Barin-Le Guellec et al. [
] investigated toxicities associated with chemotherapy regimens containing a fluoropyrimidine in France. Specifically, approximately 1200 patients were reported to have a life-threatening prognosis or disability/disability each year, including 150 toxic deaths. Having observed one death in 513 patients treated in a French region in the Centre-Val de Loire, and with 76,200 patients treated in France, the authors believe that they can deduce that the best estimate of the total number of deaths will be 76,200/513 = 148.54 rounded up to 150. After observing 8 serious adverse events (SAEs), they estimate the number of SAEs to be 76,200 × 8/513 = 1188.30 rounded to 1200 .
- Barin-Le Guellec
- et al.
Toxicities associated with chemotherapy regimens containing a fluoropyrimidine: a real-life evaluation in France.
Eur J Cancer. 2020; 124 ([PubMed]): 37-46https://doi.org/10.1016/j.ejca.2019.09.028
|Calculation method||Lower limit||Upper limit|
|95% confidence interval for lethal SAEs.|
|95% confidence interval for SAEs.|
Comparison of methods for determining the 95%CIs.
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- Toxicities associated with chemotherapy regimens containing a fluoropyrimidine: a real-life evaluation in France.Eur J Cancer. 2020; 124 ([PubMed]): 37-46https://doi.org/10.1016/j.ejca.2019.09.028
- Notification to the PRAC/EMA secretariat of a referral notification under article 31 of directive 2001/83/EC. ANSM, Mars, 2019
- Fluoropyrimidine chemotherapy: recommendations for DPYD genotyping and therapeutic drug monitoring of the Swiss Group of Pharmacogenomics and Personalised Therapy.Swiss Med Wkly. 2020; 150: w20375https://doi.org/10.4414/smw.2020.20375
Published online: February 13, 2023
Accepted: January 21, 2023
Received in revised form: January 18, 2023
Received: November 9, 2022
© 2023 Elsevier Ltd. All rights reserved.
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- Toxicities associated with chemotherapy regimens containing a fluoropyrimidine: A real-life evaluation in FranceEuropean Journal of CancerVol. 124
- PreviewDespite fluoropyrimidines (FPs) constituting the main component of the chemotherapy combination protocols in 50% of chemotherapies for solid tumour treatments, incidence data for FP-related toxicity are poorly documented in real life. This study evaluated the number of patients receiving FP-based chemotherapies in France, along with the true incidence of FP-related serious adverse effects (SAEs) before the recent mandatory dihydropyrimidine dehydrogenase (DPD)-screening was introduced by French health authorities, DPD being the rate-limiting enzyme of 5-fluorouracil (5-FU) catabolism.