X-ACT Subanalysis Finds First-Line Adjuvant Capecitabine Cost-Effective vs 5-FU/LV for Dukes’ C Colon Cancer

VICTORIA, Australia-Six months' adjuvant treatment with capecitabine(Drug information on capecitabine) (Xeloda) substantially reduces medical resource use vs standard bolus fluorouracil(Drug information on fluorouracil) (5-FU)/leucovorin (LV), according to an analysis of medical resource utilization data from the large phase III X-ACT trial (abstract 3578). Reduced resource use was mostly related to fewer clinic visits, fewer resources needed to treat adverse events, and fewer hospitalizations related to treatment, said investigator Joseph J. McKendrick, MD. "Just from the basic patient point of view, not having injections and having tablets is much more tolerable for the patient," said Dr. McKendrick, head of Hematolo- gy, Medical Oncology and Palliative Care at Box Hill Hospital, Victoria, Australia. The analysis is a substudy of XACT, the large phase III randomized trial that now establishes capecitabine as first-line adjuvant treatment for colorectal cancer. The main X-ACT results show that capecitabine offers improved safety and convenience, and a trend toward improved survival vs bolus 5-FU/LV in patients with Dukes' C colon cancer (see related story on page 1 of this supplement). 'Sufficiently Different' "I think that [the results are] sufficiently different, in terms of endpoints in the main study and this substudy, to suggest that capecitabine should be the standard for adjuvant treatment at this point," Dr. McKendrick told ONI. Medical resource utilization was measured prospectively in the X-ACT trial, which compared 6 months of oral capecitabine (1,250 mg/m² twice daily) on days 1-14 every 3 weeks vs intravenous bolus 5-FU/LV (Mayo Clinic regimen) in nearly 2,000 patients. Investigators collected data on visits to providers, visits for study drug administration, hospitalizations for any reason, and medication needed for adverse events. 'Substantial Savings' They found patients on the Mayo Clinic regimen typically had 30 clinic visits for treatment administration, vs just 8 visits for capecitabine (1 at the start of each cycle). Patients on capecitabine used more low-cost medications than patients on the Mayo regimen, including emollients (999 vs 230 days of use per 100 patients) and vitamins. By contrast, patients on IV 5-FU-based therapy needed more higher-cost drugs to treat adverse events. Antibiotics/cephalosporins were used more frequently in the 5-FU/LV arm (453 vs 185 days of use per 100 patients), as were antiemetics and anti-diarrheals (1,127 vs 863 days of use per 100 patients). Use of nonsteroidal anti-inflammatory drugs was considerably higher in the 5-FU/LV arm (870 vs 474 days of use per 100 patients). There were fewer treatment-related hospitalizations in the capecitabine group (106 vs 124), although the total number of days in hospitalization was not different (961 vs 959). There was also no difference in the number of additional visits to specialists or general practitioners during the study (about 1 extra visit per patient). Importantly, patients spent considerably less time related to treatment in the capecitabine arm. The estimated number of hours spent trav- paeling, waiting, and receiving treatment (both scheduled and for adverse events) was only 20.6 hours for capecitabine vs 124.4 hours for 5-FU/LV. The differences in medical resource utilization add up to "substantial savings" favoring capecitabine treatment. "Combining this with the additional clinical benefits, it is likely that capecitabine will not only be a cost-effective treatment strategy, but also a 'dominant' clinical strategy [ie, because of lower associated costs and greater benefits] in most countries," the investigators wrote.