Capecitabine as Adjuvant Treatment for Stage III Colon Cancer
- Study type
- Clinical trial
- Study name
- X-ACT
- Design
- Randomised non-inferiority trial comparing oral capecitabine with bolus fluorouracil plus leucovorin
- Sample size
- 1987 patients
- Source
- N Engl J Med · 2005
In plain words
In this study, patients with stage 3 colon cancer who had had surgery received, after the operation, either capecitabine tablets or the injected drug fluorouracil with leucovorin for 24 weeks. The capecitabine tablets worked at least as well as the injected treatment. They also caused fewer side effects.
Key results
Treatment arms and regimens
Capecitabine 1250 mg/m² orally twice daily, days 1 to 14 of each 21-day cycle, 8 cycles in total (24 weeks); the dose was reduced for baseline creatinine clearance of 30 to 50 mL/min (1004 patients).
Mayo Clinic regimen: fluorouracil 425 mg/m² and leucovorin 20 mg/m² IV (bolus), days 1 to 5 of each 28-day cycle, 6 cycles in total (24 weeks) (983 patients).
Source of the regimen details: FDA label for capecitabine (XELODA; Clinical Studies section, X-ACT)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Study population
Patients aged 18 to 75 years with stage III colon cancer (Dukes C; at least one positive lymph node) who had undergone complete resection of the primary tumour within 8 weeks before randomisation; no prior chemotherapy or immunotherapy, ECOG 0 or 1, neutrophils ≥1.5×10⁹/L, platelets ≥100×10⁹/L, creatinine ≤1.5 times the upper limit of normal, bilirubin ≤1.5 times and AST/ALT ≤2.5 times the upper limit of normal, and normal CEA (per the FDA label).
Endpoints
Primary efficacy endpoint: at least equivalence in disease-free survival. Primary safety endpoint: incidence of grade 3 or 4 fluoropyrimidine-related toxicity. Relapse-free survival was also reported.
Safety and side effects
Capecitabine was associated with significantly fewer adverse events than fluorouracil plus leucovorin (P<0.001). Exact rates of grade 3 or 4 adverse events are not given in the abstract and are in the full text.
Clinical significance and place in guidelines
This study showed that oral capecitabine can be an effective alternative to bolus fluorouracil plus leucovorin in the adjuvant treatment of stage 3 colon cancer. Its place in current guidelines should be checked in up-to-date sources.
Limitations
The abstract gives no information on limitations, exact rates of grade 3 or 4 adverse events or overall survival values; these should be checked in the full text.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.