General Information

Eloxatin, administered as an injection in combination with infusional 5-fluorouracil (5-FU) and leucovorin (LV), is indicated for the treatment of metastatic colon or rectum carcinomas that have recurred or progressed within six months following first-line therapy of 5-FU/LV and irinotecan. Eloxatin received FDA approval faster than any other cancer treatment to date. It was approved under a special FDA program enabling the promising, and much needed, drug to be sold prior to proof of its ability to prevent or delay death.

Colorectal cancer, according to the American Cancer Society, is the second leading cause of malignancy-related death in the US, and there has been very little available in the way of effective treatment for patients with advanced stages of this disease. Eloxatin may provide a worth while option where there previously was none.

Eloxatin was released in France in 1996 and Europe in 1999. It is currently marketed in over 55 countries and continues to be studied for new indications.

Clinical Results

A multi-center, randomized, controlled study of 463 patients with advanced colorectal cancer, which had relapsed or progressed within six months of first-line therapy with bolus 5-FU/LV and irinotecan, found that treatment with Eloxatin in combination with 5-FU/LV was more effective than either 5FU/LV or Eloxatin alone. A decrease in tumor size by at lease 30% was maintained for at least four weeks, in 9% of patients treated with Eloxatin in combination with 5-FU/LV, as compared to 0% and 1% in the 5-FU/LV and Eloxatin alone groups, respectively. In addition, in patients treated with Eloxatin in combination with 5-FU/LV the median time to tumor progression was two months greater than that in patients treated with 5-FU/LV alone and three months greater than that in patients treated with Eloxatin alone.

While so far the results show an increase in response rate and time to tumor progression with the combined therapy of Eloxatin and 5-FU/LV over treatment with Eloxatin or 5-FU/LV alone, there is as of yet no data to prove a clinical benefit (i.e. A decrease in disease-related symptoms, or increased survival rate) of the new combination therapy. However, the study continues with 821 patients enrolled, and tumor response as well as patient survival will be assessed.

Side Effects

Adverse events associated with the use of Eloxatin in combination with 5-FU/LV may include (but are not limited to) the following:

Peripheral neuropathy

Fatigue

Diarrhea

Nausea

Vomiting

Anemia

Leukopenia

Neutropenia

Thrombocytopenia

Eloxatin may also cause anaphylactic-like reactions, which are usually treatable with epinephrine, corticosteroids, and antihistamines. In addition, Eloxatin is linked to pulmonary toxicity which can be fatal.