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Annals of Oncology
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643 CETUXIMAB PLUS MFOLFOX-6 AS FIRST-LINE THERAPY FOR
UNRESECTABLE LIVER METASTASIS FROM COLORECTAL
CANCER: AN OPEN, NON-RANDOMIZED, MULTICENTER
PHASE II CLINICAL TRIAL
S. Cai 1 , W. Zhang 2 ,W.Li 2 ,Y.Xu 1 ,W.Gu 1 , Z. Guan 1 , J. Cai 3 , C. Song 4 ,J.Xu 5 ,
P. Chi 6
1 Department of Colorectal Surgery, Fudan University Shanghai Cancer Center,
Shanghai, CHINA, 2 Department of Medical Oncology, Fudan University Shanghai
Cancer Center, Shanghai, CHINA, 3 Department of Abdominal Surgery, Cancer
Hospital & Institute Chinese Academy of Medical Sciences Peking Union Medical
College, Beijing, CHINA, 4 Department of Colorectal Surgery, Liaoning Cancer
Hospital, Liaoning Province, CHINA, 5 Department of Colorectal Surgery,
Zhongshan Hospital of Fudan University, Shanghai, CHINA, 6 Department of
Colorectal Surgery, Fujian medical university Union hospital, Fujian Province,
CHINA
Background: This study is for KRAS wildtype patients with unresectable liver only
metastasis of colorectal cancer, using cetuximab + modified FOLFOX-6 as first-line
chemotherapy, to observe whether the addition of targeted drug further increases the
curative resection rate and improves long-term survival for patients.
Methods: Up to May 1st,a total of 82 KRAS wild-type patients enrolled and received
cetuximab (500 mg/m 2 q2w)Plus mFOLFOX-6 including oxaliplatin 85 mg/m 2 plus
CF 400 mg/m 2 and 5-FU as a 400 mg/m 2 bolus followed by 2400 mg/m 2 infusion
over 46 hours on day 1, repeated every 2 weeks for maximum of nine cycles. The
primary endpoint was R0 resection rate.
Findings: The objective response rate (RR) was 81.82% ± 5.81% among 44 patients with
efficacy assessment. Among 38 cases went through surgical evaluation (finished
medication), 16 cases went through R0 resection and R0 resection rate was 42.11% ±
8.01%, 4 cases went through R1 resection and R1 resection rate was 10.53% ± 4.98%, and
4 cases went through R0 + RFA. There were AEs reported in 64 cases, mainly including
rash and malaise. One SAE was reported and the subject was withdrawn due to allergy.
Interpretation: Cetuximab + mFOLFOX-6 was well tolerated and provided good RR,
R0 resection rates, which would be potentially used as a first-line treatment for
patients with unresectable liver only metastasis of colorectal cancer. Funding: This
study was supported by Fudan University Shanghai Cancer Center; Merck KGaA
Darmstadt, Germany.
Funding: This study was supported by Merck KGaA Darmstadt, Germany and
Sanofi-aventis.
Disclosure: All authors have declared no conflicts of interest.
644 OUTCOME OF PATIENTS WITH COLORECTAL LIVER
METASTASIS: ANALYSIS OF 1613 CONSECUTIVE CASES
J. Xu, D. Zhu, L. Ren, Y. Wei, H. Wu, Y. Zhong
Department of General Surgery, Zhongshan Hospital Fudan University,
Shanghai, CHINA
Objective: To evaluate the long-time outcome of patients with colorectal liver metastasis
(CRLM) undergoing different types of therapy and identify prognosis factors.
Methods: From 2000 to 2010, 1613 consecutive patients with CRLM were identified.
Clinicopathological and outcome data were collected and analyzed by univariate and
multivariate analyses.
Results: Synchronous liver metastasis (SLM), female, grade III-IV, T4 and N positive of
primary tumor, bilobar disease, number of liver metastases ≥ 4, size of largest liver
metastases ≥ 5 cm, serum CEA level ≥5 ng/ml and CA19-9 level ≥ 37u/ml were the
predictors of adverse outcome using univariate analysis. The median survival and
five-year survival rate for patients after resection of liver metastases was 49.8 months
and 47%, better than that for those after other therapy. In addition, patients without
treatment had the poorest survival. Sixty-four initially unresectable patients underwent
surgery after conversion therapy with a median survival of 36.9 months and a five-year
survival of 30%. By multivariate analysis, SLM, poorly differentiated primary tumor,
number of liver metastases ≥ 4, size of largest liver metastases ≥ 5 cm, and no surgical
treatment of liver metastases were found to be independent predictors of poor survival.
Conclusions: Patients with CRLM could get long-term survival benefit from different
types of therapy, and resection of liver metastases was the optimal strategy. A
predictive model using these above five factors may be of use in stratifying patients
who may benefit from intensive surveillance and adjuvant therapy.
Disclosure: All authors have declared no conflicts of interest.
645 THE PROGNOSTIC SIGNIFICANCE OF TYMIDINE KINASE
ACTIVITY LEVELS IN METASTATIC COLORECTAL CANCER
E.S. Seber 1 , T. Korkmaz 2 , K. Okutur 3 , F. Dane 4 , P.F. Yumuk 4 , B. Aktas 5 ,
M. Kanıtez 4 , G. Demir 3 , S.N. Turhal 1
1 Medical Oncology, Marmara University Hospital, Istanbul, TURKEY, 2 Medical
Oncology Department, Dr Lutfi Kirdar Kartal Research and Educational Hospital,
Istanbul, TURKEY, 3 Medical Oncology Department, Bilim University, Istanbul,
TURKEY, 4 Medical Oncology Department, Marmara University Hospital, Istanbul,
TURKEY, 5 Internal Medicine Dpt, Medical Oncology Division, Marmara University
Faculty of Medicine, Istanbul, TURKEY
Aim and background: Serum thymidine kinase 1 (TK1) is a sensitive marker of tumor
cell proliferation. It has been reported as a predictive factor for response rate and disease
free survival for hematological and early stage solid organ tumors but its importance as
a prognostic factor in metastatic solid organ malignancies is not well studied. In this
study we aimed to investigate the prognostic significance of serum TK1 activity in
metastatic colorectal cancer (MCRC) patients receiving palliative chemotherapy.
Method: We prospectively measured serum TK1 activity immediately before the first
and second cycle of the treatment in 46 consecutive metastatic MCRC patients. 10
healthy volunteers were also included as a control group. TK1 activity was measured
by means of high sensitive non-radioactive DIVITUM assay. The patients’
performance status, age, gender, weight loss, hematological and biochemical
parameters, serum CEA and CA 19.9 levels and serum TK1 activity levels relation
with survival were analyzed.
Results: The mean TK1 level in the study group was significantly higher than the
controls (162.1± 27.8 vs 32.97 ± 7.307; p < 0.03, respectively). In multivariate analysis
adjusted for known clinicopathological risk factors, serum tumor markers,
hemoglobin levels and trombosit count TK1 levels before chemotherapy and weight
loss remained as independent prognostic factors ( p = 0.001; 0.018, respectively).
Patients with TK1 activity level above 65 Du/L and 230 Du/L had a longer PFS (624
vs. 231 days) and OS time respectively (p