Celltrion, |nc., Exhibit 1011
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`1 of 5
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`Celltrion, Inc., Exhibit 1011
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`

`

`THIRTY-SECOND
`Annual Meeting of the
`American Society of Clinical Oncology
`May 18-21, 1996
`PROGRAM/PROCEEDINGS
`
`Philadelphia, PA
`
`Contents
`
`ASCO Program lnfomrnLion
`Officers and Direct0rs ............................................................................................................................. .
`iii
`Calc11dar of Eve11ts ................................................................................................................................. .
`iv
`Committee Rosters ................................................................................................................................ .
`ix
`General Information .............................................................................................................................. .
`x
`Special Events........................................................................................................................................
`xiv
`Tumor Panels.......................................................................................................................................... xx ii
`Scientific Symposia ................................................................................................................ ················ xx111
`Educational Sessions .............................................................................................................................. xx~v
`Meet the Professor Sessions................................................................................................................... xx1x
`
`. . ~J
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`:fl
`64
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`: :
`: :
`: : : + l!I
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`Cancer Biology and Molecular Genetics·······························································································
`
`Clinical Pharmacology (Adult and Pediatric)......... ...............................................................................
`
`Gastrointestinal Tract Cai~cer...................................................................... ...........................................
`g~~~ ~~~~~~~~~~.~~~·I·~'.~.~.~.:::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::::: ~~~
`Genitourinary Tract Cancer.................................................................................................................... 2.69
`Growth Factors/Cytokines ..................................................................................................................... .
`
`~:n
`
`Volume 15 • March 1996
`Tio.I---·-··-···-- ---1-J
`
`Allogcneic Bone Marrow Transplantation.............................................................................................
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`84
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`1 5
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`2 of 5
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`Celltrion, Inc., Exhibit 1011
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`
`!-ligh-Dose Therapy/Stem Cell Support ······················································································:::::::::::
`
`Molecular Genetics ................................................................................................. ·······························
`Monoclonal Antibodies ............................................................................................ ······························
`Multiple Myeloma ................................................................................................................................. .
`Myeloproliferative Syndromes ............................................................................ ···································
`Nutrition ................................................................................................................................................ .
`Other Adult Solid Tumors ..................................................................................................................... .
`Pediatric Solid Tumors .......................................................................................................................... .
`Pharmacokinetics/Dynamics ................................................................................................................. .
`Phase I Trials ......................................................................................................................................... .
`Preclinical Experimental Therapeutics .................................................................................................. .
`Prevention ............................................................................................................... ································
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`Signal Transduction ............................................................................................................................... .
`Supportive Care and Bioethics/Infectious Disease ............................................................................... .
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`xi
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`3 of 5
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`Celltrion, Inc., Exhibit 1011
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`PrograDJ/Proceedings
`of the
`American Society of Clinical Oncology
`
`American Society of Clinical Oncology
`
`Officers
`1995-1996
`
`John H. Glick, MD
`President
`
`James 0 . Armitage, MD
`President-Elect
`
`Karen H. Antman, MD
`Immediate Past President
`
`Mark J. Ratain, MD
`Secretary/Treasurer
`
`Board of Directors
`Paul A. Bunn, Jr., MD
`Bruce D. Cheson, MD
`C. Norman Coleman, MD
`Sarah S. Donaldson, MD
`Ross C. Donehower, MD
`Elizabeth A. Eisenhauer, MD
`Brian J. Lewis, MD
`John D. Minna, MD
`David Prager, MD
`Nicholas J. Vogelzang, MD
`James Lloyd Wade Ill, MD
`William C. Wood, MD
`
`John R. Durant, MD
`Executive Vice President
`
`Michael C. Perry, MD
`Program/Proceedings Editor
`
`Editorial staff provided by W.B. Saunders Company
`
`Copyright © 1996 by the American Socie1y of Clinical Oncology
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`4 of 5
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`Celltrion, Inc., Exhibit 1011
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`BREAST CANCER
`
`*80
`ll ER-2/11e11 O VER-EXPRESS IO N AND CLINI CAL TAXANE
`Sl3NSITIVITY: A MULTlVARIATE ANALYSIS IN PATI ENTS
`WITH METASTATIC BREAST CANCER (MOC) Seidma n AD', J
`Baselga' . T-J Yao, T Gilewski, PP Rosen. L Non on. Me morial
`Sloan-Kettering Cancer Center. New York , NY 10021
`Proto-oncogene HER2 amplificalion and ove r-expression have
`been implica!Cd as chemotherapy response variables in MBC and in the
`adjuvant (stage II) setting. although the direction (sensitivity vs.
`resis tance) is unclear. We therefore studied by immunohistoche mis try
`126 MOC patienis (pls) with available tissue who were Lrcated on phase
`II protocols o f s ingle-agent paclitaXe l (n= I06) or docetaxel (n=20).
`5 1/126 (40.5%) had tumor ~2+ positive for HER2. 7 fac tors were
`as.~esscd for associati on with tum or response: HER2 ove r-expression
`(+!·),number of (lrgan systems with metastases (1-2 vs >2), prior
`d oxorub ici n (yes/n o), ER (+/· ), num ber o f prio r c he m o the rapy
`regimens (1 -2 vs. >2), dominant visceral involvement (yes/no). and
`Karnofsky Perform ance Status (KPS ; 60- 80 vs. 90- 100%). The
`response proponion was 46.8% (59/ 126) (95% C.I. 38. 1-
`overall
`55.5%); 58.8% (30/5 1) if HER2 (+)vs. 38.7%(29175) if HER2 (·)
`(Mantel Haenswl test, p=.027). Visceral dominance (p=.0 11). low
`KPS (p=.057), and e xtcnsive prior the rapy (p=.006) correlated with
`poor clinical response . Among these, HER2 over-expression was
`posi tive ly correlated with low KPS (p=.002). and low KPS with
`should bias against
`extensive prior the rapy. These eorrel:uions
`response in HER2 (+) cases , which was not observed . Indeed,
`s tratified analysis controlling for confounding variables demonstrated
`the value of HER2 status in predicting good taxane response. The
`odds rati os of tum or response for HER2 ( +) vs. ( · ) were 2.4 6
`(p=.020). 2.32 (p=.023), and 1.93 (p=.087) afte r adjus ting for
`low KPS,
`viscernl dominance, exte ns ive pri or therapy, and
`respective ly. Thus, HER2 over-expression in MBC seems to confer
`sensitivity rather th an resistance to 1axanes, in spite of a positive
`correlation of HER2 positivity with poor progno.~tic features . Cellulnr
`mechanisms for this effect arc under investigation. [Supponed in part
`by• ASCO Career Development Awards & NCI contract l-CM0731 l J.
`
`*82
`~E~~°!!M~~o,~Rl~R o~~g~~~~v';J1"6~~~:~~p~R~~~
`
`CANCER EARLY REPORT.
`u o - he A Bremond. P Kcrbral, M Nomer. P. f'umo lc;1u,
`nd v Po lin. on bc:halr " ' 1hc
`J. Bonncacrrc (I ). ~· C
`·
`M-J. Ooud1cr. P. Fnrgeol. M. Bnrdonncl· omac •
`French Adj11vnn1 Study Gro up (FASO)
`I I) Centre Oscar Lamb rcl LILLE! I-RA NCE.
`Aim : To dc1crminc whether increasing the cpirubicin ( !;pi) dO>C fro m 50 mg/111'
`to 100 mg/m' impro ved d isease-free su':'ival (D~'S) <1nd ()vernll 'urv1v11I rOS) an
`nodc·po•ilivc o pcmblc brc:isl cnnccr paucn1s (p1>).
`Mtthods : From Apr;I 1990 10 July 1993. S6S breast ca'."'cr pt> under 65 w11h 4
`or more posi11ve nodes (or I 10 3 posuivc n~ wuh SOR grade - 2 or ~ and
`negative hormonal receptors) were random11.cd 10 rccc~~c 6 .cycle> u.r FEC ~O
`rarm A) or FEC 100 (arm 8 ) every 3 week.. 111c MJC regime n cooupm~d
`nuorournc1I SOO mg/m' <>n DI. cyctopho>ph~midc 500 mg/m' " " l)J + l't"
`SO mg!m' on DI IFEC SO) or llp1 100 mglm' on DI IFEC 100) All pts fir-t
`underwent ourgery, Md received locnl radinuon n[1er lit<: chcmoahempy. All (><\\I
`mcnop'1u,11I pas also received Tnmoxircn 30 rnj;id for 3 yenrs.
`Rosul~ . C.:hnical progn0>11c fac:lors were equally di.r<1bu1cd in the ~wo .mn'
`T oxicity and ourv1val were analy\Cd in 497 pis (2-19 = A. 248 = B ). rhc 111can
`dose intcn>lly (ndm101>lcrcd/planncd dose) or the 3 drui;> was 9·t I 'II in nrn1 A
`"'
`and 92.2% 1n am1 8.
`Tolerabilily : grade J-4 ncuaropcnia occurred in 11 % and 24 "' or fll' in arm A
`and ll. rc' pcctovely Ip ,, 0.001 ). No rcbrilc ncu1topcnio wa.~ ob~rvcd Alopcc1a
`nnd s1unm1it1s were les' frequent wnh FEC 50 (p = O.Olll ). l·our<a>c> of grade I
`12 =A. 2 = Il l nod 1 ci" e or gmdc 2 Cami 13 ) cardrnc mxicl1y were oh,erved. hut
`dtd not nccc» il:t.lc treatmcnl intctrup11on.
`Arter o median follo w·up of 30 months. prchmonary rC\Uh\ >h11w a '1g111f1<:,1111
`d ifference in DFS heawccn the 1wo am1s : 3 years DFS "62. 1 'II·, and 705~ 111
`nrni< A nnd D. rcspcc1ively (p = 0.02). There " no difference in OS.
`Conclusion ; our preliminary rcsuhs ; uggesl 1ha1 FEC.: 100 signiffoanily improve,
`OFS compared 10 FEC 50 1n 1h1> cmcgory of pt>.
`
`*81
`REDUCTION O F SKELETAL MORBID ITY AND PREVENTION O F BONE
`METASTASES WITH O RAL CLO DRON ATE IN W O MEN WITI I RECURRENT
`BREAST CANCER IN THE ABSENCE O F SKELETAL METASTASES: A. H.G. Pa1erson.
`E.V. McCloskey, S. Ashley, T.J. Powles, J.A. Kanis, Tom Baker Cancer Centre and
`University o f Calgary, Alberta, Canada; Ro yal Marsden Hospital, Su!lo n, U.K.; W HO
`Collaborating Centre for Me1abolic Bo ne D isease, She ffie ld, U.K.
`The b1sphosphona1e, Clodronate, 1s an anii-os1eoly1ic agent which reduces skeletal
`morbidity (episodes of hypercalceml a, vertebral fractures and requirem ents for
`radio!herapy to 1he spine fo r back pain) when given o rally toge1her w i1h syste mic
`1herJpy in women with b reast cancer and skeletal metas1Jses. (A.S.C.O. 1992) In
`1he present randomized, double bhnd con11olled study, we examined 1he effect or
`clodrona1e on the incidence o f skeletal me1as1Jses and skeletal mo rbidity in women
`with recu rrent b reast cancer who had no rad iographic o r scin1igraph1c evid ence o f
`skeletal metastases. In ~di1ion 10 an1i-1umor therapy, Il l women received ell her
`clodronare 1600 mg daily by mouth (n-66) or an iden11cal placebo (n - 6n. The
`Clodro na1e w as well 1olcra1ed w ith no signlficanl ly increased to xicity ove r p lacebo.
`Hypocalcemia w as no1 noted. There have been 28 2 pa1ien1 years o f follow-up
`available f0t analysis. Fewer pa1ien1s developed skeletal me1as1ases during
`clodronate trea1men1 ( t S vs 19, NS) and the 101al number or skeletal metastases was
`sig nificantly decreased (32 vs 6 3, P < 0.005). rrea1me n1 also reduced the number
`of hypercalcemic episodes ( 10 vs 17) and vet1ebral d eformities (35 vs 54). The la!ler
`e ffect was m os1 marked in those w11h vertebral deformities at entry (41 .9 vs 150 .0
`fractures/100 pa11ent years, P < 0 .005). There was also an effect of clodronate on the
`freq uency o r non·verlebral fraciures (75% e ffect; p< O.O I). The combined rate o f a ll
`morbid skelet•I events was reduced by 26 % (P < 0.01). Combined cortical w id th of
`the metacarpals increased by 5.3'l. Ct 2.9'l.l al 12 months 1n the clodronate group
`and decreased 2.J 'll> ( .I: 2. t "Yo) 1n the placebo g roup (p< 0 .05). No significan t
`differe nce in survival was noted between the g ro ups in 1his trial. W e conclude tha1
`or JI clodronaic r~-duces the the ra1e of p rogression o f skeletal metastases in patients
`w11h recurrent b<east cancer and provides a useful adjunct in the management of
`these patients. This is one or the fi rst clinical studies suggesting 1ha1 an agent which
`has an effect p red ominantly o n no rmal !issue cells (osteoclasts) mig ht influence 1he
`cl1n1ca l appearJnce of mc1as1atic disease. Trials in operable breast cancer are
`w arramed and underway.
`
`*83
`COMBINATION OF MAMMAPLASTY ANO BREAST IRRADIATION IN
`CONVENTIONAL
`FOR
`UNSUITABLE
`CANCERS
`BREAST
`CONSERVAT IVE TREATMENT.
`I. Cot hier , L. Lan tieri, F. Feu i lhade,
`Y. ~guinc, E. Cal ilchi,
`J.P. Le Bourgeois,). Baruch. C .H.U. H en ri Mo ndor 940 10 Cltte il · France.
`Conservative treatme nt o f breas t cancer is row routinely proposed
`fOT small tumors and its i ndications arc being extended to larger tumor by
`preoperative irradiatio n a nd /or che mothera py. H o wever for some tumors
`good oncologic results, es pecially in te rms of local recurrence, cannot be
`achieved by limited s urgery. These cases require a wide g landula r
`resectio n which would lead 10 a residual d eformity and a poor cosmetic
`result. There fo re, fnim 1983 to 1990, 5 1 patients with b rea st cancer
`unsuitable for conve ntional conservative surgery were treated by wide
`reS<.'Clion 350 g) combined with immedia te
`lump<.'Cto my (mean weight
`rcmodt'ling of 1hc gland by mam maplasty. This tech nique was o n ly
`perfo rmed in medium-sized o r la rge breasts a nd 10 a void m astecto m y 1 he
`to be
`rest'Ction m.11gins and the rc tronrco lar nrca had , pe ro peratively,
`fo und m icroscopically free o f tumo r.
`This approach was ind ica ted in 4 ;,itua tions:
`extensi ve microca lcifica tions (17 cases; 33%)
`residual tumor, after preoperative irra d iation and I or ch e mothe rapy.
`larger than 4 cm in diameter ( 18 cases; 35'JG.l
`ex te ns ive D uctal Carcinoma In Situ (4 cases; 8~) OT tumor asS(l(iated
`with fibrocys1ic m astosis (6 ca ses; 12%)
`bifocal lesion loca ted in two adjacent q u ad ra nts (6 cases; 12%).
`According to 1hc UICC t umor da;,sification there were 2 TO, 7 Tl . 22
`T2 a nd 20 T.l. Adjuvani t herapy (radiotherapy and I o r medical trea t ment)
`was conductl'CI according lo our ins1ilu1 ion's usual breast cancer pro tocol
`treatme nt. W ith a m ean fo llow-up o f 8 ye;ars, 4 patie nts (8%1 d eve lo ped .1
`local rccum:nce trcatt'd by salvage surgery. The DI'S a t 5 yc;ars w as 76'1.. l t
`has to be s tressed that the examina tio n o f t he contro latc ral s ide revNlcd 2
`infiltrating carcinoma and I DCIS and thnt c pilht•lial prolife ratio n w as
`fo u nd in 7 cases.
`Tilc cosmetic =ult was considerl'CI to be good or very good in 78"',
`moderate 111 20% and poor in 2% of patient>.
`
`PROCEEDINGS OF ASCO VOL. 15 MARCH 1996
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`5 of 5
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`Celltrion, Inc., Exhibit 1011
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