Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Teysuno

Teysuno 15 mg/4.35 mg/11.8 mg hard capsules · Abschnitt 4.8 · PDF-Seite 17

HOS-123738 · Präparat HOS-095721

Safety of Teysuno in patients with metastatic colorectal cancer for whom it is not possible to continue treatment with another fluoropyrimidine due to hand-foot syndrome or cardiovascular toxicity In a subgroup of 53 mCRC patients, within a cohort study of 200 patients with different solid tumours, the majority of these mCRC patients (92%) who developed cardiotoxicity while on capecitabine- or 5-FU- based chemotherapy could safely switch to S-1 and continue treatment, with recurrent cardiotoxicity (grade 1) seen in 8%. Other adverse events during S-1 treatment in this subgroup included grade 3-4 haematologic toxicity in 8% and grade 2-4 non-haematologic adverse events in 36% (neuropathy 15%, infection 7%, thromboembolic event 6%, diarrhoea 4%, nausea 2%, hand-foot syndrome 2%). In a retrospective cohort study of 47 metastatic colorectal cancer patients from the Dutch colorectal cancer registry (PLCRC) switching to S-1 due to capecitabine-induced hand-foot syndrome (n=36) or cardiotoxicity (n=10) the severity of HFS decreased or completely resolved during treatment with S-1 and no case of recurrence of cardiac toxicity was reported in any of the 10 patients that switched to S-1 due to cardiac adverse events.

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