Table 5 Similar clinical studies on XELOXIRI
Study and population | Schedule | Irinotecan (mg/m2) | Oxaliplatin (mg/m2) | Capecitabine (mg/m2/d) | Targeted drug | Grade 3–4 AEs | DLT | ORR (%) | PFS (months) | OS (months) |
|---|---|---|---|---|---|---|---|---|---|---|
Italy-GONO (2009) Phase 2, N = 36 | Q2w | 165 | 85 | 2000 | - | Neutropenia (30%), febrile neutropenia (11%), diarrhea (30%) | - | 67 | 10.1 | 17.9 |
Italy-ITMO (2007) phase 2, N = 38 | Q2w | 180 | 85 | 2000 | - | Diarrhea (24%), nausea (16%) | Diarrhea | 63 | 8.5 | 23.5 |
Italy (2015) phase 2, N = 51 | Q2w | 180 | 85 | 2000 | - | Neutropenia (6%), diarrhea (31%), mucositis (4%) | - | 62 | 10.3 | 22 |
Spain (2010) phase 1, N = 87 | Q2w | 150 | 85 | 2000 | - | Neutropenia (27%), diarrhea (11%) and leukopenia (8%) | Neutropenia, diarrhea | 66.6 | 12 | 27 |
Canada (2018) phase 1, N = 39 | Q3w | 160 | 100 | 1900 | - | Neutropenia (56%), diarrhea (15%) | Febrile neutropenia, diarrhea | 67 | 11 | 25 |
Japan QUATTRO-II (2021), phase 2, N = 9 (Safety lead-in results) | Q3w | 200 | 130 | 1600 | Bev 7.5 mg/kg | Neutropenia (44%) | Febrile neutropenia | 89 | - | - |
Japan (2015) Phase 1, N = 12 | Q3w | 150 | 100 | 1700 | Bev 7.5 mg/kg | Neutropenia (41%), febrile neutropenia (8%), diarrhea (8%) | Neutropenia | 83 | 15 | - |
Japan (2017) Phase 1, N = 12 | Q3w | 150 | 100 | 1700 | Cet 250 mg/m2 qw (Increase the first dose) | Neutropenia (50%), febrile neutropenia (8%), diarrhea (17%) | Neutropenia | 83 | 14.5 | - |
Japan (2019) phase 1, N = 6 | Q2W | 150 | 85 | 2000 | - | Febrile neutropenia (2/6) | Febrile neutropenia | - | - | - |