Article Figures & Data
Figures
- FIGURE 1.
CONSORT flow diagram for phase II. All 73 patients who signed consent for formal eligibility assessment are included.
- FIGURE 2.
pCR rates overall and by subgroup (ITT analysis).
- FIGURE 3.
Box plots of reduction in SULmax in patients with pCR and non-pCR. Horizontal line inside box shows median. Lower and upper hinges of box represent 25th and 75th percentiles, respectively. ● = actual values of percentage reduction in SULmax.
Tables
Characteristic Vorinostat arm (n = 31) Placebo arm (n = 31) Overall (n = 62) Age (y) Median 48 48 48 Range 31–68 24–72 24–72 Race Caucasian 24 (77) 19 (61) 43 (69) Black 5 (16) 8 (26) 13 (21) Other 2 (7) 4 (13) 6 (10) Eastern Co-operative Oncology Group Performance Status 0 29 (94) 30 (97) 59 (95) 1 2 (6) 1 (3) 3 (5) Tumor size (cm) Median 4 5 4 Range 1.5–11.5 1.7–18 1.5–18 Baseline nodal status Negative 14 (45) 10 (32) 24 (39) Positive 17 (55) 21 (68) 38 (61) Tumor grade 2 7 (23) 11 (35) 18 (29) 3 24 (77) 20 (65) 44 (71) Receptor status ER-negative/PR-negative 12 (39) 12 (39) 24 (39) ER-positive/PR-positive 10 (32) 12 (39) 22 (36) ER-positive/PR-negative 6 (19) 6 (19) 12 (19) ER-negative/PR-positive 3 (10) 1 (3) 4 (6) BRCA status BRCA1/2 mutation 4 (13) 3 (10) 7 (11) BRCA-negative 7 (22) 9 (29) 16 (26) Unknown 20 (65) 19 (61) 39 (63) Data in parentheses are percentages.
Variable Responders (n = 16) Nonresponders (n = 43) P* Baseline SULmax Mean ± SD 8.2 ± 3.3 5.9 ± 3.5 Median 7.6 (range, 4.3–15.1) 5.3 (range, 1.4–21.0) 0.015 Percentage change in SULmax Mean ± SD 55.5 ± 23.6 30 ± 32.5 Median 63.0 (range, 4.4–85.3) 32.9 (range, −84.2 to 77.1) 0.003 ≥50% reduction (n) 12 (75.0%) 13 (30.2%) 0.003 ↵* Exact Wilcoxon rank sum test for continuous variables and Fisher exact test for binary variables.
Pooled ITT analysis.
Univariate analysis Multivariable analysis* Variable Odds ratio P Adjusted odds ratio Adjusted P Baseline SULmax 1.18 (1.01–1.42) 0.051 1.07 (0.88–1.30) 0.469 Percentage change in SULmax 1.04 (1.01–1.08) 0.011 1.03 (1–1.07) 0.057 Percentage change in SULmax, ≥50% vs. <50% 6.6 (1.9–27.3) 0.004 5.1 (1.3–22.7) 0.023 ↵* Multivariable logistic regression adjusting for ER and PR status.
Pooled ITT analysis. Data in parentheses are 95% CIs.
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