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).

Table 1.

Characteristics of exploratory patient cohort

CharacteristicsBevacizumab armNonbevacizumab armP*
(n = 138)(n = 46)
Age, median (range), y56 (30–82)58 (25–83).73
Sex, No. (%)1.00
 Female62 (44.921 (45.7)
 Male76 (55.1)25 (54.3)
BMI, median (range), kg/m225.8 (18.5–49.5)26.6 (15.9–55.2).72
Tumor site, No. (%).07
 Colon112 (81.1)31 (67.4)
 Rectum26 (18.915 (32.6)
Diabetes mellitus, No. (%)17 (12.3)7 (15.2).62
Chemotherapy, No. (%).05
 FOLFOX131 (94.9)39 (84.8
 CAPOX7 (5.1)7 (15.2)
Oxaliplatin cycles, median (range)9 (6–19)9 (6–14).79
Cumulative oxaliplatin dose, median (range), mg1414 (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), cm3217 (59–684)231 (81–683).84
Baseline platelet count, median (range), K/µL320 (161–1013)304 (151–887).91
CharacteristicsBevacizumab armNonbevacizumab armP*
(n = 138)(n = 46)
Age, median (range), y56 (30–82)58 (25–83).73
Sex, No. (%)1.00
 Female62 (44.921 (45.7)
 Male76 (55.1)25 (54.3)
BMI, median (range), kg/m225.8 (18.5–49.5)26.6 (15.9–55.2).72
Tumor site, No. (%).07
 Colon112 (81.1)31 (67.4)
 Rectum26 (18.915 (32.6)
Diabetes mellitus, No. (%)17 (12.3)7 (15.2).62
Chemotherapy, No. (%).05
 FOLFOX131 (94.9)39 (84.8
 CAPOX7 (5.1)7 (15.2)
Oxaliplatin cycles, median (range)9 (6–19)9 (6–14).79
Cumulative oxaliplatin dose, median (range), mg1414 (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), cm3217 (59–684)231 (81–683).84
Baseline platelet count, median (range), K/µL320 (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.

Table 1.

Characteristics of exploratory patient cohort

CharacteristicsBevacizumab armNonbevacizumab armP*
(n = 138)(n = 46)
Age, median (range), y56 (30–82)58 (25–83).73
Sex, No. (%)1.00
 Female62 (44.921 (45.7)
 Male76 (55.1)25 (54.3)
BMI, median (range), kg/m225.8 (18.5–49.5)26.6 (15.9–55.2).72
Tumor site, No. (%).07
 Colon112 (81.1)31 (67.4)
 Rectum26 (18.915 (32.6)
Diabetes mellitus, No. (%)17 (12.3)7 (15.2).62
Chemotherapy, No. (%).05
 FOLFOX131 (94.9)39 (84.8
 CAPOX7 (5.1)7 (15.2)
Oxaliplatin cycles, median (range)9 (6–19)9 (6–14).79
Cumulative oxaliplatin dose, median (range), mg1414 (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), cm3217 (59–684)231 (81–683).84
Baseline platelet count, median (range), K/µL320 (161–1013)304 (151–887).91
CharacteristicsBevacizumab armNonbevacizumab armP*
(n = 138)(n = 46)
Age, median (range), y56 (30–82)58 (25–83).73
Sex, No. (%)1.00
 Female62 (44.921 (45.7)
 Male76 (55.1)25 (54.3)
BMI, median (range), kg/m225.8 (18.5–49.5)26.6 (15.9–55.2).72
Tumor site, No. (%).07
 Colon112 (81.1)31 (67.4)
 Rectum26 (18.915 (32.6)
Diabetes mellitus, No. (%)17 (12.3)7 (15.2).62
Chemotherapy, No. (%).05
 FOLFOX131 (94.9)39 (84.8
 CAPOX7 (5.1)7 (15.2)
Oxaliplatin cycles, median (range)9 (6–19)9 (6–14).79
Cumulative oxaliplatin dose, median (range), mg1414 (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), cm3217 (59–684)231 (81–683).84
Baseline platelet count, median (range), K/µL320 (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.

Close
This Feature Is Available To Subscribers Only

Sign In or Create an Account

Close

This PDF is available to Subscribers Only

View Article Abstract & Purchase Options

For full access to this pdf, sign in to an existing account, or purchase an annual subscription.

Close