Table 1.
Clinical characteristics of the study population in Metagenomic and LC-MS/MS analysis sets
| Metagenomic analysis set (n = 88) | LC-MS/MS analysis set (n = 54) | ||||||
|---|---|---|---|---|---|---|---|
| Characteristic | No. of patients | DCB (%) | NDB (%) | No. of patients | DCB (%) | NDB (%) | |
| Pathology | |||||||
| ICC | 55 | 23 (48.9) | 32 (78.0) | 34 | 13 (44.8) | 21 (84.0) | |
| GBC | 17 | 13 (27.7) | 4 (9.8) | 11 | 7 (24.1) | 4 (16.0) | |
| ECC | 16 | 11 (23.4) | 5 (12.2) | 9 | 9 (31.0) | 0 | |
| Response | |||||||
| Partial response | 26 | 26 (55.3) | NA | 16 | 16 (55.2) | NA | |
| Stable disease | 36 | 21 (44.7) | 15 (36.6) | 24 | 13 (44.8) | 11 (44.0) | |
| Progressive disease | 26 | NA | 26 (63.4) | 14 | NA | 14 (56.0) | |
| Sex | |||||||
| Female | 36 | 23 (48.9) | 13 (31.7) | 20 | 12 (41.4) | 8 (32.0) | |
| Male | 52 | 24 (51.1) | 28 (68.3) | 34 | 17 (58.6) | 17 (68.0) | |
| Age, y | |||||||
| ≥ 60 | 51 | 28 (59.6) | 23 (56.1) | 32 | 16 (55.2) | 16 (64.0) | |
| < 60 | 37 | 19 (40.4) | 18 (43.9) | 22 | 13 (44.8) | 9 (36.0) | |
| Hepatitis | |||||||
| Yes | 16 | 6 (12.8) | 10 (24.4) | 9 | 1 (3.4) | 8 (32.0) | |
| No | 72 | 41 (87.2) | 31 (75.6) | 45 | 28 (96.6) | 17 (68.0) | |
| ECOG | |||||||
| 0 | 56 | 33 (70.2) | 23 (56.1) | 33 | 21 (72.4) | 12 (48.0) | |
| 1 | 30 | 14 (29.8) | 16 (39.0) | 19 | 8 (27.6) | 11 (44.0) | |
| 2 | 2 | 0 | 2 (4.9) | 2 | 0 | 2 (8.0) | |
| Child–Pugh | |||||||
| A | 68 | 38 (80.9) | 30 (73.2) | 41 | 24 (82.8) | 17 (68.0) | |
| B | 20 | 9 (19.1) | 11 (26.8) | 13 | 5 (17.2) | 8 (32.0) | |
| Grade | |||||||
| Poor | 25 | 16 (34.0) | 9 (22.0) | 16 | 10 (34.5) | 6 (24.0) | |
| Moderate | 32 | 18 (38.3) | 14 (34.1) | 21 | 12 (41.4) | 9 (36.0) | |
| Well | 7 | 2 (4.3) | 5 (12.2) | 3 | 0 | 3 (12.0) | |
| NA | 24 | 11 (23.4) | 13 (31.7) | 14 | 7 (24.1) | 7 (28.0) | |
| TNM stage | |||||||
| II | 7 | 5 (10.6) | 2 (4.9) | 2 | 2 (6.9) | 0 | |
| III | 40 | 20 (42.6) | 20 (48.8) | 26 | 14 (48.3) | 12 (48.0) | |
| IV | 41 | 22 (46.8) | 19 (46.3) | 26 | 13 (44.8) | 13 (52.0) | |
| Vascular invasion | |||||||
| Yes | 19 | 9 (19.1) | 10 (24.3) | 11 | 5 (17.2) | 6 (24.0) | |
| No | 67 | 38 (80.9) | 29 (70.7) | 43 | 24 (82.8) | 19 (76.0) | |
| NA | 2 | 0 | 2 (4.9) | ||||
| Intrahepatic metastasis | |||||||
| Yes | 56 | 31 (66.0) | 25 (61.0) | 41 | 24 (82.8) | 17 (68.0) | |
| No | 31 | 16 (34.0) | 15 (36.6) | 13 | 5 (17.2) | 8 (32.0) | |
| NA | 1 | 0 | 1 (2.4) | 0 | 0 | 0 | |
| Tumor number | |||||||
| 1 | 20 | 13 (27.7) | 7 (17.1) | 4 | 4 (13.8) | 0 | |
| 2 | 10 | 3 (6.4) | 7 (17.1) | 5 | 1 (3.4) | 4 (16.0) | |
| 3 | 2 | 1 (2.1) | 1 (2.4) | 1 | 0 | 1 (4.0) | |
| > 3 | 36 | 23 (48.9) | 13 (31.7) | 26 | 18 (62.1) | 8 (32.0) | |
| NA | 20 | 7 (14.9) | 13 (31.7) | 18 | 6 (20.7) | 12 (48.0) | |
| Size# | |||||||
| ≥ 5 cm | 41 | 19 (40.4) | 22 (53.7) | 26 | 12 (41.4) | 14 (56.0) | |
| < 5 cm | 47 | 28 (59.6) | 19 (46.3) | 28 | 17 (58.6) | 11 (44.0) | |
| Alpha fetoprotein | |||||||
| ≥ 20 U/mL | 6 | 4 (8.5) | 2 (4.9) | 3 | 2 (6.9) | 1 (4.0) | |
| < 20 U/mL | 79 | 42 (89.4) | 37 (90.2) | 49 | 26 (89.7) | 23 (92.0) | |
| NA | 3 | 1 (2.1) | 2 (4.9) | 2 | 1 (3.4) | 1 (4.0) | |
| CA19−9 | |||||||
| ≥ 200 U/mL | 24 | 10 (21.3) | 14 (34.1) | 16 | 6 (20.7) | 10 (40.0) | |
| < 200 U/mL | 63 | 37 (78.7) | 26 (63.4) | 38 | 23 (79.3) | 15 (60.0) | |
| NA | 1 | 0 | 1 (2.4) | 0 | 0 | 0 | |
| Total bilirubin | |||||||
| ≥ 17 umol/L | 35 | 20 (42.6) | 15 (36.6) | 24 | 13 (44.8) | 11 (44.0) | |
| < 17 umol/L | 53 | 27 (57.4) | 26 (63.4) | 30 | 16 (55.2) | 14 (56.0) | |
| Direct bilirubin | |||||||
| ≥ 7 umol/L | 33 | 13 (27.7) | 20 (48.8) | 22 | 9 (31.0) | 13 (52.0) | |
| < 7 umol/L | 55 | 34 (72.3) | 21 (51.2) | 32 | 20 (69.0) | 12 (48.0) | |
| Bile acids | |||||||
| ≥ 10 umol/L | 35 | 21 (44.7) | 14 (34.1) | 19 | 10 (34.5) | 9 (36.0) | |
| < 10 umol/L | 50 | 23 (48.9) | 27 (65.9) | 32 | 16 (55.2) | 16 (64.0) | |
| NA | 3 | 3 (6.4) | 0 | 3 | 3 (10.3) | 0 | |
| Therapeutic regimen | |||||||
| IM + MTT | 77 | 40 (85.1) | 37 (90.2) | 48 | 25 (86.2) | 23 (92.0) | |
| IM + MTT + CHEMO | 11 | 7 (14.9) | 4 (9.8) | 6 | 4 (13.8) | 2 (8.0) | |
#Maximum tumor diameter. DCB, durable clinical benefit; NDB, non-durable clinical benefit; ICC, intrahepatic cholangiocarcinoma; GBC, gallbladder cancer; ECC, extrahepatic cholangiocarcinoma; ECOG, Eastern Cooperative Oncology Group; TNM, tumor node metastasis; CA19-9, Carbohydrate antigen 19 − 9; IM, immunotherapy; MTT, molecular targeted therapy; CHEMO, chemotherapy