Supplementary Table 2. Adverse events

advertisement
Supplementary Table 1. Clinicopathologic characteristics according to weight change during
chemotherapy
ΔW1m<3%
ΔW/m<1%
N = 417
Age
Sex
ECOG
Median (range)
60 (22-86)
63 (22-82)
56 (21-89)
62 (35-82)
< 60-year-old, N (%)
202 (48.4)
45 (42.1)
92 (57.9)
13 (36.1)
≥ 60-year-old, N (%)
215 (51.6)
62 (57.9)
67 (42.1)
23 (63.9)
Male, N (%)
291 (69.8)
79 (73.8)
113 (71.1)
25 (69.4)
Female, N (%)
126 (30.2)
28 (26.2)
46 (28.9)
11 (30.6)
0-1, N (%)
386 (92.6)
102 (95.3)
133 (83.6)
33 (91.7)
31 (7.4)
5 (4.7)
26 (16.4)
3 (8.3)
Initially metastatic, N (%)
269 (64.5)
71 (66.4)
116 (73.0)
23 (63.9)
Recurrent, N (%)
148 (35.5)
36 (33.6)
43 (27.0)
13 (36.1)
GEJ, N (%)
380 (91.1)
98 (91.6)
143 (89.9)
35 (97.2)
37 (8.9)
9 (8.4)
16 (10.1)
1 (2.8)
Adenocarcinoma, N (%)
346 (83.0)
83 (77.6)
116 (73.0)
32 (88.9)
Signet ring cell, N (%)
62 (14.9)
21 (19.6)
39 (24.5)
3 (8.3)
2, N (%)
Palliative setting
Tumor location
Other stomach, N (%)
Pathology type
ΔW1m<3% ΔW1m≥3% ΔW1m≥3%
ΔW/m≥1% ΔW/m≥1% ΔW/m<1%
N = 107
N = 159¶
N = 36†
P-value
P-value
(4 groups)
(¶ vs.†)
0.006
0.003
0.023
0.018
0.870
0.847
0.003
0.457
0.280
0.278
0.578
0.162
Other types, N (%)
Lauren
HER2
Metastasis
Metastasis to
Chemotherapy regimen
9 (2.1)
3 (2.8)
4 (2.5)
1 (2.8)
0.114
0.102
Contains signet ring cell feature, N (%)‡
98 (23.5)
30 (28.0)
57 (35.9)
4 (11.1)
0.003
0.004
Intestinal, N (%)
60 (37.0)
25 (58.1)
12 (23.5)
5 (29.4)
Diffuse, N (%)
78 (48.2)
14 (32.6)
35 (68.6)
10 (58.8)
Mixed, N (%)
24 (14.8)
4 (9.3)
4 (7.8)
2 (11.8)
0.012
0.747
HER2 checked, N (%)
313 (75.1)
84 (78.5)
121 (76.1)
31 (86.1)
0.464
0.191
HER2 positive, N (%)
86 (27.5)
28 (33.3)
17 (14.1)
12 (38.7)
0.003
0.002
Number of involved organs, mean ± SE
2.2 ± 0.9
2.3 ± 0.8
2.5 ± 1.0
2.4 ± 1.0
0.139
0.910
Involved organs < 3, N (%)
283 (67.9)
71 (66.4)
93 (58.5)
21 (58.3)
Involved organs ≥ 3, N (%)
134 (32.1)
36 (33.6)
66 (41.5)
15 (41.7)
0.154
0.986
Peritoneal seeding, N (%)
218 (52.3)
65 (60.8)
105 (66.0)
26 (72.2)
0.005
0.475
Lymph node, N (%)
199 (47.7)
49 (45.8)
82 (51.6)
15 (41.7)
0.656
0.283
Liver, N (%)
100 (24.0)
27 (25.2)
36 (22.6)
9 (25.0)
0.966
0.762
Bone, N (%)
42 (10.1)
6 (5.6)
15 (9.4)
2 (5.6)
0.451
0.456
Others, N (%)
65 (15.6)
21 (19.6)
31 (19.5)
11 (30.6)
0.114
0.145
Fluoropyrimidine + Platinum, N (%)
389 (93.3)
98 (91.6)
144 (90.6)
35 (97.2)
+ Trastuzumab, N (%)§
54 (13.0)
16 (15.0)
11 (6.9)
7 (19.4)
0.076
0.019
Treatment response
Taxane + Platinum, N (%)
16 (3.8)
4 (3.7)
9 (5.7)
1 (2.8)
Others, N (%)
12 (2.9)
5 (4.7)
6 (3.8)
0
CR, N (%)
13 (3.1)
4 (3.7)
0
2 (5.6)
PR, N (%)
154 (36.9)
26 (24.3)
31 (19.5)
11 (30.5)
SD, N (%)
194 (46.5)
59 (55.1)
82 (51.6)
23 (63.9)
PD, N (%)
48 (11.5)
14 (13.1)
41 (25.8)
0
8 (1.9)
4 (3.7)
5 (3.1)
167 (40.8)
30 (29.1)
31 (20.1)
Not evaluable, N (%)
Objective response*, N (%)
0.739
0.372
0
<0.001
<0.001
13 (36.1)
<0.001
0.041
‡ Contains signet ring feature: number of patients who had either pure signet ring cell carcinoma (i.e. poorly cohesive carcinoma) or adenocarcinoma
containing signet ring features.
§ Trastuzumab was added to a combination regimen of flouropyrimidine plus platinum.
* Objective response: complete response plus partial response.
ΔW1m: percent weight loss after one month of chemotherapy; ΔW/m: average weight loss per month during chemotherapy; CR: complete response; GEJ:
esophagogastric junction; HER2: human epidermal growth factor receptor 2; PD: progressive disease; PR: partial response; SD: stable disease.
Supplementary Table 2. Adverse events
Adverse events*
Total
N = 719
ΔW1m ≥ 3%
N = 195
ΔW1m < 3%
N = 524
P-value
Any, Grade III or IV, N (%)
69 (9.6)
12 (6.2)
57 (10.9)
0.056
Cytopenia, Grade III or IV, N (%)
38 (5.3)
9 (4.6)
29 (5.5)
0.624
Neuropathy, Grade III or IV, N (%)
14 (2.0)
0
14 (2.7)
0.021
Nausea/Vomit, Grade III or IV, N (%)
4 (0.6)
1 (0.5)
3 (0.6)
0.924
Others, Grade III or IV, N (%)
14 (2.0)
2 (1.0)
12 (2.3)
0.275
ΔW1m: percent weight loss after one month of chemotherapy
* Grade of adverse events
14_QuickReference_5x7.pdf)
was
referred
from
NCI
CTCAE
version
4.03
(http://evs.nci.nih.gov/ftp1/CTCAE/CTCAE_4.03_2010-06-
Download