BREMEN, GERMANY-CAPOX
and FUFOX have comparable
toxicity profiles and efficacy in the
first-line treatment of metastatic colorectal
cancer, according to a phase III
German study. "Offering the convenience
of an oral regimen, CAPOX is a
possible alternative to FUFOX," concluded
the study's lead investigator,
Hendrik-Tobias Arkenau, MD, of
Hospital Bremen East in Bremen, Germany
(abstract 3507).
The study randomized 476 patients
to receive one of the two following
regimens:
-
CAPOX (capecitabine [Xeloda],
1,000 mg/m2 twice daily on days 1-14; oxaliplatin(Drug information on oxaliplatin) [Eloxatin], 70 mg/m2 on
days 1 and 8) every 3 weeks
-
FUFOX (fluorouracil, 2,000 mg/
m2 as a 24-hour infusion; folinic acid,
500 mg/m2; oxaliplatin, 50 mg/m2 on
days 1, 8, 15, and 22) every 5 weeks.
All patients had measurable disease,
an Eastern Cooperative Oncology
Group (ECOG) performance status
of 0 to 2, and normal renal and
hepatic function. Baseline characteristics
were well balanced for the 242
patients in the CAPOX arm and the
234 patients in the FUFOX arm. The
median age of patients was 66 years in
the CAPOX arm and 64 years in the
FUFOX arm.
Toxicity and Response
The two regimens had comparable
toxicity profiles, although there was
more hand-foot syndrome, particularly
grade 2/3, in the CAPOX arm.
The most common grade 3/4 clinical
adverse event was neurosensory
toxicity.
The study was based on a noninferiority
design, and CAPOX showed no
inferiority compared with FUFOX
within the investigators' statistical assumptions.
Study results follow for CAPOX vs
FUFOX:
-
Overall response rates were 47%
for CAPOX (95% CI, 41%-54%) vs
49% for FUFOX (95% CI, 43%-56%),
with complete response rates of 2% vs
5%, partial response of 45% vs 44%,
and stable disease in 27% vs 24%.
-
Median progression-free survival
was 7 vs 8 months (P =.11).
-
Median overall survival was 16.3
vs 17.2 months (P = .72)
"Like the safety analysis, there is no
difference in response rates," Dr.
Arkenau reported.
Caution Advised
"Overall, this important study validates
capecitabine(Drug information on capecitabine) as an acceptable
alternative to infusional 5-FU in combination
with oxaliplatin," noted Neal
J. Meropol, MD, of Fox Chase Cancer
Center in Philadelphia, who served as
a discussant for this ASCO presentation.
"In interpreting these results, one
should note that studies in Europe
and North America have been discordant
in terms of doses of capecitabine
that are tolerable in combination with
oxaliplatin," Dr. Meropol said. "Although
a mechanism for this discordance
has not been elucidated, it suggests
that some caution is required in
applying the results of this trial to the
care of patients worldwide."
