TABLE 1.
Patient characteristics and clinical outcomes
| Overall (n = 20) | Probiotic supplemented (n = 10) | Probiotic restricted (n = 10) | p value | |
|---|---|---|---|---|
| Baseline patient characteristics | ||||
| Age, median (range) | 67.5 (32–81) | 67.0 (57–81) | 67.5 (32–78) | 0.850 |
| Gender | ||||
| Male | 15 (60%) | 8 (80%) | 7 (70%) | 0.615 |
| Female | 5 (40%) | 2 (20%) | 3 (30%) | |
| Histology | ||||
| Clear cell RCC | 16 (80%) | 8 (80%) | 8 (80%) | 0.709 |
| Non‐clear cell RCC | 4 (20%) | 2 (20%) | 2 (20%) | |
| Papillary RCC | 3 (15%) | 2 (20%) | 1 (10%) | |
| Sarcomatoid RCC | 1 (5%) | — | 1 (10%) | |
| IMDC risk category | ||||
| Favorable | 7 (35%) | 4 (40%) | 3 (30%) | 0.638 |
| Intermediate | 11 (55%) | 5 (50%) | 6 (60%) | |
| Poor | 2 (10%) | 1 (10%) | 1 (10%) | |
| VEGF‐TKI | ||||
| Cabozantinib | 9 (45%) | 7 (70%) | 2 (20%) | 0.166 |
| Sunitinib | 6 (30%) | 2 (20%) | 4 (40%) | |
| Lenvatinib/Everolimus | 4 (20%) | 1 (10%) | 3 (30%) | |
| Axitinib | 1 (5%) | — | 1 (10%) | |
| Line of therapy, median (range) | 2 (1–6) | 3 (1–6) | 2 (1–3) | 0.027 |
| Line of therapy | ||||
| First‐line | 6 (30%) | 2 (20%) | 4 (40%) | 0.650 |
| Second‐line | 6 (30%) | 1 (10%) | 5 (50%) | |
| Third‐line | 6 (30%) | 5 (50%) | 1 (10%) | |
| Further lines | 2 (10%) | 2 (20%) | 0 (0%) | |
| Clinical outcomes | ||||
| Best response | ||||
| Partial response | 3 (30%) | 2 (20%) | 1 (10%) | 0.392 |
| Stable disease | 12 (60%) | 5 (50%) | 7 (70%) | |
| Progressive disease | 3 (30%) | 1 (10%) | 2 (20%) | |
| N/E | 2 (20%) | 2 (20%) | 0 (0%) | |
| Clinical benefit rate | 75% | 70% | 80% | 0.606 |
| Progression‐free survival, months, and median (95% CI) | 10.8 (5.3–16.4) | 6.2 (2.2–10.3) | 13.8 (6.2–21.5) | 0.077 |
| VEGF‐TKI stopped | 14 (70%) | 7 (70%) | 7 (70%) | 0.639 |
| Progression | 10 (50%) | 3 (30%) | 7 (70%) | |
| Toxicity | 4 (20%) | 4 (40%) | 0 (0%) | |
| VEGF‐TKI continues | 6 (30%) | 3 (30%) | 3 (30%) | |
| Diarrhea, present | 8 (40%) | 4 (40%) | 4 (40%) | 1.000 |
| Grade 1–2 | 8 (40%) | 4 (100%) | 4 (100%) | |
| Grade 3–4 | 0 (0%) | 0 (0%) | 0 (0%) | |
| Diarrhea, absent | 12 (60%) | 6 (60%) | 6 (60%) | |
Abbreviations: IMDC, International Metastatic Renal Cell Carcinoma Consortium; N/E, not evaluable; VEGF‐TKI, vascular endothelial growth factor tyrosine kinase inhibitor.