Study protocol of the FIRE-8 (AIO-KRK/YMO-0519) trial: a prospective, randomized, open-label, multicenter phase II trial investigating the efficacy of trifluridine/tipiracil plus panitumumab versus trifluridine/tipiracil plus bevacizumab as first-line treatment in patients with metastatic colorectal cancer

Table 5 Dose calculation of trifluridine/tipiracil according to BSA for dose reduction levels

Dose (mg/m²)	BSA (m²)	Dose in mg (BID)	Tablets per Dose (BID) 15 mg/6.14 mg	Tablets per Dose (BID) 20 mg/8.19 mg	Total daily dose (mg)
Level 1 dose reduction: From 35 mg/m² to 30 mg/m²
30	< 1.09	30	2	0	60
	1.09–1.24	35	1	1	70
	1.25–1.39	40	0	2	80
	1.40–1.54	45	3	0	90
	1.55–1.69	50	2	1	100
	1.70–1.94	55	1	2	110
	1.95–1.09	60	0	3	120
	2.10–2.28	65	3	1	130
	≥ 2.29	70	2	2	140
Level 2 dose reduction: From 30 mg/m² to 25 mg/m²
25	< 1.10	25 ^a	2 ^a	1 ^a	50
	1.10–1.29	30	2	0	60
	1.30–1.49	35	1	1	70
	1.50–1.69	40	0	2	80
	1.70–1.89	45	3	0	90
	1.90–2.09	50	2	1	100
	2.10–2.29	55	1	2	110
	≥ 2.30	60	0	3	120
Level 3 dose reduction: From 25 mg/m² to 20 mg/m²
20	< 1.14	20	0	1	40
	1.14–1.34	25^a	2 ^a	1 ^a	50
	1.35–1.59	30	2	0	60
	1.60–1.94	35	1	1	70
	1.95–2.09	40	0	2	80
	2.10–2.34	45	3	0	90
	≥ 2.35	50	2	1	100

BSA Body surface area, BID twice daily
^aAt a total daily dose of 50 mg, patients should take 1 × 20 mg /8.19 tablet in the morning and 2 × 15 mg/6.14 mg tablets in the evening

ISSN: 1471-2407