Table 1 Overview of the study cohort characteristics. Patient characteristics stratified by response status for all 65 patients from Moffitt Cancer Center receiving ICI for stage III/IV non-small cell lung cancer. Values are represented in number and percentage or mean and standard deviation. Responder (R) vs. non-responder (NR) study cohort characteristics
| Â | Total | % or SD | R | % or SD | NR | % or SD |
|---|---|---|---|---|---|---|
Number of patients (total = 65) | 65 | 100% | 18 | 28% | 47 | 72% |
Liquid Dental Transport Medium (LDTM) stool | 16 | 25% | 4 | 22% | 6 | 13% |
Gender | ||||||
 Male | 33 | 51% | 8 | 44% | 25 | 53% |
 Female | 32 | 49% | 10 | 56% | 22 | 47% |
Race | ||||||
 White | 58 | 89% | 17 | 94% | 41 | 87% |
 Black or African American | 6 | 9% | 1 | 6% | 5 | 11% |
 Others | 1 | 2% | 0 | 0% | 1 | 2% |
Antibiotics taken 2 months prior to treatment | 18 | 28% | 5 | 28% | 13 | 28% |
Pro/prebiotics taken 2 months prior to treatment | 10 | 15% | 3 | 17% | 7 | 15% |
NSCLC stage at ICI treatment start | ||||||
 IIIA | 3 | 5% | 1 | 6% | 2 | 4% |
 IIIB | 1 | 2% | 0 | 0% | 1 | 2% |
 IV | 61 | 94% | 17 | 94% | 44 | 94% |
Type of immunotherapy given | ||||||
 Anti-PD-1 | 43 | 66% | 15 | 83% | 29 | 60% |
 Anti-PD-L1 | 19 | 29% | 3 | 17% | 16 | 34% |
 Anti-PD-1, CTLA-4 | 2 | 3% | 0 | 0% | 2 | 4% |
Tumor biopsy PDL-1 gene mutation test result | ||||||
 Positive | 35 | 54% | 12 | 67% | 23 | 49% |
 Negative | 21 | 32% | 4 | 22% | 17 | 36% |
 Not tested | 9 | 14% | 2 | 11% | 7 | 15% |
Mean PLD-1 percent (if positive) | 57% | ± 35% | 65% | ± 34% | 53% | ± 36% |
Adverse event related to treatment | 53 | 82% | 14 | 78% | 39 | 83% |
Prior/concurrent treatment | ||||||
 Chemotherapy use prior to ICI | 37 | 57% | 8 | 44% | 29 | 62% |
 Thoracic radiation prior to ICI | 19 | 29% | 5 | 28% | 14 | 30% |
 Other radiation prior to ICI | 24 | 37% | 6 | 33% | 18 | 38% |
 Targeted therapy prior to ICI | 14 | 22% | 2 | 11% | 12 | 26% |
 Immunotherapy prior to ICI | 3 | 5% | 1 | 6% | 2 | 4% |
 Concurrent chemotherapy | 37 | 57% | 11 | 61% | 26 | 55% |
 Concurrent thoracic radiation | 8 | 12% | 1 | 6% | 7 | 15% |
 Concurrent other radiation | 14 | 22% | 3 | 17% | 11 | 23% |
Baseline smoking history (current or former) | 60 | 92% | 17 | 94% | 43 | 91% |
Prior presence of colitis | 8 | 12% | 2 | 11% | 6 | 13% |
Prior presence of H. pylori infection | 2 | 3% | 1 | 6% | 1 | 2% |
Durable response | ||||||
 Responder | 22 | 34% | 18 | 100% | 0 | 0% |
 Non-responder | 43 | 66% | 0 | 0% | 47 | 100% |
Mean PFS | 292.7 | ± 231.3 | 514.7 | ± 209.3 | 207.7 | ± 177.7 |
Mean age at presentation | 66.2 | ± 8.9 | 64.7 | ± 7.0 | 66 | ± 9.7 |
Mean BMI | 26.1 | ± 6.3 | 26.0 | ± 3.8 | 26.1 | ± 7.0 |