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Annals of Oncology
did not modify CSS, irrespective of AC choice (interaction p for capecitabine and
age = 0.26; interaction p for FOLFOX and age = 0.40).
Conclusions: EPs with stage III CC frequently received either no adjuvant treatment
or capecitabine monotherapy due to advanced age and comorbidities. The treatment
effect of AC on CSS is similar across age groups, with comparable side effects and
rates of discontinuation between EPs and YPs. AC should not be withheld from CC
patients based on advanced age alone.
Disclosure: All authors have declared no conflicts of interest.
602P COMPARATIVE BUDGET IMPACT ANALYSIS OF TREATMENT
SEQUENCES IN METASTATIC COLORECTAL CANCER
(MCRC): FROM FIRST (1ST) LINE TO THIRD (3RD) LINE
THERAPIES
J.A. Maroun 1 , T. Boucher 2 , K. Alloul 3
1 Medical Oncology, The Ottawa Hospital Regional Cancer Centre, Ottawa, ON,
CANADA, 2 Evidence Value and Access, Sanofi Canada, Montréal, QC,
CANADA, 3 Health Economics and Health Outcomes, Sanofi Canada, Montreal,
QC, CANADA
Background: In the context of personalized cancer care, patients (pts) should receive
the therapy that best meets their needs while optimizing the use of healthcare
resources. A budget impact model was developed to compare each of the most
commonly used mCRC treatment sequences – from 1 st line to 3rd line in a Canadian
context.
Methods: This Excel based model considers the price of each agent, the number of
cycles per treatment course, the relative dose intensity of the regimens to determine the
cost of the most commonly used mCRC therapies and calculates the costs per overall
sequence from 1 st line to 3 rd line. It takes into account the percentage of pts who benefit
from a R0 resection post 1 st line chemotherapy and who forego subsequent treatments.
Factors such as different percentage use of 1 st line FOLFOX vs FOLFIRI and pts’
volumes per line of therapy are considered in this model. Users can choose the
scenarios they would like to examine. Key variables can be extracted through expert
opinion, the literature or, to assess real-world local practices, through chart reviews.
Results: As scenarios considered, the budgetary impact of the 1 st line use of FOLFOX
or FOLFIRI both given with bevacizumab (bev) on 1 st to 3 rd line therapy costs was
assessed. The relative use of FOLFOX and FOLFIRI with bev was varied from 80% use
of FOLFOX and 20% use of FOLFIRI to the opposite. As key variables, the model
compares, as 1 st line therapy, 18 cycles of FOLFIRI and bev to 8 cycles of mFOLFOX6
followed by 10 cycles of 5FU/LV given with 18 cycles of bev. Also 80% of 1 st line pts
receive a second line chemotherapy. Assuming a cohort of a 100 pts, when FOLFOX’s
1 st line use varies from 80% to 20%, the budget varies from $4.14M to $3.85M, with all
pts undergoing a R0 resection varying from 11.8 to 8.2 pts.
Conclusions: Focusing on drug costs only, this dynamic and flexible model goes
beyond the comparison of upfront 1 st line mCRC costs and considers cascading costs
on subsequent lines (2 nd and 3 rd line) and consequences. It can be used to assess
variability in local and provincial practice patterns and their impact on overall budget
costs and number of pts benefiting from a R0 resection.
Disclosure: J.A. Maroun: Advisory board member for Roche and Sanofi. Involved in
research projects with Roche and Sanofi. T. Boucher: Employee of Sanofi. K. Alloul:
Employee of Sanofi Canada Inc.
603P FREQUENCY OF SECOND AND THIRD LINE TREATMENT
AMONG ELDERLY MEDICARE STAGE 4 COLON CANCER
PATIENTS
C.D. Mullins 1 , K. Bikov 2 , E. Onukwugha 2 , N. Hanna 3 , B. Seal 4
1 PHSR, Univ of MD, Baltimore, MD, UNITED STATES OF AMERICA, 2 PHSR,
Univ of MD, Baltimore, MD, UNITED STATES OF AMERICA, 3 Surgery, Univ of
MD, Baltimore, MD, UNITED STATES OF AMERICA, 4 Health Economics and
Outcomes Research, Bayer HealthCare, Wayne, NJ, UNITED STATES OF
AMERICA
Background: Stage 4 colon cancer (CC4) patients may receive multiple lines of
chemotherapy and/or biologics as treatment (TX) to improve survival or quality of life.
The tendency to use less aggressive treatment with elderly CC4 patients suggests that
elderly CC4 patients may receive fewer TX lines than equivalent younger patients.
Methods: Elderly (65+) SEER-Medicare patients diagnosed with CC4 in 2003-2007
were followed through death or 2009 to examine variation across sub-groups in the
number of TX lines. We examined NCCN treatments that included any combination
of 5-fluorouracil and/or (levo) leucovorin (5FU/LV), irinotecan (IRI), oxaliplatin
(OX), and bevacizumab, cetuximab, or panitumumab (collectively identified as
BIOLOGICS). Certain non-NCCN treatments were also considered as possible last
TX line. A hierarchy categorized treatments as: 1) IROX (IRI + OX); 2) IRI or OX; 3)
5FU/LV; 4) BIOLOGICS without chemotherapy; and 5) other TX. Gaps in TX or
changes from OX or IRI to 5FU/LV were not considered new lines.
Results: Of 7,937 elderly CC4 patients, 3,263 (41%) received any TX, while 1,166
(15% of all, 36% of TX) and 244 (3% of all, 7% of TX) received second and third
line TX, respectively. Fewer than 1% of treated patients had a fourth TX line. Among
the TX group, relatively younger (p < 0.01), married (48 vs. 39%, p < 0.01) and urban
(45 vs. 39, p = 0.04) patients were more likely to go on to second line TX. Medicare
buy-in coverage, which generally indicates dual Medicaid-Medicare coverage (40 vs.
45%, p = 0.05), lowered the likelihood of second line TX. Having comorbidities
impacted receipt of initial TX (CCI = 0: 44%, CCI = 1: 42%, CCI = 2: 28%; p < 0.01)
and the likelihood of second (CCI = 0: 46%, CCI = 1: 42%, CCI = 2: 39%; p= 0.02)
but not third TX (CCI = 0: 19%, CCI = 1: 21%, CCI = 2: 15%; p = 0.3) lines
conditional upon receipt of prior line treatment. There was no significant association
between second line TX and race/ethnicity or gender. There was no significant
association between the examined characteristics and receipt of third line TX.
Conclusions: One in three elderly CC4 patients who received initial TX received a
second TX line. The likelihood of having a second TX line was associated with age,
marital status, urbanicity, and comorbidity burden. Only one in fourteen elderly CC4
patients had a third TX.
Disclosure: C.D. Mullins: C. Daniel Mullins, PhD receives consulting income from
Amgen, Bayer, BMS, Celgene, GSK, Mitsubishi, Novartis, Novo Nordisk, Novartis,
and Pfizer. He also receives research funding from Bayer and Pfizer. E. Onukwugha:
Ebere Onukwugha receives consulting income from Pfizer and grant support from
Bayer, Novartis, and Pfizer. B. Seal: Brian Seal is an employee of Bayer HealthCare.
All other authors have declared no conflicts of interest.
604P PROGNOSTIC VALUE OF STEM CELL QUANTIFICATION IN
STAGE II COLON CANCER
M.A.V. Salgado 1 , J.C.M. Montero 2 , M. Devesa 1 , J.D. Trill 1 , V. Abraira 1 ,
A. Riquelme 3 , A. Carrato 1
1 Medical Oncology, Hospital Universitario Ramon y Cajal, Madrid, SPAIN,
2 Pathologist, Instituto Oftalmico/Hospital Universitario Gregorio Marañon, Madrid,
SPAIN, 3 Medical Oncology, Hospital Infanta Cristina Parla, Madrid, SPAIN
Background: Cancer stem cells (CSCs) are a subset of tumor cells with capacity to
self-renew and generate the diverse cells that comprise the tumor. They are considered
cancer (Ca) initiating cells responsible for tumor recurrence and maintenance. These
cells express pluripotency markers (CD133 and NANOG) and do not express markers
of differentiation as cytokeratin 20 (CK20). The potential prognostic value of CSCs in
colorectal cancer has been studied with conflicting results. However some of these series
were based on heterogeneous situations, involving rectal and colon cancer (CC) and
different tumor stages (I-IV). The aim of this study is to evaluate the prognostic value of
CSCs in a highly homogeneous population of stage II CC.
Methods: One hundred stage II CC patients (pts) treated by the same surgical team
at Ramon y Cajal University Hospital between 1977 and 2005 were retrospectively
analyzed. None of the pts received adjuvant chemotherapy. Inmunohistochemistry
expression of CD133, NANOG and CK20 was scored on paraffin sections using four
levels: 50% positivity. Kaplan-Meier analysis and log
rank test were used to compare survival.
Results: Median age: 68 years (45-92). Median follow up: 5.8 years. Recurrent
disease: 17 (17%). Expression of CD133 was shown in 60% of the tumors, in 95% for
NANOG and 78% for CK20. No correlation was found among expression levels of
CD133, NANOG or CK 20 and relapse-free survival (RFS) and overall survival (OS).
Conclusions: Stem Cell quantification defined by CD133 and NANOG expression
has no correlation with RFS or OS in this cohort of Stage II CC. Therefore, our
results suggest that CSCs may not play a major role in early phases of CC.
Disclosure: All authors have declared no conflicts of interest.
605P PHASE II TRIAL OF PANITUMUMAB IN COMBINATION WITH
OXALIPLATIN AND CAPECITABINE CHEMOTHERAPY AS 1ST
LINE THERAPY IN PATIENTS WITH COLORECTAL CANCER
AND ADVANCED LIVER METASTASES: THE METAPAN STUDY
F. Leone 1 , D. Marino 2 , S. Artale 3 , C. Cagnazzo 2 , S. Cascinu 4 , A.A. Martoni 5 ,
A. Sobrero 6 , M. Tampellini 7 , S. Siena 3 , M. Aglietta 8
1 Oncological Sciences, Fondazione Piemontese per la Ricerca sul Cancro Onlus,
Candiolo, ITALY, 2 Medical Oncology, Fondazione Piemontese per la Ricerca sul
Cancro Onlus-IRCC Institute for Cancer Research and Treatment, Candiolo,
ITALY, 3 Struttura Complessa di Oncologia Falck, A.O. Ospedale Niguarda Ca’
Granda, Milano, ITALY, 4 Clinica di Oncologia Medica, AOU Ospedali Riuniti
Ancona Università Politecnica delle Marche, Ancona, ITALY, 5 Medical Oncology
Unit, S. Orsola-Malpighi University Hospital, Bologna, ITALY, Bologna, ITALY,
6 Oncologia Medica, Azienda Ospedaliera Universitaria S. Martino di Genova,
Genova, ITALY, 7 Dipartimento di Oncologia Medica, Azienda Ospedaliera San
Luigi, Orbassano, ITALY, 8 Div Oncologia ed Ematologia, Fondazione Piemontese
per la Ricerca sul Cancro Onlus, Candiolo, ITALY
Background: Preoperative chemotherapy improves outcome in potentially resectable
colorectal cancer with liver metastases. We evaluated the activity of a neoadiuvant
treatment with capecitabine–oxaliplatin (XELOX) associated with the anti-EGFR
antibody Panitumumab in patients with unresectable, liver-only, metastatic colorectal
cancer (CRC).
Volume 23 | Supplement 9 | September 2012 doi:10.1093/annonc/mds397 | ix205