Table 2.
Clinical characteristics of the 21 patients who developed liver injury on durvalumab.
| DILI Cases (n=6) | Non-DILI Cases (n=15) | p-value | |
|---|---|---|---|
| Age (years) | 65 [47-70] | 63 [49-77] | 0.697 |
| Male (%) | 3 (50) | 7 (46.7) | 0.890 |
| BMI (kg/m2) | 32.3 [26-37] | 26.1 [20.7-44.1] | 0.202 |
| Caucasian (%) | 5 (83.3) | 13 (86.7) | 0.844 |
| Non-Hispanic/Latino(%) | 6 (100) | 15 (100) | NA |
| Durvalumab Infusions | 3 [1-21] | 3 [1-24] | 0.932 |
| Cumulative Durvalumab Dose (mg) | 4500 [1500-31500] | 3000 [1500-36000] | 0.469 |
| Duration of Follow Up (days) | 508 [228-756] | 272 [79-897] | 0.321 |
| ECOG (0-5) | 1 [0-1] | 1 [0-1] | 0.330 |
| Enrolled in Clinical Trial | 6 (100) | 10 (66.7) | 0.105 |
| Cancer Type | |||
| Colon Cancer | 0 (0) | 2 (13.3) | |
| HCC | 2 (33.3) | 0 (0) | |
| NSCLC | 0 (0) | 6 (40) | |
| Pancreatic Cancer | 3 (50) | 3 (20) | |
| RCC | 1 (16.7) | 3 (20) | |
| SCLC | 0 (0) | 0 (0) | |
| Urothelial Carcinoma | 0 (0) | 1 (6.7) | |
| Chemo Regimen | 0.186 | ||
| Durvalumab Alone | 0 (0) | 1 (6.7) | |
| Durvalumab Consolidation | 0 (0) | 5 (33.3) | |
| Durvalumab Combination | 6 (100) | 9 (60) | |
| Baseline Hepatic Metastases (%) | 5 (83.3) | 6 (40) | 0.072 |
| Prior Chemo or XRT to the Liver | 2 (33.3) | 5 (33.3) | 1 |
| Prior chemo | 1 (16.7) | 5 (33.3) | 0.445 |
| Prior XRT | 1 (16.7) | 2 (13.3) | 0.844 |
| Liver disease | 2 (33.3) | 1 (6.7) | 0.115 |
| Baseline Labs | |||
| AST (IU/L) | 64 [21-82] | 25 [13-95] | 0.022 |
| ALT (IU/L) | 54 [19-82] | 22 [10-96] | 0.013 |
| ALP (IU/L) | 111 [81-355] | 110 [59-838] | 0.766 |
| Tbili (mg/dL) | 0.7 [0.4-1] | 0.4 [0.2-1.9] | 0.821 |
| Other non-hepatic irAEs | 2 (33.3) | 5 (33.3) | 1 |
| Tumor Outcome Through 7/14/2020 | 0.163 | ||
| Progression | 4 (50) | 10 (66.7) | |
| Stable/remission | 2 (16.7) | 5 (33.3) | |
| Unknown | 0 (0) | 0 (0) | |
| Death | 2 (33.3) | 8 (53.3) | 0.407 |
| Durvalumab Infusions Prior to Liver Injury | 2 [1-20] | 3 [1-24] | 0.742 |
| Days to liver injury onset | 35 [7-610] | 160 [37-721] | 0.519 |
| Labs at Liver Injury Criteria | |||
| AST (IU/L) | 343 [36-790] | 82 [14-259] | <0.001 |
| ALT (IU/L) | 415 [30-946] | 96 [21-306] | 0.001 |
| ALP (IU/L) | 214 [92-579] | 288 [49-757] | 0.636 |
| Tbili (mg/dL) | 0.9 [0.6-1.7] | 0.8 [0.2-4.4] | 0.403 |
| WBC | 5.1 [1.9-11.1] | 8 [4.8-17.4] | 0.076 |
| % Eos | 2.85 [1-6] | 1.2 [1.2-10.1] | 0.403 |
| Abs Eos | 100 [0-300] | 100 [0-700] | 0.809 |
| R ratio at onset | 5.3 [0.4-17.4] | 0.9 [0.2-14.5] | 0.027 |
| Patients with LFT normalization during follow up | 6 (100) | 4 (26.7) | 0.002 |
| Time to LFT normalization (days) | 52 [14-514] | 17 [2-54] | 0.281 |
| Treated with steroids (%) | 3 (50) | 0 (0) | 0.003 |
| Durvalumab permanently discontinued | 5 (83.3) | 13 (86.7) | 0.843 |
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; RCC, renal cell carcinoma; 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; LFT, liver function tests.