Table 3.
Published phase III trials involving capecitabine in mCRC
| Author | Regimen | Line of treatment | No. of patients | ORR (%) | Median PFS (m) | Median OS (m) | G 3/4 toxicities |
|---|---|---|---|---|---|---|---|
| Comparisons of single agent capecitabine to 5-FU/LV (Mayo) | |||||||
| Hoff et al44 | Capecitabine | I | 302 | 24.8* | 4.3 | 12.5 | 15.4% diarrhea, 18% HFS, 3% S |
| 5-FU | 303 | 15.5 | 4.7 | 13.3 | 13.9% diarrhea, 1% HFS, 16% S | ||
| Van Cutsem et al45 | Capecitabine | I | 301 | 18.9 | 5.2 | 13.2 | 10.7% diarrhea, 16% HFS, 1% S |
| 5-FU | 301 | 15 | 4.7 | 12.1 | 10.4% diarrhea, <1% HFS, 13% S | ||
| Comparisons of oxaliplatin containing regimens | |||||||
| Díaz-Rubio et al48 | XELOX | I | 174 | 37 | 8.9 | 18.1 | 14% diarrhea, 2% HFS, 2% S |
| FUOX | 174 | 46 | 9.5 | 20.8 | 24% diarrhea, 1% HFS, 4% S | ||
| Porschen et al47 | CAPOX | I | 242 | 48 | 7.1 | 16.8 | 10% HFS |
| FUFOX | 234 | 54 | 8.0 | 18.8 | 4% HFS | ||
| Cassidy et al46 (NO16966) | XELOX | I | 1017 | 37 | 8.0 | 19.8 | 11% diarrhea, 6% HFS, 1% S |
| FOLFOX4 | 1017 | 37 | 8.5 | 19.6 | 20% diarrhea, 1% HFS, 2% S | ||
| Hochster et al19 (TREE-1) | CapeOX | I | 50 | 27 | 5.9 | 17.2 | Refer to Table 1 |
| mFOLFOX6 | 50 | 41 | 8.7 | 19.2 | |||
| bFOL | 50 | 20 | 6.9 | 17.9 | |||
| Rothenberg et al50 | XELOX | II | 313 | 20 | 4.7 | 11.9 | 5% diarrhea, HFS 4%, S < 1% |
| FOLFOX4 | 314 | 18 | 4.8 | 12.5 | 19% diarrhea, HFS < 1%, S < 1% | ||
| Comparison of irinotecan containing regimens | |||||||
| Fuchs et al52 (BICC-C) | CapeIRI | I | 145 | 39 | 5.8 | 18.9 | 48% diarrhea, 32% neutropenia |
| FOLFIRI | 144 | 47 | 7.6* | 23.1 | 14% diarrhea, 43% neutropenia | ||
| mIFL | 141 | 43 | 5.9 | 17.6 | 19% diarrhea, 41% neutropenia | ||
| Koopman et al51 (CAIRO) | Cap/IRI/CAPOX | I–III | 410 | 20 | 5.8 | 16.3 | 23% diarrhea, 13% HFS 3% S |
| CAPIRI/CAPOX | 410 | 41* | 7.8* | 17.4 | 27% diarrhea, 7% HFS, 2% S | ||
| Köhne et al53 (EORTC 40015) | CapeIRI | I | 44 | 34 | 5.9 | 14.8 | 37% diarrhea, 14% neutropenia, 9% CV |
| FOLFIRI | 41 | 39 | 9.6* | 19.9* | 13% diarrhea, 15% neutropenia | ||
Notes:
Achieved statistical significance. Capecitabine combinations: CapeIRI: capecitabine 1000 mg/m2 twice daily (bid) on days 1–14 + irinotecan 250 mg/m2 q3wk; CapeOX: capecitabine 1000 mg/m2 bid on days 1–15 and oxaliplatin 130 mg/m2 on D1 q3wk; XELOX: capecitabine 1000 mg/m2 bid on days 1–14 and oxaliplatin 130 mg/m2 on D1 q3wk. 5-FU combinations: bFOL: oxaliplatin 85 mg/m2 on D1 and D15 + 5-FU 500 mg/m2 + LV 20 mg/m2 on D1, D8, D15 q4wk; FOLFIRI: irinotecan 180 mg/m2, LV 400 mg/m2, 5-FU 400 mg/m2 bolus then 5-FU 2400 mg/m2 over 46 h q2wk; FUFOX: oxaliplatin 50 mg/m2, LV 500 mg/m2, and 5-FU 2000 mg/m2 over 22 h on D1, D8, D15, D22 q36 days; FUOX: continuous infusion 5-FU 2250 mg/m2 over 48 h on D1, D8, D15, D22, D29, D36 + oxaliplatin 85 mg/m2 on D1, D15, D29; FOLFOX4: oxaliplatin 85 mg/m2, LV 200 mg/m2, 5-FU 400 mg/m2 bolus then 5-FU 600 mg/m2 over 22 h on D1, D2 q2wk; mFOLFOX6: oxaliplatin 85 mg/m2 + LV 350 mg/m2, 5-FU 400 mg/m2 bolus then 5-FU 2400 mg/m2 46-h infusion q2wk.
Abbreviations: HFS, hand–foot syndrome; S, stomatitis; MCRC, metastatic colorectal cancer; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; LV, leucovorin.