Table 1.
Clinical characteristics of study population.
| All Patients (N=112) | Liver Injury (n=21) | No Liver Injury (n=91) | p-value | |
|---|---|---|---|---|
| Age (years) | 65 [42-85] | 65 [47-77] | 65 [42-85] | 0.618 |
| Male (%) | 67 (58.9) | 57 (62.6) | 10 (47.6) | 0.206 |
| BMI (kg/m2) | 27.5 [18.7-44.1] | 28.2 [20.7-44.1] | 27.5 [18.7-40.3] | 0.287 |
| Caucasian (%) | 97 (86.6) | 18 (85.7) | 79 (86.8) | 0.834 |
| Non-Hispanic/Latino | 97 (86.6) | 21 (100) | 86 (94.5) | 0.271 |
| Durvalumab Infusions | 9 [1-34] | 3 [1-24] | 10 [1-34] | 0.018 |
| Cumulative Durvalumab Dose (mg) | 7500 [600-51000] | 3000 [1500-36000] | 9000 [600-51000] | 0.076 |
| Duration of Follow Up (days) | 422 [4-1463] | 342 [79-897] | 449 [4-1463] | 0.47 |
| ECOG (0-5) | 1 [0-3] | 1 [0-1] | 1 [0-3] | 0.704 |
| Enrolled in Clinical Trial | 53 (47.3%) | 16 (76.2) | 37 (40.7) | 0.003 |
| Cancer Type | 0.005 | |||
| NSCLC | 58 (51.8) | 6 (28.6) | 52 (57.1) | |
| SCLC | 0 (0) | 0 (0) | 0 (0) | |
| Urothelial | 4 (3.6) | 1 (4.8) | 3 (3.3) | |
| Other | 50 (44.6) | 14 (66.7) | 36 (39.6) | |
| Chemotherapy Regimen | 0.002 | |||
| Durvalumab Alone | 11 (9.8) | 1 (4.8) | 10 (11.0) | |
| Durvalumab Consolidation | 59 (52.7) | 5 (23.8) | 54 (59.3) | |
| Durvalumab Combination | 42 (37.5) | 15 (71.4) | 27 (29.7) | |
| Baseline Hepatic Metastases | 26 (23.2) | 11 (52.4) | 15 (16.5) | < 0.001 |
| Prior Chemo or XRT to the Liver | 20 (37.5) | 7 (33.3) | 13 (14.3) | 0.0454 |
| Prior chemo | 17 (15.3) | 6 (28.6) | 11 (12.2) | 0.0613 |
| Prior XRT | 5 (4.5) | 2 (9.5) | 3 (3.3) | 0.0164 |
| Comorbidities | ||||
| Chronic kidney disease | 31 (27.7) | 7 (33.3) | 24 (26.4) | 0.521 |
| Diabetes mellitus | 25 (22.3) | 7 (33.3) | 18 (19.8) | 0.178 |
| Congestive heart failure | 7 (6.3) | 0 (0) | 7 (7.7) | 0.189 |
| Liver disease | 5 (4.5) | 3 (14.3) | 2 (2.2) | 0.016 |
| Baseline Labs | ||||
| AST (IU/L) | 19 [10-30] | 20 [14-25] | 19 [10-30] | 0.914 |
| ALT (IU/L) | 15 [9-31] | 14 [10-25] | 16 [9-31] | 0.947 |
| ALP (IU/L) | 96 [60-213] | 96 [60-177] | 96 [63-213] | 0.989 |
| Tbili (mg/dL) | 0.4 [0.2-0.9] | 0.3 [0.3-0.9] | 0.4 [0.2-0.9] | 0.926 |
| Other non-hepatic irAEs | 27 (24.1) | 20 (22) | 7 (33.3) | 0.273 |
| Tumor Outcome Through 7/14/2020 | 0.012 | |||
| Progression | 43 (38.4) | 14 (66.7) | 29 (31.9) | |
| Stable/remission | 67 (59.8) | 7 (33.3) | 60 (65.9) | |
| Unknown | 2 (1.8) | 0 (0) | 2 (2.2) | |
| Death | 20 (17.9) | 10 (47.6) | 10 (11) | < 0.001 |
Data presented as median [range] or n (%).
BMI, body mass index; kg/m2, kilogram per square meter; mg, milligram; ECOG, Eastern Cooperative Oncology Group performance status; NSCLC, non-small cell lung cancer; SCLC, small cell lung cancer; XRT, radiation therapy; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase, Tbili, total bilirubin; INR, international normalized ratio; IU/L, international unit/liter; mg/dL, milligram/deciliter; irAEs, immune related adverse events.