Capecitabine for locally advanced and metastatic colorectal cancer: A review

Table 4 Phase II trials for locally advanced rectal cancer treated with preoperative chemo-radiation therapy using orally capecitabine

Study	Patients enrolled	Treatment used	Complete response (%)	Down staging (%)	Severe toxicity
Dupuis et al[42]	51	RT: 45 Gy/1.8 Gy fraction/25 fractions Capecitabine: 825 mg/m2 bid throughout RT	20	48	No grade 4 toxicity
Desai et al[43]	30	RT: 50.4 Gy/1.8 Gy day Capecitabine: 1330 mg/m2 per day in 2 divided doses throughout RT	11	37	No grade 4 toxicity
Korkolis et al[44]	30	RT: 50.4 Gy/1.8Gy day Capecitabine: 825 mg/m2 bid throughout RT	23	84	No grade 4 toxicity
Willeke et al[45]	36	RT: 50.4 Gy/1.8Gy day Capecitabine: 500 mg/m2 bid ( days 1-38) Irinotecan: 50 mg/m2 weekly	15	41	Grade 4 leucopenia in 2 patients
Velenik et al[46]	57	RT: 45Gy/25 fractions/1.8 Gy Capecitabine: 1650 mg/m2 per day in 2 divided doses throughout RT	9.1	49.1	No grade 4 toxicity
Krishnan et al[47]	54	RT: 52.5 Gy/30 fractions Capecitabine: 825 mg/m2 bid throughout RT	18	52	No grade 4 toxicity
De Paoli et al[48]	53	RT: 50.4 Gy/1.8 Gy day Capecitabine: 825 mg/m2 bid throughout RT	24	57	No grade 4 toxicity
Machiels et al[49]	40	RT: 45 Gy/25 fractions/1.8 Gy Capecitabine: 825 mg/m2 bid throughout RT Oxaliplatin: 40 mg/m2 weekly for 5 wk	14	32	Grade 3/4 toxicity 30%
Kim et al[50]	95	RT: 50 Gy/25 fractions Capecitabine: 1650 mg/m2 per day in 2 divided doses throughout RT	12	71	No grade 4 toxicity
Carlomagno et al[51]	43	RT: 45 Gy/25 fractions Capecitabine: 825 mg/m2 per day twice daily on days 1-14 every 3 wk/2 Cycles Oxaliplatin 50 mg/m2 days 1 and 8 every 3 wk	20.9	NR	No grade 4 toxicity
Fakih et al[52]	25	RT: 50.4 Gy/1.8 Gy day Capecitabine: 725 mg/m2/d twice daily Monday to Friday concomitant with RT Oxaliplatin 50 mg/m2 weekly for 5 wk	24	52	Grade 3 diarrhea, in 20% of patients
Craven et al[53]	70	RT: 45 Gy/1.8 Gy day Capecitabine: 900 mg/m2 per day Monday to Friday concomitant with RT	9.2	66	No grade 4 toxicity

RT: Radiation therapy; bid: Twice daily; NR: Not recorded.