THIRTY-FIRST Annual Meeting of the

American Society of Clinical Oncology

May 20-23, 1995

PROGRAM/PROCEEDINGS Los Angeles, CA

ASCO Program lnf6m1ation Contents

B!iTIS!t LIBWY DC~f"""'ll s·~'3Pl Y r.-~

0 4JUL1995 CONFE .. d.;CE

INDEXED

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 ............................................................................... .

Volume 14 • March 1995

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

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

2 of 3 Celltrion, Inc., Exhibit 1022

*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 health tes corresponded 10 the overall benefit I nsk bal(lllCC of up 10 6

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. 3d\'c1SC c

13105' were oblllincd from chnic:il uial dalll (published and

Rcspocu<:bl L...o) supplemented by c.•pcn chrucal opinion. COS!$ were taken from unpu 15

""" • • f P and D ed be 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.

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'. POU&' CO\IUH ftf bigh doH J'M: C'l'U 100 9Qa/al,, doltOl'ubiclft 10 199/ al, 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 and " 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

crel• 1 Cl)'Ch 2 cycle l cycle •

rbu. cat-a.r CH Pt• ) plae41bo ll2 ptMl

2.5 1.0 2 . 0 1.0 s.o 1.0 5 . O '1.CI

.. ..,.. 1.ateae lt,y ,_ .,. .. •/-.J/n) s "1 2'1 Ooit0rublci.f.n l' Cyolopboaphaa.f.d.a J2' ""°· •4-l••lo.. f.Oril• •-t .. opeoJ •

" ' >I )11

p•0 . 004 pd. 001 p .. o.ou p.o .ou

p<0.001 pc0 .001 pc0 . 001

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 •Hnta ., .... inft1aquent t:s. 10\ l and var• alaJ. lar in both groupa . Orad• 1/2 favar and 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 awpported 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,

PROCEEDINGS OF ASCO VOL. 14 MARCH 1995

106

3 of 3 Celltrion, Inc., Exhibit 1022