FDA Approves Oral Chemotherapy Pill for Colon Cancer

Colon
FDA Approves Oral Chemotherapy Pill for Colon Cancer
By Roche, Jun 17, 2005 - 9:21:38 AM

THE FDA HAS APPROVED THE ORAL CHEMOTHERAPY, XELODA, TO TREAT DUKES C COLON CANCER PATIENTS WHO HAVE UNDERGONE COMPLETE RESECTION OF THE PRIMARY TUMOR WHEN FLUOROPYRIMIDINE THERAPY ALONE IS PREFERRED.

THE ADJUVANT INDICATION WAS BASED ON DATA FROM THE X-ACT TRIAL. THIS PIVOTAL TRIAL SHOWED THAT XELODA MET ITS PRIMARY ENDPOINT OF NON-INFERIORITY TO 5-FU/LV FOR DISEASE-FREE SURVIVAL. AT THIS TIME, NEITHER XELODA NOR COMBINATION CHEMOTHERAPY HAS BEEN SHOWN TO PROLONG OVERALL SURVIVAL; COMBINATION CHEMOTHERAPY HAS DEMONSTRATED AN IMPROVEMENT IN DISEASE FREE SURVIVAL COMPARED TO 5-FU/LV.

DR. HOWARD BURRIS OF THE SARAH CANNON RESEARCH INSTITUTE IN NASHVILLE SAYS THIS APPROVAL IS IMPORTANT FOR PATIENTS.

"It provides a safe, effective, alternative means offering patients the opportunity to receive pill therapy in the comfort of their home rather than needing to come into the clinic for repeated IV injections."

LIKE ALL CHEMOTHERAPY DRUGS, XELODA MAY NOT BE RIGHT FOR SOME PATIENTS. PATIENTS TAKING WARFARIN SHOULD CONSULT THEIR PHYSICIANS. IM CHRIS ALLEN.

More about Xeloda

Indication:

Xeloda is indicated as a single agent for adjuvant treatment in patients with Dukes C colon cancer who have undergone complete resection of the primary tumor when treatment with fluoropyrimidine therapy alone is preferred. Xeloda was non-inferior to 5-fluorouracil and leucovorin (5-FU/LV) for disease-free survival (DFS). Although neither Xeloda nor combination chemotherapy prolongs overall survival (OS), combination chemotherapy has been demonstrated to improve disease-free survival compared to 5-FU/LV. Physicians should consider these results when prescribing single-agent Xeloda in the adjuvant treatment of Dukes C colon cancer.

Xeloda is indicated as first-line treatment of patients with metastatic colorectal carcinoma when treatment with fluoropyrimidine therapy alone is preferred. Combination chemotherapy has shown a survival benefit compared to 5-FU/LV alone. A survival benefit over 5-FU/LV has not been demonstrated with Xeloda monotherapy. Use of Xeloda instead of 5-FU/LV in combinations has not been adequately studied to assure safety of preservation of the survival advantage.

Xeloda in combination with docetaxel is indicated for the treatment of patients with metastatic breast cancer after failure of prior anthracyline- containing chemotherapy.

Xeloda monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracycline- containing chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated, e.g., patients who have received cumulative doses of 400 mg/m2 of doxorubicin or doxorubicin equivalence. Resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse within six months of completing treatment with an anthracycline-containing adjuvant regimen.

Safety:

A clinically important drug interaction between Xeloda and warfarin has been demonstrated; altered coagulation parameters and/or bleeding and death have been reported. Clinically significant increases in prothrombin time (PT) and INR have been observed within days to months after starting Xeloda, and infrequently within one month of stopping Xeloda. For patients receiving both drugs concomitantly, frequent monitoring of INR or PT is recommended.

Age greater than 60 and a diagnosis of cancer independently predispose patients to an increased risk of coagulopathy.

Xeloda is contraindicated in patients who have a known hypersensitivity to 5-fluorouracil, and in patients with known dihydropyrimidine dehydrogenase (DPD) deficiency. Xeloda is contraindicated in patients with severe renal impairment. For patients with moderate renal impairment, dose reduction is required. Xeloda can induce diarrhea, sometimes severe. Patients with severe diarrhea should be carefully monitored. Patients 80 and older receiving Xeloda monotherapy may experience a greater incidence of grade 3 or 4 adverse events. Xeloda may cause fetal harm when given to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with Xeloda. It is recommended that nursing be discontinued when using Xeloda. Men should use birth control when using Xeloda.

Common adverse events in the adjuvant setting were: diarrhea (Xeloda 47%, 5-FU/LV 65%), nausea (Xeloda 34%, 5-FU/LV 47%), stomatitis (Xeloda 22%, 5- FU/LV 60%), vomiting (Xeloda 15%, 5-FU/LV 21%), fatigue (Xeloda 16%, 5-FU/LV 16%) and hand-foot syndrome (Xeloda 60%, 5-FU/LV 9%). As with any cancer therapy, there is a risk of side effects, and these are usually manageable and reversible with dose modification or interruption.

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