Table 5 Phase II studies of capecitabine chemoradiation regimens in patients with LARC
Reference | No. of evaluated patients | Treatment | Downstaging rate (%) | Response (%) | Sphincter preservation (%) | Main adverse events |
|---|---|---|---|---|---|---|
De Bruine et al [10] | 60 | Pelvic RT(2 Gy/day, total 50 Gy) +C (825 mg/m2 b.i.d. on radiotherapy days) ×5 weeks | 67 | pCR (13) | 50 | Grade 3 diarrhea (2%), radiation dermatitis (3%). |
De Paoli et al [21] | 53 | Pelvic RT (1.8 Gy/day, total 45 Gy) + presacral boost(3 × 1.8 Gy) + C (825 mg/m2 b.i.d.), 7-days/week | 57 | pCR (24) | 59 | Grade 3 leucopenia (4%), hand-foot syndrome (4%). |
Dunst et al [22] | 69 (efficacy) 63 (safety) | Pelvic RT (1.8 Gy/day) + presacral boost(3 × 1.8 Gy) + C (825 mg/m2 b.i.d.), ×6 weeks | 73 | pCR (4) | NR | Grade 3 leuko-/lymphocytopenia (10%), diarrhea (4%), |
Dunst et al [23] | 96 | Pelvic RT (50.4–55.8 Gy, conventional fractionation) + C (825 mg/m2 b.i.d.) | 61 | pCR (7) | 51 | Grade 3 lymphopenia (12%), leucopenia (16%), hand-foot syndrome (12%), diarrhea(7%) |
Dupuis et al [24] | 51 | Pelvic RT (1.8 Gy/day, total 45 Gy) + C (825 mg/m2 b.i.d.), 7-days/week | 58 | pCR (20) | 58 | Grade 3 diarrhea (12%), radiation dermatitis (8%). |
Kim et al [25] | 38 | Pelvic RT (1.8 Gy/day) + presacral boost(3 × 1.8 Gy) + C (825 mg/m2 b.i.d.) + LV (20/m2/day) days 1–14, 2 cycles of 14 days. | 63 | pCR (31) | 72 | Grade 3 hand-foot syndrome (7%), diarrhoea (4%), dermatitis (2%). |
Lin et al [26] | 53 (efficacy) 52 (safety) | Pelvic RT (1.8 Gy/day, total45 Gy) + primary tumor/perirectal node RT(1.75 Gy/day, total 52.5 Gy) + C(825 mg/m2 b.i.d.) ×5 weeks | 62 | pCR (17) | NR | Grade 3 diarrhoea (13%), radiation dermatitis (6%) |
Velenik et al [27] | 57 | Pelvic RT (1.8 Gy/day, total 45 Gy) + C (825 mg/m2 b.i.d.), 7-days/week | 49 | pCR (9) | 65.5 | Grade 3 dermatitis (34.5%), diarrhoea (3.6%), |
Present study | 43 | Pelvic RT (1.8 Gy/day, total 45 Gy) +C (825 mg/m2 b.i.d. on radiotherapy days) ×5 weeks | 74 | pCR (9) | 46.5 | Grade 2 anemia(9%) leucopenia(5%), diarrhoea (4%) Grade 1 hand-foot syndrome (2%). |