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
| 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 |