Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access |
Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc |
Journal website https://www.gastrores.org |
Original Article
Volume 000, Number 000, October 2024, pages 000-000
Risk Factors Predicting Outcomes in Advanced Upper Gastrointestinal Cancers Treated With Immune Checkpoint Inhibitors
Tables
Baseline characteristics | Distribution |
---|---|
AA: African American; ICI: immune checkpoint inhibitor; HER2: human epidermal growth factor receptor 2; FOLFOX: combination of 5-flurouracil and oxaliplatin. | |
Age of diagnosis | 62 years (33 - 87) |
Gender (male) | 84% |
Race | Caucasian: 88%, AA: 5%, Asian: 1%, other: 6% |
Primary tumor type, esophageal vs. gastric | Esophageal: 61% (n = 39), gastric: 39% (n = 25) |
Agent | Nivolumab: 42%, pembrolizumab: 58% |
Line of ICI, > 2 lines vs. 1 - 2 lines | 1 - 2: 73%, > 2: 27% |
History of surgery | 23% |
History of radiation | 41% |
Chemotherapy combination | 11% (FOLFOX: n = 4, and FOLFOX + trastuzumab: n = 2) |
Lung metastasis-present | 23% |
Liver metastasis-present | 44% |
Bone metastasis-present | 22% |
Distant lymph node metastasis-present | 50% |
Other metastatic sites | 33% |
White blood cell count (baseline) | 7.46 |
Red blood cell count | 3.75 |
Hemoglobin (baseline) | 10.73 |
Platelet count (baseline) | 225.79 |
Neutrophil count (baseline) | 6.71 |
Lymphocyte count (baseline) | 0.93 |
Platelet to lymphocyte ratio | 336.55 |
Neutrophil to lymphocyte ratio | 12.14 |
Total bilirubin (baseline) | 0.68 |
Albumin (baseline) | 3.40 |
Alkaline phosphatase (baseline) | 162.74 |
Aspartate transferase (baseline) | 24.00 |
Thyroid stimulating hormone (baseline) | 24.77 |
T4 (baseline) | 30.60 |
HER2 status | 4.37 |
Immune-related adverse event | Positive: 14%, negative: 69%, not available: 17% |
Programmed cell death ligand 1(PD-L1) status | Yes: 8% |
Negative: 8%, 1 - 5: 28%, > 5: 25%, not available: 39% | |
Microsatellite instability-high | 11% |
Source | Survivala | |||||
---|---|---|---|---|---|---|
PFS | OS-ICI | OS | ||||
P value | HR | P value | HR | P value | HR | |
aHazard ratios of the factors with insignificant (P > 0.05) were not mentioned. HR: hazard ratio; ICI: immune checkpoint inhibitor; HER2: human epidermal growth factor receptor 2; PD-L1: programmed cell death ligand 1; PFS: progression-free survival; OS: overall survival; OS-ICI: ICI-related overall survival. | ||||||
Gender, male vs. female | 0.0274 | 0.132327 | 0.1238 | 0.0072 | 0.043668 | |
Race | 0.6482 | 0.4371 | 0.4106 | |||
Primary tumor type, esophageal vs. gastric | 0.499 | 0.8346 | 0.2608 | |||
Line of ICI, > 2 lines vs. 1 - 2 lines | 0.0259 | 0.176569 | 0.0404 | 0.160335 | 0.0003 | 0.02733 |
History of surgery | 0.9153 | 0.8765 | 0.006 | 0.119958 | ||
History of radiation | 0.9914 | 0.5511 | 0.2714 | |||
Chemotherapy combination, yes vs. no | 0.0071 | 0.08406 | 0.0514 | 0.706241 | 0.8084 | |
Lung metastases, yes vs. no | 0.0682 | 5.051652 | 0.2754 | 0.0613 | 0.971694 | |
Liver metastases, yes vs. no | 0.4401 | 0.8525 | 0.9595 | |||
Bone metastases, yes vs. no | 0.3596 | 0.0305 | 3.633746 | 0.0009 | 10.98695 | |
Distant lymph node metastases, yes vs. no | 0.074 | 2.414344 | 0.3901 | 0.3246 | ||
Other organs with metastases, yes vs. no | 0.562 | 0.6469 | 0.0848 | |||
White blood cell count (baseline) | 0.6029 | 0.2715 | 0.1165 | |||
Red blood cell count (baseline) | 0.0206 | 5.792107 | 0.0373 | 5.556215 | 0.0202 | 1.202369 |
Hemoglobin (baseline) | 0.6823 | 0.2597 | 0.0332 | 6.718667 | ||
Platelet count (baseline) | 0.1289 | 0.7293 | 0.4175 | |||
Neutrophil count (baseline) | 0.1697 | 0.2122 | 0.7309 | |||
Lymphocyte count (baseline) | 0.0285 | 0.273647 | 0.0817 | 0.374776 | 0.4688 | |
Total bilirubin (baseline) | 0.3151 | 0.6339 | 0.5006 | |||
Albumin (baseline) | 0.1049 | 0.2023 | 0.7287 | |||
Alkaline phosphatase (baseline) | 0.0224 | 1.00661 | 0.448 | 0.8361 | ||
Alanine transferase (baseline) | 0.0072 | 1.123848 | 0.2477 | 0.4527 | ||
Aspartate transferase (baseline) | 0.0289 | 0.897763 | 0.4947 | 0.5988 | ||
Thyroid stimulating hormone (baseline) | 0.0443 | 1.124609 | 0.2159 | 0.013 | 1.179802 | |
T4 (baseline) | 0.6535 | 0.4648 | 0.8827 | |||
HER2 | 0.0061 | 0.563667 | 0.0525 | 0.096411 | 0.835 | |
Immune-related adverse event, yes vs. no | 0.1034 | 0.0813 | 0.192533 | 0.114 | ||
PD-L1, negative vs. > 1 vs. unavailable | 0.0465 | 0.395261 | 0.3545 | 0.3955 | ||
Microsatellite instability-high, yes vs. no | 0.5449 | 0.9917 | 0.5808 |
Outcome measured | Negative effect (hazard ratio > 1) | Positive affect (hazard ratio < 1) |
---|---|---|
RBC: red blood cell; ALP: alkaline phosphatase; ALT: alanine transferase; TSH: thyroid-stimulating hormone, PD-L1: programmed cell death ligand 1; AST: aspartate transferase; ICI: immune checkpoint inhibitor; HER2: human epidermal growth factor receptor 2. | ||
Progression-free survival | HER2 positivity | Male gender |
Baseline RBC count, ALP, ALT, TSH | When used in the third line or more | |
Used in combination with chemotherapy | ||
PD-L1 positive | ||
Baseline lymphocyte count and AST | ||
ICI-related overall survival (OS-ICI) | Bone metastasis | When used in the third line or more |
Baseline RBC count | Baseline AST | |
Overall survival (OS) | Bone metastasis | Male gender |
Baseline RBC count, hemoglobin, and TSH levels | When used in the third line or more | |
History of surgery |
Higher | Lower | |
---|---|---|
ICI: immune checkpoint inhibitor; ALP: alkaline phosphatase; TSH: thyroid-stimulating hormone, PD-L1: programmed cell death ligand 1; AST: aspartate transferase; WBC: white blood cell. | ||
Bad responders | Esophageal cancers | Chemotherapy combinations |
ICI use in the third line or more | Albumin | |
History of radiation | ||
Baseline total bilirubin and ALP | ||
Poor responders | ICI use in the third line or more | |
Baseline WBC, total bilirubin, ALP, and TSH | ||
Bad ICI-related overall survival (OS-ICI) | History of radiation | Chemotherapy combinations |
Baseline WBC count, total bilirubin, ALP, and TSH | Albumin | |
Poor ICI-related overall survival (OS-ICI) | History of radiation | Chemotherapy combinations |
Baseline WBC count, total bilirubin, ALP, AST, and TSH | Albumin | |
Bad overall survivors | Higher WBC count | History of surgery |
Poor overall survivors | ICI use in the third line or more | History of surgery |
Liver metastasis | PD-L1 positive tumors | |
Baseline WBC, platelet, and lymphocyte count |