AVENTIS EXHIBIT 2123
`Mylan v. Aventis, IPR2016-00712
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`1
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`J
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`SMO
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`Annals of
`Oncology
`
`Official Journal of the European Society
`for Medical Oncology and the Iapanese
`Society of Medical Oncology
`
`Volume 21, 2010 Supplementl 6
`
`_
`_
`ESMO Conference:
`12"‘ World Congress on Gastrolntestrnal Cancer
`
`30 lune to 3 Iuly, 2010: Barcelona, Spain
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`Chairs:
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`Mario Dic-.110, M D
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`Annals of Oncology
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`Official Journal ofthe European Society for
`Medical Oncology and the Japanese Society of Medical Oncology
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`abstracts
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`Posters
`Author index
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`“/Ul|llH(,' 71 | T$I1;»;Jl<21i1r3I1l Ii
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`| July 2010
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`Annals of Oncology
`
`of 3-year DFS in pts <70 and >70 years showed a similar advantage of XELOX over
`5-FU/LV. Additional analyses are currently being conducted and will be presented.
`
`O-0006. DOUBLE-BLIND, PLACEBO-CONTROLLED RANDOMIZED
`PHASE III TRIAL OF AFLIBERCEPT (A) PLUS GEMCITABINE (G)
`VERSUS PLACEBO (P) PLUS GEMCITABINE (G) IN PATIENTS WITH
`METASTATIC PANCREATIC CANCER: FINAL RESULTS
`
`Riess H1, Manges R2, Karasek P3, Humblet Y4, Barono C5, Santoro A6,
`Wojcik-Tomaszewska J7, Assadourian S8, Hatteville L8, Vincent G8, Philip P9,
`Rougier P10
`1Charite´, University Medicine, Berlin, Germany, 2Investigative Clinical Research
`LLC, Indianapolis, Indiana, USA, 3Masaryk Memorial Cancer Institute, Brno,
`Czech Republic, 4Saint-Luc University Hospital, Bruxelles, Belgium, 5Medical
`Oncology Unit, Gemelli Hospital, Roma, Italy, 6Istituto Clinico Humanitas,
`Milano, Italy, 7Wojewodzkie Centrum Onkologii, Gdansk, Poland, 8Sanofi-
`aventis, Antony, France, 9Karmanos Cancer Institute, Detroit, Michigan, USA,
`10Hoˆpital Ambroise Pare´, Boulogne, France
`
`Background: Aflibercept, a recombinant fusion protein, is a potent inhibitor of
`vascular endothelial growth factor (VEGF) that also binds to placental growth factor.
`The primary objective of this multicenter randomized study (EFC10547) was to
`determine whether AG prolongs overall survival (OS) compared to PG, in patients
`(pts) with metastatic pancreatic cancer (MPC).
`Methods: Main eligibility criteria were: metastatic disease, no prior therapy for
`advanced disease, PS 0-2 and no bleeding risk. Pts were stratified on PS (0 vs 1 vs 2),
`primary pancreas tumor resection (yes/no) and geographical region. This trial had 90%
`power to detect a median OS improvement from 5.5 to 6.3 months (mo). The trial
`was stopped according to recommendation of the independent Data Monitoring
`Committee after first interim analysis (IA) as pre-specified futility criteria was met.
`Results of final analysis including the period from data cutoff (May 09) for IA to the
`unblinding of pts (Sep 09) are presented.
`Results: Between December 2007 and September 2009, 546 patients were randomized
`to receive either placebo or aflibercept 4mg/kg administered every 2 weeks (q2w) in
`combination with weekly intravenous gemcitabine 1000 mg/m2, 7 weeks on/1 week off,
`then day 1, 8, 15 q4w. Pts characteristics (275PG/271AG): male (57%/59%),
`age>65year (35%/41%), PS1-2 (64%/63%), pancreas tumor resection (11%/10%), >1
`organ involved (58%/60%). Median duration of follow-up was 7.9mo. As of 11
`Sep 09, 284 (142/142) pts have died. Median OS (PG/AG) 7.8/6.5mo (HR 1.16; 95%CI:
`0.92, 1.47). Median progression free survival (PFS) (PG/AG) 3.7/3.7mo (HR 1.02;
`95%CI: 0.83, 1.25). 541 pts were treated and evaluable for safety. Median infusions
`P5/G10, A4/G7. Main grade (Gr) 3/4 adverse events (AE) related to VEGF blockade
`(%pts PG/AG): hypertension 3.0/14.1, venous thromboembolic events 10.0/7.0,
`proteinuria 1.2/5.3, bleeding 1.5/3.7, arterial thromboembolic events 1.8/2.2, cardiac
`dysfunction 0.4/1.5. Other Gr 3/4 AE >10%pts (%PG/AG): neutropenia 24.5/30.8,
`asthenia 10.3/14.8, alkaline phosphates increase 11.1/11.9, thrombocytopenia 6.4/11.2,
`hyperbilirubinemia 10.5/8.0. 26 fatal AEs: 12 pts in PG arm (main reasons: 4pts
`unknown cause, 3 pts sepsis), 14 pts in AG arm (3 pts cerebrovascular accident, 3 pts
`sepsis, 2 pts gastrointestinal hemorrhage).
`Conclusions: The addition of A to G did not result in an OS benefit in patients
`with MPC. The median survival time in PG arm was longer than expected for this
`disease setting. The safety profile of AG was in accordance with what was expected
`in this disease setting and with such combination treatment including a VEGF pathway
`inhibitor.
`
`O-0007. A PHASE III STUDY COMPARING LAROTAXEL TO 5-FU
`(CONTINUOUS INTRAVENOUS 5-FU OR CAPECITABINE) IN
`PATIENTS WITH ADVANCED PANCREATIC CANCER (APC)
`PREVIOUSLY TREATED WITH A GEMCITABINE CONTAINING
`REGIMEN
`
`Van Cutsem E1, Macarulla T2, Van Laethem J3, Couture F4, Peeters M5, Gehn
`Hoff M6, Roman L7, Lequesne L8, Charpentier E8, Conroy T9
`1University Hospital Gasthuisberg, Leuven-cfr, Belgium, 2Hospital Vall
`d’Hebron, Barcelona, Spain, 3Hoˆpital Erasme, Bruxelles, Belgium, 4CHUQ
`Hospital Hotel-Dieu, Quebec, Canada, 5UZ Gent, Gent, Belgium, 6Hospital Sirio
`Libanes, Sao Paulo, Brazil, 7Leningrad Regional Oncology Center, St-
`Petersburg, Russia, 8Sanofi-aventis, Antony, France, 9Centre Alexis Vautrin,
`Nancy, France
`
`Background: Larotaxel (LARO) is a microtubule interacting agent with reduced
`recognition to P-glycoprotein that showed preclinical efficacy in tumors resistant to or
`refractory to docetaxel, another taxane that had shown clinical activity in patients (pts)
`with APC. The primary objective of this international randomized study was to
`determine whether LARO prolongs overall survival (OS) compared to 5-FU (5-FU
`continuous intravenous (CIV) or capecitabine according to the choice of the
`investigator for whole study duration) in pts with APC.
`Methods: Main eligibility criteria were: advanced disease, previous treatment with
`a gemcitabine-based regimen for advanced disease or in adjuvant setting with disease
`free interval less than 6 months, performance status (PS) 0-1, no prior locoregional
`
`oral presentations
`
`O-0004. EFFICACY FINDINGS FROM THE X-ACT TRIAL OF
`CAPECITABINE VS. 5-FU/LV AS ADJUVANT THERAPY FOR
`PATIENTS WITH STAGE III COLON CANCER: NO IMPACT OF AGE ON
`DISEASE-FREE SURVIVAL OR OVERALL SURVIVAL
`
`Twelves C1, Scheithauer W2, McKendrick J3, Nowacki M4, Seitz J5, Van Hazel
`G6, Wong A7, Diaz-Rubio E8, Gilberg F9, Cassidy J10
`1University of Leeds, St James’ University Hospital, Leeds, UK, 2Vienna
`University Medical School, Vienna, Austria, 3Box Hill Hospital, Melbourne,
`Australia, 4Maria Sklodowska-Curie Memorial Cancer Center and Institute of
`Oncology, Warsaw, Poland, 5Hoˆpital La Timone, Marseille, France, 6Mount
`Medical Centre, Perth, Australia, 7Tom Baker Cancer Centre, Calgary, Alberta,
`Canada, 8Hospital Clı´nico San Carlos, Madrid, Spain, 9F. Hoffmann-La Roche,
`Basel, Switzerland, 10Glasgow University, Glasgow, Scotland
`
`Background: The X-ACT trial demonstrated that the oral fluoropyrimidine
`capecitabine is at least equivalent to bolus i.v. 5-FU/LV as adjuvant therapy for patients
`with stage III colon cancer [Twelves et al. NEJM 2005]. In a recent analysis of the
`ACCENT database, investigators concluded that improved efficacy associated with
`newer adjuvant regimens vs. 5-FU/LV may not be preserved in patients aged >70 years
`[McCleary et al. ASCO 2009]. We therefore examined disease-free survival (DFS) and
`overall survival (OS) across age groups in the X-ACT trial to determine the efficacy of
`capecitabine in patients aged >70 years.
`
`Methods: 1987 patients with resected stage III disease were randomised to capecitabine
`(n=1004) or bolus 5-FU/LV (Mayo Clinic regimen; n=983) for 24 weeks. The primary
`efficacy endpoint was DFS.
`Results: After a median follow-up of 6.9 years, capecitabine was at least equivalent to 5-
`FU/LV in terms of DFS in the intent-to-treat (ITT) population [hazard ratio (HR) 0.88,
`95% CI, 0.77–1.01; P<0.001 for upper 95% CI limit vs. predefined non-inferiority
`margin of 1.20]. A subgroup analysis by age shows that there is a consistent trend across
`all age groups for greater benefit with capecitabine vs. 5-FU/LV (see Table).
`
`5-year DFS (%)
`
`5-year OS (%)
`
`Age
`(years)
`
`Patients
`(n)
`
`ITT
`<40
`40–69
`>70
`
`1987
`76
`1513
`396
`
`Cape 5-FU/
`LV
`54.6
`49.0
`54.5
`55.8
`
`59.1
`56.0
`59.4
`58.1
`
`HR [95% CI]
`
`0.88 [0.77–1.01] 70.9
`0.82 [0.42–1.62] 79.1
`0.87 [0.75–1.01] 70.9
`0.97 [0.72–1.31] 68.8
`
`Cape 5-FU/
`LV
`67.8
`65.6
`68.6
`65.0
`
`HR [95% CI]
`
`0.86 [0.74–1.01]
`0.65 [0.30–1.44]
`0.87 [0.73–1.04]
`0.91 [0.65–1.26]
`
`Conclusions: Oral capecitabine is an effective alternative to 5-FU/LV as adjuvant
`therapy for stage III colon cancer and can be considered for use in all age groups,
`including patients aged >70 years.
`
`O-0005. EFFICACY FINDINGS FROM A RANDOMISED PHASE III
`TRIAL OF CAPECITABINE 1 OXALIPLATIN VS. BOLUS 5-FU/LV FOR
`STAGE III COLON CANCER (NO16968): NO IMPACT OF AGE ON
`DISEASE-FREE SURVIVAL
`
`Haller D1, Cassidy J2, Tabernero J3, Maroun J4, De Braud F5, Price T6, Van
`Cutsem E7, Hill M8, Gilberg F9, Schmoll H10
`1University of Pennsylvania, Department of Hematology/Oncology, Philadelphia,
`Pennsylvania, USA, 2Glasgow University, Glasgow, Scotland, 3Vall d’Hebron
`University Hospital, Barcelona, Spain, 4Ottawa Regional Cancer Centre, Ottawa,
`Ontario, Canada, 5Istituto Europeo di Oncologia, Milan, Italy, 6The Queen
`Elizabeth Hospital, Adelaide, Australia, 7University Hospital Gasthuisberg,
`Leuven, Belgium, 8Maidstone Hospital, Maidstone, UK, 9F. Hoffmann-La
`Roche, Basel, Switzerland, 10Martin Luther University, Innere Med. IV, Halle,
`Germany
`
`Background: Adjuvant capecitabine is at least equivalent to bolus i.v. 5-FU/LV for
`disease-free survival (DFS) and overall survival (OS) in stage III colon cancer.
`NO16968 compared XELOX with bolus i.v. 5-FU/LV (standard regimen at study start)
`for stage III colon cancer. In a planned safety analysis, XELOX had an acceptable safety
`profile [Schmoll et al. JCO 2007]. In a recent analysis of the ACCENT database,
`investigators concluded that improved efficacy associated with newer adjuvant
`regimens vs. 5-FU/LV may not be preserved in patients (pts) >70 years [McCleary
`et al. ASCO 2009]. We examined DFS across age groups in NO16968 to determine
`XELOX efficacy in pts >70 years.
`Methods: Pts were randomized to either XELOX (capecitabine 1000mg/m2 bid
`d1–14 + oxaliplatin 130mg/m2 i.v. d1, q3w x8) or bolus i.v. 5-FU/LV regimens: Mayo
`Clinic (LV 20mg/m2 + 5-FU 425mg/m2 d1–5, q4w x6) or Roswell Park
`(LV 500mg/m2 + 5-FU 500mg/m2 d1, w1–6 in 8w cycles x4).
`Results: 1886 pts were randomized between Apr 2003 and Oct 2004. 1864 were
`evaluable in the previously reported safety analysis. After a median follow-up of 57
`months, 1886 pts are evaluable for DFS (primary endpoint), which was significantly
`superior for XELOX (HR=0.80; 95% CI, 0.69–0.93, p=0.0045) (see Table). Analysis
`
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`Volume 21 | Supplement 6 | July 2010
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`Annals of Oncology
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`radiotherapy and adequate biological functions. Pts were stratified on disease stage
`locally advanced (LA) vs. metastatic (M) and prior adjuvant therapy yes vs. no. A total
`of 400 pts had to be randomized to detect 30% reduction in hazard ratio (HR) in LARO
`group with 90% power. Starting dose of LARO was reduced from 90 to 75 mg/m2
`following safety issues (Amendment 2) – patients randomized prior to amendment 2
`were excluded from Intent To Treat population.
`Results: Between July 2007 and July 2009, 408 patients (204 patients by arm) were
`randomized to receive either LARO 75 mg/m2 on day 1 every 3 weeks (q3w) or 5-FU
`q3w (5-FU 1000 mg/m2/day CIV over 4 days or capecitabine 2000 mg/m2/day over
`14 days and 1 week rest). In 5-FU arm, 71 pts (34.8%) were treated with 5-FU CIV.
`Results are presented LARO/5-FU. Pts characteristics were well balanced: male 55.4%/
`59.3%, age‡65year 40.2%/34.8%, PS 0 37.7%/37.7%, PS 1 60.8%/60.8%, metastatic
`93.1%/92.6%, pancreatectomy 36.8%/36.3%, >2 organs involved 50.5%/45.1%.
`Efficacy results: median OS 4.8/5.1 months (mos) (HR 1.05; 95%CI: 0.842, 1.30,
`p= 0.69); median progression free survival 2.0/2.0 mos (HR 1.02; 95%CI: 0.83, 1.26). In
`both arms, pts with PS 0 had a better prognostic compared to pts with PS1: median
`OS PS0/PS1 in LARO arm was 6.2/4.0 mos; in 5-FU arm was 7.3/3.7 mos. A total of
`395 pts were treated and evaluable for safety (198/197). Median (min-max) number
`of cycles were 2 (1-25) and 2 (1-22). Incidence per pts of clinical adverse events of any
`NCI grade with ‡10% difference between both arms were diarrhea 47.0%/29.9%
`(including colitis 2.0%/1.0%, enteritis 1.5%/0%), nausea 39.4%/28.9%, alopecia
`35.4%/3.0%, constipation 24.7%/13.7%, sensory neuropathy 19.2%/6.6%, myalgia
`13.1%/1.0%, stomatitis/mucositis 15.7%/27.9%, and hand foot syndrome 0.5%/22.3%.
`Main hematological toxicities were grade 3-4 neutropenia 42.1%/6.3%, and
`complicated neutropenia (febrile neutropenia and/or neutropenic infection)
`15.7%/0.5%.
`Conclusions: In patients with APC previously treated with a gemcitabine-based
`regimen the median survival times were longer than expected and no difference was
`observed between LARO and 5-FU. The safety profile of LARO was as expected for
`a taxane in this setting.
`
`O-0008. PHASE III STUDY OF FOLFOX4 VS. DOXORUBICIN IN
`ASIAN PATIENTS WITH ADVANCED HCC: SUBGROUP ANALYSES
`ACCORDING TO BASELINE DISEASE STATUS
`
`Qin S1, Fan J2, Cheng Y3, Lim H4, Kang W4, Cho J5, Thongprasert S6,
`Bhudhisawasdi V7, Chao Y8, Yang T9, Shen W9, Sun Y10
`1PLA Cancer Center of Nanjing Bayi Hospital, Nanjing, China, 2Zhongshan
`Hospital Fudan University, Shanghai, China, 3Jilin Provincial Cancer Hospital,
`Jilin, China, 4Department of Medicine, Samsung Medical Center, Seoul, Korea,
`5Yonsei University College of Medicine, Gangnam Severance Cancer Hospital,
`Seoul, Korea, 6Faculty of Medicine, Chiang Mai University, Chiang Mai,
`Thailand, 7Department of Surgery, Khon Kaen University, Khon Kaen, Thailand,
`8Cancer Center, Taipei Veterans General Hospital, Taipei, Taiwan, 9Chang Gung
`Memorial Hospital, Linkou, Taiwan, 10Cancer Institute and Hospital, Chinese
`Academy of Medical Sciences, Beijing, China
`
`Background: In Asia, where hepatitis B is very common, hepatocellular carcinoma
`(HCC) is the third most common cancer. Locally advanced or metastatic HCC are not
`eligible for surgery or localized treatments and median survival is only 3 months with
`supportive care. Although sorafenib prolongs survival in HCC patients, tumour
`response is seen in <3% of those treated. Systemic chemotherapies are used but there
`is no evidence of a survival benefit. Oxaliplatin-containing regimens have shown
`efficacy against advanced HCC in several Phase II trials.
`Methods: This open-label, randomized, multicentre Phase III study was conducted in
`patients from mainland China, Taiwan, Korea and Thailand, who had locally advanced
`or metastatic HCC and were ineligible for complete resection or local treatment.
`Patients were randomized 1:1 to receive either FOLFOX4 (oxaliplatin 85mg/m2 i.v. d1;
`LV 200mg/m2 i.v. h0–h2 d1 and d2; 5FU 400mg/m2 i.v. bolus h2, then 600 mg/m2 over
`22 hours d1 and d2 q2w) or doxorubicin (50 mg/m2 i.v. q3w). Treatment was
`continued until disease progression, intolerable toxicity, or eligibility for surgical
`resection. The primary objective was to determine whether FOLFOX4 improves overall
`survival (OS) compared with doxorubicin; secondary objectives included time to
`tumour progression (TTP), response rate (RR) by RECIST 1.0, and safety. Data from
`subgroup analyses according to disease status at baseline (metastatic vs. localized
`disease) are presented.
`Results: Primary results have been reported elsewhere.1 The analysis after 266 events
`(deaths) has shown that in patients with metastatic disease who received FOLFOX4
`(N=104) and doxorubicin (N=112), respectively, median OS was 5.7 months (95% CI:
`4.8, 7.8) vs. 4.5 months [95% CI: 3.8, 5.5; P=0.028; HR: 0.688 (95% CI: 0.498, 0.950)];
`median TTP was 2.8 months (95% CI: 2.1, 3.5) vs. 1.7 months [(95% CI: 1.5, 2.1;
`P=0.0059; HR: 0.641 (95% CI: 0.471, 0.874)]. RR was 9.6% vs. 2.7% (P=0.0322) and
`DCR was 49.0% vs. 23.2% (P<0.0001). In patients whose tumour was confined to the
`liver and received FOLFOX4 (N=80) and doxorubicin (N=75), respectively, median
`OS was 6.8 months (95% CI: 5.3, 7.3) vs. 6.5 months (95% CI: 4.3, 8.2; P=0.8482);
`median TTP was 3.3 months (95% CI: 2.6, 4.1) vs. 2.2 months (95% CI: 1.7, 3.2;
`P=0.0119). RR was 6.3% vs. 2.7% (P=0.4440) and DCR was 56.3% vs. 44.0%
`(P=0.1274). Toxicity was consistent with previous experience of FOLFOX4 and
`doxorubicin.
`Conclusions: In this large international Phase III study of systemic chemotherapy in
`patients with unresectable HCC, a statistically significant survival benefit was seen with
`
`oral presentations
`
`FOLFOX4 in those with metastatic disease and FOLFOX4 significantly increased
`TTP, RR and DCR vs. doxorubicin.
`Reference:
`1. Qin S, Bai Y, Ye S et al. ASCO, Chicago, USA. 4–8 June 2010. Abstract #42222
`(submitted).
`
`O-0009. EVIDENCE OF ACTIVITY AND CLINICAL BENEFIT WITH
`SUNITINIB IN PATIENTS WITH PANCREATIC NEUROENDOCRINE
`TUMORS (NET)
`
`Raymond E1, Niccoli P2, Raoul J3, Bang Y4, Borbath I5, Lombard-Bohas C6,
`Valle J7, Ho¨ rsch D8, Patyna S9, Lu D9, Korytowsky B9, Mundayat R9, Chao R9,
`Vinik A10
`1Service Inter-Hospitalier de Cancerologie et Service de
`Gastroenteropancre´atologie, Hoˆpital Beaujon, Clichy, France, 2Assistance
`Publique, Hoˆpitaux de Marseille CHU Timone, Institut Paoli-Calmettes and
`RENATEN network, Marseille, France, 3Euge`ne Marquis Centre and European
`University in Brittany, Rennes, France, 4Seoul National University Hospital,
`Seoul, Korea, 5Cliniques Universitaires Saint-Luc, Brussels, Belgium, 6Hoˆpital
`Edouard Herriot, Hospices Civils de Lyon, France, 7The Christie NHS
`Foundation Trust, Manchester, UK, 8Center for Neuroendocrine Tumors, Bad
`Berka Central Clinic, Bad Berka, Germany, 9Pfizer Inc., New York, NY, USA,
`10EVMS Strelitz Diabetes Research Center and Neuroendocrine Unit, Norfolk,
`VA, USA
`
`Background: In a randomized, double-blind phase III trial, sunitinib was associated
`with superior progression-free survival (PFS; primary endpoint) over placebo in
`patients with progressive pancreatic NET (11.4 vs. 5.5 mo, respectively; P=0.0001). We
`report further assessment of clinical benefit in this trial, including patient reported
`outcome and exploratory analyses of prognostic factors for PFS.
`Methods: Patients with advanced well-differentiated pancreatic NET, and disease
`progression in the past 12 mo, were randomized 1:1 to receive sunitinib 37.5 mg orally
`once-daily (n=86) or placebo (n=85), each with best supportive care. Patients
`completed the 15-domain EORTC Quality-of-Life (QoL) Questionnaire–Core 30
`(QLQ-C30) version 3.0, on Day 1, every 4 wks (cycle) thereafter, and at end of
`treatment/withdrawal. Repeated-measures mixed-effects models were used to assess
`statistical (2-sided P value; 0.05 level) and clinical (‡10 point minimally important
`difference) mean between-treatment differences in QLQ-C30 changes from baseline.
`The influences of baseline characteristics on treatment effect were assessed using a Cox
`proportional hazards model.
`Results: At baseline, all 15 QLQ-C30 domain scores had a £7-point mean difference
`between treatment arms. Post-baseline QLQ-C30 data were available for 73/86 and
`71/85 patients in the sunitinib and placebo arms, respectively, through up to 10 cycles
`(during which each arm had ‡10 patients). Overall, compared with the placebo arm,
`patients on sunitinib had a clinically and statistically significant worsening of diarrhea
`(diff.=21.38; P<0.001) and a significant trend toward worsening of insomnia
`(diff.=7.753, P=0.0372). However, within the QLQ-C30, there were no clinically or
`statistically significant between-treatment differences in the following domains:
`cognitive, emotional, physical, role, social functioning nor other symptoms and scales;
`in addition, there were no significant between-treatment differences in mean change
`from baseline in the global QoL domain nor most other domains, when compared
`using a 2-sample T-test. The treatment effect significantly favored sunitinib regardless
`of age (<65 vs. ‡65 yrs), race (white vs. non-white), gender, ECOG status (0 vs. 1/2),
`number of metastatic sites (£2 vs. ‡3), or time from diagnosis to study enrolment
`(<3 vs. ‡3 yrs). Sunitinib showed benefit over placebo in non-functioning tumors, with
`a trend for benefit in functioning tumors. The hazard ratio (HR) for PFS favored
`sunitinib patients, regardless of treatment with or without somatostatin analogs, which
`were allowed before and/or during the study. Similarly, sunitinib improved PFS relative
`to placebo regardless of prior chemotherapy use. By multivariate analysis, only time
`from diagnosis to enrolment (‡3 vs. <3 yr) was a potential independent predictor of
`PFS (HR 0.603; 95% CI 0.382, 0.952; P=0.0299). The PFS advantage with sunitinib was
`greater when adjusting for time from diagnosis (HR 0.374; 95% CI 0.234, 0.599;
`P<0.0001).
`Conclusions: Complementing prior reports of efficacy from this trial in which
`sunitinib demonstrated improved PFS in patients with pancreatic NET, these results
`indicate that sunitinib maintains global QoL with overall clinical benefit observed
`across all patient subgroups studied.
`
`O-0010. 90 YTTRIUM-DOTA-OCTREOTATE FOR THE TREATMENT
`OF ADVANCED NEUROENDOCRINE TUMOURS
`
`Toumpanakis C, Caplin M, Quigley A, Marelli L, Chilkunda D, Khan M, Meyer T,
`Buscombe J
`Royal Free Hospital, Neuroendocrine Tumour Unit, London, UK
`
`Background: Peptide receptor therapy for neuroendocrine tumours (NETs) is
`a relatively new treatment modality, which was first trialed in 1992 using high dose
`111In-octreotide Progress has resulted in the use of beta emitting radionuclides
`Yttrium90 and Lutetium177. The results with Lu177 and Y90 therapies are very promising
`especially when one considers that these patients have often failed other therapies. Aim:
`
`Volume 21 | Supplement 6 | July 2010
`
`doi:10.1093/annonc/mdq268 | vi13
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`5