Table 3.
Chemotherapy studies for older patients with advanced/metastatic colorectal cancer.
| Author/study | Type of study | No. of patients |
No. of older patients (%)/ age cutoff (years) |
Endpoints | Outcomes |
|---|---|---|---|---|---|
|
Folprecht et al. [2008] |
Pooled analysis (data from four phase III trials) |
2691 |
599 (22.2%)/ 70 |
Iri/5FU versus 5FU as first line in younger versus older patients: (i) RR (ii) OS (iii) PFS |
(i) RR: improved with Iri-based therapy Y:46.6 versus 29.0%, p < 0.0001 E: 50.5 versus 30.3%, p < 0.0001 (ii) OS: improved with combination therapy Y:HR 0.83 (95% CI 0.75–0.92; p = 0.0003) E: HR 0.87 (95% CI 0.72–1.05; p = 0.15) (iii) PFS improved with Iri-based therapy Y: HR 0.77 (95% CI 0.70–0.85, p < 0.0001) E: HR 0.75 (95% CI 0.61–0.90, p = 0.0026) |
| Cassidy et al. [2010] | Retrospective pooled analysis (AVF2107g, AVF219g, NO16966, E3200 trials) |
3007 |
1142 (37.9%)/ 65 |
(i) PFS (ii) OS with FU-based CT ± Bev |
(i) ≥ 65 years: 9.3 (+ Bev) versus 6.9 months HR 0.58 (95% CI 0.49–0.68, p < 0.0001) ≥70 years: 9.2 (+ Bev) versus 6.4 months HR 0.54 (95% CI 0.44-0.66, p < 0.0001) (ii) ≥65 years: 17.9 (+ Bev) versus 15 months HR 0.85(95% CI 0.74–0.97, p = 0.015) ≥70 years, 17.4 (+ Bev) versus 14.1 months HR 0.7 (95% CI 0.66–0.93, p = 0.005) |
|
Adam et al. [2010] |
Multicentre cohort study |
7764 |
999 (12.8%)/ 70 |
Older versus younger patients with liver metastasectomy: (i) (a) postoperative mortality (b) morbidity (ii) OS (iii) DFS |
(i) (a) 5 versus 2.2% for major hepatectomies (p < 0.001) 4.1 versus 0.9% for limited resections (p < 0.001) (b) 37.8 versus 35.2 % after major hepatectomy (p = 0.19) 30.3 versus 21.9% after limited resections (p < 0.001) (ii) 3 years: 57.1% versus 60.2% (p < 0.001) (iii) 3 years: 37% versus 31.9% (p = 0.051) |
|
Seymour et al.
[2011] (FOCUS2) |
Multicentre, randomized phase III | 438 |
199 (43%)/ 75 |
(a) Intravenous infusion 5FU (b) Ox + 5FU (c) Ox + Cap (d) Cap (i) PFS: (a) versus (b), (c) versus (d) (ii) QOL assessment with Cap instead of 5FU |
(i) 5.8 versus 4.5 months, HR 0.84 (95% CI 0.69–1.01, p = 0.07) (ii) Replacement of FU with Cap did not improve QOL |
| Cunningham et al. [2013] (AVEX) | Multicentre, randomized phase III |
280 |
280 (100%)/ 70 |
(i) PFS (a) Cap (n = 140) (b) Cap + Bev (n = 140) (ii) assessment of treatment-related AE |
(i) 9.1 (+ Bev) versus 5.1 months HR 0.53 (95% CI 0.41–0.61, p < 0.0001) (ii) ≥Grade 3: 40% (+ Bev) versus 22% serious AEs in 14% and 8% respectively |
5FU, 5 fluorouracil; AE: adverse event; Bev, bevacizumab; Cap, capecitabine; CI, confidence interval; CT, chemotherapy; DFS, disease-free survival; E, elderly group; HR, hazard ratio; Iri, irinotecan; OS, overall survival; Ox, oxaliplatin; PFS, progression-free survival; QOL, quality of life; RR, response rate; Y, younger group.