results of a small phase II advanced
colorectal cancer trial comparing
a protracted fluorouracil
(5-FU) infusion plus oxaliplatin
(Eloxatin)(FOX) with capecitabine
(Xeloda) plus oxaliplatin (XELOX)
concluded that the capecitabine combination
had similar efficacy and tolerability,
Andrea Martoni, MD, of
Orsola-Malpighi Hospital in Bologna,
Italy reported (abstract 3617).
The median time to disease progression
(TTP) was 6+ months with
FOX vs 8.5+ months with XELOX.
Dr. Martoni said that survival data are
not mature, as 56% of patients are still
"These results suggest that XELOX
has comparable activity to FOX in firstline
treatment of advanced colorectal
cancer. Toxicity is low and substantially
similar in the two arms. Oral
capecitabine combinations could be
an acceptable alternative to protracted
5-FU infusion regimens," Dr. Martoni
Dr. Martoni reported data for 111
patients randomized to the two treatment
arms, 101 of whom were evaluable
for response. The median number
of cycles delivered was 6 (1-11) in
arm A (FOX) and 6 (1-11) in arm B
The objective responses were as follows:
Arm A (FOX): complete response
(CR) 2%, partial response (PR) 44.1%,
stable disease (SD) 24.5%, progressive
disease (PD) 14.3%. Arm B (XELOX):
CR 5.8%, PR 34.6%, SD 36.6%, PD
17.3%; response rate 44.9% vs 40.3%.
The median TTP was 8.5 months with
FOX vs 9 months with XELOX.
Surgical resection of liver metastases
after chemotherapy was performed
in 4.7% of patients in arm A vs 8.9% of
patients in arm B. Only two patients
showed grade 4 toxicity (diarrhea) in
arm A (1) and in arm B (1).
Grade 3 treatment-related toxicities
in arm A and B were neutropenia
(2.4% vs 0), thrombocytopenia (2.4%
vs 2.4%), stomatitis (3.8% vs 0), diarrhea
(11.8% vs 7.1%), hypertransaminasemia
(0 vs 1.8 %), hyperbilirubinemia
(1.9% vs 1.8%), and
neurotoxicity (15.4% vs 25.5%).
"Our preliminary results suggest
that FOX and XELOX, as administered
in this trial, show high activity as
first-line treatment," Dr. Martoni concluded.
"Toxicity is low and substantially
similar in the two arms," Dr.