Download the ESMO 2012 Abstract Book - Oxford Journals
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Novartis, Genentech, and sanofi-aventis. All o<strong>the</strong>r authors have declared no<br />
conflicts of interest.<br />
335P DYSPHONIA AS A PREVIOUSLY UNREPORTED SIDE EFFECT<br />
OF BEVACIZUMAB TREATMENT IN PATIENTS WITH<br />
METASTATIC BREAST CANCER<br />
S.A. Radema 1 , P. Souverein 2 , R. Meyboom 2 , F. Ahmadizar 2 , C. Onland-Moret 2 ,<br />
A. Maitland-Vd Zee 2<br />
1 Internal Medicine, Gelre Ziekenhuizen, Apeldoorn, NETHERLANDS,<br />
2 Department of Pharmaceutical Sciences, Division of Pharmacoepidemiology<br />
and Clinical Pharmacology, Utrecht University, Utrecht, NETHERLANDS<br />
Introduction: Bevacizumab is a humanized monoclonal antibody directed against<br />
vascular endo<strong>the</strong>lial growth factor A and has been approved for <strong>the</strong> treatment of<br />
several metastatic tumours. There is considerable heterogeneity in <strong>the</strong> response to<br />
treatment with bevacizumab, both in effectiveness and in toxicity. Here we describe a<br />
previously unreported adverse drug reaction (adr) in pts with MBC treated with<br />
bevacizumab.<br />
Methods: In a teaching hospital in <strong>the</strong> Ne<strong>the</strong>rlands (from Sep 2009 to Jul 2011), 32<br />
consecutive pts with MBC treated with chemo<strong>the</strong>rapy and bevacizumab were<br />
registered in a retrospective database. TNM stage, comorbidities, concomitant<br />
medication, prior treatment for <strong>the</strong> primary tumour, date of metastatic disease, prior<br />
treatment for metastatic disease and toxicities were recorded. The WHO global<br />
individual case safety report database, VigiBase, contains summaries of suspected<br />
spontaneous case reports summated by health care professionals and pts to national<br />
pharmacovigilance centres . As of May 2010, VigiBase contained >5 million case<br />
reports. . We searched <strong>the</strong> VigiBase extraction of Dec 2011 for dysphonia. Reporting<br />
odds ratios (ROR) were calculated for <strong>the</strong> occurrence of dysphonia compared with<br />
o<strong>the</strong>r adr for bevacizumab and paclitaxel.<br />
Results: In total, 9/32 pts (28%) reported dysphonia during treatment with<br />
bevacizumab and 5/9 pts underwent ENT examination. In several pts marked<br />
oedema of <strong>the</strong> vocal cords and/or chronic laryngitis were found. As of Dec 2011,<br />
6,880,361 reports were available in VigiBase, of which16,239 were related to<br />
dysphonia. For bevacizumab <strong>the</strong>re were 51 reports for dysphonia and 46,041 reports<br />
for o<strong>the</strong>r adr. Corresponding figures for all o<strong>the</strong>r drugs were 22,108 reports for<br />
dysphonia and 25,151,628 reports for o<strong>the</strong>r adverse effects: ROR of 1.26 (95% CI:<br />
0.95-1.66). For paclitaxel <strong>the</strong>re were 45 reports for dysphonia and 85,988 reports for<br />
o<strong>the</strong>r adr. Corresponding figures for all o<strong>the</strong>r drugs were 22,114 reports for<br />
dysphonia and 25,111,681 reports for o<strong>the</strong>r adverse effects: ROR of 0.59 (95% CI:<br />
0.44-0.80)meaning that <strong>the</strong> risk of angiooedema is significantly higher in<br />
bevacizumab users compared to paclitaxel users.<br />
Conclusion: Dysphonia is a previously unreported side-effect in pts with MBC<br />
treated with bevacizumab and paclitaxel.<br />
Disclosure: S.A. Radema: I am member of an advisory board for Roche. All o<strong>the</strong>r<br />
authors have declared no conflicts of interest.<br />
336P PATTERNS OF CLINICAL MANAGEMENT AND RESOURCE<br />
UTILIZATION FOR POSTMENOPAUSAL<br />
HORMONE-RECEPTOR–POSITIVE HER2-NEGATIVE (HR+<br />
HER2–) ADVANCED BREAST CANCER (ABC) IN EUROPE<br />
G. Jerusalem 1 , N. Marinsek 2 , J. Ricci 3 , J. Etchberger 2 , R. Degun 2 , G. Benelli 4 ,<br />
S. Saletan 5 , F. André 6<br />
1 Centre Hospitalier Universitaire du Sart Tilman, Centre Hospitalier Universitaire<br />
du Sart Tilman, Liège, BELGIUM, 2 Navigant Consulting, Inc, Navigant<br />
Consulting, Inc, London, UNITED KINGDOM, 3 Wellmera AG, Wellmera AG,<br />
Basel, SWITZERLAND, 4 Novartis Farma S.p.a., Saronno, ITALY, 5 Onco Ex Dir<br />
Clinical Res Phys, Novartis Pharmaceuticals Corporation, East Hanover, NJ,<br />
UNITED STATES OF AMERICA, 6 Breast Cancer Unit, Institut Gustave Roussy,<br />
Villejuif, FRANCE<br />
Objective: To understand treatment patterns and quantify resource utilization of<br />
HR + HER2 − aBC, with <strong>the</strong> overall aim of comparing costs and disease burden as<br />
patients progress from hormonal <strong>the</strong>rapy (HT) to chemo<strong>the</strong>rapy (CT).<br />
Methods: We conducted a chart audit in France, Germany, The Ne<strong>the</strong>rlands,<br />
Belgium, and Sweden of 375 living and deceased postmenopausal female patients (75<br />
per country) diagnosed with ER + HER2 − aBC in <strong>the</strong> past 4 years. Patients were<br />
required to have progressed on ≥ 1 line of prior HT ei<strong>the</strong>r in <strong>the</strong> adjuvant or<br />
advanced setting and to have completed ≥ 1 line of CT treatment (minimum 2 full<br />
cycles) in <strong>the</strong> aBC setting. The chart audit was completed online using a<br />
standardized form developed with <strong>the</strong> assistance of European academic physicians,<br />
pharmacy directors, and hospital administrators. Participation was sought from 25<br />
oncologists per country, except in Germany (15 oncologists and 10 gynecologists to<br />
reflect local clinical practice). Data collection was compliant with European and<br />
country market research regulations.<br />
Results: Our report details <strong>the</strong> patient care pathway, CT side effects, and resource<br />
utilization in <strong>the</strong> inpatient and outpatient settings throughout <strong>the</strong> continuum of aBC<br />
Annals of Oncology<br />
care. Preliminary analyses indicate that 55% of HR + HER2 − aBC patients are first<br />
treated with HT and switch to CT after 1.5 lines of HT. This switch is primarily<br />
influenced by <strong>the</strong> extent (56%) and progression rate (36%) of metastases. The switch<br />
from HT to CT is associated with increased resource utilization and <strong>the</strong> associated<br />
costs of treating aBC. In addition to cost of drug <strong>the</strong>rapies, <strong>the</strong> main drivers of cost<br />
are treatment for CT side effects (chiefly febrile neutropenia and diarrhea) and<br />
related hospitalization events. CT side effects that have <strong>the</strong> greatest impact on <strong>the</strong><br />
overall disease burden of aBC include alopecia, nausea, vomiting, fatigue, and<br />
peripheral neuropathy.<br />
Conclusions: Our results highlight <strong>the</strong> increased costs and disease burden for<br />
postmenopausal ER + HER2 − aBC patients treated with CT versus HT.<br />
Disclosure: G. Jerusalem: Consultant, Novartis Pharmaceuticals Corporation. N.<br />
Marinsek: Consultant, Novartis Pharmaceuticals Corporation. J. Ricci: Advisor,<br />
consultant, Novartis Pharmaceuticals Corporation. J. Etchberger: Consultant,<br />
Novartis Pharmaceuticals Corporation. R. Degun: Consultant, Novartis<br />
Pharmaceuticals Corporation. G. Benelli: Employees of Novartis with stock/stock<br />
options. S. Saletan: Employee of Novartis with stock/stock options. F. André:<br />
Financial support from sanofi-aventis, Novartis, Roche, AstraZeneca<br />
337P EFFICIENCY FRONTIER ANALYSIS (EFA) OF METASTATIC<br />
BREAST CANCER (MBC) TREATMENTS: A UK PERSPECTIVE<br />
C. Burudpakdee 1 , D. Bertwistle 2<br />
1 Health Economics and Outcomes Research, IMS Health, Philadelphia, PA,<br />
UNITED STATES OF AMERICA, 2 Heor, IMS Health, London, UNITED KINGDOM<br />
Background: As newer <strong>the</strong>rapies for mBC become available, understanding <strong>the</strong><br />
efficiency of <strong>the</strong>se <strong>the</strong>rapies will be important for HTA recommendations and<br />
treatment decisions. EFA may be a useful method of assessing <strong>the</strong> efficiency of newer<br />
interventions. The EFA displays <strong>the</strong> outlay (cost) and gains with technologies, and<br />
displays <strong>the</strong> next most efficient option going forward. This study was designed to<br />
evaluate whe<strong>the</strong>r EFA could be useful in identifying <strong>the</strong> efficiency of mBC <strong>the</strong>rapies<br />
adopted by <strong>the</strong> NHS, and to identify <strong>the</strong> efficiency frontier for newer technologies.<br />
Methods: A literature search was performed to identify mBC treatments that<br />
underwent HTA in <strong>the</strong> UK. Reports were reviewed to identify treatment efficacy and<br />
HTA recommendations. Costs were determined for a course of treatment. The<br />
incremental costs per patient were plotted on <strong>the</strong> horizontal axis and incremental<br />
median overall survival (ΔOS) of each treatment was plotted on <strong>the</strong> vertical axis to<br />
construct <strong>the</strong> EFA line. Treatments below this line are considered inefficient options.<br />
Treatments above this line have better OS and may redefine <strong>the</strong> efficiency frontier.<br />
Treatments in <strong>the</strong> upper right quadrant beyond <strong>the</strong> frontier line are in an area where<br />
ceiling price has not been defined. Treatments in <strong>the</strong> lower right quadrant beyond<br />
<strong>the</strong> frontier line are inefficient due to higher cost for lower OS.<br />
Results: Ten reports that evaluated efficacy in terms of median OS were included in<br />
<strong>the</strong> EFA. The <strong>the</strong>rapies are paclitaxel albumin, gemcitabine, trastuzumab,<br />
bevacizumab, lapatinib, eribulin and fulvestrant. On <strong>the</strong> frontier line are paclitaxel<br />
albumin (ΔOS of 2.3 months at £2020), gemcitabine (ΔOS of 2.8 months at £6020),<br />
and trastuzumab (ΔOS of 4 months at £16939); all received positive<br />
recommendations. Lapatinib (ΔOS of 1.9 months at £10180), bevacizumab (ΔOS of<br />
1.7 months at £36560), eribulin (ΔOS of 2.5 months at £4834) and fulvestrant (ΔOS<br />
of 2.3 months at £2481) are all below <strong>the</strong> frontier line and received negative<br />
recommendations.<br />
Conclusion: EFA may be a useful method for assessing <strong>the</strong> efficiency of new mBC<br />
treatment options for clinical use. Fur<strong>the</strong>r studies are needed to better understand<br />
value in terms of efficiency of treatments in o<strong>the</strong>r tumor types and disease areas.<br />
Disclosure: All authors have declared no conflicts of interest.<br />
338P A CONJOINT ANALYSIS OF WILLINGNESS TO PAY TO AVOID<br />
METASTATIC BREAST CANCER SIDE EFFECTS<br />
D. Lalla 1 , M. Brammer 1 , R. Carlton 2 , T. Bramley 2 ,A.D’Souza 3<br />
1 Health Outcomes, Genentech/Roche, South San Francisco, CA, UNITED<br />
STATES OF AMERICA, 2 Global Value Strategies, Xcenda, Palm Harbor, FL,<br />
UNITED STATES OF AMERICA, 3 Data Analytics, Xcenda, Palm Harbor, FL,<br />
UNITED STATES OF AMERICA<br />
Background: Patients with metastatic breast cancer (MBC) are treated with a variety<br />
of regimens with differing side effect profiles. In addition to efficacy, side effect<br />
profile can be an important consideration in <strong>the</strong>rapy choice. Conjoint analysis is a<br />
research method used to evaluate how trade-offs are made between different<br />
attributes. This study assessed <strong>the</strong> willingness to pay (WTP) to avoid side effects<br />
related to MBC treatment using conjoint analysis. The WTP thus informs clinicians<br />
of patients’ preferences and which side effects <strong>the</strong>y are most desirous of avoiding.<br />
Methods: An online, self-administered survey of MBC patients in <strong>the</strong> US was<br />
conducted. The survey was fielded with a sample of adult female patients with a<br />
diagnosis of MBC. Key variables (attributes) included in <strong>the</strong> analysis and with levels<br />
described in lay terms were: Alopecia, Diarrhea, Fatigue, Pain, Nausea, Neuropathy,<br />
Neutropenia and Out of pocket costs. 15 scenarios (choice-based conjoint questions)<br />
ix122 | <strong>Abstract</strong>s Volume 23 | Supplement 9 | September <strong>2012</strong>