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Impressive Antitumor Activity With XELOX in Phase II Trial

Impressive Antitumor Activity With XELOX in Phase II Trial

BARCELONA, Spain—A large European, multicenter phase II trial of XELOX—capecitabine
(Xeloda) and oxaliplatin (Eloxatin, investigational in the United States)—as
first-line therapy for patients with metastatic colorectal cancer produced
an objective response in 55% of patients.

Josep Tabernero, MD, Oncologia Medica, Vall d’Hebron Hospital,
Barcelona, Spain, presented the results at the 38th Annual Meeting of the
American Society of Clinical Oncology (abstract 531).

"The most important finding is that XELOX is a highly effective
regimen with a good safety profile," Dr. Tabernero said. "And it
is very convenient for the patient."

The XELOX regimen is a logical drug combination, said Christopher Twelves,
MD, Cancer Research UK, Glasgow, Scotland. Dr. Twelves spoke at an
industry-sponsored symposium held in conjunction with the Orlando ASCO
meeting.

"These two molecules have clearly different modes of action, and we
know from past experience that fluorouracil (5-FU)/leucovorin combined with
oxaliplatin is a highly active regimen," Dr. Twelves said. "Xeloda
is at least as effective as 5-FU and has the advantage of being taken
orally. There is no overlap in major toxicities with oxaliplatin and Xeloda.
The major toxicity with oxaliplatin is sensory neuropathy, which isn’t a
feature of Xeloda. We also have preclinical data suggesting genuine synergy
between fluoropyrimidines and oxaliplatin."

Study Protocol

The study involved 96 patients with metastatic colorectal cancer who were
given a 2-hour intravenous infusion of oxaliplatin 130 mg/m² on day 1 and
oral capecitabine 1,000 mg/m² bid on days 1 through 14, followed by a 7-day
rest. Treatment continued for 11 cycles in patients with stable disease or
tumor response, or until disease progression.

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