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

September 1, 2004

The 30 reports in this special supplement to Oncology News International represent highlights of ongoing major clinical trials and new research presented at ASCO 2004 regarding state-of-the-art chemotherapeutic management of gastrointestinal and other cancers. Important developments in capecitabine as adjuvant therapy, novel targeted agents, and new combinations are discussed.

VICTORIA, Australia-Sixmonths' adjuvant treatment withcapecitabine (Xeloda) substantially reducesmedical resource use vs standardbolus fluorouracil (5-FU)/leucovorin(LV), according to an analysis ofmedical resource utilization data fromthe large phase III X-ACT trial (abstract3578).Reduced resource use was mostlyrelated to fewer clinic visits, fewer resourcesneeded to treat adverse events,and fewer hospitalizations related totreatment, said investigator Joseph J.McKendrick, MD. "Just from the basicpatient point of view, not havinginjections and having tablets is muchmore tolerable for the patient," saidDr. McKendrick, head of Hematolo-gy, Medical Oncology and PalliativeCare at Box Hill Hospital, Victoria,Australia.The analysis is a substudy of XACT,the large phase III randomizedtrial that now establishes capecitabineas first-line adjuvant treatment for colorectalcancer. The main X-ACT resultsshow that capecitabine offers improvedsafety and convenience, and atrend toward improved survival vs bolus5-FU/LV in patients with Dukes' Ccolon cancer (see related story on page1 of this supplement).'Sufficiently Different'"I think that [the results are] sufficientlydifferent, in terms of endpointsin the main study and this substudy, tosuggest that capecitabine should bethe standard for adjuvant treatment atthis point," Dr. McKendrick told ONI.Medical resource utilization wasmeasured prospectively in the X-ACTtrial, which compared 6 months oforal capecitabine (1,250 mg/m2 twicedaily) on days 1-14 every 3 weeks vsintravenous bolus 5-FU/LV (MayoClinic regimen) in nearly 2,000 patients.Investigators collected data onvisits to providers, visits for study drugadministration, hospitalizations forany reason, and medication neededfor adverse events.'Substantial Savings'They found patients on the MayoClinic regimen typically had 30 clinicvisits for treatment administration, vsjust 8 visits for capecitabine (1 at thestart of each cycle).Patients on capecitabine used morelow-cost medications than patients onthe Mayo regimen, including emollients(999 vs 230 days of use per 100patients) and vitamins. By contrast,patients on IV 5-FU-based therapyneeded more higher-cost drugs to treatadverse events. Antibiotics/cephalosporinswere used more frequentlyin the 5-FU/LV arm (453 vs 185 daysof use per 100 patients), as were antiemeticsand anti-diarrheals (1,127 vs863 days of use per 100 patients). Useof nonsteroidal anti-inflammatorydrugs was considerably higher in the5-FU/LV arm (870 vs 474 days of useper 100 patients).There were fewer treatment-relatedhospitalizations in the capecitabinegroup (106 vs 124), although the totalnumber of days in hospitalization wasnot different (961 vs 959). There wasalso no difference in the number ofadditional visits to specialists or generalpractitioners during the study(about 1 extra visit per patient).Importantly, patients spent considerablyless time related to treatmentin the capecitabine arm. Theestimated number of hours spent trav-paeling,waiting, and receiving treatment(both scheduled and for adverseevents) was only 20.6 hours for capecitabinevs 124.4 hours for 5-FU/LV.The differences in medical resourceutilization add up to "substantial savings"favoring capecitabine treatment."Combining this with the additionalclinical benefits, it is likely that capecitabinewill not only be a cost-effectivetreatment strategy, but also a 'dominant'clinical strategy [ie, because oflower associated costs and greater benefits]in most countries," the investigatorswrote.