adult and Pediatric)
`Other Hematological Tumors
`immunology and Biological Response Modifiers
`Pediatric Solid Tumors
`Psychosocial Aspects of Cancer
`Radiation Biology
`Supportive Care, infectious Disease, Nutrition
`Surgical Oncology
`Author index
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`Subject index
`
`1
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`7
`23
`
`25
`
`53
`76
`96
`1 12
`126
`
`154
`175
`197
`215
`218
`234
`247
`254
`256
`275
`279
`
`291
`
`Volume 4 . March 1985
`
`WAAAAAA
`AstraZeneca Exhibit 2146 p. 1
`InnoPharma Licensing LLC V. AstraZeneca AB IPR2017-00904
`Fresenius-Kabi USA LLC V. AstraZeneca AB IPR2017-01910
`
`

`

`Proceedings of the
`American Society of Clinical Oncology
`
`
`AMERICAN SOCIETY OF CLINICAL ONCOLOGY,
`
`INC.
`
`OFFICERS
`
`1 984-1 985
`
`President, Sydney E. Salmon
`
`President-Elect, John R. Durant
`
`immediate Past President, Philip S. Schein
`
`Secretary-Treasurer, David L. Ahmann
`
`BOARD OF DIRECTORS
`
`Martin D. Abeloff
`Bruce A. Chabner
`Charles A. Coltman, Jr.
`Alfred Van Horn lli
`Executive Director
`
`Eli Glatstein
`Sharon B. Murphy
`Steven A. Rosenberg
`
`
`
`Editorial Staff
`
`Margaret Foti, Managing Editor
`Mary Anne Mennite, Assistant Managing Editor
`Heide M. Pusztay, Senior Staff Editor
`
`Denise E. Grant
`Elizabeth A. Moore
`Ellen M. McDonaid
`Rosemary Griffin
`Margaret A. Crawford
`Lilliane M. Chouinard
`Kimberly A. Collins
`Sandra E. Pattie
`William A. Borrelle
`Diane E. Nolte
`Rita laquinto
`Aileen M. McHugh
`
`
`Copyright 1985 by the American Society of Clinical Oncology. Printed for the American Society of Clinical
`Oncology. by Waverly Press, inc., Baltimore, MD 21202.
`
`AstraZeneca Exhibit 2146 p. 2
`
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`

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`BREAST
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`Wsmatznal mam Dratzctndhv Cawngm‘awmfl: 1m 3 cm}
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`C~217
`TREATMENT OF ADVANCED BREAST CANCER WITH MEDROXY—
`PROGESTERONE ACETATE.
`A phase III evaluation of the dose—response relaw
`tionship at two dose levels.
`
`cfiosefiflfiouridsen, B.Engelsman, M.Nooi, R.Syl~
`Vester. N.Rotmensz for the EORTC Breast Cancer
`Group, Finsen Institute. 49 Stranéboulevarden,
`2100 Copenhagen Q), Denmark.
`medroxyprogesterone acetate (MPA) binds specifiu
`Cally to the progesterone receptor in the human
`mammary tumor cytosol, but it has also affinity
`for the glucocorticoid and the androgen recegtors.
`It is therefore conceivable,
`that MPA given at
`high fioses may affiect mammary tumor growth by bin—
`ding not only to progesterone, but also to the ot~
`her
`two receptors. The EORTC Breast Cancer Group
`has therefore conducted a randomized 60se—response
`trial comparing the contineous oral aéministration
`of 300 and 900 mg of MPA daily. Patients with ad»
`vanced measurable cancer, clinically resistant to
`prior cytotoxic and/or enflocrine therapy were eli—
`gible for the study.
`the overall response
`Among 201 evaluable patients,
`rate was 23 and 16 % in patients treated at the
`high and low dose level, respectively (9:0.08).
`The time to progression was significantly longer
`in those treateo with the high éose (peo.o2).Re—
`sponse duration and survival was insignificantly
`prolonged in those receiving high dose MPA.
`The results indicate a dose response relationship
`for treatment with progestins.
`
`C-218
`STUDY OF HUMAN BREAST CANCER IN SOFT AGAR CULTURE
`T. K. Banerjee, J. J. Marx; Jr., S. K. Spencer, B. J. Ault,
`Don Steiner, S. M, Sajjad, Marshfield Clinic and Mershfield
`Medical Foundation9 Mershfield, N: 54449.
`(Sponsored by
`T. K. Banerjee}
`One hundred and forty three malignant samples (67
`tissues and 76 fluids) from 101 women with breast cancer
`were subjected to human tumor clansgenic assay (HTCA).
`Eighteen samples were not plated because of insufficient
`tumor cells and 6 culture plates were contaminated with
`bacterial or fungal infection. Sixty three of 119 (53%)
`samples had aéeqnate growth (230 colonies). Eleven samples
`has inadequate growth (<30 colonies).
`Twenty seven of 56
`tissue samples (ass) had adequate growth and 6 had
`inadequate growth. Of these 56 samples 30 were taken from
`primary breast tumors and 26 were from metastatic sources.
`There were 53.3% (létBO) of primary scarces and 46% (12/26)
`Of metastatic sources that grew adequately.
`The pleural
`fluid samples grew 65% (SO/4%) an& the ascitic samples 29%
`(5/1?) adequately. Eleven of twenty two of estrogen
`receptor (ER) positive and 12/20 ER negative tissue
`Specimens grew.
`It appeared that the colony numbers on an
`average was lower in ER positive tumors with 2181 le/ng
`0f protein values.
`The colony growths of 2 malignant
`fluids were confirmed as malignant
`tumor cells by electron
`microscoPic examination.
`No correlation with histiclogic
`grading and colony growth can be made. When receptor
`results were plotted against sensitivity to various
`harmonal agents there were a great deal of variations in
`individual samples.
`In 2 instances, even though the ER
`Was negative there was wide range of sensitivity in the
`HTCA against various hormonal agents rested.
`HTCA results
`0f 6 tissue and 18 fluid samples were evaluated clinically.
`Twenty three percent of those shown to be sensitive,
`reaponded to the indicates drug and ?7% thought
`to be
`resistant actually were.
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`C-219
`PRDSPECTIVE COMPARISON OF COMBINAIION CHEMOTHERAPY WITH OR
`WITHOUT A PROSTAGLANDlN SYNTHESIS INHIBITUR IN ADVANCED
`BREAST ClNCER. A. Khojasteh, R.D, Reynolds, A.R, Garcia,
`E.P. Mitchell9 J. Walter, N.0. Anson. Ellis Fischel Cancer
`Center, Columbia9 Missouri 65203.
`The safety and efficacy of mitnmycin—C (MTG) and
`continuously infused vinblastine (VLB)
`therapy in metastatic
`breast cancer have previously been demonstrated.
`The
`ability of prostaglandin synthesis inhibitors (PSI) to
`reduce growth of mammary carcinoma has recently been
`described in experimental and clinical settings.
`An ongoing
`phase III trial has been conducted to determine the impact
`of a FSI (ibuprofen) on the response of advanced breast
`carcinoma (BC)
`to a combined chemotherapy (VLB + MTG)
`regimen. At the time of this evaluation 13 gretreated
`females with measurable BC (age range: 29 to 64 years; 2
`premenopausal,
`11 postmenopausal) have entered in this
`study.
`7 patients received VLB (1.5 mgfmz l.V. over 24
`hours on days l~5) + MTG (10 mg/m2 I.V. on day 3) every
`five weeks,
`6 patients were treated with aforementioned
`chemotherapy plus ibuprofen (1800 mg, p.o. daily). Both
`treatment groups were comparable in age, menoyausal and
`hormonal receptor status and number of courses of therapy.
`The treatment was well tolerated by most patients.
`The
`overall partial response following 2 to 8 courses of the
`therapy was observeé in 5fl3 patients. Stabilization of
`measurable lesions for 10 to 37 weeks was noted in 3/13
`patients.
`The remaining patients (3/13) failed to respond.
`The preliminary results suggest that,
`in the limited number
`of studied cases.
`ibuprofen at the current dose schedule
`does not contribute to the improvement of response rate to
`chemotherapy. More extensive trails of the PSI combined
`with chemotherapy regimens, with specific reference to in-
`cidence of osseous metastasis, bone pain, hypertalcsmia
`and therapeutic index of ancineoplastic agents in connection
`with chemotherapy related mucosal damage, are in process.
`
`C—220"
`WAN TREATMENT WITH TN’UXIFEN IN WM PATIENTS NIH-2
`HIGH RISK Eli-EAST CW: 78 MZNTHS CF LIFE TPBLE ANALYSIS.
`HJ. Macaw. C. Rose, SM. Thorpe,
`.1. Wm. M. Blidert—Yof’t.
`and KM. Ardersen for the Dmisn Breast Cancer {Imperative Gran (m),
`Finsen Institute. 0,? Stxer‘rcbi:ulsvamen5 21m Copsrhagen El, Denmark.
`
`This mtmide trial 1:1:le pcstnempalsal (8.9. 5 years of
`Wheels) patients less the: 80 years of age with primary h1g1 risk
`{9.9. made positive) breast tamer. Primary treatrrmt was total wastes»
`tcmy and axillary sampling Follow by radiotlerapy (R?) to the scar
`and regional 1W. Fran angst 1977 to mvenber 1982 1650 patients
`mterec‘. the trial: 821 ms rad-mixed to no fUrtJ‘er therapy (RI-group)
`am 829 to treatrre’lt For 1 year with tamifeh 30 mg daily (mum—9mm.
`At 6 years life table analysis the rewrreme Free survival (W5)
`is M36 in the RT-i-TNLgtup and 4&5 in the RI—gmp ($00003). mival
`is identical (5136) in the two 9mm ($320.53). The date have been
`further analysed in relation to pragmatic factors e.g. age, mes of”
`armlesis, tumr size and umber of positive nodes. The RFS is lower
`in all sweets of patients treated with RT 4» TM, but the different:
`is statistically significant only in patients 50—59 yws of age. with
`tums of grade I, or with a or mare positive 1W.
`Estmgmreseptur <ER) mtmtim were measured in a sheet of
`292 of the patients. A cut-off limit of lo fund/Hg cytcsol protein
`sigfificmtly distirglistm between patients with long RPS and those
`wfifbeerly recurnat disease.Patients wiflaER content below loo finolfig
`did not benefit from the mane them my time with Wire
`time above 100 fml/ng fed a sigfificmtly longer RFS. 19B of the
`onienasnaipnxxstemxe naxp x (Rfi) asennketiae an we fif
`positive patimts treated with TM did Siglif'icmtly better than 1316
`cmtrol 91w (920.015).
`Evaluation of the clinical results as of April 1985 will be brew
`eatai
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`PROCEEDINGS OF ASCO VOL. 4 MARCH 1985
`57
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`AStraZeneca Exhibit 2146 p. 3
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