- EPOC Results Published in March 22 Issue of The Lancet -
BRIDGEWATER, N.J., March 20 /PRNewswire-FirstCall/ -- Sanofi-aventis
today announced that efficacy results of the randomized phase III EORTC
40983 Intergroup study published in the March 22 issue of The Lancet showed
that in eligible patients Eloxatin(R) (oxaliplatin injection) in
combination with 5-fluorouracil/leucovorin (5-FU/LV), a chemotherapy
regimen called FOLFOX4, significantly improved three-year PFS
(Progression-Free Survival) compared to surgery alone when given
perioperatively (before and after surgery) to colorectal cancer patients
with initially resectable liver metastases. PFS is the time from
randomization until disease progression/recurrence or death. The EORTC
40983 Intergroup study is also referred to as the EPOC (Eloxatin(R) for
Peri-Operative Use) trial.
Among the 342 eligible patients treated in the EPOC study,
perioperative FOLFOX4 chemotherapy and surgery significantly improved PFS
by 8.1% (from 28.1% to 36.2%) versus surgery alone (Hazard Ratio (HR) of
0.77; Confidence Interval (CI): 0.60-1.00; p=0.041). Among patients who
were also able to undergo resection of the liver metastases, post-entry
(n=303), perioperative FOLFOX4 significantly improved PFS by 9.2% (from
33.2% to 42.4%) compared with surgery alone (HR=0.73 (CI: 0.55-0.97,
p=0.025)).
"Seventy-five percent of patients relapse after liver metastases have
been surgically removed. We found that the investigational use of
perioperative FOLFOX4 reduces the risk of relapse by one fourth over
surgery alone," said principal investigator Professor Bernard Nordlinger,
past chairman of the EORTC GI group, chair of the Department of Surgery and
Oncology, Hospital Ambroise Pare, Assistance Publique-Hopitaux de Paris,
Boulogne, France. "EPOC is the first randomized phase III clinical trial to
demonstrate three-year PFS of perioperative FOLFOX4 in eligible metastatic
colorectal patients with initially resectable liver metastases.
Perioperative chemotherapy was found compatible with major liver surgery
with operative mortality of less than one percent in both treatment arms."
The most common adverse events seen with pre-operative FOLFOX4 include:
neutropenia (Grade 3/4: 18.1%), diarrhea (Grade 3: 8.2%),
stomatitis/pharingitis (Grade 3: 6.4%), leucopenia (Grade 3/4: 5.9%), other
neurological toxicity (Grade 3: 5.8%), and nausea (Grade 3: 3.5%). The most
common adverse events seen with post-operative chemotherapy include:
neutropenia (Grade 3/4: 34.8%), leucopenia (Grade 3: 12.2%), other
neurological toxicity (Grade 3: 12.2%), sensory neuropathy (Grade 3: 9.6%),
thrombocytopenia (Grade 3: 7.0%), infection (Grade 3: 6.0%), hepatic (Grade
3: 5.2%), diarrhea (Grade 3: 5.2%), allergy (Grade 3/4: 4.4%), nausea
(Grade 3: 4.3%), dysesthesia (Grade 3: 4.3%), and febrile neutropenia
(Grade 3: 3.5%). In both patient groups, operative mortality remained very
low (<1%): two deaths occurred after surgery in the standard arm and one in
the experimental arm. Reversible complications of surgery were more
frequent among patients who had received chemotherapy before surgery.
Background on the EPOC Study
The EPOC Study is a randomized multicenter phase III Intergroup study
sponsored and conducted by the EORTC (European Organization for Research
and Treatment of Cancer), in collaboration with AGITG (Australasian
Gastro-Intestinal Trials Group), EORTC GITCG (EORTC Gastrointestinal Tract
Cancer Group), ALM-CAO (Arbeitsgruppe Lebermetastasen und-tumoren in der
Chirurgischen Arbeitsgemeinschaft Onkologie), CRUK (Cancer Research UK) and
FFCD (Federation de Cancerologie Digestive). The EPOC study was supported
by sanofi-aventis.
The EPOC trial is among the few prospective studies that have examined
the combination of chemotherapy and surgery for patients with initially
resectable liver metastases from colorectal cancer. It is distinguished by
its evaluation of perioperative chemotherapy. The primary endpoint was
progression-free survival. The primary objective of the trial was to detect
a 40% increase in median PFS or equivalently an increase of 3-year PFS from
21% to 32.8% in all patients randomized to perioperative chemotherapy, with
80% power and two-sided significance level of 5%, resulting in HR=0.71.
In this parallel-group trial, 364 patients with up to four liver
metastases initially considered resectable were randomly assigned to the
standard regimen arm to be treated by either surgery alone or to the
experimental arm for treatment with perioperative FOLFOX4 given in six
cycles for three months before and six cycles for three months after
surgery 182 patients in each arm. Upon further evaluation, 11 patients in
each arm were found ineligible for inclusion. In the chemotherapy arm, 159
patients were operated (87.4%) against 170 in the surgery arm (93.4%).
Resection of the liver metastases was able to be performed in a similar
number of patients in each arm: 152 (83.5%) patients in the surgery arm and
151 patients in the FOLFOX4 arm (83.0%). Of these, 115 patients (63%) also
received post-operative chemotherapy.
About Colorectal Cancer
Metastatic colorectal cancer means that the cancer has spread to other
nodes and/or organs in the body. The most frequent sites of colorectal
cancer metastases are the liver and the lung. More than half of colorectal
cancer patients (55%) develop liver metastases, usually within the first
two years following surgery removing the primary tumor.
Colorectal cancer is a leading cause of death. Every year, about one
million new cases of colorectal cancer are diagnosed worldwide. About
150,000 new cases are detected each year in the United States. According to
the American Cancer Society, colorectal cancer is the third leading cause
of cancer-related death in the U.S., accounting for about 10% of all cancer
deaths. Over a lifetime, about 1 in 18 people develop colorectal cancer,
and more than 52,000 people are expected to die from it in the U.S. this
year.
About sanofi-aventis
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY).
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Forward-Looking Statements" in sanofi- aventis' annual report on Form 20-F
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Contact: Noelle Boyd, sanofi-aventis, (908) 981-6489
SOURCE sanofi-aventis
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