Serious adverse events with fluoropyrimidines in France
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Serious adverse events with fluoropyrimidines in France In patients from France with incident solid tumours, the serious adverse event (SAE) incidence rate during the first 6 months of fluoropyrimidine (FP) treatment was 32.2%, according to study results reported in the European Journal of Cancer, which highlights "the significant public health issue related to FP toxicity". The study evaluated 513 patients receiving FP-based chemotherapy in the Centre-Val de Loire region during 2013–2014, using the SIRCADE cohort. SAEs were investigated in patients receiving 5-fluorouracil (88.5%), capecitabine (7.4%), tegafur-uracil (1.2%) or combination therapy. There were 63 patients who only received a FP (12.7%). Fifteen patients (2.9%) underwent dihydropyrimidine dehydrogenase (DPD) screening before initiating treatment. There were 495 patients who received a FP from the beginning of treatment, and 2 patients who initiated a FP from the second cycle. Of these patients, 96 (19.3%) developed 116 SAEs; the most frequent type was haematological toxicity (53.4%), followed by gastrointestinal toxicity (12.9%) and nervous system toxicity (6.9%). For 2 DPD-deficient patients who received reduced FP dosages, no SAEs developed. There was one toxic death in a patient with febrile neutropenia, and a further 6 patients had life-threatening SAEs or those leading to incapacity/disability for an overall severe event incidence rate of 1.4%. During the first 6 months of chemotherapy, 165 patients (32.2%) presented with at least one SAE. One patient had a life-threatening SAE, which increased the total to 8 patients with severe events, for an overall incidence rate to 1.6%. Two of these events "were likely linked to DPD deficiency", note the authors, a rate of 0.39%. When extrapolated to the national level, an estimated 76 200 patients receive FP treatment annually, for an expected SAE incidence of 24 500 patients during the first 6 months of treatment and 14 700 patients during the first 2 cycles. An estimated 1200 patients would develop severe events, with an estimated 150 toxic deaths. The severe events could be related to DPD deficiency in 300 patients. "It is hoped that recent French recommendations advocating mandatory DPD-deficiency screening will dramatically reduce severe FP-related iatrogenic events and help eradicate toxic deaths", note the authors. Barin-Le Guellec C, et al. Toxicities associated with chemotherapy regimens containing a fluoropyrimidine: A real-life evaluation in France. European Journal of Cancer 124: 37-46, 9 Nov 2019. Available from: URL: http://doi.org/10.1016/ 803436951 j.ejca.2019.09.028
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Reactions 30 Nov 2019 No. 1781
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