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Renal function, body surface area, and age are associated with risk of early-onset fluoropyrimidine-associated toxicity in patients treated with capecitabine-based anticancer regimens in daily clinical care
- Source :
- European Journal of Cancer, 54, 120. Elsevier Ltd
- Publication Year :
- 2016
-
Abstract
- Background The objective of this analysis was to determine the factors associated with early onset treatment-related toxicity in patients treated with capecitabine-based anticancer regimens in daily clinical care. Patients and Methods A total of 1463 patients previously included in a prospective cohort study and treated with standard-of-care capecitabine-based anticancer regimens (monotherapy or combined with other chemotherapy or radiotherapy) were analysed. Logistic regression models were developed to investigate associations between patient- and treatment-related factors and occurrence of early – i.e. cycle one or two – severe (grade ≥ 3) treatment-related toxicity, toxicity-related hospitalisation, and toxicity-related treatment discontinuation. Performance of models was evaluated using receiver-operating characteristic (ROC) curves and internal validity was explored using bootstrap analysis. Results Among 1463 patients included, 231 patients (16%) experienced early severe toxicity, 132 patients (9%) were hospitalised for toxicity, and 146 patients (10%) discontinued treatment for toxicity; in total, 321 patients (22%) experienced any early toxicity-related adverse outcome. Predictors of early grade ≥3 toxicity, after adjustment for treatment regimen, were renal function (odds ratio [OR] 0.85 per 10 ml/min/1.73 m 2 , p = 0.0007), body surface area (BSA) (OR 0.33 per m 2 , p = 0.0053), age (OR 1.14 per decade, p = 0.0891), and elevated pre-treatment uracil concentrations (OR 2.41 per 10 ng/ml, p = 0.0046). Age was significantly associated with fatal treatment-related toxicity (OR 5.75, p = 0.0008). Area under the ROC curve (AUC) of a model to predict early grade ≥3 toxicity was 0.704 (95% confidence interval 0.666–0.743, optimism-corrected AUC 0.690). Conclusion Renal function, BSA, and age, in addition to pre-treatment uracil, are associated with clinically relevant differences in risk of early severe toxicity in patients treated with capecitabine in routine clinical care.
- Subjects :
- Male
Cancer Research
medicine.medical_specialty
Antimetabolites, Antineoplastic
Time Factors
Drug-Related Side Effects and Adverse Reactions
Antimetabolites
Body Surface Area
030204 cardiovascular system & hematology
Kidney
Gastroenterology
Severity of Illness Index
Capecitabine
03 medical and health sciences
0302 clinical medicine
Risk Factors
Internal medicine
Severity of illness
Antineoplastic Combined Chemotherapy Protocols
medicine
Odds Ratio
Journal Article
Humans
Adverse effect
Prospective cohort study
Aged
Body surface area
business.industry
Age Factors
Odds ratio
Middle Aged
Antineoplastic
Surgery
Discontinuation
Hospitalization
Logistic Models
Treatment Outcome
Oncology
ROC Curve
030220 oncology & carcinogenesis
Area Under Curve
Toxicity
Female
business
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 09598049
- Database :
- OpenAIRE
- Journal :
- European Journal of Cancer, 54, 120. Elsevier Ltd
- Accession number :
- edsair.doi.dedup.....2ac8d47d5248ba5c10c5d845a788184c