What is the efficacy of Xeloda (capecitabine)?

From the Guidelines

Capecitabine (Xeloda) has been shown to be an effective treatment for stage III colon cancer, with a favorable toxicity profile and equivalent disease-free survival (DFS) compared to 5-fluorouracil (5-FU)/leucovorin (LV) therapy, as demonstrated in the X-ACT trial [@3@]. The efficacy of Xeloda (capecitabine) in the treatment of colon cancer has been evaluated in several studies.

• The X-ACT trial compared capecitabine monotherapy with 5-FU/LV therapy in stage III colon cancer patients and found equivalent DFS between the two treatments after 4.3 years of follow-up [@3@].
• The XELOXA international phase III study assessed the safety and efficacy of adjuvant capecitabine plus oxaliplatin (XELOX) versus bolus FU/LV and found a benefit in DFS for XELOX, although the toxicity profile was different 1.
• A study published in the Journal of Clinical Oncology found that capecitabine plus oxaliplatin was effective as first-line therapy for metastatic colorectal cancer, with a similar response rate and time to progression compared to fluorouracil/folinic acid plus oxaliplatin 1. The use of capecitabine in combination with oxaliplatin has also been evaluated, with studies showing that it is an active agent with a favorable toxicity profile and may reduce overall costs compared to intravenous treatments [1, @4@]. Overall, the evidence suggests that capecitabine is an effective treatment for stage III colon cancer, with a favorable toxicity profile and equivalent DFS compared to 5-FU/LV therapy.
• The recommended dose of capecitabine is 1250 mg/m2 twice daily days 1-14 every 3 weeks for 24 weeks, as outlined in the Journal of the National Comprehensive Cancer Network 1.
• The choice of treatment should be based on individual patient factors, including performance status, comorbidities, and preferences.
• Further research is needed to fully understand the role of capecitabine in the treatment of colon cancer and to determine the optimal duration of adjuvant therapy.

From the FDA Drug Label

The primary objective of the study was to compare disease-free survival (DFS) in patients receiving XELODA to those receiving IV 5-FU/LV alone In this trial, 1987 patients were randomized either to treatment with XELODA 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period, given as 3-week cycles for a total of 8 cycles (24 weeks) or IV bolus 5-FU 425 mg/m2 and 20 mg/m2 IV leucovorin on days 1 to 5, given as 4-week cycles for a total of 6 cycles (24 weeks)

The efficacy of Xeloda (capecitabine) is demonstrated by its ability to be compared to IV 5-FU/LV alone in terms of disease-free survival (DFS) in patients with Dukes' C colon cancer.

• Key points:
  • Xeloda was administered at a dose of 1250 mg/m2 orally twice daily for 2 weeks followed by a 1-week rest period.
  • The study showed that Xeloda had a comparable efficacy to IV 5-FU/LV alone in the adjuvant treatment of patients with colon cancer 2

From the Research

Efficacy of Xeloda (Capecitabine)

• The efficacy of Xeloda (capecitabine) has been demonstrated in various studies as a first-line treatment for metastatic colorectal cancer (MCRC) 3, 4, 5.
• In a study published in 2004, capecitabine in combination with oxaliplatin (XELOX) showed high efficacy as a first-line treatment for MCRC, with an objective response rate of 55% and a median time to disease progression of 7.7 months 3.
• Another study published in 2013 found that maintenance therapy with bevacizumab and capecitabine after initial treatment with bevacizumab and XELOX resulted in a significantly longer progression-free survival compared to continuous treatment with bevacizumab and XELOX 4.
• A phase II randomized study published in 2006 compared XELOX with protracted infusion of 5-fluorouracil and oxaliplatin (pviFOX) as first-line treatment for advanced colorectal cancer, and found that both regimens were effective and safe, with XELOX being favored due to its convenience and lack of need for central venous catheter 5.
• Capecitabine has also been studied in combination with oxaliplatin for the treatment of advanced gastric cancer, with a phase I study published in 2017 finding that the combination was well-tolerated and effective, with a recommended dose of oxaliplatin 130 mg/m2 in combination with capecitabine 2000 mg/m2/day 6.

Safety and Tolerability

• The safety and tolerability of capecitabine have been evaluated in various studies, with common adverse events including diarrhea, stomatitis, and sensory neuropathy 3, 4, 5.
• A study published in 2012 found that the addition of CKD-732 to XELOX resulted in a manageable safety profile, with frequently encountered non-hematological grade 3/4 adverse events including insomnia, fatigue, and sensory neuropathy 7.
• Another study published in 2017 found that the combination of capecitabine and oxaliplatin for advanced gastric cancer was well-tolerated, with one case of grade 3 stomatitis considered a dose-limiting toxicity 6.