Table 4. Outcome measures.
| EOX (n=17) | OX (n=19) | X (n=19) | Total (n=55) | |
|---|---|---|---|---|
| Median PFS (months; 95% CI) | 5.4 (2.3–11.7) | 5.6 (2.7–8.7) | 3.0 (2.4–4.1) | 4.4 (2.8–5.6) |
| Median OS (months; 95% CI) | 8.1 (2.3–11.7) | 9.5 (5.0–NR) | 3.6 (2.4–8.1) | 7.1 (4.3–10.1) |
| RECIST response at week 12 | ||||
| Response rate CR+PR | 5 (29%) | 9 (47%) | 2 (11%) | 16 (30%) |
| Disease control CR+PR+SD | 10 (59%) | 11 (58%) | 8 (44%) | 29 (54%) |
| OTU score at week 12 | ||||
| Good | 3 (18%) | 6 (32%) | 1 (6%) | 10 (19%) |
| Intermediate | 4 (24%) | 4 (21%) | 4 (22%) | 12 (22%) |
| Poor | 8 (47%) | 6 (32%) | 10 (56%) | 24 (44%) |
| Missing | 2 (12%) | 3 (16%) | 3 (17%) | 8 (15%) |
| Patient acceptability scores | ||||
| Category Aγ | 3 (18%) | 6 (32%) | 3 (17%) | 12 (22%) |
| Category Bη | 7 (41%) | 9 (47%) | 6 (33%) | 22 (41%) |
| Died before assessment | 5 (29%) | 1 (5%) | 6 (33%) | 12 (22%) |
| Missing | 2 (12%) | 3 (16%) | 3 (17%) | 8 (15%) |
| QLQ-C30 scores at week 12 | ||||
| Mean global QoL score at 12 weeksa | 67.8 (CI 54.5–81.2) | 70.3 (CI 58.3–82.3) | 64.8 (CI 51.5–78.2) | 67.0 (CI 60.1–73.8) |
| Mean fatigue score at 12 weeksa | 31.7 (CI 18.4–45.1) | 25.6 (CI 14.3–37.0) | 42.6 (CI 29.3–55.8) | 32.9 (CI 25.9–40.0) |
| Mini-nutritional assessment | ||||
| Mean global MNA score at week 12a | b | 24.2 (CI 22.3–26.2) | 25.8 (CI 21.0–30.6) | 24.2 (CI 22.5–25.9) |
| Nottingham ADL at week 12 | ||||
| Mean global NADL score at 12 weeksa | 13.4 (CI 11.4–15.3) | 14.8 (CI 13.0–16.5) | 14.3 (CI 12.4–16.3) | 14.2 (CI 13.2–15.2) |
| Physical tests at week 12 | ||||
| Mean weight at 12 weeksa | 65.8 (CI 62.1–69.4) | 69.3 (CI 66.7–71.9) | 67.4 (CI 64.5–70.3) | 67.6 (CI 65.9–69.3) |
| Mean arm circumference at 12 weeksa | 24.5 (CI 23.1–26.0) | 25.5 (CI 24.2–26.8) | 23.3 (CI 21.8–24.8) | 24.4 (CI 23.6–25.2) |
Abbreviations: ADL=Activities of Daily Living; CI=95% confidence interval; CR=complete response; EOX=epirubicin, oxaliplatin and capecitabine; MNA=Mini-nutritional assessment; NADL=Nottingham Activities of Daily Living; NR = not reached; OS=overall survival; OTU=overall treatment utility; OX=oxaliplatin and capecitabine; PFS=progression-free survival; PR=partial response; QoL=quality of life; RECIST=Response Evaluation Criteria in Solid Tumours; SD=stable disease; X=capecitabine. (%)=Percentage of patients who attended visit.
The symbol ‘%' indicates the percentage of patients in the trial or trial arm.
a
Adjusted for baseline score and repeated measures.
b
No patient fully completed the 12-week mini-nutritional assessment in the EOX group.