Journal of Oncology Pharmacy Practice - January 2022 - 51

Lee et al.
51
Table 1. Baseline patient demographics.
Obese
(n¼44)
Age (years), median (range)
No. of females (%)
Race
White
Black
Other
Weight (kg), median (range)
BMI (kg/m2), median (range)
Obesity class
Class I (BMI 30-34.9)
Class II (BMI 35-39.9)
Class III (BMI >40)
Hormone receptor status
ER positive
PR positive
Tumor stage, no. of patients (%)
I
II
III
IV
Prior therapy, no. of patients (%)
Anthracycline
Capecitabine
Carboplatin
Cyclophosphamide
Endocrine therapy
Eribulin
Pertuzumab
Taxane
Trastuzumab
Vinorelbine
Past medical history
Diabetes
Hepatic disease
Peripheral neuropathy
Baseline LVEF (%), median (range)
Baseline ALT (IU/L), median (range)
Baseline AST (IU/L), median (range)
Baseline Total bilirubin (mg/dL), median (range)
23 (52%)
21 (48%)
94.4 (66.8-149.5)
34.0 (30.3-51.6)
25 (57%)
12 (27%)
7 (16%)
29 (66%)
19 (43%)
1 (2%)
9 (21%)
3 (7%)
31 (70%)
5 (11%)
7 (16%)
23 (52%)
7 (16%)
18 (41%)
1 (2%)
36 (82%)
41 (93%)
44 (100%)
3 (7%)
10 (23%)
3 (7%)
13 (30%)
60 (50-70)
22 (7-198)
25 (9-177)
0.45 (0.1-2.1)
55 (73%)
19 (25%)
1 (2%)
64.8 (44.0-88.0)
25.1 (17.8-29.6)
N/A
0.028
0.016
1.0
<0.001
<0.001
N/A
56 (29-79)
43 (98%)
Non-Obese
(n¼75)
57 (29-88)
75 (100%)
p value
0.184
0.370
49 (65%)
36 (48%)
0.703
0.704
16 (21%)
3 (4%)
56 (75%)
13 (17%)
9 (12%)
32 (43%)
18 (24%)
38 (51%)
1 (1%)
58 (77%)
64 (85%)
71 (95%)
4 (5%)
7 (9%)
2 (3%)
18 (24%)
60 (45-75)
20 (6-106)
26 (11-351)
0.5 (0.2-11.2)
ALT: alanine transaminase; AST: aspartate transaminase; BMI: body mass index; LVEF: left ventricular ejection fraction.
treatment discontinuation in the obese group was
peripheral neuropathy (9%).
Within the obese cohort, the primary endpoint of
treatment modifications due to T-DM1-induced
adverse events was met in 11 (44%), 7 (58%), and 2
(29%) patients with Class I, Class II, and Class III
obesity, respectively. In patients with Class I, II, and
III obesity. T-DM1 treatment delays occurred in
8 (32%), 6 (50%), and 2 (29%) patients with Class I,
II, and III obesity, respectively. T-DM1 was dose
reduced in 5 (20%), 4 (33%), and 1 (14%) patient
with Class I, II, and III obesity, respectively.
The most common adverse events were aspartate
transaminase elevations (74%), and thrombocytopenia
(57%), with similar rates between both groups
(Table 3). An increase in total bilirubin occurred in
32% of patients in the obese group compared to 12%
of patients in the non-obese group. A decrease in left
ventricular ejection fraction occurred in 11% of obese
patients compared to 5% of non-obese patients. New
or worsening of peripheral neuropathy occurred in
34% of obese patients compared 27% of non-obese
patients. More cases of new-onset peripheral neuropathy
were reported in the obese group (32%) compared
0.370
1.0
0.669
0.671
0.438
0.585
0.345
0.356
0.345
1.0
0.645
0.249
0.295
0.709
0.058
0.357
0.523
0.149
0.273
0.778
0.995
Journal of Oncology Pharmacy Practice - January 2022

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