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Cetuximab Combinations Promising in Phase II Trials

Cetuximab Combinations Promising in Phase II Trials

ISTANBUL, Turkey--Adding the
targeted antibody cetuximab (Erbitux)
to standard cytotoxic chemotherapy as
first-line treatment for patients with advanced
colorectal cancer improves response
rates, two groups of researchers
said at the 31st Congress of the European
Society for Medical Oncology (ESMO).

At an ESMO press briefing, Volker
Heinemann, MD
, PhD, of Klinkum
Grosshadern, Munich, Germany, described
a phase II study (abstract 327 O)
in which patients were randomly assigned
to XELIRI—capecitabine (Xeloda) 800
mg/m2 twice daily orally on days 1 to 14
and irinotecan (Camptosar) 200 mg/m2
intravenously on day 1—or XELOX—
capecitabine 1,000 mg/m2 twice daily on
days 1 to 14 and oxaliplatin (Eloxatin)
130 mg/m2 intravenously on day 1. In
both arms, cetuximab was given at a dose
of 400 mg/m2 intravenously on day 1 of
the first 3-week cycle and then at 250
mg/m2 for each subsequent cycle.

The overall response rate (complete
and partial responses) in the XELIRI/
cetuximab arm was 42.4% (14 of 33 patients)
and in the XELOX arm, 65.5%
(19 of 29 patients). Disease control (responders
plus patients with stable disease)
was 91% for XELIRI/cetuximab and
93% for XELOX/cetuximab.

The most common grade 3–4 toxicities
in both arms were skin toxicity, allergic
reactions, diarrhea, neurotoxicity, and
leukopenia. There were more hematological
adverse events in the irinotecan
arm and more nonhematological adverse
events in the oxaliplatin arm.

"In summary," Dr. Heinemann said,
"cetuximab enhances the activity of cytotoxic
chemotherapy. New agents like
the monoclonal antibodies cetuximab or
bevacizumab [Avastin] hold promise to
prolong survival among patients with
metastatic colorectal cancer."

Cetuximab Plus XELOX
Another study (abstract 328 O) compared
XELOX with or without cetuximab.
The study was conducted by Daniel
Helbling, MD, of University Hospital
Bern, and his colleagues through the Swiss
Group for Clinical Cancer Research
(SAKK). Compared with other colon cancer
chemotherapy regimens, XELOX is
easy to administer, Dr. Helbling said. Patients
attend the clinic once every 3 weeks
for an infusion of oxaliplatin and take
capecitabine tablets for 14 days.

In the multicenter, randomized phase
II trial, patients were given oxaliplatin
130 mg/m2 on day 1 and oral capecitabine
1,000 mg/m2 twice daily on days 1 to 14
every 21 days, with or without
cetuximab 250 mg/m2 weekly following
a loading dose of 400
mg/m2. Therapy was stopped
after a maximum of six cycles.

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