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New drug aids in the treatment of colorectal cancer

Dr. V. Upender Rao

By Dr. V. Upender Rao
Published April 18, 2006

Eloxitin is a chemotherapeutic drug that is active and widely used against both early and advanced colorectal cancer. It can cause neurotoxicity, for which there is neither a preventive nor a therapeutic agent available at this time.

In a recent clinical trial, a new drug, Xaliproden, was shown to prevent Eloxitin-related neurotoxicity by approximately 30 percent. Dr. James Cassidy, professor of medical oncology and director of the Clinical Trials Unit at Glasgow University, announced these results at the Gastrointestinal Cancer Symposium.

Cassidy and his team conducted a randomized placebo-controlled, double-blind study comparing Xaliproden to placebo in patients receiving Eloxitin for the first time for advanced colorectal cancer. They received either one of these agents starting one day before starting Eloxitin and continued it for 15 days after the last dose.

The results showed a decrease of 40 percent in the probability of developing grade 3 neuropathy and a decrease of 6 percent in the incidence of this side effect.

Xaliproden, however, did not have any protective effect against a rare side effect of Eloxitin consisting of throat numbness, muscle cramps and jaw pain. These are either precipitated or exacerbated by exposure to cold.

Cassidy explained that this type of side effect might involve a different mechanism and therefore require a different kind of treatment.

While patients with early disease take Eloxitin along with other drugs for six months, those with metastatic or advanced disease receive it for prolonged periods. Because patients now are living much longer on chemotherapy, they will be exposed to cumulatively larger doses and the attendant side effects.

Sensory neurotoxicity (alteration of sensory perception) is a dose-related toxicity seen with Eloxitin. Oncologists, therefore, must closely monitor the patients and either decrease the dose or eliminate Eloxitin from the treatment regimen.

Both these strategies are counterproductive from an efficacy standpoint. Availability of Xaliproden is a welcome addition to the supportive care armamentarium of the oncologists.

One concern for the investigators was to ensure there was no loss of efficacy due to the protective effect of Xaliproden. To confirm this they performed a "non inferiority" analysis and found equal response rates and time to progression in both the treated groups. Cassidy announced that they are planning a larger confirmatory trial.

V. Upender Rao, MD, FACP, practices at the Cancer and Blood Disease Center in Lecanto.

[Last modified April 18, 2006, 01:50:23]