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FDA Approval for Capecitabine

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Brand name(s): Xeloda®

  • Approved for Dukes' stage C colon cancer

Full prescribing information is available, including clinical trial information, safety, dosing, drug-drug interactions and contraindications.

On June 15, 2005, the U.S. Food and Drug Administration approved capecitabine (Xeloda® Tablets, made by Hoffman-LaRoche Inc.) as a single-agent adjuvant treatment for Dukes' stage C colon cancer patients who have undergone complete resection of the primary tumor in those instances when fluoropyrimidine therapy alone would be preferred.

Dukes’ stage C colon cancer is when the cancer has spread outside the colon to one or more lymph nodes; also called stage III colon cancer.

Approval is based on non-inferiority in disease-free survival (DFS) to bolus 5-fluorouracil plus leucovorin (5-FU/LV). In 2004, the FDA approved oxaliplatin for injection (Eloxatin™) in combination with infusional 5-FU/LV for adjuvant stage III colon cancer. Although neither capecitabine nor the combination of oxaliplatin plus 5-FU/LV prolonged overall survival in the adjuvant setting, the combination chemotherapy regimen was associated with an improvement in DFS compared to 5-FU/LV in stage III colon cancer. Physicians should consider these results when prescribing single-agent capecitabine in the adjuvant treatment of Dukes' C colon cancer.

Safety and efficacy for capecitabine in the adjuvant indication were demonstrated in one multicenter, randomized, open-label, international clinical trial. There were 1987 patients with stage C colon cancer who had undergone complete resection of the primary tumor. The patients were equally randomized to one of two arms: capecitabine (1250 mg/m2 twice daily for 14 days followed by seven days rest, repeated every 21 days for eight cycles) or bolus 5-FU/LV (Mayo Clinic regimen).

At a median follow-up of 4.4 years, a non-inferiority analysis for the primary endpoint of DFS in the all randomized population showed capecitabine retained at least 75 percent of the active control effect of 5-FU/LV. The three-year DFS rates for capecitabine and 5-FU/LV were 66 percent and 63 percent, respectively (hazard ratio 0.87, 95 percent CI: 0.76-1.00; test for difference: p = 0.055). No statistical difference in overall survival was shown between the treatment arms in the all randomized population (hazard ratio 0.88, 95 percent CI: 0.74-1.05; p = 0.17).

The incidence of grade 3 or 4 adverse events was 36 percent on the capecitabine arm and 35 percent on the 5-FU/LV arm. The most common capecitabine toxicities (diarrhea, stomatitis, nausea, and palmar-plantar erythrodysesthesia) are described in the current label, and in 93 percent of cases were reversible within 30 days. The incidence of febrile neutropenia or neutropenic sepsis was less than 1 percent.

  • Updated: July 2, 2013