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Annals of Oncology<br />
58% were female and 42% were male. Incidence of breast cancer in female were<br />
predominant (29.99%), followed by cervical carcinoma (23.99%). Tobacco habits<br />
predominated among 80% of males and 20% of females. Hence oral cancer was <strong>the</strong><br />
most common (35.98%) amongst men, followed by lung cancer (29.98 %).<br />
Conclusion: The results showed a strong association of overweight and obesity with<br />
cancer in this group primarily due to life style, dietary and smoking habits. Hence<br />
some minor lifestyle choices which encompasses dietary restriction of calorie/fat<br />
intake and avoiding animal protein especially red meat, cessation of tobacco and<br />
alcohol intake, exercising and maintaining an ideal body-mass index, healthy body<br />
weight and composition through a diet rich in fruits and green vegetables reduces <strong>the</strong><br />
risk of cancer.<br />
Disclosure: All authors have declared no conflicts of interest.<br />
1376P NEXT GENERATION CANCER REGISTRY; OPPORTUNITIES<br />
OF WEB 3.0 AND PHYSICIAN PERSPECTIVE<br />
A.S. Alfaar, M. Kamal, M. Sabry<br />
Research Department, Children’s Cancer Hospital Egypt, Cairo, EGYPT<br />
Background: Cancer registry is a systematic data collection about cancer incidents.<br />
They are ei<strong>the</strong>r population based or hospital based (also known as center based)<br />
cancer registries. Population-based cancer registries can help in building hypo<strong>the</strong>ses<br />
about cancer shared risk factors in contrast with hospital-based registries which focus<br />
more on improving quality of <strong>the</strong>rapy. Standardizing documentation and<br />
communication methods fosters collaboration between different regional institutes for<br />
building a national cancer registry. In our study we aim at demonstrating how recent<br />
Web 3.0 technologies can help cancer registries.<br />
Material and methods: We started by studying <strong>the</strong> available information technology<br />
resources by qualified researchers who work on analyzing clinical research needs.<br />
We’ve developed a system analysis after studying paper and computer-based cancer<br />
registries. Starting from this set of recommendations we started to match needs and<br />
available technologies. Development took place in adherence to international<br />
standards of medical documentation and communication. Implementation and<br />
Evaluation phases were conducted with assistance of o<strong>the</strong>r clinical researchers,<br />
research nurses and cancer registrars.<br />
Results: The analysis phase stated that cancer registries can be improved using<br />
interoperability, semantic and visual data entry, client & server side-validation,<br />
real-time analysis, rich presentation, tagging, social integration, data mining and<br />
artificial intelligence technologies that are offered by current Internet era.<br />
. Delivery for mobile phones with intelligent validation and interpretation facilitated<br />
<strong>the</strong> portability of <strong>the</strong> system. Integration with knowledge bases added a decision<br />
support property to cancer registry with providing real-time reports and diagrams<br />
plotted over demographic maps. Usability was enhanced by providing user-friendly<br />
interfaces.<br />
Conclusions: Cancer registries have potential stunning future by gaining benefit<br />
from <strong>the</strong> recent web technologies. Research on improving cancer information systems<br />
should go hand in hand with continuous internet revolution.<br />
Disclosure: All authors have declared no conflicts of interest.<br />
1377P BURDEN OF SKELETAL-RELATED EVENTS (SRES) IN<br />
PATIENTS (PTS) WITH SOLID TUMORS: RESULTS OF THE<br />
STARS OBSERVATIONAL STUDY IN THE US VS EU<br />
I. Duran 1 , A. Mahmood 2 , H. Hoefeler 3 , H. Ghazal 4 , D. Lueftner 5 , M. Fink 6 ,<br />
A. Bahl 7 , G. Hechmati 8 ,R.Wei 9 , C. Atchison 10<br />
1 Departamento de Oncologia, Hospital Madrid Norte San ChinarroCentro<br />
Integral Oncologico Clara Campal, Madrid, SPAIN, 2 Cancer Specialists of South<br />
Texas, Corpus Christi Cancer Center, Corpus Christi, TX, UNITED STATES OF<br />
AMERICA, 3 Forschungszentrum Ruhr, Klifocenter, Witten, GERMANY,<br />
4 Oncology, Kentucky Cancer Clinic, Hazard, KY, UNITED STATES OF AMERICA,<br />
5 Oncology, Universitätsmedizin Berlin, Berlin, GERMANY, 6 Oncology, Orange<br />
Coast Memorial Medical Center, Fountain Valley, CA, UNITED STATES OF<br />
AMERICA, 7 Clinical Oncology, Bristol Haematology and Oncology Centre, Bristol,<br />
UNITED KINGDOM, 8 International Health Economics, Amgen (Europe) GmbH,<br />
Zug, SWITZERLAND, 9 Global Biostatistical Science, Amgen, Inc., Thousand<br />
Oaks, CA, UNITED STATES OF AMERICA, 10 Global Health Economics, Amgen,<br />
Inc., Thousand Oaks, CA, UNITED STATES OF AMERICA<br />
Background: The STARS study was a prospective, multicenter, international,<br />
observational study designed to measure <strong>the</strong> burden of SREs (radiation or surgery to<br />
bone, pathologic fracture, or spinal cord compression) in pts with advanced cancer<br />
and bone metastases. Here we report results in pts with solid tumors by geographical<br />
region for US vs EU (Germany, United Kingdom, Spain, and Italy).<br />
Methods: This analysis included pts with bone metastases secondary to breast,<br />
prostate, or lung cancer and ≥1 SRE in <strong>the</strong> 97 days before enrollment (05/08 – 05/<br />
10). Data on SREs and health resource utilization (HRU), including inpatient stays,<br />
outpatient visits, emergency room visits, nursing home/long-term care facility stays,<br />
home health visits, procedures, and certain medications, were collected<br />
retrospectively for <strong>the</strong> 97 days before enrollment and prospectively for up to 21<br />
months. Investigators were responsible for attributing HRU to each SRE.<br />
Results: US = 190 pts with 354 SREs; EU = 478 pts with 893 SREs. Baseline<br />
demographics and disease characteristics were similar for US and EU. Inpatient stays<br />
were more frequent in EU compared with US, and <strong>the</strong> length of stay was longer in<br />
EU (table). Outpatient visits were more frequent in US vs EU, while emergency room<br />
visits were similar between regions. Nearly every SRE was associated with a<br />
procedure in both regions; however, <strong>the</strong> number of procedures per SRE was higher in<br />
US, which was in part due to a much greater number of external beam radiation<br />
procedures per SRE in US likely reflecting standard use of multi-fraction radiation.<br />
Slightly more pts were receiving bisphosphonates at/before enrollment in US<br />
compared with EU, and pts in US received IV bisphosphonates sooner than in EU.<br />
Conclusion: The HRU burden of SREs was substantial in both US and EU. Some<br />
regional differences were observed, particularly with respect to hospitalization, length<br />
of stay, and time to receipt of IV bisphosphonates.<br />
HRU US (n = 354)* EU (n = 893)*<br />
Inpatient Stays (IS) Proportion of SREs with IS<br />
Number/SRE<br />
14.7% 29.5%<br />
Mean 0.18 0.32<br />
Median Length of Stay (days) 0.0 0.0<br />
Mean 10.6 19.9<br />
Median 7.0 17.0<br />
Outpatient Visits (OV) Proportion of SREs<br />
with OV Number/SRE<br />
88.1% 74.1%<br />
Mean 9.1 4.8<br />
Median 9.0 2.0<br />
Emergency Room Visits (ERV) Proportion of<br />
SREs with ERV Number/SRE<br />
4.0% 4.1%<br />
Mean 0.05 0.04<br />
Median 0.0 0.0<br />
Inpatient/Outpatient Procedures (P)<br />
Proportion of SREs with P Number/SRE<br />
95.5% 96.4%<br />
Mean 11.3 6.9<br />
Median 12.0 5.0<br />
Bisphosphate (BP) Use Proportion of pts<br />
receiving oral or IV BP<br />
70.0% 63.0%<br />
at or before enrollment Time from diagnosis of<br />
bone metastasis to first IV BP use (months),<br />
median**<br />
1.8 6.7<br />
*n = number of SREs; **Kaplan-Meier estimate<br />
Disclosure: I. Duran: Advisory Board Member, Amgen. A. Bahl: Advisory Board<br />
member Amgen, Novartis. G. Hechmati: Employee of Amgen and owns Amgen<br />
stock. R. Wei: Employee of Amgen and owns Amgen stock. C. Atchison: Employee<br />
of Amgen and owns Amgen stock. All o<strong>the</strong>r authors have declared no conflicts of<br />
interest.<br />
1378P STATISTICAL CONSIDERATION OF BIASES IN<br />
PROGRESSION-FREE SURVIVAL (PFS) RESULTING FROM<br />
DIFFERENCES IN IMAGING SCHEDULES<br />
T. Tanase 1 , C. Hamada 2 , H. Fujii 3 , N. Nakayama 4 , T. Denda 5 , T. Takayama 6 ,<br />
T. Yoshino 7 , A. Ohtsu 7<br />
1 Data Science, Taiho Pharmaceutical Co., Ltd, Tokyo, JAPAN, 2 Faculty of<br />
Engineering, Tokyo University of Science, Tokyo, JAPAN, 3 Division of Clinical<br />
Oncology, Jichi Medical University, Tochigi, JAPAN, 4 Department of<br />
Gastroenterology, Kanagawa Cancer Center, Kanagawa, JAPAN, 5 Department<br />
of Gastroenterology, Chiba Cancer Center, Chiba, JAPAN, 6 Department of<br />
Gastroenterology and Oncology, University of Tokushima Graduate School,<br />
Tokushima, JAPAN, 7 Department of Gastroenterology & Gi Oncology, National<br />
Cancer Center Hospital East, Chiba, JAPAN<br />
Backgroud: In <strong>the</strong> three PIII trials for metastatic colorectal cancer (mCRC) patients<br />
who are refractory to standard chemo<strong>the</strong>rapy: NCIC CTG CO.17 (NEJM<br />
2007;357:2040-8), 20020408 (JCO 2007;25:1658-65), and CORRECT (<strong>2012</strong><br />
ASCO-GI, #LBA 385) trial, <strong>the</strong> median PFS (mPFS) were similar and <strong>the</strong> early part<br />
of PFS curves overlapped between treatment groups regardless of significance.<br />
Generally, experimental treatments can potentially have biomarkers in such cases.<br />
However, we consider that <strong>the</strong> scheduling of imaging tests affects PFS evaluations.<br />
Material and methods: We simulated PFS computationally under <strong>the</strong> assumptions<br />
for mCRC patients in first (L1), second (L2), and third line (L3) as “True<br />
Parameters” in <strong>the</strong> following table (show L3 only). In addition, we assumed that <strong>the</strong><br />
probability of unscheduled progression was 0 and 20%, and <strong>the</strong> imaging schedules<br />
Volume 23 | Supplement 9 | September <strong>2012</strong> doi:10.1093/annonc/mds410 | ix449