Aims and Background Rarely are conclusions from clinical trials summarized in international consensus conferences and promptly transferred to patient care. The adjuvant therapy for colorectal cancer used in daily clinical practice in Italy is described and compared with the recommendations of the 1990 NIH Consensus Conference. Patients and Methods We audited prescriptions of adjuvant systemic therapies for Italian colorectal cancer patients in 82 centers during a fixed one-week period. Results Among 434 patients receiving adjuvant chemotherapy there were 139 (42.5%) colon cancer patients with N- and 169 (51.7%) with N+ regional nodal involvement. Treatment at academic centers, a young age, T4 and a low total number of lymph nodes removed at surgery were the factors potentially justifying the decision for adjuvant chemotherapy in stage II colon cancer patients. The most common chemotherapy used was a bolus of 5-fluorouracil/folinic acid for 6 months (75.8%). Adjuvant radiotherapy was not administered to 37 (38.5%) of 96 patients with stage II and III rectal cancer. Conclusions The study shows that a substantial proportion of patients on adjuvant treatment at a certain time point in a large enough sample of Italian centers are stage II (potential over-treatment) and that an under-treatment of stage II and III rectal cancer patients (lack of radiotherapy) occurs too often in daily clinical practice in this country.
13518 Background: In the X-ACT adjuvant trial, X showed consistent benefits over bolus 5-FU/LV, with at least equivalent disease-free survival (DFS) and an improved safety profile [Twelves et al. 2005]. In addition, X demonstrated superior relapse-free survival (65.5% vs. 61.9% at 3 years follow-up; p=0.0407) and improved covariate-adjusted overall survival (p=0.0208). We used the results from X-ACT to assess the cost-effectiveness of X from the Italian hospital and societal perspective. Methods: Trial-based data were collected on treatment period medical resource use. Unit costs for drug administration, hospitalizations, emergency room visits, and concomitant medications were considered using published sources in Italy. Cost for physician consultation visits, pt time and travel were also considered in the societal perspective. A health-state transition model was used to estimate incremental cost impact and the effectiveness in terms of gains in quality-adjusted life months (QALMs). Costs and effectiveness were discounted at 3.5%. Results: Mean duration of treatment was similar with X and 5-FU/LV; pts received 92% and 93% of planned treatments, respectively. Administration of X required fewer clinic visits per pt (7.4 vs. 28.0 with 5-FU/LV). Acquisition costs of X were higher than 5-FU/LV, approximately 2533 vs. 231€, but this difference was more than fully offset by the difference in administration cost of 5-FU/LV (4338 vs. 152€ for X). Total hospital days for treatment-related adverse events (AEs) and medication costs for treating AEs were higher for 5-FU/LV than X. The cost of emergency room visits for treating AEs and physician consultation did not differ. Compared with 5-FU/LV, X is projected to increase QALMs by 6.5 months, with overall treatment period cost savings of 2234€ for the hospital. From a societal perspective, the cost savings increase to 3976€. These findings show that X is a dominant (cost-saving and more effective) treatment in this setting. Conclusions: X as adjuvant treatment for pts with colon cancer is clinically effective with an improved safety profile vs. 5-FU/LV and is also a dominant choice from an economic perspective. [Table: see text]
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.