First case report of Xeloda induced coronary artery disease.

Xeloda (capecitabine) is a fluropyrimidine carbamate with antineoplastic activity, used for the treatment of metastatic colorectal cancer and metastatic breast cancer, two of the most commonly diagnosed forms of cancer among Americans. Xeloda, an oral cancer therapy was initially approved for breast cancer on April 30, 1998. Xeloda is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluropyrimidine therapy alone is preferred. Combination chemotherapy with docetaxel has shown a survival benefit compared to 5-FU/LV alone. Xeloda in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy. In Xeloda monotherapy for metastatic colorectal cancer, the most common adverse events were anemia (80%), diarrhea (55%), hand-foot syndrome (54%), hyperbilirubinemia (48%), nausea (43%), fatigue/weakness (42%), abdominal pain (35%), dermatitis (27%), vomiting (27%), appetite decreased (26%), stomatitis (25%), pyrexia (18%), edema (15%), constipation (14%), dyspnea (14%), neutropenia (13%), pain (12%), back pain (10%), and headache (10%). We present the first case report of coronary artery disease induced by Xeloda in a 66-year-old male treated for relapsing metastatic colon cancer. The patient developed typical anginal type chest pain 5 days into the treatment. Adenosine cardiolyte stress test revealed severe ischemia with markedly diminished left ventricular global function, ejection fraction of 30%. The patient had normal exercise stress test with Duke Treadmill score of +6, 2 months prior to initiation of Xeloda, performed for evaluation of atypical chest pain. Xeloda was originally approved under the accelerated approval program that allows early marketing of products for serious or life-threatening illnesses based on "surrogate endpoints." Today's approval is based on actual patient benefit as shown in the clinical trial. Cardiovascular side effects are uncommon and should be considered while patients are treated with Xeloda.

Anil K. Goli, MD, Madhav Koduri, MD, Jack Whitaker, MD, Ann Jackson, MD, and Stephen A. Fahrig MD, Johnson City, TN.