Barin-Le Guellec et al. [
[1]
] 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 .
Table 1
| Calculation method | Lower limit | Upper limit | ||
|---|---|---|---|---|
| Value | Probability | Value | Probability | |
| 95% confidence interval for lethal SAEs. | ||||
| Dichotomy | 0.0000493 | 2.497% | 0.01081 | 2.503% |
| Normal approximation | −0.0018675 | nonsense | 0.0057662 | 20.46% |
| Clopper-Pearson exact | 0.0000494 | 2.50% | 0.0108126 | 2.50% |
| Wilson | 0.0003442 | 16.19% | 0.0109580 | 2.35% |
| Jeffreys | 0.0002104 | 10.23% | 0.0090745 | 5.31% |
| Agresti-Coull | −0.0008115 | nonsense | 0.0121137 | 1.40% |
| 95% confidence interval for SAEs. | ||||
| Dichotomy | 0.0067560 | 2.50% | 0.0304953 | 2.50% |
| Normal approximation | 0.0048729 | 0.41% | 0.0263162 | 7.63% |
| Clopper-Pearson exact | 0.0067560 | 2.50% | 0.0304953 | 2.50% |
| Wilson | 0.0079227 | 5.43% | 0.0304671 | 2.52% |
| Jeffreys | 0.0073994 | 3.93% | 0.0292084 | 3.58% |
| Agresti-Coull | 0.0073658 | 3.84% | 0.0310241 | 2.15% |
Comparison of methods for determining the 95%CIs.
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References
- 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
https://www.itl.nist.gov/div898/handbook/prc/section2/prc241.htm.
- 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
Article info
Publication history
Published online: February 13, 2023
Accepted:
January 21,
2023
Received in revised form:
January 18,
2023
Received:
November 9,
2022
Identification
Copyright
© 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.
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