Table 1.
Patients' characteristics in the Italian study cohort. 5‐FU, 5‐fluorouracil; dCCA, distal cholangiocarcinoma; ECOG PS, Eastern Cooperative Oncology Group Performance Status; iCCA, intrahepatic cholangiocarcinoma; IHC, immunohistochemistry; IQR, interquartile range; MGMT, O6‐methylguanine DNA methyltransferase; NA, not available; pCCA, perihilar cholangiocarcinoma.
| Characteristic | N (%) |
|---|---|
| Total number of patients | 164 (100.0) |
| Age in years [median (IQR)] | 66 (57–72) |
| Gender | |
| Male | 71 (43.3) |
| Female | 93 (56.7) |
| ECOG PS | |
| 0–1 | 128 (85.3) |
| ≥ 2 | 22 (14.7) |
| NA | 14 |
| Primary tumor location | |
| iCCA | 100 (61.0) |
| pCCA | 7 (4.3) |
| dCCA | 23 (14.0) |
| Gall bladder | 34 (20.7) |
| Primary tumor resected | |
| Yes | 107 (65.2) |
| No | 57 (34.8) |
| Adjuvant treatment | |
| Yes | 46 (28.0) |
| No | 61 (37.2) |
| Not applicable | 57 (34.8) |
| Diagnosis of advanced disease a | |
| Synchronous | 85 (51.8) |
| Metachronous | 79 (48.2) |
| Liver‐limited disease | 48 (29.3) |
| Sites of metastatic disease | |
| Lymph nodes | 78 (47.6) |
| Bones | 11 (6.7) |
| Liver | 90 (54.9) |
| Lungs | 34 (20.7) |
| Peritoneum | 31 (18.9) |
| Total lines of treatment for unresectable/metastatic disease | |
| Best supportive care | 4 (2.4) |
| 1 | 43 (26.2) |
| 2 | 40 (24.4) |
| > 2 | 42 (25.6) |
| NA | 35 |
| First line treatment regimen | |
| Best Supportive Care | 4 (2.4) |
| Capecitabine/5‐FU | 12 (7.3) |
| Gemcitabine | 12 (7.3) |
| Capecitabine/5‐FU + Oxaliplatin | 15 (9.1) |
| Gemcitabine + Oxaliplatin | 11 (6.7) |
| Gemcitabine + Cisplatin | 88 (53.7) |
| Other | 18 (11.0) |
| NA | 4 |
| Platinum‐based first line regimen b | |
| Yes | 115 (73.7) |
| No | 41 (26.3) |
| NA | 8 |
| MGMT promoter methylation [median (IQR)] | 5 (3–10) |
| MGMT expression by IHC | |
| Positive | 27 (27.0) |
| Weakly positive | 32 (32.9) |
| Negative | 41 (41.0) |
| NA | 64 |
a
Diagnosis of advanced disease was considered synchronous if occurring < 6 months from primary tumor detection, metachronous if ≥ 6 months.
b
One patient was treated with Carboplatin‐based chemotherapy.