Table 1. Clinical and pathological characteristics at baseline of the second-line of chemotherapy.
Overall Population | Second-line therapy without trastuzumab | Second-line therapy with trastuzumab | P-value | |
---|---|---|---|---|
N= 104 | N = 65 | N = 39 | ||
Age | 0.41 | |||
Mean | 60.0 | 61.3 | 57.9 | |
Median [range] | 60.8 [17.3–80.3] | 59.0 [34.0-80.3] | 61.1 [17.3-80.1] | |
Gender | 0.53 | |||
Male | 82 (78.8%) | 50 (76.9%) | 32 (82.1%) | |
Female | 22 (21.2%) | 15 (23.1%) | 7 (17.9%) | |
ECOG PS | 0.81 | |||
0-1 | 74 (71.2%) | 45 (69.2%) | 29 (74.4%) | |
≥ 2 | 23 (22.1%) | 15 (23.1%) | 8 (20.5%) | |
Unknown | 7 (6.7%) | 5 (7.7%) | 2 (5.1%) | |
Primary tumor site | <0.0001 | |||
Gastro-esophageal junction | 57 (54.8%) | 25 (38.5%) | 32 (82.1%) | |
Stomach | 47 (45.2%) | 40 (61.5%) | 7 (17.9%) | |
Histological type | 0.06 | |||
Intestinal | 54 (51.9%) | 34 (52.3%) | 20 (51.3%) | |
Diffuse or mixed | 12 (11.6%) | 4 (6.2%) | 8 (20.5%) | |
Other or unknown | 38 (36.5%) | 27 (41.5%) | 11 (28.2%) | |
Tumor grade | 0.41 | |||
Well/Moderately differentiated | 63 (60.6%) | 37 (56.9%) | 26 (66.7%) | |
Poorly differentiated | 29 (27.9%) | 21 (32.3%) | 8 (20.5%) | |
Unknown or missing | 12 (11.5%) | 7 (10.8%) | 5 (12.8%) | |
Extent of disease | 0.15 | |||
Locally advanced | 1 (1.0%) | 0 (0%) | 1 (2.5%) | |
Metastatic | 103 (99.0%) | 65 (100%) | 38 (97.5%) | |
Measurable disease | 91 (87.5%) | 55 (84.6%) | 36 (92.3%) | 0.32 |
Number of metastatic sites | 0.03 | |||
0-1 | 32 (30.8%) | 15 (23.1%) | 17 (43.6%) | |
≥2 | 72 (69.2%) | 50 (76.9%) | 22 (56.4%) | |
HER2 status | 0.16 | |||
IHC 3+ | 83 (79.8%) | 49 (75.4%) | 34 (87.2%) | |
IHC 2+/FISH-positive | 17 (16.4%) | 14 (21.5%) | 3 (7.7%) | |
Unknown | 4 (3.8%) | 2 (3.1%) | 2 (5.1%) | |
First-line chemotherapy regimen | <0.0001 | |||
FP + oxaliplatin + trastuzumab | 50 (48.1%) | 21 (32.3%) | 29 (74.4%) | |
FP + cisplatin + trastuzumab | 54 (51.9%) | 44 (67.7%) | 10 (25.6%) | |
Second-line chemotherapy regimen | 0.03 | |||
FOLFIRI | 67 (64.4%) | 48 (73.9%) | 19 (48.7%) | |
Taxane | 23 (22.1%) | 11 (16.9%) | 12 (30.8%) | |
FP + platinum salts | 14 (13.5%) | 6 (9.2%) | 8 (20.5%) |
Abbreviations: IHC, immunohistochemistry; FISH, fluorescence in-situ hybridization; FP, Fluoropyrimidine