Table 5.
Demographic and clinical characteristics of study participants undergoing second-line therapy at baseline (n= 410).
| Characteristic | Overall |
|---|---|
| Death | |
| No | 52 (12.78%) |
| Yes | 355 (87.22%) |
| Progression of disease | |
| No | 19 (4.63%) |
| Yes | 369 (90%) |
| Not reported | 22 (5.37%) |
| Gender | |
| Male | 199 (48.54%) |
| Female | 211 (51.46%) |
| Age at second-line therapy (years) | 64.19 (9.75) |
| Age range at second-line therapy (years) | |
| ≤60 | 135 (33.17%) |
| 61 to 70 | 145 (35.63%) |
| ≥71 | 127 (31.2%) |
| Clinical sensitivity | |
| No | 133 (32.44%) |
| Resistant (PD within 90 days) | 55 (13.41%) |
| Sensitive (PD after 90 days) | 221 (53.9%) |
| Not reported | 1 (0.24%) |
| Primary tumor site | |
| Intrahepatic | 218 (53.56%) |
| Extrahepatic | 84 (20.64%) |
| Gallbladder | 77 (18.92%) |
| Ampullary tumor | 27 (6.63%) |
| Not reported | 1 (0.25%) |
| Biliary drainage | |
| No | 328 (80.59%) |
| Yes | 79 (19.41%) |
| Surgery on primary tumor | |
| No | 209 (51.35%) |
| Yes | 198 (48.65%) |
| ECOG PS | |
| 0 | 180 (44.23%) |
| 1 | 190 (46.68%) |
| 2 | 10 (2.46%) |
| 3 | 2 (0.49%) |
| Not reported | 25 (6.14%) |
| Disease status | |
| Locally advanced | 87 (21.38%) |
| Metastatic | 319 (78.38%) |
| Not reported | 1 (0.25%) |
| Type of first-line therapy | |
| Cisplatin + gemcitabine | 99 (24.32%) |
| GEMOX | 177 (43.49%) |
| Gemcitabine | 64 (15.72%) |
| FOLFOX/CAPOX | 21 (5.16%) |
| Fluoropyrimidine monotherapy | 8 (1.97%) |
| Other | 38 (9.34%) |
| Time in first-line therapy (months) | 8.21 (6.08) |
| Not reported | 1 (0.24%) |
| Period of second-line therapy | |
| 2002-2009 | 112 (27.52%) |
| 2010-2013 | 145 (35.63%) |
| 2014-2017 | 150 (36.86%) |
| Type of second-line therapy | |
| FOLFOX/CAPOX | 24 (5.9%) |
| FOLFIRI | 65 (15.97%) |
| Cisplatin + gemcitabine | 25 (6.14%) |
| GEMOX | 28 (6.88%) |
| Gemcitabine | 47 (11.55%) |
| Fluoropyrimidine monotherapy | 117 (28.75%) |
| Gemcitabine + capecitabine | 41 (10.07%) |
| Other | 60 (14.74%) |
| Group of second-line therapy | |
| COMBINED | 154 (37.84%) |
| FOLFOX or FOLFIRI | 89 (21.87%) |
| MONO | 164 (40.29%) |
| Response | |
| CR | 11 (2.7%) |
| PR | 84 (20.64%) |
| SD | 128 (31.45%) |
| PD | 184 (45.21%) |
COMBINED, includes the following combination regimens: Cisplatin + gemcitabine, GEMOX, Gemcitabine + capecitabine and other; FOLFOX, 5-fluorouracil/leucovorin + oxaliplatin; FOLFIRI, 5-fluorouracil/leucovorin + irinotecan; MONO, includes the following agents administered as monotherapy: gemcitabine or fluoropyrimidine.
Results are expressed as mean with standard deviation or as number of subjects with percentage.