Of the 184 patients treated with fluoropyrimidine and oxaliplatin, 138 received bevacizumab. The majority of patients, 93%, received FOLFOX chemotherapy, with the remainder receiving CAPOX. There were no statistical differences between the two groups (Table 1). In particular, the cumulative oxaliplatin exposure was similar between the bevacizumab- and nonbevacizumab-treated cohorts. The median time to splenic enlargement of 30% or greater was longer in the bevacizumab cohort (7.6 vs 5.5 months, P = .02). The six-month cumulative incidence rates of splenic enlargement of 30% or greater were 63% in the nonbevacizumab cohort and 44% in the bevacizumab cohort (P = .08) (Supplementary Figure 1A, available online). There was no difference when using a higher threshold of 50% or greater (P = .82). The six-month cumulative incidence of thrombocytopenia (platelet count < 100 000/mm3) did not differ between the nonbevacizumab cohort and the bevacizumab cohort (17% vs 17%, P = .69) (Supplementary Figure 1B, available online). Due to the low event rate, an exploratory analysis using a platelet count threshold below the lower limit of normal (<150 000/mm3) was conducted, and the six-month cumulative incidence was 70% in the nonbevacizumab cohort and 56% in the bevacizumab cohort (P = .04) (Supplementary Figure 1C, available online). When comparing patients with and without splenic enlargement of 30% or greater, the rate of thrombocytopenia (platelet count < 100 000/mm3) at three months was 40% vs 16%, respectively (P < .001). In the Cox model regarding the time to splenic enlargement, where propensity score was used to adjust for covariate bias and difference, an estimated 1.61-fold reduction in the rate of splenomegaly was observed with the addition of bevacizumab (hazard ratio [HR] = 0.62, 95% confidence interval [CI] = 0.38 to 1.02, P = .06). Similarly, the use of bevacizumab was associated with an estimated 1.59-fold reduction in the rate of thrombocytopenia (platelet count < 150 000/mm3; HR = 0.63, 95% confidence interval [CI] = 0.40 to 1.00, P = .05) (Supplementary Table 1, available online).
Characteristics . | Bevacizumab arm . | Nonbevacizumab arm . | P* . |
---|---|---|---|
(n = 138) . | (n = 46) . | ||
Age, median (range), y | 56 (30–82) | 58 (25–83) | .73 |
Sex, No. (%) | 1.00 | ||
Female | 62 (44.9 | 21 (45.7) | |
Male | 76 (55.1) | 25 (54.3) | |
BMI, median (range), kg/m2 | 25.8 (18.5–49.5) | 26.6 (15.9–55.2) | .72 |
Tumor site, No. (%) | .07 | ||
Colon | 112 (81.1) | 31 (67.4) | |
Rectum | 26 (18.9 | 15 (32.6) | |
Diabetes mellitus, No. (%) | 17 (12.3) | 7 (15.2) | .62 |
Chemotherapy, No. (%) | .05 | ||
FOLFOX | 131 (94.9) | 39 (84.8 | |
CAPOX | 7 (5.1) | 7 (15.2) | |
Oxaliplatin cycles, median (range) | 9 (6–19) | 9 (6–14) | .79 |
Cumulative oxaliplatin dose, median (range), mg | 1414 (570–3480) | 1423 (696–3300) | .73 |
Cumulative 5-FU dose, median (range), mg* | 45901 (28 576–94 470) | 47789 (26 111–84 869) | .4 |
Baseline spleen size, median (range), cm3 | 217 (59–684) | 231 (81–683) | .84 |
Baseline platelet count, median (range), K/µL | 320 (161–1013) | 304 (151–887) | .91 |
Characteristics . | Bevacizumab arm . | Nonbevacizumab arm . | P* . |
---|---|---|---|
(n = 138) . | (n = 46) . | ||
Age, median (range), y | 56 (30–82) | 58 (25–83) | .73 |
Sex, No. (%) | 1.00 | ||
Female | 62 (44.9 | 21 (45.7) | |
Male | 76 (55.1) | 25 (54.3) | |
BMI, median (range), kg/m2 | 25.8 (18.5–49.5) | 26.6 (15.9–55.2) | .72 |
Tumor site, No. (%) | .07 | ||
Colon | 112 (81.1) | 31 (67.4) | |
Rectum | 26 (18.9 | 15 (32.6) | |
Diabetes mellitus, No. (%) | 17 (12.3) | 7 (15.2) | .62 |
Chemotherapy, No. (%) | .05 | ||
FOLFOX | 131 (94.9) | 39 (84.8 | |
CAPOX | 7 (5.1) | 7 (15.2) | |
Oxaliplatin cycles, median (range) | 9 (6–19) | 9 (6–14) | .79 |
Cumulative oxaliplatin dose, median (range), mg | 1414 (570–3480) | 1423 (696–3300) | .73 |
Cumulative 5-FU dose, median (range), mg* | 45901 (28 576–94 470) | 47789 (26 111–84 869) | .4 |
Baseline spleen size, median (range), cm3 | 217 (59–684) | 231 (81–683) | .84 |
Baseline platelet count, median (range), K/µL | 320 (161–1013) | 304 (151–887) | .91 |
For FOLFOX-treated patients. Two-sided P values are based on the Fisher exact test statistic for categorical variables and Wilcoxon rank-sum for continuous variables. BMI = body mass index; CAPOX = capecitabine and oxaliplatin; FOLFOX = infused fluorouracil, folinic acid, and oxaliplatin.
Characteristics . | Bevacizumab arm . | Nonbevacizumab arm . | P* . |
---|---|---|---|
(n = 138) . | (n = 46) . | ||
Age, median (range), y | 56 (30–82) | 58 (25–83) | .73 |
Sex, No. (%) | 1.00 | ||
Female | 62 (44.9 | 21 (45.7) | |
Male | 76 (55.1) | 25 (54.3) | |
BMI, median (range), kg/m2 | 25.8 (18.5–49.5) | 26.6 (15.9–55.2) | .72 |
Tumor site, No. (%) | .07 | ||
Colon | 112 (81.1) | 31 (67.4) | |
Rectum | 26 (18.9 | 15 (32.6) | |
Diabetes mellitus, No. (%) | 17 (12.3) | 7 (15.2) | .62 |
Chemotherapy, No. (%) | .05 | ||
FOLFOX | 131 (94.9) | 39 (84.8 | |
CAPOX | 7 (5.1) | 7 (15.2) | |
Oxaliplatin cycles, median (range) | 9 (6–19) | 9 (6–14) | .79 |
Cumulative oxaliplatin dose, median (range), mg | 1414 (570–3480) | 1423 (696–3300) | .73 |
Cumulative 5-FU dose, median (range), mg* | 45901 (28 576–94 470) | 47789 (26 111–84 869) | .4 |
Baseline spleen size, median (range), cm3 | 217 (59–684) | 231 (81–683) | .84 |
Baseline platelet count, median (range), K/µL | 320 (161–1013) | 304 (151–887) | .91 |
Characteristics . | Bevacizumab arm . | Nonbevacizumab arm . | P* . |
---|---|---|---|
(n = 138) . | (n = 46) . | ||
Age, median (range), y | 56 (30–82) | 58 (25–83) | .73 |
Sex, No. (%) | 1.00 | ||
Female | 62 (44.9 | 21 (45.7) | |
Male | 76 (55.1) | 25 (54.3) | |
BMI, median (range), kg/m2 | 25.8 (18.5–49.5) | 26.6 (15.9–55.2) | .72 |
Tumor site, No. (%) | .07 | ||
Colon | 112 (81.1) | 31 (67.4) | |
Rectum | 26 (18.9 | 15 (32.6) | |
Diabetes mellitus, No. (%) | 17 (12.3) | 7 (15.2) | .62 |
Chemotherapy, No. (%) | .05 | ||
FOLFOX | 131 (94.9) | 39 (84.8 | |
CAPOX | 7 (5.1) | 7 (15.2) | |
Oxaliplatin cycles, median (range) | 9 (6–19) | 9 (6–14) | .79 |
Cumulative oxaliplatin dose, median (range), mg | 1414 (570–3480) | 1423 (696–3300) | .73 |
Cumulative 5-FU dose, median (range), mg* | 45901 (28 576–94 470) | 47789 (26 111–84 869) | .4 |
Baseline spleen size, median (range), cm3 | 217 (59–684) | 231 (81–683) | .84 |
Baseline platelet count, median (range), K/µL | 320 (161–1013) | 304 (151–887) | .91 |
For FOLFOX-treated patients. Two-sided P values are based on the Fisher exact test statistic for categorical variables and Wilcoxon rank-sum for continuous variables. BMI = body mass index; CAPOX = capecitabine and oxaliplatin; FOLFOX = infused fluorouracil, folinic acid, and oxaliplatin.
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