Chemotherapy options improve for patients with advanced colorectal
cancer
Medical Study News
Published: Monday, 6-Jun-2005





For the first time, researchers have shown that a chemotherapy
regimen of capecitabine plus oxaliplatin (CAPOX) is as safe and
effective as infusional 5-fluorouracil/folinic acid plus oxaliplatin
(FUFOX) in the first-line treatment of metastatic colorectal
carcinoma (MCRC). The findings are reported at the 2nd ESMO
Scientific & Educational Conference (ESEC) in Budapest, Hungary.
"We conducted this phase III study because the combination of oral
capecitabine and oxaliplatin showed promising effects in different
phase II studies. The idea of this study was to look whether CAPOX
can replace the standard treatment of iv. 5-FU/folinic acid in
patients with MCRC", said lead author Dr. Hendrik-Tobias Arkenau,
from Clinic Bremen East in Germany.

From 2002 to 2004, the authors randomly assigned 476 patients who had
not undergone previous chemotherapy to receive either FUFOX (5-
fluorouracil (5-FU) 2000mg/m2 24h infusion, folinic acid 500mg/m2,
oxaliplatin 50mg/m2 d1,8,15,22; q5 wks) or CAPOX (capecitabine
1000mg/m2 bid d1-14, oxaliplatin 70mg/m2 d1 and 8; q3 wks).

So far, based on an analysis of 2541 treatment cycles (1026 FUFOX,
1515 CAPOX), both regimens are comparably toxic and showed similar
response rates (ITT-RR: 50% FUFOX and 47% CAPOX, p=NS).

Median length of time without progression of disease was 34.7 weeks
in the FUFOX arm and 30.3 weeks in the CAPOX arm, respectively, a
difference that was not statistically different (p=0.1), the authors
found. Additionally, both treatment arms showed similar overall
survival, FUFOX 74.9 weeks and CAPOX 70.9 weeks, p=0.72.

The authors conclude that CAPOX shows comparable efficacy and
toxicity profiles compared to the FUFOX regimen in patients
chemonaive MCRC.

"This study is important for patients because the CAPOX regimen is
more convenient to administer. Patients will appreciate needing to
come only twice in three weeks as outpatients to receive the 2 hourly
oxaliplatin dose. Especially in the palliative setting of MCRC,
patients gain more autonomy and improved quality of life," Dr.
Arkenau said.

"We hope that oral capecitabine plus oxaliplatin will become the new
standard treatment in first-line treatment for patients with
metastatic colorectal carcinoma."

Commenting on the study, Professor Hans Joachim Schmoll of Martin-
Luther-Universit?Halle-Wittenberg in Germany said the results of the
trial "are of major importance for the clinical routine, at least for
those patients who would like to avoid intravenous infusional
protocols, ports and pumps."

The 5-FU-infusion in combination with cytostatic agents like
oxaliplatin or irinotecan in patients with colorectal cancer is
complicated and needs support and a pump for the patient, he said.
This is a cause of major discomfort, meaning it is important to
investigate alternatives substituting the infusion of 5-FU by oral
agents.

"This study for the first time shows that an oral based Cap/Ox
regimen is able to substitute for the complex intravenous 5-FU 2-drug-
or 3-drug-combination in colorectal cancer. Large trials are
underway to definitely answer this question with several thousand
patients; however, the results of these studies will not be available
before 2006," Professor Schmoll said.

http://www.esmo.org/