Table 2.
Changes in grade and extent of dysplasia after 48 weeks of treatment*
| Low-grade stratum |
High-grade stratum |
Combined |
|||||||
|---|---|---|---|---|---|---|---|---|---|
| Change | Celecoxib | Placebo | P† | Celecoxib | Placebo | P† | Celecoxib | Placebo | P† |
| Biopsy sample‡ | |||||||||
| Median proportion of biopsy samples with dysplasia at baseline (lQR) |
0.14 (−0.04 to 0.32) | 0.14(0.03 to 0.25) | 12 | 0.34 (0.02 to 0.66) | 0.26 (−0.03 to 0.55) | .99 | 0.19 (−0.09 to 0.47) | 0.15(0.03 to 0.27) | 18 |
| Median change in proportion of biopsy samples with dysplasia or cancer (lQR) |
−0.09 (−0.32 to 0.14) | −0.07 (−0.27 to 0.13) | .64 | 0.12 (−0.31 to 0.55) | 0.02 (−0.24 to 0.28) | .88 | −0.08 (−0.39 to 0.23) | −0.06 (−0.35 to 0.23) | .84 |
| Change in highest grade of pathology | |||||||||
| % patients with decrease (95% Cl) | 48.1 (28.7 to 68.1) | 51.8 (31.9 to 71.3) | .82 | 31.2 (11.0 to 58.7) | 16.7 (2.1 to 48.4) | .42 | 41.9 (27.0 to 57.9) | 41.0(25.6 to 57.9) | .89 |
| % patients with no change (95% CI) | 40.7 (22.4 to 61.2) | 37.0 (19.4 to 57.6) | 50.0 (24.7 to 75.3) | 58.3 (27.7 to 84.8) | 44.2(29.1 to 60.1) | 43.6 (27.8 to 60.4) | |||
| % patients with increase (95% CI) | 11.1 (2.4 to 29.1) | 11.1 (2.4 to 29.1) | 18.8 (4.0 to 45.6) | 25.0 (5.5 to 57.2) | 14.0(5.3 to 27.9) | 15.4 (5.9 to 30.5) | |||
|
Median No. of biopsy samples with dysplasia at baseline (IQR) |
3 (0 to 6) | 2 (−2 to 6) | .93 | 6 (0 to 12) | 4 (−4 to 12) | .36 | 4 (−2 to 10) | 3 (0 to 6) | .37 |
|
Change in No. of biopsy samples with dysplasia or cancer |
|||||||||
| % patients with decrease (95% CI) | 70.4 (49.8 to 86.2) | 70.4 (49.8 to 86.2) | .86 | 62.5 (35.4 to 84.8) | 50.0(21.1 to 78.9) | .41 | 67.4 (51.5 to 80.9) | 64.1 (47.2 to 78.8) | .81 |
| % patients with no change (95% CI) | 3.7 (0.1 to 19.0) | 11.1 (2.4 to 29.2) | 6.2 (0.2 to 30.2) | 0.0 (0.0 to 26.5) | 4.7 (0.6 to 15.8) | 7.7 (1.6 to 20.9) | |||
| % patients with increase (95% CI) | 25.9(11.1 to 46.3) | 18.5(6.3 to 38.1) | 31.2 (11.0 to 58.7) | 50.0(21.1 to 78.9) | 27.9(15.3 to 43.7) | 28.2 (15.0 to 44.9) | |||
| Quantitative endoscopy§ | |||||||||
| Median total surface area affected by Barrett’s esophagus at baseline, cm2 (IQR) |
24.4 (−1.11 to 59.9) | 17.6 (−18.0 to 53.2) | .85 | 28.2 (−7.0 to 63.4) | 15.6 (−14.9 to 46.1) | .61 | 26.5 (−6.8 to 59.8) | 15.6 (20.4 to 51.6) | .53 |
| Median change in total surface area affected by Barrett’s esophagus, cm2 (IQR) |
−2.2 (−10.6 to 6.2) | −0.6 (−8.5 to 7.3) | 17 | −3.8 (−13.7 to 6.1) | −0.6 (−5.2 to 4.0) | .34 | −2.5 (−12.4 to 7.4) | −0.6 (−8.5 to 7.3) | 12 |
Changes were calculated by subtracting the baseline value from the value at 48 weeks. Data for six patients (all in the high-grade stratum; three assigned to celecoxib and three assigned to placebo) who had missing data at their 48-week visit but were diagnosed with esophageal adenocarcinoma before their 48-week visit were imputed with information from their most recent follow-up visit before the 48-week visit For change in number of biopsy samples with dysplasia or cancer, data from these six patients were imputed to the patients increase category. Central reading or adjudicated reading if disagreement with local reading in highest grade of pathology was used; 28% of celecoxib specimens and 33% of placebo specimens had adjudicated readings at the 48-week visit. IQR = interquartile range; CI = confidence interval.
P values for proportion of biopsy samples with dysplasia at baseline were obtained by use of binomial regression with robust variance estimation due to within-patient clustering. P values for change in proportion of biopsy samples with dysplasia or cancer also used binomial regression with robust variance estimation modeling the follow-up value adjusted for the baseline value. P values for change in grade and change in number of samples with dysplasia or cancer were obtained by use of ordered logistic regression. P values for the number of biopsy samples with dysplasia at baseline, total surface area at baseline, and change in total surface area were obtained by use of the Wilcoxon rank sum test. All statistical tests were two-sided.
Number of participants: in the low-grade stratum, 27 from celecoxib arm and 27 from placebo arm; in high-grade stratum, 16 from celecoxib arm and 12 from placebo arm; in combined, 43 from celecoxib arm and 39 from placebo arm.
Number of participants: in low-grade stratum, 20 from the celecoxib arm and 22 from the placebo arm; in high-grade stratum, 11 from celecoxib arm and five from placebo arm; in combined, 31 from celecoxib arm and 27 from placebo arm.