Randomized Controlled Trial
Copyright ©The Author(s) 2022.
World J Clin Cases. Jun 26, 2022; 10(18): 6069-6081
Published online Jun 26, 2022. doi: 10.12998/wjcc.v10.i18.6069
Table 1 Patient characteristics

Icotinib
Chemotherapy + icotinib
Chemotherapy + icotinib, n = 34
2DP
2PP
4DP
4PP
n = 22
n = 34
n = 11
n = 10
n = 4
n = 9
Age (yr)57.0 ± 7.452.7 ± 11.0552.9 ± 11.549.8 ± 9.249.8 ± 13.757.1 ± 11.7
Sex
Male11 (50.0)9 (26.5)2 (18.2)2 (20.0)2 (50.0)3 (33.3)
Female11 (50.0)25 (73.5)9 (81.8)8 (80.0)2 (50.0)6 (66.7)
Stage
IIIB01 (2.9)0001 (11.1)
IV22 (100.0)33 (97.1)11 (100.0)10 (100.0)4 (100.0)8 (88.9)
EGFR mutation
19 Del12 (54.5)19 (55.9)5 (45.5)5 (50.0)4 (100.0)5 (55.6)
21 L858R7 (31.8)14 (41.2)5 (45.5)5 (50.0)04 (44.4)
Other3 (13.6)1 (2.9)1 (9.1)000
Smoking
Yes6 (27.3)4 (11.8)1 (9.1)1 (10.0)1 (25.0)1 (11.1)
No15 (68.2)30 (88.2)10 (90.9)9 (90.0)3 (75.0)8 (88.9)
Quit smoking1 (4.5)00000
ECOG PS
05 (22.7)6 (17.6)1 (9.1)2 (20.0)03 (33.3)
113 (59.1)25 (73.5)7 (63.6)8 (80.0)4 (100.0)6 (66.7)
22 (9.1)00000
Other2 (9.1)3 (8.8)3 (27.3)000
Table 2 Response to treatment

n
PR (95%CI)
SD (95%CI)
PD (95%CI)
NE (95%CI)
ORR (95%CI)
DCR (95%CI)
Icotinib2254.5 (32.2-75.6)36.4 (17.2-59.3)4.5 (0.1-22.8)4.5 (0.1-22.8)54.5 (32.2-75.6)90.9 (70.8-98.9)
Chemotherapy + icotinib3444.1 (27.2-62.1)52.9 (35.1-70.2)2.9 (0.1-15.3)44.1 (27.2-62.1)97.1 (84.7-99.9)
2-cycle chemo2147.6 (25.7-70.2)52.4 (29.8-74.3)47.6 (25.7-70.2)100.0 (83.9-100.0)
2DP1136.4 (10.9-69.2)63.6 (30.8-89.1)36.4 (10.9-69.2)100.0 (71.5-100.0)
2PP1060.0 (26.2-87.8)40.0 (12.2-73.8)60.0 (26.2-87.8)100.0 (69.2-100.0)
4-cycle chemo1338.5 (13.9-68.4)53.8 (25.1-80.8)7.7 (0.2-36.0)38.5 (13.9-68.4)92.3 (64.0-99.8)
4DP450.0 (6.8-93.2)50.0 (6.8-93.2)50.0 (6.8-93.2)100.0 (39.8-100.0)
4PP933.3 (7.5-70.1)55.6 (21.2-86.3)11.1 (0.3-48.2)33.3 (7.5-70.1)88.9 (51.8-99.7)
DP1540.0 (16.3-67.7)60.0 (32.3-83.7)40.0 (16.3-67.7)100.0 (78.2- 100.0)
PP1947.4 (24.4-71.1)47.4 (24.4-71.1)5.3 (0.1-26.0)47.4 (24.4-71.1)94.7 (74.0-99.9)
Total5648.2 (34.7-62.0)46.4 (33.0-60.3)3.6 (0.4-12.3)1.8 (0.0-9.6)48.2 (34.7-62.0)94.6 (85.1-98.9)
Table 3 Subsequent treatments

Icotinib
Chemotherapy + icotinib
Chemotherapy + icotinib, n = 34
2DP
2PP
4DP
4PP
n = 22
n = 34
n = 11
n = 10
n = 4
n = 9
Chemotherapy13 (59.1)16 (47.1)6 (54.6)4 (40.0)2 (50.0)4 (44.4)
Osimertinib10 (45.5)17 (50.0)6 (54.6)4 (40.0)2 (50.0)5 (55.6)
Other TKI2 (9.1)3 (8.8)1 (9.1)002 (22.2)
Radiotherapy3 (13.6)7 (20.6)1 (9.1)3 (30.0)2 (50.0)2 (22.2)
Other3 (13.6)5 (14.7)1 (9.1)2 (20.0)02 (22.2)
Table 4 Possible treatment-related adverse events

All-grade TRAE
Grade 3-4 TRAE
Icotinib (n = 22)
Chemotherapy + icotinib (n = 34)
Icotinib (n = 22)
Chemotherapy + icotinib (n = 34)
Rash9 (40.9)19 (55.9)0 (0.0)0 (0.0)
Gastrointestinal system disorders0 (0.0)28 (82.4)0 (0.0)2 (5.9)
Alanine transaminase elevation6 (27.3)14 (41.2)0 (0.0)0 (0.0)
Aspartate aminotransferase elevation3 (13.6)10 (29.4)0 (0.0)0 (0.0)
Leukopenia0 (0.0)22 (64.7)0 (0.0)3 (8.8)
Thrombocytopenia0 (0.0)4 (11.8)0 (0.0)0 (0.0)