Study | Design | Population | Treatment | Sample size | Primary endpoint | Key Results |
---|---|---|---|---|---|---|
Sastre, 2011 [18] | Prospective single arm, phase II. | Patients aged ≥70 with unselected mCRC | Cetuximab monotherapy | 41 | Overall response rate (ORR) | ORR 14.6% (95% CI 5.6–29.2) |
Sastre, 2012 [20] | Prospective, Single arm, phase II | Patients aged ≥70 with unselected mCRC | Cetuximab plus capecitabine | 66 | Overall response rate (ORR) | ORR 31.8% (95% CI 20.9–44.4) 29 patients had KRAS wild-type disease: response rate 48.3% (95% CI 29.4–67.5), |
Sastre, 2015 [19] | Prospective, Single arm, phase II | Patients aged ≥70 with RAS wild-type mCRC | Panitumumab monotherapy | 33 | PFS at 6 months | 6-month PFS rate 36.4% (95% CI 20.0–52.8) |
Kinele, 2018 [22] | Prospective, open label randomised phase II | Patients > 75 years, or patients ≥70 years with at least one adverse factor | Cetuximab monotherapy; cetuximab plus capecitabine | 24 | PFS at 12 weeks | PFS at 12 weeks: monotherapy arm 55% (95% CI 23–83); combination arm 69%; 95% CI 39–91) |
Lonadi, 2019 (abstract) [21] | Prospective, open label randomised phase II | Patients aged ≥70 years with RAS-BRAF wt mCRC | 5FU/LV plus panitumumab; FOLFOX plus panitumumab | 185 | PFS in both arms | Median PFS: FOLFOX-pan 9.6 m (95% CI 8.8–10.9); 5FU/LV-pan 9.1 m (95% CI 7.7–9.9). Response rate: FOLFOX-pan 65%; 5FU/LV-pan 57% |