THIRTY-FIRST
`Annual Meeting of the
`American Society of Clinical Oncology
`May 20-23, 1995
`PROGRAM/PROCEEDINGS
`
`Los Angeles, CA
`
`B!iTIS!t LIBWY
`DC~f"""'ll s·~'3Pl Y r.-~
`0 4JUL1995
`CONFE .. d.;CE
`INDEXED
`
`Contents
`
`ASCO Program lnf6m1ation
`Officers and Directors ............................................................................................................................. .
`Calendar of Events ......................................................................................................... .
`Committee Rosters ......................................................................................................... .
`General Information ....................................................................................................... .
`Special Events ...... ' ......................... : ............................................................................... .
`Educational Symposia .................................................................................................... ..
`Scienti fic Sessions ......................................................................................................... .
`ASCO Proceedings .......................................................................................................... .
`Allogenic Bone Marrow Transplantation ............................................................................. .
`Apoptosis ........................................ ............................................................................. .
`Biomarkers: Diagnosis ................................................................................................... ..
`Bion1arkers: Response .................... ............ ........ ... ........................................................ ..
`Breast Cancer .............................................................................................................. ..
`CNS Tumors ..................................................................................................... ............ .
`Cancer Biology and Molecular Genetics ............................................................................ ..
`Cancer Control ................................... ......... ........... ....................................................... .
`Carcinogenesis..... .. . . .............................................................. .................................. .
`Cell Cycle ................................................................................................................. ..
`Chemoprevention ........................................................................................................ ..
`Clinical Pharmacology (Adult and Pediatric) ...................................................................... ..
`Cytogenetics ................................................................................................................. .
`Drug Resistance ........................................................................................................... ..
`Endocrine Tumors ........................................................................................................ ..
`Epidemiology ............................................................................................................... .
`Gastrointestinal Tract Cancer ........................................................................................... .
`Gene Therapy ............................................................................................................... .
`Genitourinary Tract Cancer .............................................................................................. .
`Growth Factors/Cytok.ines .............................................................................................. ..
`Gynecological Tumors .................................................................................................... .
`HIV/ALDS .................................................................................................................... .
`Head and Neck Cancer .................................................................................................... .
`Health Care Research ..................................................................................................... .
`High-Dose Therapy/Stem Cell Support ............................................................................... .
`
`iii
`iv
`VIII
`ix
`Jllll
`xvii
`I
`73
`74
`78
`81
`85
`90
`144
`155
`160
`163
`164
`165
`167
`178
`179
`184
`185
`189
`226
`230
`255
`266
`288
`293
`305
`311
`
`Volume 14 • March 1995
`
`1 of 3
`
`Celltrion, Inc., Exhibit 1022
`
`

`

`Progralll/Proceedings
`of the
`American Society of Clinical Oncology
`
`./
`
`Michael C. Perry, MD
`Program/Proceedings Editor
`
`Editorial staff provided by W.B. Saunders Company
`
`American Society of Clinical Oncology
`
`Officers
`1994-1995
`
`Karen H. Antman, MD
`President
`
`John H. Glick, MD
`President-Elect
`
`George P. Canellos, MD
`Immediate Past President
`
`Mark J. Ratain, MD
`Secretary/Treasurer
`
`Board oj'Directors
`Joseph S. Bailes, MD
`Bruce D. Cheson, MD
`C. Norman Coleman, MD
`Sarah S. Donaldson, MD
`Ross C. Donehower, MD
`Elizabeth A. Eisenhauer, MD
`Charlotte D. Jacobs, MD
`Brian J. Lewis, MD
`Allen S. Lichter, MD
`C. Kent Osborne, MD
`David Prager, MD
`Nicholas J. Vogelzang, MD
`
`John R. Durant, MD
`Executive Vice President
`
`Robert E. Becker, JD, CAE
`Executive Director
`
`Copyright © 1995 by the American Society of Clinical Oncology
`
`iii
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`2 of 3
`
`Celltrion, Inc., Exhibit 1022
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`

`

`BREAST CANCER
`
`*124
`PHASE 11 STUDY OF IN1U VENOUS RECOMBINANT HUMAN1ZEO
`AN'T1·pl85 HER·2 MONOCLONAL AN'TlBOOY (rltuMAb treJt·2) PU.JS
`OSPl..ATIN IN PATIENTS Willi HER-2/NEU OVEIU!XPRESSINO
`METASTATIC BREAST CANCER. M.ftmml,A.Li~,R. f>iensl,o.
`Haycs3, B. wcbet4.J. Basclga5, D. Tripathy6, T. Twlldoll7,J, Olaspyl, and 0.
`s1amon1.
`IUCLA, Los Angeles. CA; 2Hershcy Med Cir., Hcnhcy, PA; 3oFCJ, Boslon,
`MA; 4u Penn, Philaddphia, PA; 5MSKCC, New York, NY; 6ucSF, San
`Francisco. CA; 7oencntcch, S. San Franc.boo, CA
`Phase I studies conduclcd at UCLA show that rltuMAb Hl!R-2 has no
`subsllnllal IOl<lcity II any dose level and locallus 10 m11lgnan1 c:clh
`overuprcsslng the Hl!R·2 tt:ceplOr pro1ein. In preclinical $Wdics, therapy with
`this antibody plus cisplatln (COOP) cl lei is a synergisdc and eyiocidal effoct on
`tumor cells which overupess pl8SHE.R·2.'"'" (O•coge11t ' ' (1994). 1829), In a
`pbue U open· label, mulliccnltl clinical trial, the ovciall response rate io rltuMAb
`HER·2 plus COOP in patients (pu.) whh HER-2.lne• -<lveteJprwing mcWladc
`btt3SI cancer (MBC) was der.ermincd. The swdy POPu!adon COIUbltd or pu. with
`2• or 3+ HER·2.'M• Ovcrollp<CSSlon dc!ined immunohislOcbcmic:ally who hid
`progressed on slandatd chcmothc:rlpr. The median numbet of prior chcmolherapy
`rcgimens was 2(rllnge 1-6). Prior ~thcrapy was reponcd in S411>ofpu.
`and prior radiochernpy in 6911>. The median number of mcWlallc sites was 2
`(range 1-6). Each pi. recclved a i~g loading dose or rhuMAb l!ER-2 followed
`by weekly IOOmg dose$ ror 8 weclts. Pu. rcceiV<ld CDDP (75mg/ml)on days 1.
`29, and S1. Objcctiveclink:al rcspooscswuc dclcnnincd on day 70. RClpOOsive
`pts. and pLS. with stable disease were eligible ror a mainlClWICC program, Or 36
`evaluable pu., one complei.e response (CR) and 7 pania.I responses CPR) wen>
`recorded. During the malr.ICnallee plwe one additional PR was rcconled among
`18 )lOUCl\IS cvalWWld. The overall best response (main study plu. maint.enancc) ror
`the evaluable pu. u as follows: CR+ PR• 9/36 (2511>). mine<• suiblc disease=
`9/36 (2S11>). and progressive dlscasc 18/36 (S011>). Oracle m or IV ioxlcily was
`obsenlcd in 21/39 pts. (5411>). Theioxlci1y prornewos that cxpcclcd from COOP,
`and there were no acute !Cliou. adverse event! rcoordcd following irea1mcn1 with
`rhuMAb HER-2. Theuscol rltuMAb Hl!R-2 plu. COOP In patients wilh HER·
`2,/M• overcxprcssing MBC resullcd ln rcsponsc rai.es above that expected f""11
`CDDP alone. and the combination showed no apparent inaeasc in ioxlcity.
`(Supported by the Revlon/UCLA Women's Cancer Rcscan:h Program and
`Ocncnieeh, Inc.)
`
`*125
`• u..oc:.((.UD • 9.0Uaa'lft ftD.L TO W'D.l.m.n. TD UJ'llC'l'9 or m:u c;m .. a r
`VltUO-. •LACll80 D A llJQS oosa PAC AO.lVV'UIT ~ PWOGIUM. POa
`ftAGS U Am STAGS tt:J .aBft CAllCSlt.
`~· N . lchott-• t.aedt. t.. Dunca.11, a. IU1'by, a. Qood, a. hM•l ,
`T, O•ort•• o . Snyder, o. Mat.kjn•, c. O.nb• a, A., K• y•• a.nd .\, au.bi.n,
`T• .••• On-cology, o.U.aa TX 15246 and lMut1ex Corp ., l ••ttl•, WA Jtt01
`Ia a r ando.iaad prO•P•Ct.lva trial wa COMparad tb• affect• o t
`rbu Gii-Cir (br9ruioatia) to placat.c. in an •djuvant eba.athaupy
`prograa Cor patient• v J.t.b ltaga D or lU invaalv• brae.at c ancat'.
`ftf bigh doH J'M: C'l'U 100 9Qa/al,, doltOl'ubiclft 10 199/ al,
`POU&' CO\IUH
`and cyclopboaphaaida 750 -e•/-2) wao follovad by daUy •\\bc:utaneou•
`inj.ctioD• of phc•bo or .. bu CIK·Ctr (250 K9•/al) on d•r• 1-u ot
`••ch 21 day eych . Th• andpoJ.nt• ot thh t.l'hl .,.r. th• ct.aye ot
`nautrOP•nh Cabaolut.• nautl'ophtl CO\u.\t fA»CJ c soo a nd " 1000/->J.
`th• incide n.ca oil: boapitalhatlon tol' febrile ne1.1uop•nh, and
`:~:-:::•::In~:::r!:~:·!H· p:~T:=~!•!:!i. 0~;! ~~'!!!0:~~!:. s::c.~:n
`SIU Hd 1/t4, 1'2 pathr:tta. •SIH 25 · 0 wu·· •nt • ... d. AU puient•
`"•r• avaluabl• tor at 1•.a.et 1 c:yc.l• a.nd Ul for aU 4 9ycl•••
`11:eault• ot thJ.a tdal are abown b•lo•u
`
`rbu. cat-a.r CH Pt• ) plae41bo ll2 ptMl
`
`1.0
`1.0
`1.0
`'1.CI
`
`p•0 . 004
`pd. 001
`p .. o.ou
`p.o .ou
`
`"' >I
`
`)11
`
`p<0.001
`pc0 .001
`pc0 . 001
`
`""°· •4-l••lo..
`f.Oril• •-t .. opeoJ •
`With reapact t.o toaicity, Grade l/t throe.boqttopenl• "•• .ore t~ent
`in cycl•• l u.d t in patient• ncelvlng rbu Cbe•car . Ot.har Oud.• l/t
`t:s. 10\ l and var• alaJ. lar in both groupa . Orad•
`•Hnta ., .... inft1aquent
`1/2 favar a nd injection eit• raaction.a var• iaora frequent vitb rhu
`OM·CIP and aouth ulc• ... aore fceqv.•nt. vl th pl_acabo . ln a.-..cy. thl•
`undoah• d controll•d ulal da:IM)n•trat•d d9nitlo•ntly h-.r d•Y• of
`tl•utropania a.nd a19nUtca.ndy higher do•• 1nt• nalty oC: ueat:.aent
`a wpported by rhu aM·C£:P COllP•n4 to phc•bo througb all • cyoh• oc:
`PAC: adjuv...:lt cl).-otb•r•py. tn add.It.ton, the U•• ot prophyhctic
`c1proUoitac1n •PPAH'•d to r•duc• t.h• lncJ.d•.Qce ot ho•pf.t.al adalaalon•
`tor hbdla neutl"OJH1nia ln both group• of pathJtu . Wbatb•r thH•
`effect• vUl ultt .. tely tranal&t·• into l•pr-ovact 1on11•t•r-. outcn-
`c ... ln to b• detel'.ain•d,
`
`*122
`ST-UTILITY STUDY OF OOCETAXEL (0) ANO PACUTAXEL
`A CO T}{£ TREATMENT OF RECURRENT MET ASTA TIC BREAST
`(P) ~ER (MBC} IN THE US. M· Borowitz , J Hunon and M Roll=
`CAN M·,..·cal Technology (llld Policy RCSC3rch Center, Arlinl.'IOO VA
`Oatelle
`....,
`22201
`In the absence of comparati.v~ clinical lrial data of 0 versus P as
`ccond line lhc.rapy in MBC. a dec1s1on-(lllal)'lle computer b:ued model was
`~igncd. 10 evaluate lhc effcelS of 0 or P for prerncnopausal women with
`CSlrogen-rcccptor ncg;in,·e pnmary tumors The model used a combmed
`decision tree / Marl<ov process. The model :uialysed dLS";"° states (response,
`stable disease. progressive discaSC). res~ rates (>50 Yo tumor rcgrem?")
`and ioxiciucs (minor, acute and cumulanve) for ~ch 1rcn1mcn1. Spcclfie
`tes corresponded 10 the overall benefit I nsk bal(lllCC of up 10 6
`health
`s~ chemolhcrnpy l\dmististered C\'U)' 3 weeks, dunng the period until
`eye:: 1 robability, 3 cost. and a utility was determined for each health stllC.
`dea
`p Y3S based 00 resources used in 1rea1mcn1 plus m:mngcmcn1 of
`The cost ~CCIS thc utility was based on • <k.'tlliled 3nAlysis of hcnlth Sillies.
`' were oblllincd from chnic:il uial dalll (published and
`3d\'c1SC c
`13105
`Rcspocu<:bl L...o) supplemented by c.•pcn chrucal opinion. COS!$ were taken from
`unpu 15
`f P and D
`be
`ed
`"""
`• •
`ublisbed sources. and the acquLS•llon cosu o
`. were assum
`10
`p al Ut liucs for the various hcalth sillies were cstablis.bcd using Slandard
`cqu ble a:.i visual (lll31og methods with 20 US oncology nu.rscs. as pan of a
`~Ire one >""'r study involving over 120 oncology nurses m Europe and the
`us as proxy paticnu.
`In thc base-case. probability of response to 0 of 0,55, total costs of
`'
`tr<!alJTlClll were cqu1valcn1 (S 15,746) but the utility was higher for D (0.7496
`QALYs) than for p (0.7075 QALYs).
`.
`Scnsiuvtty analysis showoc;i that thlS findmg was robust 10 changes in
`response rate. tolerability and maJor cost factors.
`
`*123
`
`GllOll'Ill Of FRESll llUKAll BREAST CANCER USING MATIUGBL
`IN tH!!UNODl!FlCIENT H.ICE. D J Schwartzentxl!ber,
`l( ,J, Merino, ancl S .A. llosenberg. Surgery Branch ancl
`Deparcaenc of Puhology, National Cancer ln•titute,
`Bethucla, HD, 20892.
`Tho long term growth of freoh hwaan breaat
`cancer in tl.saue culture or lmau.nodeflcient alee
`would be of value in studies of breut cancer: auch
`efforu heve been largely unauccuaful in the put .
`Thi• atudy vaa perforaed to •••••• the g.rowth of
`fr .. h hwaan breast cancers injoctocl with Mtrigol in
`beige/nucle/Xicl triple 1-unoclaficient (NIH lll·nu)
`feule 11ic.e . Surgical apeci~ona vero obtained from
`15 patients lnclucllng 9 pri•ary breast cancera (Bil),
`6 110taata1H to lymph nodeo (Ul), 1 to ovary (OV),
`and l malignant pleural effusion (PL).
`Speci . . na
`were eru:yme digutecl encl cryopreaervecl. After
`thawing, tumor coll• (0. 7 • 12 x 10') wore • uapenclecl
`lo 0.4 cc of 1Utdgel, and injectecl lo the ..... ry
`fat pacl of •ice. IUce were elao t.plentecl vlth a 60
`. clay 1usta1nocl reloue utrogen ta.blot using a
`trocar. Tuaora grew aubcutaneoualy froa 5 of 9 BR,
`4 of 6 UI, 0 of 1 OV encl l of 1 PL tuaor aourcea
`(clerlvocl fro• 8 patient•) . Haxlmua grovth (5·18 -
`in greateat dlueter) occurred at a aedl.an of 99
`clay• (range 35 co 146). Necropaiu revealecl no
`gro•• aecaat.atlc d.laeaae and all cuaors exaalned
`(n- 7) were confir.ocl hl1tologlcally. In conclusion,
`cyropr uervecl froah hwaan breast canceu from 8 of
`15 pathnt• grew slowly in i1111unocleficient mice. No
`g.reater a1uccea1 haa been reported 1-n the llteratur•.
`conflmlng the cllfficulty tn propagating breut
`c ancer cell• following surgical exciaion.
`
`crel• 1
`2.5
`2 . 0
`Cl)'Ch 2
`s.o
`cycle l
`cycle •
`5 . O
`.. ..,.. 1.ateae lt,y ,_ .,. .. •/-.J/n)
`s "1
`2'1
`Ooit0rublci.f.n
`l'
`J2'
`Cyolopboa phaa.f.d.a
`
`PROCEEDINGS OF ASCO VOL. 14 MARCH 1995
`106
`
`3 of 3
`
`Celltrion, Inc., Exhibit 1022
`
`