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Table 5 Recommended dose modifications for FTF/TPI in case of haematological and non-haematological adverse reactions [21]

From: Study protocol of an open-label, single arm phase II trial investigating the efficacy and safety of Trifluridine/Tipiracil combined with irinotecan as a second line therapy in patients with cholangiocarcinoma (TRITICC)

Adverse reaction

Recommended dose modifications

• Febrile neutropenia

• Interrupt dosing until toxicity resolves to Grade 1 or baseline

• Grade 4 neutropenia (< 0.5 × 109/L) or thrombocytopenia (< 25 × 109/L) that results in more than 1 week’s delay in start of next cycle

• When resuming dosing, decrease the dose level by 5 mg/m2/dose from the previous dose level

• CTCAE version 4 non-haematologic Grade 3 or Grade 4 adverse reaction; except for Grade 3 nausea and/or vomiting controlled by antiemetic therapy or diarrhoea responsive to antidiarrhoeal medicinal products

• Dose reductions are permitted to a minimum dose of 20 mg/m2/dose BID daily

• Do not increase dose after it has been reduced